Comments on Chapter 10 – Qualitative Research General

Comments on Chapter 10 – Qualitative Research
General comments on this chapter:
J'ai lu avec grand plaisir -- et beaucoup de curiosité- la proposition de nouvelle de l'EPTC. Beaucoup de changements, en effet ! Plusieurs aspects devraient faire plaisir aux chercheurs
en sc. humaines et sociales, enfin je l'espère. Il y a certainement là une base pour des échanges solides et fructueux (notamment le chap. 10).
Thank you very much for providing me -and so quickly, with copies of the Draft 2e of TCPS -much appreciated. I have distributed the copies among my full-time and part-time faculty,
and I'm sure it will give rise to faculty-grad.student discussion too. As a
, I am very pleased to see the Qualitative Research section, which is much more flexible,
sensitive and appropriate to my discipline's 'fieldwork' experience and needs, around the world, than is the reigning bio-science review paradigm. Thank you/Merci.
Les explications que contient ce chapitre sur la recherche qualitative interviennent comme une bouffée d’air frais. Elles permettront aux membres des CÉR d’évaluer de manière plus
compétente les projets de recherche qui se situent à l’extérieur de l’univers bio-médical.
A welcome addition. This will remove some unnecessary impediments and misunderstandings.
This comment relates to the frequent reference to Qualitative research as a domain that needs different criteria of ethics review (eg oral consent) because of different tradition in this
area of research. I think this is a weak argument that should be abandoned. It was the tradition in most areas of research to have looser and easier (and more sensible in many instances)
rules before the imposition of stricter rules since the 1990s. I agree in most specific examples in the draft text with the recommendations regarding easier access to human subjects in
Qualitative research. But these recommendations should not be limited to Qualitative researchers and the justification should not be focused on Qualitative research alone.
The discussion (10.5) regarding the identification of participants is extremely helpful. In participatory research identifying participants is often an important mark of respect for the
work they have contributed to the research project. Portraying the tension between two principles of anonymity and acknowledgement is likely to assist the thinking of many
researchers involved in this type of work.
appreciates the expression of principles in Article 10.7 regarding emergent research designs. This is strongly supportive of collaborative research methodologies and
permits the degree of freedom necessary to respect the influence of participants.
were unanimous in their praise for this Chapter. It is a critically important area that needs to be addressed in the TCPS and, overall, is covered very well. Our
congratulations and thanks also to those who drafted this Chapter.
The draft second edition of the TCPS includes several significant improvements over the earlier edition that we would like to commend:
•
Chief among these is the inclusion of the Qualitative Chapter (Chapter 10), which provides a far more nuanced appreciation for the particularities and complexities of the
kind of qualitative research that many social scientists engage in.
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The chapter on Qualitative Research is a welcome addition but could use some streamlining.
There is variability in the quality of chapters and some may require major streamlining (in particular, chapters 1, 8, 10, 11, 12 and 13).
ont apprécié la reconnaissance accordée par l’Énoncé des caractéristiques à la recherche qualitative.
Ce chapitre ajoute des bons éléments à propos de la nature de la recherche qualitative. Il restera à accomplir un travail de traduction opérationnelle de ces principes pour le benefice
des chercheurs et des CER
Le chapitre sur la recherche qualitative est apparu très bien fait et adapté au contexte de ce type de recherche.
The new chapter - Chapter 10 Qualitative Review - is an excellent and welcome addition to the revised guidelines. It provides welcome advice and direction on how the particular
challenges of research ethics review within the context of social sciences and humanities and other qualitative research activities may be addressed. There is a need to have greater
elaboration as to how this flexibility may be applied in the practical or operational sense. Best practices and some examples of how these qualitative processes work would be
appreciated and helpful.
Overall the new Articles added to Chapter 10 on Qualitative Research are an improvement on the previous draft. However, there are several concerns:
This chapter on qualitative research is long awaited and welcomed.
commends your Chapter 10 on Qualitative research and particularly appreciates the acknowledgment of action research approaches.
congratulates you on the addition of this chapter. We offer minor suggestions for clarification.
This chapter is well done overall and will be very helpful to REB members unfamiliar with qualitative research. However, the detail should be placed in Part II for those who need it.
This section should include reference to public health research issues as well.
Article #
10.1
Issue Raised
Lines 3971-73 – Is this necessary? The following sentence is the important one.
10.1
2. On page 113, in lines 3978-3979, the statement “Under a variety of circumstances, written consent is not required in qualitative research” is problematic if not
controversial, particularly in health sciences and psychological research, and should be recognized as such. Consider adding there a statement such as “in some
cases, assumed or verbal consent may be sufficient, but researchers should be aware that written consent may be necessary in some circumstances” and such
circumstances should be listed, even if not exhaustively.
3. On page 113, in lines 3993-3996, that sentence should be better qualified, e.g., by adding at the end of it “although measures should be taken and
10.1
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demonstrated to the REB that there is no misconception of the participant about his or her right to not participate in the study or to withdraw from it at any
time”.
Lines 3985-3996 There seem to be two different things being discussed in this paragraph. The second sentence seems to refer to organizational research where a
person provides the researcher with information in the course of fulfilling their normal professional duties (like a professional might give a researcher factual
information about the company he is employed by…. he is an information source, not a human subject). We would exempt this from ethics review altogether
(assuming there is no focus on the professional’s experience or personal opinions in the research). The remaining text seems to suggest that all that is needed in
terms of consent from ‘elite’ research participants is agreement. However, it does not illuminate the process by which this agreement is obtained; rather it seems
to imply that Consent need not be informed by any oral or written means. Is the intent to apply a different moral standard to these individuals? The definition of
‘elite’ is vague and thus very problematic. The word is entirely contextual in its application, based on an individual’s own value system or experience. I would
never think of a senior partner in a law firm (which is a private, not public organization) as an ‘elite’ individual, but I might think of a Federal Cabinet Minister
as one. If we are to treat these individuals differently then much more needs to be said about why this is appropriate and what criteria can be used to identify
what kinds of individuals could be included in this categorization. A Faculty member is a person in a position of power in relation to a graduate student. Would
this mean that they don’t need to be afforded the usual considerations of informed consent as a research subject?
Page 113, Article 10.1, 3978-3984: It should be made clear that evidence of consent should be demonstrable in some manner that would be obvious to an
external reviewer. In its current form, there are no ‘teeth’ in the example to indicate that the approach requires “confirmation” in some form.
Line 3977 Replace “intentions” with goals or objectives.
On page 113, in lines 3978-3979, the statement “Under a variety of circumstances, written consent is not required in qualitative research” is problematic if not
controversial, particularly in the context of health sciences and psychological research and it should be recognized as such. Consider adding to end of the above
statement the following text; “in some cases, assumed or verbal consent may be sufficient, but researchers should be aware that written consent may be
necessary in some circumstances” and the circumstances alluded to in this statement should then be listed.
On page 113, the sentence appearing in lines 3993-3996 should be qualified by adding the following text at the end of the statement; “although measures should
be taken and demonstrated to the REB that there is no misconception of the participant about his or her right to not participate in the study or to withdraw from
it at any time”.
Would not Article 10.1 Modalities of Free and Informed Consent apply in some cases to quantitative research, e.g., use of oral rather than written consent? If I
correctly understood Chapter 3 on Free and Informed Consent it appears that it would. If this is a reiteration of matters covered in Chapter 3 (as I believe it is),
then should that not be said explicitly here?
We are not convinced that a separate chapter on qualitative research is necessary because we do not personally feel there are separate ethical issues. However, if
there must be one it will be important to begin by clearly conveying how qualitative research differs from quantitative. At present this is not achieved (and, in
fact, survey questionnaires – generally quantitative in nature - are actually cited (3983) as an example). Chapter 10 does make many good points about research,
but most apply to all methodological approaches and we think that other chapters relating to the topics mentioned would benefit from the inclusion of these
insights. We use the TCPS categories for “General Principles and Methodological Requirements and Practices” (3860-3956) to illustrate this:
(a) Inductive Understanding: All forms of research are necessarily founded on inductive or deductive reasoning and hypotheses about the world. If human
participants are involved (even in biomedical research) “social settings, processes and experiences” (3865) must surely be of relevance to reliable and valid
conclusions. “Participants’ perceptions of themselves and others… behaviours” (3867-3868) are more often assessed with quantitative measurement in
human sciences. Qualitative approaches would be more concerned with a deeper understanding of why people think and behave as they do.
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(b) Diversity of Approaches: The ability to devise and apply different approaches to research problems is essential to useful research in any field. All research
with or about people must in some way enter their world (3870-3878).
(c) Dynamic, Reflective and Continuous Research Process: Similarly, “flexibility, reflexivity and responsiveness contribute to the overall strength and rigour of
data analysis” regardless of discipline, issue or method (3881).
(d) Diverse, Multiple and Often Evolving Contexts: All research “takes places in a variety of contexts” (3884) that may present complex ethical issues. We doubt
that many are actually unique, and we maintain that ethical issues applying to qualitative approaches are potentially present in all research involving people.
The rest of (d) is commentary about social science research in general and not qualitative research in particular (3896).
(e) Data Collection and Sample Size: It is correct that qualitative methods are concerned with depth (quality/texture) of understanding (3898). In the past,
qualitative studies have tended to involve small numbers of participants. The development of software to handle qualitative data has changed this. There are
now a number of qualitative studies with more cases than many quantitative surveys (and certainly more cases than most experimental models). Purposeful
sampling is also used in quantitative research (3904). Multiple method approaches may include quantitative elements. Textual analyses alone are qualitative,
but do not involve human participants (3909). The comments on confidentiality and data protection are generally applicable and do not seem to add anything
to Chapters 2 & 5 (3912-3917).
(f) Research Goals and Objectives: “The aims of qualitative research are very diverse, both within and across disciplines” (3918). The aims of quantitative and
experimental research designs are not diverse?
(g) Dynamic, Negotiated and Often Ongoing Free and Informed Consent Process: The points raised here are of importance and it would be valuable to include
them in the Chapter 3 discussion. They are potentially relevant to any research involving people where a relationship needs to be established (3924-3938)
especially where multiple sessions and follow up are required (especially relevant to health research).
(h) Research Partnerships:
is heavily involved in partnership research. The points made re the complexity of such relationships are valuable but are
not confined to qualitative approaches (3939-3942). These remarks would perhaps be more useful in the Chapter 8 discussion of multi-jurisdictional
research as would those concerning the timing of REB review (4139 -4196). These points are more relevant to collaborative projects in general than
qualitative methods in particular.
It is rare that any research relationship would “extend over a lifetime” (3951), but we would agree that any form of research conducted face-to-face may
bring about strong connections especially for the participant.
(i) Research Results: The point here is unclear, but seems to be related to matters of reliability and validity important to all forms of research and a matter of
design and sample size more than approach.
10.1
10.1
10.1 Modalities of Free and Informed Consent: It should be clear that choosing another modality for consent does not exempt the researcher from providing
participants all information normally available on a consent form. A straightforward example is that of survey research, where all of the information normally
contained in a consent form should be provided in a cover letter.
Line 3977 speaks to Consent but it does not specify the necessity to ensure that consent is “informed”. This section may invite confrontation between
Researchers and the REB. Qualitative research should require written informed consent rather than relying on oral consent…otherwise there may be a gap and
potential for misunderstanding, potential for participant harm and no provision for oversight of the consent process.
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10.1
Researchers, including qualitative researchers, strongly tend (even if unintentionally) to commit three errors in their efforts to recruit participants:
1. Researchers tend to leave out study details that are important to participants (e.g., where and when interviews are to take place, who will conduct the
interview, the nature of the questions that will be asked).
2. Researchers tend to underestimate the power differential (of researcher over participants) that often exists and that can be perceived as coercive by
participants. By not explicitly stating safeguards for participants, they allow for fear and/or intimidation to enter the process.
3. Researchers tend to under-estimate the risks to participants, especially vulnerable participants and, therefore, do not adequately state these risks and
do not make adequate provision for counter-acting the harm (e.g., emotional distress) that some participants experience.
Requiring a written consent form that participants sign has proven to be a good way to enable REB’s to see in advance what potential participants will see and
to correct errors and/or omissions before they occur. The consent form acts as (a) a contract between the parties, (b) an enduring record of the information that
participants were given so as to allow for informed consent (not just consent), and (c) a verifiable indication that a participants did, indeed, give consent.
10.1
10.1
10.1
10.1
10.6
10.1
10.1
Over an year period, involving dozens of applications from qualitative researchers, the
has encountered only
one instance of written informed consent being impossible and/or inappropriate. This involved a research project in
, regarding which the researchers
presented persuasive cultural evidence that
participants (the intended target group) would not understand the concept of written informed consent
and, therefore, it would be meaningless. In this instance, the REB approved an alternative procedure involving a recruitment script and oral consent.
In the absence of a requirement for written informed consent, the probability of the errors cited above not being corrected will increase enormously. Moreover,
any disagreement between a researcher and a participant regarding what was stated and/or agreed to will result in an unresolvable (by the REB) “he said, she
said” conflict. Finally, researchers, including qualitative researchers, will be far more likely to claim that, regarding their particular project, written informed
consent is impossible and/or inappropriate, even when experience has shown that this is clearly not the case. This will create unnecessary animosity, waste
valuable time and human resources, and discourage academics who have more rewarding things to do from serving on REBs.
Page 113 line 3970 I could not endorse more strongly this section. The very attempt to formalize the consent process can in some cases create a “power”
relationship or at least a sense of distrust and apprehension where none is intended.
The revised document also effectively clarifies many of the issues surrounding obtaining consent (Articles 3.6-3.8, 3.12 and 10.1) and provides a much more
appropriate and flexible approach to the complexities involved for social science researchers.
The specific requirements for research into questions of public policy are also more fully recognized in this draft. The TCPS II does a better job of recognizing
the extent to which research subjects are often powerful and bear some responsibility for communicating with researchers as a part of their jobs (e.g. lines 398596, 1247-54), as well as noting the social and democratic importance of certain critical research findings (e.g. lines 288-98, 498-514, article 3.6).
Dans la section portant sur l’application de l’article 10.1, l’on donne l’exemple d’« une recherche portant sur des “élites” » dans le cadre de laquelle le
chercheur « s’intéresse aux structures de pouvoir et aux personnes occupant des postes d’autorité ». Est-il bien approprié d’indiquer que « dans ce type de
recherche, le fait qu’une personne ait accepté d’être interviewée par le chercheur peut suffire à indiquer son consentement à participer à la recherche »
(lignes 4848-4850)? Il faudrait préciser que le consentement, même verbal, peut être consigné, et ce, indépendamment du pouvoir dont jouit le participant.
What is the process for ongoing consent in studies such as ethnographies where the researcher is attempting to “blend in”?
4819 à 4820 : La phrase qui débute par : « Les chercheurs devraient exposer.. » pourrait être supprimée. Elle est inutile compte tenu de la phrase qui suit.
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4825 à 4836 : La deuxième phrase débutant à la ligne 4825 n’est pas très éclairante. À la ligne 4827, remplacer « cette » par « la » confiance. À la ligne 4828,
remplacer « dans certaines circonstances » par « sous certaines circonstances ». À la ligne 4829, remplacer « qui font appel à des méthodes qualitatives
utilisent » par « font alors appel à toute une gamme de modalités de». Aux lignes 4834 à 4836, il est suggéré de supprimer la parenthèse et de terminer la phrase
par : « lequel, une fois complété devient la preuve de leur consentement.».
“Consent is implied if the researcher is researching someone in a high position” – would the researcher need to have obtain an informed consent - what if they
felt coerced from someone higher up then themselves (line 3985)?
Re article 10.1: concern with statement that “informed consent can be inferred by the participant’s agreeing to interact with the researcher for the purpose of the
research”. Question that unless consent is specific, it by definition is not informed.
Lines 3971-3974 - should be revised to state that researchers also have a responsibility to provide rationale for deviation from standard accepted procedures for
obtaining consent, as well as explaining how issues of power will be addresses and risks to the participant will be minimized.
Lines 3985-3996 neglects to emphasize that informed consent is a process, not just a form. This section appears to imply that “elite” participants are not
required the same level of care or consideration as other participants. A proper invitation to participate or information letter should be required at the very
minimum.
3981 It would be useful in the discussion of alternative strategies to offer the more specific suggestion that consent can be documented in field notes in the form
of consent logs. Another suggestion, given the length of time some researchers engage with communities of participants in qualitative research, is to think about
consent - where appropriate - in more processual terms, checking in with participants from time to time about their on-going willingness to continue with the
research.
3989 The observation that in cases where participants are in positions of power or routinely engage in similar communicative interactions, consent can be
inferred from agreement to participate is reasonable. However, care should be taken to ensure in such instances that participants are nevertheless fully informed.
This could be done by providing in advance as part of the invitation or leaving behind a letter of information about the research with full contact information for
the researcher(s).
3990-91 To say that in cases of inferred/implied consent “No further verification is needed…” seems unnecessarily strong. In fact, it would be advisable to
document the consent in some way, perhaps in the form of a consent log or a note in one’s field notes.
Qualitative research always comes in the middle of something. Something has already “started” (e.g. a relationship, conversation or experience with an issue or topic).
The consent process is not just signing a form. The consideration of research partnerships and relationships need to be considered.
10.1
Line 3985 – Given the variety of qualitative research, this sentence could be changed from “research relationship” to “relationships.”
10.1
Article 10.1 was a bit disconcerting. Are we reading this correctly to surmise that there would be no need for a researcher to go through a formal consent process with
select people in positions of power over the researcher? We would expect to go through a formal consent process with any research participant entered into a study as an
individual. Participants need to have the opportunity to receive detailed information about a study and to decline once they have this information. Further, a participant
should have printed information to refer back to following data collection and to have easy access to information about who to contact should there be something
unacceptable to the participant about the research process.
10.1
3975-3977 : “The consent process should usually reflect trust between the research participants and the researcher. Often this is based on mutual understanding
of the project’s intentions.”
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The consent process, by definition, MUST be based on mutual understanding of the project’s intentions.
3990-3991: Allowing exemption from all consent processes is not wise, even for so-called 'elite' research. Common courtesy when approaching people in
positions of leadership would require a letter of introduction, which could easily include the necessary consent information. Eliminating any consent
information runs the risk of these individuals failing to distinguish between 'research' and 'journalism' which have two very different sets of standards. The
researcher should be required to state that they are researchers and should be able to give (usually in writing) an indication of what sorts of issues will be
discussed, how long it will take (these are busy people), and what sorts of dissemination the information will have. Simply because a person is in a position of
power, does not mean they are immune from breaches of privacy. The addition of this section is quite misguided and will cause difficulties.
4. On pages 113, in lines 4001-4005, consider elaborating on the definition of “public places.” While a space might be technically/legally public, it may be
considered private by community members, or it may be considered public among members but closed to outsiders (e.g. a meeting place space in a secluded
members-only community). Also consider elaborating further that assumed consent may be contentious in places that are regarded as public to all users, but that
house activities with an assumed level of privacy (e.g. a public prayer area).
Lines 4001-4005 While I see that there may not be a need for informed consent for observation of people in public places, I don’t see how you can say that
people who are the subject of observation for the purposes of research are not human research subjects. REB review is intended to ensure that such research
does not, by virtue of the particular circumstances of its execution, become covert surveillance and an invasion of privacy. I agree that this research may qualify
for a waiver of consent, but not necessarily for a waiver of REB review.
Page 114, 4006-4008: “public spaces” – The term “public spaces” should be clarified and a statement should be included stating to the effect that a researcher is
presumed NOT to interact with participants but is a NEUTRAL observer. In addition, photographs or recordings of identifiable individuals in public spaces
should be addressed here as well.
With regard to Article 10.2 and research in public places, I still have some concerns about research done in this context and where it falls within the guidelines.
For instance, for the last two years, I've been on radio call-in programs, television shows and in other public forums where I've talked about my research.
During the programs, people have called to tell me their stories and for days after the program people continue to call. Sometimes I am able to stop them for
long enough to explain the research and how it will be used. But not always. Could this aspect of research be clarified.
Line 4001 Insert… required for the observation …
Line 4006 Insert… involving the observation of people …
On page 113, in lines 4001-4005, consider elaborating on the definition of “public places”. While a place might technically or legally qualify as a public place,
it may be considered to be private by community members, or the space may be considered to be public for members of the community but private from the
perspective of non-community members. Also consider elaborating further that assumed consent may be contentious in places that are regarded as being public
to all users which also have a housing element having an assumed level of privacy such as in the case of a public prayer area.
Similarly Article 10.2 repeats matters covered in Article 2.2. There should at least be a cross-reference.
While I agree with the intent of Article 10.2 about not requiring REB review of people in public places, I think that there is missing from the application the sort
of nuanced discussion of public/private spaces as pervades Chapter 3 Privacy and Confidentiality. As I note in a comment on Chapter 3, what counts as public
or private may vary from culture to culture. There needs to be a reminder here that researcher are not simply at liberty to impose their notions of public space on
communities that believe they are in private places. This article removes the possibility of REB educating researchers especially student researchers about
appropriate observation techniques.
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10.2
Observation Article 2.5 exempts “research involving observation of people in public places that does not allow for the identifications of the individuals in
research materials…” (370-373). This is essentially repeated in Article 10.2 (4001-4005). The assumption is that individuals in public spaces have no
expectation of privacy and also that there is no ethical concern if individuals are not identified. We note that this exemption stands in contradiction with the
TCPS statement on welfare (56-85). We believe this position on welfare indicates the need for observational studies to be reviewed, a point the TCPS makes in
Chapter 10 (4062-4073), along with raising a number of other important considerations about the implications of observation research (4074-4112).
Our position is that there is a documented history of academic extrapolations from observations causing harm to groups, especially vulnerable groups. Therefore
observational studies should not be exempt from REB approval. We offer some contemporary examples of observational research in public spaces that are of
concern:
o Watching school children.
is aware of an observational research study where a professor observed children in school playgrounds. He
repeatedly watched them but he did not inform the school administration of his identity, credentials or intent. Needless to say, this caused considerable
upset. The bad feeling between the school board and the university involved, interfered with good research relations for many subsequent years.
o Aboriginal and ethnic ceremonies. A particular concern is the possibility that culturally uninformed researchers may attend and observe cultural
ceremonies and events, without the involvement, permission or review of reporting. This is not culturally respectful, nor in keeping with the ethical
concerns for Aboriginal people outlined in Chapter 9.
o Vulnerable groups without a voice and/or subject to coercion. The TCPS is concerned at length with capacity to consent (1157-1363; 1418 -1453) and
issues in the inclusion of vulnerable persons or groups (1385-1417). Yet the particular vulnerability to public space observation and subsequent
pronouncements is overlooked for people who are homeless, disabled, mentally ill, or substance addicted.
10.2
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10.2
o What is considered ‘public space? We also have concerns about the conduct of observations without permission and review in sites such as hospitals
and courthouses where there is: a) potential for overhearing conversation where privacy was expected or should have been observed; and b) a potential
for an uninformed researcher to misinterpret and misreport with harmful consequences.
10.2 Exemption of consent for observational studies. Three points: First, there is a class of study that is not mentioned here, namely observational studies that
are anonymous but that involve intervention (e.g., studying the propensity of bystanders to help in an emergency normally requires a staged emergency).
Second, the blanket waiver of consent here is not appropriate, given that in almost all of the instances described, participants could be asked retrospectively to
give their consent. Third, there is an unacknowledged potential for loss of trust if participants discover that they have been unwitting participants in a research
study.
Lines 4001-4005 - should be modified to ensure that identifying information is not collected in observational research (interaction or nor) if not requiring REB
review. “Public places” needs to be better defined. A mall is thought of as public, yet it is private property. Is permission from the owner required? Bars are
sometimes considered public, yet patrons pay to gain access. Presumption of privacy is lacking in definition and context in this section. Appropriate examples
and applications would be helpful.
4010 Further clarification is needed regarding “public spaces”. Shopping malls for example are listed as public spaces in this policy, but are in fact privately
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Section A
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owned. Would permission from the owners/managers of the mall be required in this instance?
Further clarification is also needed on the use of photography and videography as part of observation in public settings.
Chapitre 10 Recherche qualitative
Préambule et partie A. Nature de la recherche qualitative intéressants pour camper le sujet, mais un peu long. Peut-on synthétiser?
L’article 10.2 semble faire double-emploi avec les articles 2.2, 2.3 et 2.4. L’inclure spécifiquement dans l’un des ces articles.
Même remarque pour 10.3 en regard des mêmes articles du chapitre 2.
L’article 10.6 pourrait être inclus dans l’article 6.11.
Observational Studies
Articles 10.2 and 10.3 (Lines 4006 – 4019)
This area discusses research in public places and web-based research. A more complete definition of “public” place would be helpful.
• Could this be a public hospital, a schoolyard, or a classroom?
• Does it involve free access to subjects?
• Are there examples of observational research in public places where it might be inappropriate to conduct research or to expect that all potential
participants would be willing to participate?
• Is there opportunity to obtain consent and will this be “informed” consent in these situations?
• In what situations should such access perhaps be limited?
• Why does this research not require some level of REB review?
Études par observation (ligne 4854)
Cette section gagnerait en clarté si elle était divisée en deux sections, l'une portant sur « l'étude par observation dans un lieu public sans collecte de
renseignement personnel », et l'autre portant sur « l'étude avec collecte de renseignement personnel ». Dans l'état, il est un peu difficile de s'y retrouver.
Aux lignes 4961 et 4964, l'ÉPTC présente un exemple de recherche basé sur l'observation et présentant des risques minimaux. Conformément à la politique, le
chercheur pourrait donc demander au CÉR une dérogation en matière de consentement éclairé : « l'observation des comportements dans les files d'attente d'un
centre commercial est un exemple d'étude sensée ne comporter qu'un risque minimal que l'on ne pourrait mener à terme si les acheteurs savaient qu'ils sont
observés » (ligne 4961). Or, cet exemple semble contredire l'article 10.2 qui exempte de tout examen éthique (et non du seul consentement) une observation
dans un lieu public sans collecte de données (ligne 4856).
10.3
10.3
10.3
Le GER pourrait réviser cette section de manière à lever toute ambiguïté.
Page 114, 4020: “does not require direct interaction...” Suggested word change to “does not involve direct...”
Page 114, 4023 and p.115, 4049-4058: “Cyber-material” Does this include list-mining?
L. 4017-4019 – Web-based research does not require REB review…? This does not seem ethically sound…
Are there going to be any further recommendations coming out around studies of new media use?
The mismatch of the Canadian IP law to that of the collective ownership of Aboriginally based material must be addressed; otherwise, appropriation and
other ethically questionable practices will continue.
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10.3
10.3
10.3
10.3
10.3
10.4
10.3
10.3
10.3
10.4
À l’article 10.3, les enjeux concernant le consentement libre et éclairé des participants rejoints par le moyen d’Internet ne sont pas soulignés. Cet article semble
traiter de l’utilisation d’informations déjà présentes sur Internet et recueillies sans l’intervention des chercheurs. Or l’article 10.2, qui touche la « recherche axée
sur l’observation des gens dans un lieu public ne comportant pas la collecte de renseignements personnels identifiables dans le cadre d’une interaction directe »
(lignes 4857-4859), n’englobe-t-il pas une telle situation?
4886 : Remplacer le terme « matière » par celui de « matériel ».
Lines 4017-4030 - this section is a great starting part, but web-based research is becoming more popular and greater guidance is required by REBs. Greater
clarification should be offered (as well as a broader range of examples) to assist researchers and REBs alike. Research within internet forums can be
problematic, as well as trolling for information. Some sites require registration and log-in, which gives forum participants a sense of privacy and security, yet
anyone can register, log in, and exploit issues at hand. The draft indicates that privacy rights in this arena are out of the scope of REBs, but many believe the
opposite is true and should be addressed in the document.
Given the rate at which web-based research is burgeoning, it would be useful to have more detailed guidance from the TCPS on how to consider such research.
The drafters may want to examine the Queens’ University REB guidelines developed with regard to cyber research.
4020 Research must be non-intrusive. Defining “non-intrusive” would be helpful as all research by definition is intrusive to some extent. This should be crossreferenced to (4102) and Chapter 9 (3184) where concerns about intrusiveness are also raised.
Page 10, Article 2.3: Does not mention online research, but in the Appendix, line 637, says “postings to public websites”. They do not offer any explanations
and skirts the issue of online research. Perhaps should have some reference here to Article 10.3 and 10.4. However, Article 10.3 does not define “exclusively
publicly available information for which there is no presumption of privacy”. This is problematic because user expectations of the privacy of their internet data
varies according to the type of site, whether membership is required, and the characteristics of the site (e.g. for survivors of sexual abuse only). The fact that
data can be collected from participants unwittingly in real time begs the question of whether this can not be considered to involve human participants. This is
also inconsistent with Article 2.1, page 8, line 242-3 in which research participants are defined as living individuals whose data is relevant to the research
question. Material online is data relevant to the research if the researcher decides it is and this data is posted by living individuals. Other problems with online
research are the difficulty in verifying the age of participants online. Are comments made by a 13 year old and archived without their awareness to be
distinguished by comments made by a 40 year old with full awareness of their potential exposure? Article 10.4 does get into some of these nuances but we fear
that researchers interested in online research will not read past 10.3 and be under the impression that they have carte blanche. It should also be pointed out that
in offline studies involving naturalistic observation, the observed have some chance of spotting the observer and choosing to move away. Online, the observed
are completely unaware, and therefore, are more vulnerable.
(based on the previous TCPS) for more
detail.
4023 This section on non-intrusiveness could be cross referenced with Article 10.4 (4044) which establishes the need to consider the presumption of privacy in
some cyber-materials (ex. chat rooms). Drafters may want to consult Gunther Eysenbach, “Ethical issues in qualitative research on internet communities” BMJ
2001; 323:1103-1105 10 November. This paper discusses research on chat rooms where posters were offended by lurking researchers.
4017-4019: This is, in fact, what
REB has been doing for the past several years, but it is gratifying to have this direction in the TCPS. This works
quite well, along with a proportionate approach to review of sites on which there is an expectation of privacy (the degree of which varies on a case-by-case
basis). (Article 10.4)
The material on web-based research covered in article 10.3 and 10.4 should apply to quantitative as well as qualitative research. If that is not intended, then that
should be clarified and justified. However, I can’t envisage a convincing rationale for making such a distinction between qualitative and quantitative web-based
10
10.3
10.4
10.4
10.4
10.4
10.4
10.4
10.4
10.4
10.4
10.4
10.4
research.
The new sections on Web-based research and a related proportionate approach to observations (Articles 10.3 and 4) are good. I would like to see more attention
however given to the participant and interactive aspects of qualitative research in a web based or electronic forum. These days a lot of qualitative research takes
places in digital environments such as Second Life, interactive blogs, and on facebook. In these digital forums researchers have little clarity as to what kinds
rules/ethics govern their conduct. Current literature shows that research participants will often be more candid in cyberspace than in a physical environment.
So I'm not sure that digital space is as "public" as the language in these sections suggest.
As many of us experience, research no longer ends in the field. When our interviews are over, we return to their desks, and computers and telephones become
the tools we use to continue conversations. Some additional content that acknowledges this research fact would be useful and as would some directions
regarding the ethics of e-mail. Clarification on these issues is important at small institutions where REBs are comprised of people who are often unfamiliar with
qualitative research and interpret vague guidelines based on their own bio-medical model.
Lines 4057-4061 It is not clear what is meant by this sentence. What codes and guidelines are being referred to? This is somewhat obscure and thus fails to
provide REBs with guidance on what kinds of priority needs to be given to the TCPS principles when faced with divergent practices.
Lines 4104 One of the key issues here is capacity to consent of adolescents or children who might end up participating in research, or when research is targeted
to these populations on-line. This is very much an REB issue. Are there certain kinds of research which should not be conducted on-line without the appropriate
ability to determine the real age of participants? Or the ability to intervene the way one might do upon the revelation of a potential risk to participants if one
were conducting the research other than via the internet? Why is this outside the scope of ethical research? The overall discussion of internet research is very
limited and given the burgeoning tendency towards electronic data collection a fuller consideration would be warranted.
The section where researchers are required to identify themselves to participants is helpful. Sometimes only first and second names have been provided
(without degrees, positions, or appointments) on letters of invitation or consent form. Of course there can be cultural exceptions. However, it seems reasonable
to include the researchers role, affiliation with an employer and professional qualifications (i.e., student, licensed in a profession) where relevant to assist
participants make informed decisions.
Page 114, Article 10.4, 4033-4035: “presumption of privacy” Please provide examples.
Line 4062 Replace
The first “of” should be either “for” or “about”
Line 4086 Change
Needs to need
Line 4087 Change
Justify to justifies
Line 4103 Insert
… be regarded as being of minimal risk.
Would not a proportionate approach to review of observational studies called for in Article 10.4 apply to both qualitative and quantitative studies? If not, why
not?
4049-4061 Is the discussion of participant observation applicable to quantitative research such as that conducted by experimental psychologists? For example,
11
10.4
10.4
10.4
10.4
10.4
10.4
10.4
10.4
10.4
10.4
10.4
10.4
10.4
10.4
would it be all right for researchers not to identify themselves if they want to stage a rerun of the Milgram experiment in a naturalistic setting?
4078-4084 Reading these two sentences in sequence gives the impression that covert study of criminal organizations is minimal risk research. I doubt that was
what was intended.
4101-4109 This passage reads, “Observational research that does not allow for the identification of the participants and that is not staged and is non-intrusive
should normally be regarded as of minimal risk.” Would this apply if the group but not its members can be identified? What if the group was one that was
highly vulnerable to social stigmatization?
4083: The example given of queuing behaviours would be exempt from review as described in 4010 and is not a good example of covert research.
Article 10.4 (Line 4052)
Please clarify “covert” participant observation and provide specific examples of same.
ƒ Does a researcher need to exercise judgment in this area specific to whether or not the researcher and participant are unidentifiable?
ƒ What safeguards are in place to protect the participant in covert observational research?
ƒ What safeguards are in place to protect the researcher?
ƒ How does one provide debriefing information or informed consent (and how can this be verified)?
Article 10.4 (Lines 4086 – 4088)
The statement “Researchers should justify whether the needs for such covert research justify an exception to the general principle of free and informed consent,
and REBs should exercise their judgment in this type of situation” requires clarification. Examples would be helpful as this could be difficult for the REB to
operationalize.
Dans la section traitant de l’application de l’article 10.4, le Sous-comité suggère de préciser ce que l’on entend par les notions de « lignes directrices » ou de
« codes sur les questions éthiques » (lignes 4927-4928).
4927 à 4934 : Il faudrait annoncer au lecteur que ces lignes seront traitées plus loin. Ces lignes suggèrent une compréhension de chacun des codes, des guides et
des lignes directrices existants sur ces questions d’éthique. C’est souhaitable. Mais est-ce vraiment réaliste?
4945 : Il faudrait préciser la nature des attentes des éventuels participants
The specific mention of a proportionate approach in this regard seems odd since REBs should be applying a proportionate approach in all reviews. Perhaps it
would be better to suggest more specifically that REBs should focus on projects above the threshold of minimal risk, modulating requirements and protection
proportionate to the magnitude and probability of harm.
4036-56 provides suggestions and a good balance of examples but here too greater attention to web-based research is required.
4049 Recognizing that participant observation may or may not require permission to observe was welcomed.
4056-61 We welcomed as well the acknowledgment that disciplines and methodological approaches also provide guidelines with respect to how researchers
doing observational studies should proceed and the recommendation that REBs take such guidelines into account, seeking ”mutual understanding and
clarification.” However, we were left with the question of what to do if TCPS guidelines are at odds with the direction provided by disciplinary/professional
codes and guidelines attached to particular methodologies. Does the TCPS trump guidelines offered in disciplinary codes or methodological approaches?”
4074 We regard as a useful addition explicit mention of the fact that covert observation is justified in cases where knowledge that one is being observed would
change behaviour or where the research would not otherwise be done (e.g. criminal organizations). This will allow REBs to consider these special
circumstances. At the same time, we were pleased to see in line 4086 that researchers need to justify the need for covert research.
Sub-section on Observational studies: Given the diversity of observational research, with this sub-section it looks like REBs would need to implement a statement
12
regarding proportionality for reviewing studies that involve observations.
10.4
Line 4077 – Is the sentence not direct or no direct?
10.4
Lines 4089 to 4090, page 116
Add to this sentence: “and may sometime require consent to be obtained after the fact” to address the full range of consent possibilities in qualitative research.
4104-4109: Clarification is needed here. Does these mean we should not have to worry about minors accessing research questionnaires on which it is openly
stated that only those over a certain age should respond? It is quite difficult (read impossible) to determine the age of a respondent, and web-based research may
deal with sensitive issues. It is hoped that this section means that as long as a warning exists, it is not the responsibility of the researcher or the REB if a minor
or other vulnerable populations access information clearly labeled for others. Please make this very clear if this is the intent.
10.4
10.4
10.6
10.5
10.5
10.5
10.5
10.5
10.5
10.5
10.5
10.5
10.5
There are some valuable references in the document to the need to defer to disciplinary practices and professional norms (lines 273-7; 277-82; 288-98; 498 511;
4089-90; 4186-8). As a professional association, we strongly support the inclusion of these references in the TCPS II since they are a useful way to address the
diversity of experiences and the accumulated knowledge about ethics across disciplines and professions. We will give serious consideration to developing new
guidelines to such practices and norms in our discipline that would be designed to complement the TCPS II.
Lines 4114-16 – This needs rewriting. Either individual research subjects should be identified if that is what they want or there is no obligation for researchers
to identify them. Which is it? And what do lines 4122-24 mean in this context?
5. On page 116, in lines 4114-4116, clarify or illustrate in what types or examples of situations identifying participants would be appropriate (e.g. in the case of
outstanding contribution to a community’s development) and add that it would be wise to obtain some documentation of the individual’s wish to be identified.
Page 116, 4121, “The default approach is to guarantee confidentiality of the research data.” This contradicts parts of article 5.2 (page 46) which suggests that
researchers cannot guarantee confidentiality of research data.
Page 116, 4119-4124: Clarification required between the words “anonymity” and “confidentiality”.
On page 116, in lines 4114-4116, consider clarifying the types of situations which may arise in which identifying participants would be appropriate such as in
the case of an outstanding contribution made to a community’s development. Also add text which states that it is recommended that some obtain some
documentation regarding an individual’s wish to be identified before proceeding to do so.
Dans la section du texte portant sur l’application de l’article 10.5, il serait sans doute préférable d’unir les deux paragraphes que forment les lignes 5014 à 5027.
Lines 4115-4116 - Expansion on the right of participants to be identified if they wish is very helpful, especially for those researchers conducting oral history
where the participants want to be identified.
4125-34 Clarifying that participants can ask to be identified, that identification is the standard practice in certain methodological traditions and that in some
cases participants would feel disrespected if they were not identified is a welcomed addition.
4114-4116 : “Article 10.5 Subject to the research context and the scholarly traditions used in the research proposal, research ethics board review should
acknowledge that individuals may want to be identified for their contribution.”
Why should this be subject to the research context and the scholarly traditions used? Any individual is entitled to due credit for their contribution.
Article 10.5, ligne 5019 : l'expression « participants éclairés » nous paraît malheureuse. Elle pourrait être remplacée par la phrase suivante : « si des participants
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10.5
Section B
10.6
10.6
10.6
10.6
10.6
10.6
10.6
10.6
10.6
10.6
10.6
10.6
ont exprimé en toute connaissance de cause le souhait de voir leur nom mentionné….»
Certaines clarifications seraient à faire relativement à « l’obtention de l’accès », « de l’établissement de rapports de recherche » (ligne 4805), et relativement à la
protection de la vie privée et de la confidentialité lors de la diffusion des résultats (art. 10.5, p. 132).
6. On page 118, in lines 4180-4182, clarify or illustrate what types or examples of changes demand additional REB review and which do not.
Article 10.6 exempts exploratory (qualitative) research from needing ethics approval.
hearing about this section rather pleased an
anthropologist friend of mine who noted that her research was 'always exploratory' and so she would never need to get ethics approval again. While I am
extremely sympathetic to the justification for Section 10.6--it is crucial for many researchers to do exploratory field research before developing a final research
design--exempting exploratory research would only be appropriate if in fact there were no ethical risks for exploratory research. In fact qualitative 'fishing
expeditions' may pose at least as substantial a risk as qualitative research with a more developed research design--whether or not there is a completed research
design is not necessarily related to risk and as such should not be a criteria for exemption. It seems more appropriate to me that REBs should review plans for
exploratory research and have some standards for their ethical conduct, and a coherent strategy for reviewing and appropriate the full research design that
follows once the exploratory research is completed.
The Board discussed the use of the word “exploratory” in Article 10.6. Other words such as “pilot” and “preliminary” and “developmental” were suggested, but
then it was pointed out that the phrase “exploratory phase” may have a specific meaning in qualitative research. In any case, there may be some confusion
around when the exploratory phase ends and the next phase begins.
I am also very excited to see the attention paid to the Timing of the REB Review and to see the language that ethics review is not required in the exploratory
stage of research.
On page 118, in lines 4180-4182, clarify what types of changes demand additional REB review and which changes do not.
Does article 10.6 on the timing of the REB review apply to quantitative research or is this a blanket exemption for qualitative researchers only? That is would
this allow quantitative researchers to engage in exploratory work before formal data collection without REB approval?
10.6 Timing of review. This section raises an issue on a related topic. Here, the guidelines suggest that “some resulting changes to the design will not require
additional REB review”. It seems to us that a similar situation arises for many other researchers who are engaged in programmatic research where one
discovery leads to another, but where the basic protocol of recruitment, consent, and debriefing remain constant across a set of studies. We believe that all
researchers, regardless of whether they are doing qualitative or quantitative work, should be granted some latitude such that not all changes to a protocol require
REB approval.
Timing of REB Review
Article 10.6 (Lines 4143 – 4144) – “formal data collection in the field” needs to be more fully defined and clarified. Examples of “formal data collection in the
field” would be helpful as this too may be difficult for the REB to operationalize.
À la section touchant l’article 10.6, le texte qui concerne le « moment auquel doit avoir lieu l’évaluation par le CÉR » (ligne 5030) devrait être présenté plus tôt
dans ce chapitre.
Chapter 6, Article 6.11 (and Chapter 10, Article 10.6), appears to contradict Schedule 2 of the MOU, which outlines a two-stage review process. More
discussion between the Agencies and PRE-SRE is required (see MOU, below). “involving human participants” should be added to the Article.
5058 à 5061 : Ces lignes devraient plutôt insister sur la nécessité de consulter officieusement le CÉR lorsque les visites exploratoires visent des populations très
sensibles ou lorsque les risques connus ou anticipés sont importants.
Lines 4140-4144- The issue of pilot studies needs to be expanded. Often information gleaned from pilot studies are used in the wider research and therefore
14
10.6
10.6
10.6
10.6
10.6
10.6
10.6
should require REB review where appropriate. Can the information gathered at this stage be used in the research itself? The difference between consultation and
pilot study should be clarified and appropriate examples given.
REB Comment: This is the current policy of
The section on the timing of REB review is well done. It provides a good discussion of the initial exploratory phase of research. The drafters might want to
comment further on the point at which exploration becomes actual data collection as this issue is still unclear.
With the emergence of community-based participatory research (CBPR) as an increasingly important method in many fields the limited discussion of such
research in this chapter was noticeable. There is some cross-referencing to Chapter 9 where CBPR figures prominently but within a specific Canadian
Aboriginal application, but further discussion that covers CBPR in other research contexts is warranted. This discussion could occur either in this section on the
timing of REB review or in a separate section positioned between Articles 10.4 and 10.5.
4166-70 Concerning the desirability for researchers to obtain group permission before seeking individual consent, timing may be an issue. At what point does
exploration of possibilities or informal information gathering become formal research? When should group permission be sought?
4175 There was an appreciation for the emphasis the draft places on the emergent nature of qualitative research and the recommendation that REBs respond
accordingly, providing additional review only when projects change significantly.
Given the consultation and relationships between researchers and research participants, communities, the timing of the REB review particularly with emergent qualities
(e.g., when should the researcher submit an application for review? when has a process moved far enough for sufficient information for a review? Etc;) will demand a
different process than the current one with REB offices, likewise with ongoing review for certain kinds of qualitative research (p. 15).
4166-4174 : “For instance, in research in Aboriginal communities or with Aboriginal populations (see Chapter 9 [“Research Involving Aboriginal Peoples”]) or
other types of community-based collaborative research, it may be desirable to obtain permission to proceed from community leaders, elders or representatives
before seeking individual consent. A researcher might use a community gathering to inform the group about the research and gain agreement from the group to
proceed with the actual research before seeking to obtain individual consent as a second step of the research implementation.”
10.6
The nature of community-based research as a collaborative process does not show through clearly enough in this paragraph, which seems to describe a more
“researcher-driven” process, i.e., researcher “informing” the group and “gaining” agreement, with a lack of forethought as to how that agreement will be gained
(e.g., through consensus-based decision making?). While the Draft speaks to permission that may be needed from leaders or representatives, it does not address
situations in which collective/community consent is involved.
Article 10.6 Selon cet article, l'étape d'exploration initiale ne requiert pas d'évaluation éthique.
10.7
L'ÉPTC admet à la ligne 5048 que « les chercheurs doivent avoir la possibilité de faire des visites préliminaires et d'engager un dialogue pour examiner les
relations de recherche qu'il est possible d'établir et de définir les modes de collaboration à la recherche dans les communautés ou des milieux particuliers ».
Nous avons abordé déjà le problème de l'accès aux bourses ou aux subventions, souvent conditionnel à l'obligation de fournir un certificat d'approbation
éthique. Cette question de l'accès aux bourses est importante car elle instaure une distinction entre ceux qui ne n'ont pas besoin d'apports financiers externes
pour effectuer leur « pré-terrain » (étape non soumise à l'obligation d'une approbation éthique), et ceux qui ont besoin de cet apport financier qui les oblige, alors
qu'ils ne sont pas prêts, à soumettre leur projet à l'examen éthique.
Méthodes de type émergent : L’article 10.7 fait référence à des situations où le questionnaire destiné aux participants à la recherche ne serait pas disponible dans
15
10.7
10.7
10.7
10.7
10.7
10.7
10.7
sa forme finale au moment où le projet est soumis au CÉR pour approbation. Selon le cadre actuel de fonctionnement, les questionnaires de recherche figurent
dans la liste des documents qui doivent faire partie du dossier soumis pour étude au CÉR. Il s’agit d’un article intéressant qui pourra faire évoluer la réflexion à
ce sujet.
Line 4191 The key word in this sentence is “cannot” … that is where the research plan details cannot be known in advance then some leeway might be
appropriate. This is very different from ‘making it up as one goes along’ because of lack of time pressures or lack of planning. In these cases the onus should be
on the researcher to demonstrate to the REB why it is not possible to provide the details. This needs to be emphasized more strongly.
Line 4194 I disagree with the categorical nature of the statement that ‘REBs should not require researchers to provide them with a full questionnaire schedule in
advance of data collection” in particular in reference to greater than minimal risk projects. We have seen studies where the questionnaire/survey was so illconceived as to have potentially resulted in a total inability of the researcher to address the research question. A list of possible research questions would never
have revealed this and there would have ultimately been no benefit to the research. Also, the ‘devil is very often in the details’ and a very vaguely described list
of questions may not reveal the true nature of the information exchange that will take place. Saying that one will ask questions about family relationships would
be factually true, but would not communicate the true nature of a study that will include an exploration of domestic violence. This is an extreme example to
illustrate the point that REBs need enough information to know, within reason, what the experience of participants will be like. This section has the potential to
severely undermine this ability. This is not to say that questionnaires and interview guides cannot adapt to emerging data or circumstances in the field. But, in
part, the value of the REBs requirement for information, if done reasonably, is to ensure that the researcher has thought through the methodology adequately
such that they are in a position to do a competent risk analysis in advance.
Seemingly not addressed with regard to “qualitative” research (under the wider definition of this, not simply the narrower view of chapter 10), is the potential
issue of a situation in which the direction of research shifts, at least to a degree, as a result of information gained in the course of an interview. This issue seems
most directly related to Articles 2.8. 3.4 and in particulate, 10.7, which address ‘emergent designs’, yet this Article does not explicitly cover this particular
aspect of emergent research. A shift in the direction of research stemming from interview-derived information will affect both the direction and content of
further interviews, and may affect the use made of material gained in earlier interviews. As well, it is quite possible that information gained from interviews in
one research project may find use – sometimes for related or sometimes for different purposes – in a later research project. A question that should be addressed,
if only for the purposes of clarity, is what are the obligations, if any, entailed for the researcher under these circumstances.
There does not seem to be much guidance when changes in the original intent of research occur (specifically the role of the REB in, for example, action research
where the research is led in different directions).
Lines 4186-4188 – This article is a vague statement and should be clarified. Standard procedures should be laid out that complete questionnaires may not be
available until after a pilot study, but the researcher should still provide the REB with a sample of questions to be asked so that the REB can place the protocol
in context. The same is true for interviews, a research cannot possibly predict every question that they may ask, but they should be required to submit an
interview script for review. An additional sentence should be inserted in this section to indicate that a complete and finalized version of the research tool will be
presented to the REB for placement in the permanent file prior to its use on/with participants.
Lines 4195-96 should be changed to place the onus on the researcher to present the REB with pertinent information that the method of data collection is in
keeping with the disciplinary/professional standards. An interdisciplinary REB cannot possibly be expected to be fully informed on every standard that exists.
Lignes 5099 à 5101, page 134, Application de l’article 10.7 (Évaluation éthique de la recherche dans le contexte des questions inhérentes à la recherche
qualitative, Moment auquel doit avoir lieu l’évaluation par le CÉR, Méthodes de type « émergent »). Écrire « les CÉR doivent demander à examiner une version
préliminaire des questions ou avoir un aperçu de la façon dont se fera la collecte des données ». La protection des participants exige que les questions ne soient
16
10.7
10.7
10.7
10.7
10.7
Section A.
Section A.
Section A.
Section A.
Section A.
Section A.
pas excessivement intrusives ou dénuées d’intérêt scientifique.
4186 Article 10.7 The wording of Article 10.7 should be amended as follows: Please see insertions within square brackets below.
ƒ When researchers are using emergent designs in data collection, research ethics boards should review and approve the general procedure [insert – “and be
informed about changes that alter risk”] in accordance with [insert – “ the TCPS and”] appropriate professional and disciplinary standards.
4186-4188: ADD TEXT: “Article 10.7 When researchers are using emergent designs in data collection, research ethics boards should review and approve the
general procedure in accordance with appropriate professional and disciplinary standards, AND IN LIGHT OF COMMUNITY RESEARCH
PARTNERSHIPS.”
4195-4196: Rather, REBs should ensure that the data collection is conducted according to disciplinary and professional standards, AND IN LIGHT OF
COMMUNITY RESEARCH PARTNERSHIPS.”
4194-4195: There is no reason why an REB cannot require a researcher to submit a full questionnaire schedule prior to the beginning of research. The REB can
review a draft of sample questions, the review can take place on this basis, and the researcher can submit a change request with the final questions prior to the
research taking place. There may be some (unusual) reasons why this is impossible, but for the vast majority, this can easily take place over time as the
questionnaires are developed.
Once again, what are these disciplinary and professional standards, how does the REB know what they are, on what grounds do they enforce them, how can a
decision be reached if they are inconsistent with the TCPS? This is entirely inappropriate. Researchers are, of course, bound by professional and disciplinary
standards, but REBs should NOT be enforcing them.
3939-3950 In some cases biomedical research involves the creation of research partnerships. For example, consider the remarkable research being done in the
downtown east side of Vancouver in HIV-AIDS.
Recognition of underlying assumptions different than that of bio-medical echo that of Aboriginal research chapter – this serves as a form of validation for this
type of research
Human-centred approach
Dynamic, reflective and continuous
Social construction of knowledge at individual and cultural level
Interpretive and inductive
“Context contingent” (dependent on social context) means there could be a diversity of approaches
Researcher-biased work
1. On page 112, in line 3953, consider adding at the end a statement such as “in some instances, a relationship that extends beyond the scope of the research or a
relationship that is anything but strictly professional may be inappropriate” with some examples of when fostering a personal relationship is not appropriate (e.g.
a patient-client relationship).
On page 112: lines 3939-3950. I especially appreciated the paragraph you included on "Research Partnerships" - well done!
Page 111, 3912-3917: “Appropriate treatments of data...” Emphasis could be added here on importance of ensuring participants are adequately informed (i.e.,
respect for autonomy).
Page 111, 3925-3927: “the process sometimes cannot be ascertained in advance of the research...”Emphasis here should be on researcher’s responsibility.
17
Section A.
Section A.
Section A.
Section A.
Section A.
Section A.
Section A.
Section A.
Section A.
Section A.
Section A.
Section A.
On page 112, in line 3953, I’d consider adding at the end of this line the following statement; “in some instances, a relationship that extends beyond the scope of
the research or a relationship that is anything but strictly professional may be inappropriate” while also providing some examples of when fostering a personal
relationship would not be appropriate such as in the context of a patient-client relationship.
3890-3896 That qualitative researchers may engage the vulnerable or the powerful is not peculiar to qualitative research. The same can occur with quantitative
research. So I question why this passage is needed here. My suspicion is that this is meant to draw a contrast with biomedical researchers who have clinical
appointments and thus generally have power over patient-participants. But the same is true for qualitative researchers who have power due to their roles as
nurses, educators, supervisors, etc. over particular participants who are under their authority or perceived to be as such by participants.
3924-3928 Is it peculiar to qualitative research that the process of informed consent may not always ascertainable prior to the commencement of research?
L. 3880-3882 – “requires a constant reflective approach and questioning from the researcher” – makes the case for emergent design
L. 3924-3928 – aligns with Aboriginal research protocol
L. 3954 - regarding research results, can this include “shared ownership”?
3892: Define legal stigmatization.
3951: Unclear stand alone sentence.
"Triangulation" (p. 111, ln 3905) has been replaced by "crystalization" because there is an increasing recognition that our empirical materials provide us with a
complex, deep, but completely partial understanding of the topic.
• "Data saturation" (p. 111, ln 3900) implies, after awhile, a person's story is irrelevant because there is nothing new to glean from it after analyzing other
participants' stories. • By contrast, there is a growing recognition that everyone's story is unique; it's the researcher's job to understand how or in what way.
• Finally, the notion of "giving voice" (p. 111, ln 3920) has been increasingly problematized because scholars in virtually every scenario have ultimate authority
over the text. That is, scholars ultimately choose how or what to represent in their published research, even after consulting with their participants. The notion of
authority over the text, therefore, suggests authors need to take credit for their interpretations.
3- Un chapitre consacré à la recherche qualitative / Avec un chapitre dédié exclusivement à la recherche qualitative, la nouvelle version de l’Énoncé devient
résolument plus inclusive. Il y avait là un besoin urgent à combler. Ce chapitre sera d’une grande aide aux CÉR appelés à évaluer ce type de recherche qui
soulève beaucoup plus de questions éthiques que la recherche quantitative en SSHAL.
Suggestion de modification : La recherche qualitative représente un lieu beaucoup plus névralgique de l’éthique que ne l’est la recherche quantitative. Le
chapitre gagnerait à préciser clairement les difficultés posées par l’évaluation éthique de recherches basées sur des méthodologies qualitatives ou mixtes. Les
CÉR moins sensibles à la réalité de ce type de recherche pourraient ainsi mieux saisir les enjeux.
Section A.
Par ailleurs, le texte décrivant la nature de la recherche qualitative à la page 124 semble réduire la connaissance produite par ce type de recherche à des
considérations interprétatives, voire au point de vue personnel du chercheur, teintées de valeurs. Qu’elle découle des sciences biomédicales, des sciences
naturelles ou des sciences sociales et humaines, la connaissance demeure une mise en forme de l’expérience suivant les règles de la méthode scientifique. Ce qui
est vrai également pour la recherche qualitative.
The draft TCPS usefully endeavours to draw a basic distinction, especially in Chapter 10, between research that conforms to a biomedical model and research
that is “qualitative.” This distinction as made in the draft, however, is inadequate and unsatisfactory. Aside from the biomedical/psychological style of study,
there is also survey/statistical research, employing questionnaires, as undertaken in Social Sciences other than Psychology. These are non-experimental in form,
but may require identifying or identifiable information from participants, and may require some ethics safeguards accordingly. This sort of quantitative research,
18
Section A.
Section A.
Section A.
Section A.
Section A.
Section A.
Section A.
Section A.
however, does not fit the notion of “qualitative” research as normally understood in the Social Sciences, yet neither does it fit easily within a basically
biomedical model. We recommend that this issue be addressed in the final draft and that any relevant guidelines specific to this issue be clarified.
The concept of “qualitative” research developed in Chapter 10 seems too narrow, as compared to the common use of the term in various disciplines of the Social
Sciences. As used in Chapter 10, it seems to fit best an observation or participant/observation mode of research as undertaken, for example, in Anthropology.
There are, however, other forms of research treated as “qualitative” in the various Social Sciences which will not conform to this model. These may use public
archives, documents and sources, and so be exempt (it would seem) from the need for ethics review. However, they could also include interviews of a sort
which fall under the ethics purview, without being survey-type or “biomedical” research. Some of the guidelines for more open-style or unstructured interviews
(Art 10.7) and for dealing with government or public figures may apply here, as well as the “professional or disciplinary standards” referred to (but left unclear)
in the draft.(Art 2.1) This issue needs to be clarified.
This raises the important issue of identifying who defines such standards and who decides whether they have been met. Moreover, the draft TCPS carries an
implication of an expected but unstated requirement for each discipline to develop an ethics position of its own. We note with approval that the
has
indicated in its draft response that it “will give serious consideration to developing new guidelines to such practices and norms in our discipline that would be
designed to complement the TCPS II” but suggest that if there is an expectation that each discipline will develop its own ethics standards, then this should be
made explicit. Moreover, as many research projects are multidisciplinary in character, there is a need for a degree of harmonization across the development of
ethics standards by different disciplines.
S’agissant de cette même section A, le Sous-comité croit que les indications selon lesquelles « la connaissance, tant sur le plan individuel que sur le plan
culturel, est traitée comme une construction sociale » et que « toute connaissance est, jusqu’à un certain point, de nature interprétative et, partant, tributaire du
contexte social » (lignes 4671-4673) sont trop générales. L’on constate également, à la lecture de cette section que le concept de pouvoir est invoqué à plusieurs
reprises (lignes 4720-4722, 4753-4757, 4766-4772) sans cependant être bien défini. Ce concept, tel qu’employé dans ces extraits, est-il spécifique à la recherche
qualitative? Le cas échéant, il serait préférable d’expliciter les incidences potentielles de cette question pour la recherche de manière à mieux exposer les enjeux
éthiques qui lui sont sous-jacents.
Line 3883 should read “contribute to the overall strength and rigour of the data collection and analysis”.
Lines 3887-3889 need clarification. In particular, what is meant by “empirically derived from other social settings”?
Lines 3894-3896 are unclear. No researcher selects a sample because it is statistically significant. The research might select the sample hoping that results will
prove to be statistically significant, but the sample itself is not statistically significant.
4663 et 4664 : La première ligne de la section A serait plus claire si elle référait à une approche centrée sur la personne, plutôt qu’à une «approche qui
privilégie la dimension humaine».
4665 à 4668 : L’approche qualitative ne vise pas seulement à «comprendre comment les gens interprètent leurs paroles et leurs actes etc.». Il faudrait peut-être
mentionner qu’elle vise plus largement à comprendre un phénomène à partir des discours, des actes, des documents. Plus spécifiquement, la deuxième phrase
de la ligne 4665 devrait plutôt utiliser l’expression «amène les chercheurs» au lieu de «oblige les chercheurs».
4690 à 4700 : Il est important de souligner que les approches qualitatives ne sont pas que des méthodologies. Il est suggéré de reprendre ce paragraphe de la
façon suivante : «La recherche qualitative fait appel à tout un éventail d’approches théoriques, de questions qui orientent la recherche, de méthodologies, de
techniques et de démarches épistémologiques qui permettent aux chercheurs de pénétrer l’univers des participants à la recherche ou d’entrer dans un contexte
social particulier. Ces approches exigent des procédures d’analyse particulières, chacune propose des étapes, des moments à respecter et élabore certaines
19
Section A.
Section A.
Section A.
Section A.
Section A.
Section A.
Section A.
Section A.
Section A.
Section A.
recommandations que l’analyse des données doit suivre. Cependant, à la base de ces différences, nous pouvons identifier un processus commun dans lequel le
chercheur doit réduire les données, les coder et extraire des conclusions même si ces tâches n’ont pas un caractère linéaire mais plutôt itératif.».
Référence : Royer et Martineau, 2008.
4707 à 4713 : La traduction déficiente de l’anglais au français rend ce paragraphe difficile à comprendre. La formulation suivante est proposée : «La recherche
qualitative étant contextualisée, les chercheurs devraient en ternir compte dans l’interprétation de leurs données ainsi que dans leurs diverses prestations. Ces
données n’ont en effet de valeur que dans le contexte dans lequel elles ont été collectées.».
4738 à 4740 : Cette phrase devrait être plus nuancée afin d’être mieux comprise. Elle devrait se lire ainsi : « Dans certains cas, le rapprochement et la
communication prolongée dans le temps sont parfois le meilleur moyen de recueillir des données fiables.
4725 à 4728 : L’atteinte du point de saturation est un élément majeur en recherche qualitative. Ces lignes devraient être corrigées pour mieux refléter cette
préoccupation. Elles devraient se lire ainsi : « La plupart des chercheurs qui emploient des méthodes qualitatives privilégient la collecte de données diversifiées
se recoupant sur un nombre limité de cas ou de situations jusqu’à atteindre un point de saturation ou de redondance thématique. Dans ces études, les stratégies
d’échantillonnages et de sites..».
4780 et 4789 : Il faut remplacer le terme «souvent» par «parfois» pour que la phrase de la première ligne fasse sens dans le contexte de la recherche qualitative.
La deuxième phrase de la ligne 4789 devrait débuter par « Il arrive » au lieu de « souvent » pour la même raison.
4794 : Il faudrait lire : « Dans certains cas » plutôt que « Dans bien des cas », pour éviter de généraliser la situation.
4797 à 4799 : Il faudrait plutôt lire : « Lorsqu’un chercheur décide de transférer des résultats de recherche d’un contexte à un autre, son opération renvoie à une
question théorique plutôt qu’à une question de procédure ou d’échantillonnage, cette dernière étant propre à la recherche quantitative. ».
tient à rappeler que la transférabilité des résultats en recherche qualitative n’est pas un but.
Risks of Qualitative research sufficiently addressed
o The risks addressed in ch 10 relative to qualitative research need to be reworked. The chapter still leaves the impression that qualitative studies present
virtually no risk because, by comparison to clinical trials for example, they do not involve physically invasive interventions. However, the history of
qualitative research has demonstrated that there are potentially real risks of harm in qualitative research. Clinical researchers may collect body samples and
DNA, which is sensitive of course. However, qualitative interviewers collect the stories of individuals, which are arguably as precious if not more so. The
psychological harms of raising questions are well known by now. In one case, intellectually challenged adults were asked about their experiences of ill
treatment in the community. Some of the stories revealed acts of harassment and violence, which the researcher felt the need to disclose to the police or
other authorities. This was both helpful and harmful to the participants who while helped out of bad situations were introduced to new challenges such as
court appearances and worsened harassment. These risks were not small. The ongoing implications were as serious, as likely and as significant to the lives of
the participants as an adverse drug event in a clinical trial.
If the research assistant is conducting the thematic analysis would he/she also be captured under this assumption as presently it refers to the researcher solely
(line 3856)?
As an REB we should find it helpful in knowing how many times a theme needs to be identified to become a ‘theme’ as this is a question we have discussed
several times when reviewing qualitative research.
The draft identifies the diversity of approaches inherent in qualitative research and as a REB what criteria would we use to determine if an approach is
appropriate when we receive proposals from a variety of disciplines and the research proposal may not be peer reviewed (line 3870)?
20
Section A.
Section A.
Section A.
Section A.
Section A.
Section A.
Section A.
Section A.
Section A.
Section A.
Section A.
In regard to unique contexts in which the qualitative research may be conducted the assumption is that this research can result in inequity, injustice and possibly
in highly vulnerable contexts. It would be helpful for the REB to know how to ascertain if the subject(s) are being protected “as much as possible” (line 3884).
In relation to data collection what would be the determining factors an REB could utilize to ascertain if the sample number is appropriate for the study and does
the research need to be completed over a longer period of time if the subject number is low? Also, can the research findings be described as ‘data’ (line 3897)?
Le chapitre 10 sur « La recherche qualitative » (p. 123) a été apprécié. Il faudrait toutefois dissocier la recherche en sciences humaines (dont la psychologie
expérimentale, par exemple) de celle en sciences sociales. De la même façon, la nature de la recherche qualitative (p. 124) telle que décrite se concentre surtout
sur la compréhension de l’action humaine. Or il y a tout un pan de la recherche qui s’intéresse aussi aux contextes sociaux dans lequel vivent les personnes, et
aux dynamiques à l’intérieur de ce contexte.
Par ailleurs, et pour l’ensemble du chapitre, la recherche qualitative semble peu rigoureuse, et semble par ailleurs nécessiter peu de préparation et moins encore
de rigueur. Le caractère exigeant de la recherche qualitative ne transparaît pas, tant le chercheur semble se laisser porter par sa recherche sans l’avoir réellement
ni réfléchie ni pensée. Ce qui peut donner une image peu représentative de la recherche qualitative. Il est écrit par exemple que le chercheur « ignore le caractère
de sa quête avant de commencer sa collecte de données » (p. 126). De la même façon, la recherche qualitative, de par sa nature, « oblige à consacrer un temps
considérable uniquement pour déterminer l’objet de la recherche » (p. 127). Ces deux aspects sont à nuancer. Il faut distinguer la préparation du protocole de
recherche de la spécificité du terrain. La préparation du protocole de recherche est rigoureux et exigeant, ce qui n’enlève rien du caractère particulier du terrain
de recherche avec les participants. Aussi, et comme dans toute recherche, le chercheur ne pourra en effet affirmer quels seront les résultats.
Line 3939-3953: A h) Research Partnerships
‐ This seems to need elaboration because it is vague enough that boundary crossing could be considered acceptable.
Some concerns about qualitative research - first - just because there are interviews does not make research qualitative - but a lot of people seem to think so!
Often one sees submissions identified as qualitative - equivalent to submitting something that is called quantitative - within qualitative there are particular
methods which should be identified - or else one would think the submitter really is not conversant with the method. If one cannot identify the particular
school/discipline/method I usually figure they don't really know what they are doing.
Qualitative research does indeed have risks - there is considerable risk depending on the topic - much of the time this is very personal and of particular
emotional/mental (not necessarily psychological!) risk in re-visiting sensitive topics, in hearing oneself speak and realizing what one is saying etc - just a note
that there is probably little physical risk but often a moderate or at least minimal emotional risk in participating.
Lines 3870-3878, it should be clarified that participatory action research can also include quantitative and mixed methods, as well as qualitative
methodologies and methods of data collection. Community-based research is expanding across the country, yet this is a difficult area to deal with for REBs
where the researcher(s) is also a participant(s). Further guidance on this type of research would be of great assistance to REBs.
Lines 3895-96, it should be recognized that government official may also be vulnerable in their positions, in addition, more powerful than the researchers.
Lignes 4794 et 4795, page 127, Nature de la recherche qualitative, h) Partenariats de recherche. Modifier la phrase « Les contacts entre les chercheurs et les
participants pourront durer plusieurs années » ce qui est plus réaliste que « toute une vie ».
The preamble is a valuable addition. It does a good job of providing the theoretical and epistemological contexts for qualitative research and of capturing the
emergent nature of such research. If Chapter 10 is ultimately eliminated and integrated into the rest of the policy, the preamble would be well worth retaining,
perhaps as an appendix.
3860 General Principles and Methodological requirements and Practices
This section provides useful information for REBs and researchers about principles and methodology in qualitative research. The examples are useful and
21
Section A.
Section A.
Section A.
Section A.
Section A.
Section A.
sufficiently detailed.
3915-7 The discussion of data destruction should be cross referenced to other sections of the Policy, including Chapter 9.
3929-3934 The discussion of variations in power differentials could also be cross referenced with the corresponding section in Chapter 9.
3860 : “General Principles and Methodological Requirements and Practices”
This section should focus specifically on the ethical issues raised for each subsection.
3878: ADD TEXT: “The term “qualitative research” covers a wide range of overlapping paradigms or perspectives. THESE MAY ALSO HAVE A
QUANTITATIVE COMPONENT (E.G., PARTICIPATORY ACTION RESEARCH).
3920-3923: “The intended goals of qualitative projects may include “giving voice” to a particular population, engaging in research that is critical of settings and
systems or the power of those being studied, affecting change in a particular social environment, or exploring previously understudied phenomena to develop
new theoretical approaches to research.”
The term “giving voice” sounds quite researcher-driven. Participatory action research (used as one of the examples of qualitative research) is about a more
collaborative process of regaining and/or claiming voice.
3929-3938 : “In some cases, research participants hold equal or greater power in the researcher–participant relationship – for example, in community-based
and/or organizational research when a collaborative process is used to define and design the research project and questions, or where participants are public
figures or hold other positions of power (for example, research involving economic, social, political or cultural elites).”
This sentence is too complex – need to break “community-based research” and “organizational research” apart into two separate sentences to avoid confusion
due to unintended conflation of the terms.
Section A.
Section A.
Section A.
Section A.
Section A.
Section A.
This paragraph is about power, not consent – it is unclear why it is under the subheading for consent.
• at line 3876, states that participatory action research is a qualitative methodology; this is not the case at all as PAR can be used with quantitative methods
as well
• the reflective approach stated in line 3881 should be expanded to the rest of document
• the discussion of research partnerships from line 3929-3950 should be placed in chapter 1; it seems out of place here given that partnerships are alluded
to many times earlier in the document
Lines 3954 to 3956, page 112
What does this sentence on “transferability of results from one setting to another being viewed as a theoretical issue” in qualitative research mean for REBs.
How should REBs take it into consideration?
nous nous interrogeons sur le parti pris épistémologique adopté par l'ÉPTC lorsqu'il soutient que toute connaissance
est vue comme une construction sociale. Nous pensons que le GER adopte un point de vue peut-être trop radicalement constructiviste, point de vue auquel
n'adhèrent pas tous les chercheurs qui utilisent des méthodes qualitatives. Cette position « forte » de la part du GER ne devrait pas être annoncée comme un
postulat.
Section A. f) Buts et objectifs de la recherche : la liste des objectifs associés aux recherches qualitatives et présentée par l'ÉPTC renvoie essentiellement à des
22
pratiques « engagées » ou « appliquées » : le fait de donner une voix ou d'influer sur le contexte, par exemple.
Il serait toutefois erroné de laisser croire que toutes les démarches de type qualitatif correspondent à ce modèle d'engagement. Certains chercheurs, au contraire,
préfèrent garder une distance critique avec l'objet de leur recherche, s'appliquant strictement à en déterminer les structures et les significations. Le poids accordé
par l'ÉPTC à l'importance de l'engagement dans sa définition des méthodes qualitatives de recherche pourrait avoir comme conséquence négative d'assimiler
toute recherche qualitative à des recherches appliquées.
Cette assimilation pourrait conduire les CÉR à évaluer une recherche qualitative en fonction d'un impératif d'engagement, exigeant du chercheur qu'il se donne
comme objectifs la résolution de problèmes sociaux ou la défense d'intérêts particuliers. Dans cette perspective, le terme « besoin » utilisé dans la phrase
suivante : parmi les buts visés par les projets de recherche qualitative, mentionnons le besoin de « donner une voix » à une population particulière » (en
ligne 4754) pourrait être remplacé par une expression plus neutre comme l'objectif ou la possibilité « de donner une voix ».
Section A.
Section B.
Cette section pourrait être reformulée de manière à conserver une posture épistémologique plus neutre, moins explicitement constructiviste, même si nous
admettons que cette approche balise aujourd'hui un grand nombre d'approches qualitatives.
Section A. i) : Résultats de la recherche
Cette section, incompréhensible à nos yeux, aurait avantage à être reformulée de manière à être plus intelligible (ligne 4797).
This submission is limited to the Tri-Council Policy (“the Policy”) as it relates to research in the humanities. The comments are based on relatively short
experience in assisting researchers in History and Classics to meet the standards set out in the Policy. At present, it generally requires multiple attempts by the
investigator to meet those standards. The main reasons for this are:
o scholars in the humanities generally do not receive much training on research methodology for research involving humans (despite the fact that a short
course is now required by graduate students at this University); and
o most scholars in the humanities depend on their research resulting in the disclosure of identifiable personal information, which is not generally the case
in other disciplines; this introduces special issues.
The current Policy can be difficult to explain to researchers because there are a number of cases where a broad statement is qualified in another part of the
Policy, and where there is not a consistent message in different parts of the Policy. These problems have not been fully resolved in the new draft of the Policy
(especially consistency between Chapters 2 and 5).
Most importantly for the humanities, the Tri-Council Policy does not clearly answer the questions that commonly arise in projects of researchers in the
humanities. In particular, the Policy does not adequately explain three matters.
o For the research that is intended to result in the dissemination of identifiable personal information, consent must address two different concerns - first,
consent to participate in the project (typically, to provide access to private records or to provide information in an interview), and second, consent to the
disclosure of their personal information when the research is disseminated.
o Privacy issues relating to third parties give rise to particular problems in the design of the research. Privacy principles require consent for the collection,
23
use and disclosure of personal information by the individual the information is about, not by the participating individual (e.g. an interviewee). Where the
individual the information is about is a public figure or an artist, the Policy is clear; it is not clear what is required where the researcher intends to
disclose personal information about an individual who is, for example, an interviewee’s spouse or other family member, friend or associate, or a member
of his or her community.
o For the REB member who must determine risk, it is unclear how to advise researchers what standard they need to meet with respect to disclosure of
personal information of third parties, e.g.
• disclose only if they can obtain consent (which may not be possible);
• disclose only if they first notify the third party, or provide the third party with a right of correction, or if they identify the source of the
information;
• disclose only if they judge that disclosure would not be harmful to the individual;
• disclose the information without specifically identifying the individual (even if disclosure of the information could reasonably allow the
individual to be identified by some readers);
• disclose on the basis that the benefit of the research outweighs any harm to the individual.
Section B.
Section B.
Section B.
To set the comments that follow in context, two examples of research in the humanities where these issues would arise are:
o research on marginalized communities under a currently existing, repressive political regime (the research subjects are not public figures)
o research on marriage and family relationships in a group of women who are public figures (the spouses, partners and children are not public figures)
This chapter is a good teaching tool as it explains many of the underpinnings of qualitative research; however, can a general template be developed within our
specific REB that considers these factors and helps to facilitate this complex and (often) emergent process?
The existing template
does not allow for the design principles of qualitative research – rather it is structured to fit the scientific model
While I think that the new draft of the policy statement is excellent, I would like to see one addition. That would be draft checklists specific to a number of
fields for research ethics boards to require applicants to fill out. For qualitative research undergoing review at a smaller institution where there might be no-one
on the ethics board qualified in the area, this kind of checklist would be invaluable to small institutions like
where ethics committees are
imbalanced and lack expertise in certain areas. The checklists would allow the researcher to outline some key components of the research model in advance of
the process and by answering detailed questions about the proportionality of harms and benefits, potential risks, and the free and informed consent process, it
would reduce the time spent by the Research Ethics Board in reviewing the application. With a checklist the board could easily decide whether the review
should be expedited because the research is minimal risk or whether full review is required. Many universities such as University of Ottawa, University of
Manitoba and University of Winnipeg already have such checklists. I ask that the panel members consider this addition.
There is an issue that has frequently arisen in my supervision of Education MA students’ thesis research – that of the conflict of interest in conducting action
research. My students are often full-time classroom teachers whose research data are drawn from their work with their own students. Often, they are unable to
gain ethics approval for working with data, such as student writing that they would normally gather in the course of their daily work with their students, until the
end of the school year after all their grades have been submitted. They’re not permitted to see which of their students’ parents have submitted consent forms
until the end of June. This means that MA students who are full-time teachers choosing to conduct action research can only complete their research at the end of
the school year. My students and I understand the potential conflict of interest in being granted access to student data before grades are submitted, but we also
24
Section B.
Section B.
Section B.
Section B.
Section B.
believe that teachers’ professionalism should be taken into consideration when applying the spirit of conflict of interest to ethics protocols for action research.
I’m wondering if it is possible for the committee revising the TCPS to look further into the special case of teachers’ action research when defining
considerations for determining conflict of interest.
Confidentiality in small communities
Ethics review lays a great deal of emphasis on protecting the confidentiality of individuals. When conducting community based research with participatory
models such as sharing circles, confidentiality goes pretty much out the window.
Regarding participatory action research,
would like to see greater clarity for complex settings where the researcher is working with a community
and where the work expresses a community's voice. The safeguards for the community’s researcher and research participants may involve complex informal
relations between the researcher and the community.
feels that the document could be strengthened by the addition of a separate section on
participatory action research and community‐based research, to address issues surrounding anonymity for the REB. The committee suggests that PRE examine
the procedures put in place at the University of British Columbia as an exemplar of guidelines for reviewing the ethical issues surrounding these types of
research (University Policy #89: Research and Other Studies Using Human Subjects).
was pleased to see that the new policy addresses some of the forms of used by humanists such as textual analysis, cultural histories, literary
biographies, or cultural studies. However, some of our members expressed the desire to see more clarity in the policy to differentiate between the “use” of
individuals as “experts” and as “research subjects” and to deal with some grey areas. For example, if an expert is interviewed about postmodernism, presumably
an ethics clearance is not required. However, is one needed if the same expert is interviewed on her most recent book on
postmodernism?
notes that whereas journalists are allowed to publish interviews, academics are often constrained by REB requirements,
preventing them from responding quickly to public events.
Les approches participatives sont à peine mentionnées dans la section sur les autochtones et la recherche qualitative. Les approches participatives se
développent en sciences de la santé notamment via la promotion de l'application des connaissances intégrée par les IRSC. Ces approches sont génériques, et
touchent les méthodes qualitatives et quantitatives. Serait-il approprié d'ajouter une section ou une annexe sur ces approches et leurs enjeux spécifiques? je ne
suis pas certain en effet que tous les CER connaissent ces approches et enjeux.
Social Science and Humanities Research
I am quite concerned about the way in which social sciences and humanities research is treated in the draft revision.
I
well understand the concerns of social sciences and humanities researchers. However, in this and the current version of TCPS, many of the exceptions and
remarks directed to social sciences and humanities research appear to me quite ad hoc.
Thus, in a number of chapters sections of text were taken from the current version of TCPS without revision. This particularly applies to various
exemptions for social science and humanities research. A good example is the discussion of “professional protocols” in Chapter 2. There is no clarity as to what
counts as such a protocol. Hence, REBs and researchers are free to make their choices without substantive limitation. A similar exemption via appeal to
“professional standards” is given to researchers who engage in “critical inquiry”.
While I deeply appreciate the value of free inquiry it is important for a major guidance document to say what the Research Agencies stand for. For
example, do the three Research Agencies require the free and informed consent of those who are interviewed, or may this be foregone in prescribed
circumstances? There is a profound governance question here – are the Councils endorsing any and all professional and disciplinary standards? Is there any
ethical bottom line like informed consent of participants? There are also a host of practical questions among them the following. What if there are conflicting
standards? May a researcher deliberately appeal to highly edgy disciplinary and professional standards? Must the REB agree with this? Must REBs be
25
Section B.
knowledgeable about any and all standards?
In the new chapter on qualitative research, I thought that characteristics asserted for qualitative research could in particular cases apply to quantitative
research. For example, dealing with power imbalances or requiring the use of research partnerships would be typical situations encountered by biomedical
researchers working with stigmatized vulnerable populations. I am concerned about TCPS being used to reinforce divisions between qualitative and quantitative
researchers when in most cases they face a common range of ethical issues in research.
One of the difficulties is that, Chapter 10 repeats material covered earlier in the draft (e.g., under consent or privacy chapters) but the overlap is not
properly acknowledged. There is a further fault in that there is a failure to explain what exceptions are claimed for qualitative researchers could not be equally
well be claimed by quantitative researchers in similar circumstances.
In this and other chapters that qualitative and other types of social science/humanities research is different than research in other areas (e.g., biomedical
research or quantitative research) it is essential to say why it should be regarded as exempt from strictures that apply to other types of research. As it stands there
is a catalogue of exemptions from various types of oversight for a variety of areas of social sciences/humanities research, e.g., qualitative research and critical
inquiry research which in many cases appear to be quite ad hoc.
It also is important to provide a plausible account of why a difference in research methodology and context makes a meaningful ethical difference in
how the research ought to be reviewed. In some cases, the accounts offered are quite implausible. For example, a particularly egregious passage (483-514) is the
discussion of balancing risks and benefits. There the argument is that social sciences and humanities research is different than biomedical research because it
does not involve risk to the physical well-being of participants. But we know that social sciences and humanities research can pose physical risks and that
biomedical research can pose non-physical risks. It is also false to imply that physical risks are inevitably more significant for participants than non-physical
risk.
5. Qualitative Review
The new chapter - Chapter 10 Qualitative Review - is an excellent and welcome addition to the new guidelines. Recognizing that qualitative research does not
fit well within the construct of the current guidelines, which seem predicated on the assumption of a discrete methodology among other things, the new chapter
provides welcome advice and direction on how the particular challenges of research ethics review within the context of social sciences and humanities and other
qualitative research activities may be addressed. The flexibility of process and implementation of the guidelines within this context is a refreshing change from
the previous biomedical orientation of the guidelines. However, there is a need to have greater elaboration as to how this flexibility may be applied in the
practical or operational sense. Best practices would be appreciated and helpful.
Section B.
Section B.
This section does not adequately address issues of potential coercion (for example a teacher who is a researcher using his/her students as participants) and the
importance of providing informed consent (and verification of same).
The
has a policy
that supports the Submission of student research for REB review. This perhaps limits the opportunity for
misunderstandings or unclear expectations re: the consent and REB review process in place for review of student research. For on-line surveys, participants
should indicate on-line that they agree with a consent document posted on-line as part of the study.
4806 et 4807 : Quel sens veut-on donner aux questions d’éthique particulières soulevées par l’utilisation des données et la publication des résultats?
Section B.
4812 et 4813 : Dans ce contexte, que veut-on dire par faire «preuve de souplesse et d’un bon jugement dans l’optique d’une approche proportionnelle du degré
Section B.
26
Section B.
Section B.
Section B.
General
General
General
General
de risque?».
The draft document describes that issues distinctive to qualitative research can occur at times. In relation to the issues that could arise during the process there is
a need by the researcher to exercise discretion, sound judgment and flexibility. Does the researcher need to address this possibility in their REB proposal and
how he/she will deal with possible anticipated issues (line 3965)?
4. Qualitative Review Recognizing that qualitative research is not always well served by current guidelines (ie. which often assume discrete methodologies), the
new chapter provides constructive advice and direction on how the particular challenges of research ethics review within the context of social sciences and
humanities and other qualitative research activities may be addressed. The flexibility of process and implementation of the guidelines within this context is a
refreshing change from the previous biomedical orientation of the guidelines. However, there is a need to have greater elaboration as to how this flexibility may
be applied in an operational sense. The development and inclusion of best practices would be a valuable addition.
Section B : Évaluation éthique de la recherche dans le contexte des questions inhérentes à la recherche qualitative :
Comme nous l'avons indiqué dans le commentaire introductif, les précisions concernant le processus du consentement devraient être intégrées au chapitre 2
consacré à cette question.
I was generally pleased with this chapter, too. Some of the language used is a bit dated, though. For example, hard core qualitative researchers now refer to data
as "empirical materials" to underscore the use of virtually anything as data (e.g., photos, text, objects, drawings).
The new material on qualitative research is valuable. However, there is a troublesome change in style restricted only to that material. This may warrant some
attention. The impression one receives from reading the material on qualitative research is that the writers are being defensive, taking great (and redundant)
care to fend off intrusive REBs. Emphasis here is on identifying research that does not warrant REB review. Only with respect to qualitative research is the
reader told (at least six times) that these researchers have disciplinary and/or professional ethics guidelines which should be respected by REBs. (Do the ethics
guidelines of other research disciplines not deserve respect?) One cannot but wonder whether the document represents a consensus or merely a truce.
Thank you for the opportunity to provide comments on the second draft of the Tri-Council Policy Statement on Research Ethics (TCPS) through the
regional consultation tour. Since this document governs all funded research involving human subjects in Canadian universities, as well as providing a
framework for individual Research Ethics Boards, its significance to the research conducted by faculty and graduate students in our Department is well
appreciated. Indeed, over the past couple of years, we have spent time in our Departmental meetings discussing this important statement
Common to research conducted by political scientists in Canada, members of our Department often engage in analysis of public policy, and likewise, a typical
reason that both professors and graduate students would approach our faculty research ethics board would be to seek approval for the use of elite interviews.
As such, for political scientists “research subjects” are often powerful people who actually have some responsibility for communicating with researchers as part
of their jobs. In light of this characteristic research performed by Political Scientists, I was especially pleased to see that the second edition of the TCPS
contains a chapter on qualitative methods, and is both sensitive and nuanced, for example by recognizing that in some instances consent can be inferred “from
the professional responsibilities of the research participant” and that in particular settings it may actually be culturally inappropriate to seek written consent
(lines 1247-1254).
My research frequently involves testing human subjects who use existing or newly designed user
interfaces in a variety of contexts. This involves a variety of methods ranging from interviews to observational studies of existing work practices. Except for
studies conducted within our lab on ourselves (which is frequently the first level of evaluation for a new technique) all of the research is performed under
certificates of approval issued by
.
27
I felt that the session was very
useful to me in understanding the wide scope of issues that are under discussion. I was very pleased to find that the panel, at least those who were in attendance,
seemed genuinely open to suggestions for further consideration. I came away from the meeting with a sense that there is a strong commitment on the part of the
panel to evolve a policy that meets the needs of all of the stakeholders, and that there has been fairly wide consultation already. I attended the meeting because I
am very interested in how the policy applies to my own research. Specifically, I have had concerns for some time that the implementation of the policy at
does not reflect the pragmatics of how research with human subjects is conducted in computer science.
I think it is worth noting that, as I mentioned at the information session when I spoke to the panel, the very first experience when I arrived at the information
session was that I was asked to sign in by filling out a form. The form listed a number of disciplines from which I could choose. Computer science was not one
of them. This is characteristic, I think, of the lack of recognition of there being legitimate research within compute science that studies human subjects in a
manner that may differ in significant ways from how research on or about computers and computing might be undertaken in other disciplines.
I should clarify this last statement. Some research in computer science is exactly the same as some research in other fields. For example, my first research with
human subjects, which was done in collaboration with psychologists, is precisely classic psychophysical experimentation. Subjects view stimuli on a computer
monitor and they respond either with button presses or they manipulate parameters that modify the stimuli in various ways until certain objective or subjective
criteria are met. Obtaining ethics approval for these studies is straightforward. As for many of my colleagues in psychology, a “one size fits all” ethics
certificate can be obtained that is renewed annually with little or no need for amendment other than to add the names of new graduate students as they join the
program.
The procedures are almost always adequately described by “Subjects are informed of the purpose of the study, they are asked to sign the consent form after
having had adequate opportunity to review it ahead of time, they view a series of stimuli on a computer display, and they respond using one or more input
devices that control the display. All interactions are logged with time stamps using computer software, and audio or video recordings are (optionally) made of
the trial sessions.” These procedures cover experiments to test variants of Fitts’s Law (1954) for traditional mouse and tablet devices as well as more exotic new
3D and 6-degree-of-freedom devices, color matching experiments reminiscent of those done to establish the CIE system (1931), and a variety of other
experiments aimed at better understanding menu selection using different styles of GUI widgets, recall of command line names and parameters, and navigation
strategies in hypertext and on the World Wide Web. Frequently standard instruments such as tests for color blindness, stereopsis, or handedness are
administered.
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Where things begin to get complicated is the questionnaires that are often administered as part of these studies. In psychophysical studies, there is little or no
need for questionnaires beyond standardized questions that might include number of years using a computer, or standard demographic measures such as age,
gender, or level of education. But when studies are conducted that relate to specific software programs (such as a commercial word processor), it is necessary to
know how much experience subjects have with the specific program or with similar programs. Because of this, it is often necessary to amend ethics certificates
to include the revised questionnaires. It is not clear to me, or to my colleagues, the degree to which an approved questionnaire can be modified without requiring
an amendment. If new questions are added about experience with a technology that has only recently arrived on the scene, such as Facebook, is it legitimate to
use an existing certificate that says only that “subjects will be asked about their experience using certain websites”? Or is this a new direction of research that
must be reviewed by a
?
Amendments are costly in terms of time – both the time of the researchers and the time of the
. This issue of time is I think one that points out a difference
between the type of studies done by some computer scientists and those in other disciplines. Many of our studies are not conducted to determine fundamental
properties of human beings, which is what the Fitts’s Law, color matching, menu selection, and command name recall studies address. They are instead
formative evaluations done within the design cycle of new techniques or interfaces for computer applications. Unlike a psychophysical study where a theoretical
framework may be developed over a matter of months, or a pharmacological study where a new drug may have been developed over a matter of years, one of
these studies may be the result of a discussion “in the hallway” on Monday, a prototype implementation completed on Tuesday, a user study conducted on
Wednesday and analyzed on Thursday, and a new and improved design on Friday.
Here is where the rub comes. A traditional computer scientist whose research is largely in the area of developing software, which often includes a user interface,
would not consider this testing to come under the auspices of the Tri-Council Policy Statement. While this might be incorrect, I can assure you that for many
decades many of my colleagues conducted their research as if this were the case. Often they did so because they were unaware that they even needed to consider
this possibility. I think there is an argument that although some degree of scrutiny is certainly called for, this type of evaluation is something with very low
inherent risk and thus there ought to be a more lightweight process for assessing it. What happens in practice is that there is a divide between two subgroups.
Those of us who conduct research that is not as lightweight end up having to obtain full ethical approval for both our “heavyweight” studies and our lightweight
studies because once we fall under the purview of the
there is no other alternative, whereas our colleagues who never venture into that type of research
are able to fly under the radar.
It may sound as if the solution is trivial: Everyone who does user studies should be subjected to the same rigorous review. I disagree. I think there are very clear
distinctions that can be made between the type of everyday user testing that is conducted as part of the design cycle for software and other types of research
conducted in computer science where there is a much more significant likelihood of harm being done to subjects that does justify full review. In particular, I
think there could be a very clear policy that would allow changes to questionnaires that only ask about use of particular software products being exempt from
requiring amendment under specific circumstances. (Aside: The circumstances are important. Changing a questionnaire from “Have you used Google on the
web?” to “Have you used Facebook on the web?” would fall under the benign category, whereas asking “Have you used AbortionReferral.com on the web”
certainly has a very different implication for expectations about privacy and informed consent.)
To summarize the main point so far: I believe that many of the procedures in place for
were developed to deal with studies that have a much
longer term (months or years) than do the relatively spontaneous and short-lived (days or weeks) studies that are often appropriate for some (not all)
29
General
investigations in human-computer interaction. The process required to obtain ethical approval seems overly complex and onerous given the risk inherent in
these types of studies.
Let me now argue the flip-side: There is research carried out by computer scientists where we get away scot free. Line 627 of the Draft 2nd Edition excludes
“website usability testing”. I think this reflects a lack of understanding on the part of the panel as to the wide range of activities this simple phrase covers. I
suspect the panel thinks that this refers to low-level tinkering by technicians who maintain websites. I disagree. As time marches on, more and more applications
will be web-based. The entire Web 2.0 and SaaS (software-as-a-service) trend will eventually mean that virtually any research on user interface design and
usage could be claimed to fall under the category of website usability testing. That would mean that none of the research would be scrutinized. This is very
wrong. Here’s but one example of why I think this is the case.
Researchers in a variety of disciplines (computer science is one) have explored how technology can improve learning outcomes at each and every level of the
education process, including post-secondary education.
developed WebCT, now a commercial product, for this purpose. A
researcher who is interested in user interface design might modify the interface to one of the modules within a system such as WebCT to test the hypothesis that
a particular style of navigation (such as threaded versus unthreaded discussion groups) better supports peer-based learning among students. This is surely a
noble goal. But if the study involved using the two different techniques in a between-subjects design where one section of a course had threaded discussions and
another did not, I would worry very much whether students in the course might be assigned term marks that reflected differences in learning outcomes that were
the result of the experimental manipulations. Students might lose twice: those using the less effective navigation style would learn less and they would
(presumably) receive a lower mark that might affect their future chances for post-graduate education.
If this seems like a contrived example that common sense says we ought to know requires ethical review, a second example might drive home the distinction I
want to make. Suppose that instead of manipulating navigation style, the research involves a new caching algorithm on the web server. Many would not even
consider this to be usability testing, because the caching algorithm only affects system performance not user interaction (caching in this case means the
information that the web server retains in fast memory so it can be sent to web clients immediately, rather than being retrieved from secondary disk storage each
time it is required). But the educational and human factors literature abounds with studies that show that response time has a great deal to do with attentiveness
and other factors that determine learning outcomes. This would mean that students taking a course the term this manipulation was performed who might
experience longer than usual or shorter than usual response times from the web-based learning tools could be expected to see their learning outcomes affected.
(Aside: Ironically, there are studies that show that slower response time leads to greater care and diligence on the part of the user, so we might expect that the
outcomes could be either positively or negatively correlated with decreases in response time (Goodman & Spence, 1982).)
General
To summarize my second point: I think the blanket exclusion of web usability testing betrays a lack of understanding of computer science research and the
growing importance of information and communications technology and the research methods that surround it.
My third point relates to comments
, that there are some references that could be consulted regarding how research involving
human subjects relates to computer science. I think this is a large area that is not really well covered by current ethics procedures. The activities I refer to are
when academic researchers interact with practitioners in the field, often those who are employed by software companies. These are in many respects our peers.
As academics, we want to engage with them to better understand how they work, since our own software development practices are usually quite different than
what is found in industry. The problem that I see is that current ethics procedures assume that interviews or observations are inherently fraught with danger and
30
that those being studied are quite likely to be naïve to those dangers. The full weight of informed consent is thus brought to bear, which can have an off-putting
effect on getting managers to approve involvement, especially if they request that researchers sign non-disclosure agreements that might preclude providing full
information on the protocols to
review members. This leaves the researchers caught in between.
answers to no one recognized by a
company developing software (i.e., the company has no reason to believe that members of
will maintain confidentiality). And
does not
believe that the company will look after the best interests of its employees.
At one time I thought I knew now to get around this problem.
ethics application had a question about whether the research involved interviews with
experts. I naively thought this was the way around the impasse. Surely software developers were experts in their fields, and thus a more lightweight “minimal
risk” process might be available. To my dismay, I found out after enquiring that interviews with “experts” trigger more, not less scrutiny. No one has been able
to explain this to me.
I suggest the following three references that might be helpful in providing a snapshot of the range of human subject research that is (or should be) conducted
within software engineering. One of the co-authors (Dr. Janice Singer) may have been involved in the discussions surrounding the Draft 2nd Edition.
Dittrich, Y., John, M., Singer, J., and Tessem, B. (2007). Editorial: For the Special issue on Qualitative Software Engineering Research. Inf. Softw. Technol. 49,
6 (Jun. 2007), 531-539. DOI= http://dx.doi.org/10.1016/j.infsof.2007.02.009
Lethbridge, T. C., Sim, S. E., and Singer, J. (2005). Studying Software Engineers: Data Collection Techniques for Software Field Studies. Empirical Softw.
Engg. 10, 3 (Jul. 2005), 311-341. DOI= http://dx.doi.org/10.1007/s10664-005-1290-x
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Singer, J. and Vinson, N. G. 2002. Ethical Issues in Empirical Studies of Software Engineering. IEEE Trans. Softw. Eng. 28, 12 (Dec. 2002), 1171-1180. DOI=
http://dx.doi.org/10.1109/TSE.2002.1158289
The text throughout this chapter, and elsewhere, repeatedly uses the phrase “disciplinary and professional standards” in a way that suggests that REB’s should
defer to them. The problem is that they are not articulated in a way that provides any guidance with respect to how the REB should consider them. For example,
could a researcher say that this is “my professional standard” and the REB must accept it? Surely, if the principles of ethics apply, then one only need to be
flexible in considering how this application may vary (methodologically) from discipline to discipline… not to invoke some other authority when the ethics are
in question.
I very much appreciated the importance of qualitative methods being addressed. This nicely legitimizes and brings into the mainstream the whole area of
participatory methods. This underscores the need to engage with stakeholders and, in particular, with communities, on the appropriateness of setting up
steering/oversight committees to oversee/govern any and all studies that include community members, usually applicable in applied population-based research.
5- Une reconnaissance de la recherche-création / La nouvelle version de l’Énoncé tient compte de la recherche-création comportant des sujets humains. Bien
qu’il s’agisse d’un pas dans la bonne direction en comparaison de la version actuelle de l’Énoncé, les auteurs traitent peu de la question sous l’article 2.6 du
document. Le mémoire produit sur la question dans le cadre des travaux du GER ayant conduit à l’article 2.6 est beaucoup plus étoffé.
Suggestion de modification : Afin de faciliter le travail des CÉR ayant à évaluer des projets de recherche-création, n’y aurait-il pas lieu de traiter de la question
dans le chapitre consacré à la recherche qualitative, en lui réservant une section propre (article et application) ?
31
General
148: There is variability in the quality of chapters and some may require major streamlining (in particular, chapters 1, 8, 10, 11, 12 and 13).
General
General
370 The discussion of observations in public places is better developed in Chapter 10 on Qualitative Research and should be cross-referenced.
While the chapter was generally well done, there was a clear division of opinion about the merits of dealing with qualitative research in a separate chapter of the
TCPS. On the plus side, some researchers felt that it would be useful to have information relevant to qualitative research in one place and would ease for
qualitative researchers the process of consulting the TCPS for guidance on specific issues. Others felt that the separation gives the impression that quantitative
research constitutes the standard with qualitative research being treated as an “add-on.” There were concerns about the messages this sends about the relative
legitimacy of the two traditions. There were concerns as well that by creating a separate qualitative chapter, qualitative researchers might be tempted to read
only this chapter and not pay much attention to the rest of the document, and that conversely quantitative researchers would ignore Chapter 10 when they too
would benefit from reading parts of this chapter.
General
General
The alternative to a separate chapter would be to integrate discussion of qualitative research into the relevant sections of the policy. If the drafters of the revised
policy reject this direction, there should be much more bi-directional cross-referencing between various sections of this chapter and the rest of the policy.
Some contradictions were noted between chapters. If someone conducts qualitative research, he/she can do “trial” studies which address the consulting aspects
in Chapters 9 and 10. But if someone is a quantitative researcher, he/she would presumably have to get approval first. They’ve created two standards.
Maybe this draft chapter needs to be more exact about qualitative and quantitative research and Aboriginal research and that they are not so distinct but
overlapping categories. There needs to be guidance in how the chapters ought to be read in relation to one another. It would be helpful to know when and how
these Chapter 9 guidelines apply and when are there differences that REBs should consider.
This chapter applies only or chiefly to qualitative research; therefore, the reviewer or REB needs to determine first the kind of study, and then if it is qualitative in order
to apply these articles. Studies involving mixed methods (qualitative and statistical) may need special consideration from the REB.
General
The triangulation of data collection methods if using qualitative methods together with statistical methods will make ethics forms more complex for REB offices.
General
We wonder about the need to educate readers of the Draft about qualitative research since other types of inquiry are not explained/described in the Draft. The
fundamental principles are the same regardless of methodology but they may require special attention or interpretation because of research methods. More of the
chapter should focus on ethical issues that arise in qualitative research, rather than a description of what qualitative research is. Given the length of the Draft, we
think a more specific focus is important. However, if qualitative research requires a chapter of its own, then this suggests the possibility that so does quantitative
research. We request careful consideration on this matter in the revision.
Comme bien des membres de la communauté universitaire, nous nous réjouissons de la place accordée par l'ÉPTC à la recherche utilisant des méthodes
qualitatives. La présence dans le nouvel énoncé politique d'un chapitre consacré aux spécificités et aux contraintes de ces approches relatives au processus
d'évaluation éthique est donc accueillie plus que favorablement. Cependant, ce chapitre gagnerait en pertinence et en efficacité s'il était présenté au tout début du
document de l'ÉPTC, plutôt que dans ses dernières pages. En effet, bien des directives nouvelles de l'ÉPTC trouveraient leur sens si le lecteur avait été exposé,
dès le départ, aux spécificités de la recherche qualitative.
General
La structure actuelle de l'ÉPTC a le défaut de diviser artificiellement la recherche universitaire en deux types bien définis : l'un correspondant au modèle
32
biomédical (ou quantitatif) qui trouverait son encadrement éthique dans l'ensemble des chapitres de l'ÉPTC, l'autre type, de nature qualitative, devant se référer
au chapitre 10 pour y trouver les critères qui lui sont adaptés, notamment en ce qui concerne les domaines du consentement ou de la protection de la vie privée.
Loin de correspondre de façon aussi mécanique à l'un ou l'autre des deux types, nous pensons, au contraire, que chaque projet de recherche soulève ses propres
enjeux éthiques, à chaque fois différents, et qu'il est possible de retrouver autant de diversité sur le plan de l'éthique entre deux projets qualifiés de
« quantitatifs », qu'entre un projet « quantitatif » et un projet « qualitatif ». Les CÉR sont donc conduits à évaluer chacun des projets en fonction des enjeux
éthiques spécifiques qu'il soulève et au moyen d'une conjugaison de critères évaluatifs à chaque fois différents.
General
L'ÉPTC, comme outil de référencement, devrait donc faciliter la tâche de l'évaluateur en rassemblant, sous une même rubrique, toutes les situations spécifiques,
toutes les solutions possibles relatives à un examen éthique. Il serait donc opportun que les situations particulières présentées au chapitre 10 soient toutes
rapportées à chacun des chapitres qui traitent spécifiquement d'une question comme celle du consentement, de la vie privée, de l'intégration, etc. Cela éviterait
d'avoir à consulter à la fois le chapitre concerné (par exemple le chapitre 3), et le chapitre 10 pour prendre connaissance de tous les choix qui s'offrent tant au
chercheur qu'au CÉR lorsque vient le temps d'appliquer un critère adapté lors de l'évaluation éthique.
My two initial hangups are Article 1.1 and the absence of a section that pertains to pop health or epidemiologic research. Article 1.1 is in a way a cornerstone
and tone-setter. To my reading, it implies that the purpose of ethics review is to protect people - period. I think that's a dangerous starting point. As for the
absence of a section on quantitative pop health or epi research, I fear that ethics committees will infer that such research was meant by your panel to be treated
as Clinical research or as Qualitative research, and that they will consequently look in the wrong place for guidelines.
There are different usages for some terms that need to be considered. For instance, you use the term "observation research" to signify research where the
researcher is literally observing (by eye) the subjects. In epidemiology, the term is often used as a synonym for "non-experimental research" and a contrast with
the term "experimental research" to signify research where we "observe" people's characteristics, habits, exposures etc by means of questionnaires or records,
not necessarily by looking at them.
There was a mention somewhere that the purview of the doc is on living people. But in epi research, we sometimes deal with subjects known to be dead, and
sometimes with subjects whose vital status is unknown and establishing it is the purpose of the research.
Introduction
This is based on an admittedly superficial glance-through. I'll try to get back to you with some more systematic commentary, and I'll try to get some more
researcher input.
Overall, Chapter 10 represents a significant addition to the TCPS1. It provides an informative overview of qualitative research that will be especially helpful for
REB members unfamiliar with qualitative research methodologies and uncertain about how to understand and respond to ethical issues that arise in ethics
review submissions. Qualitative researchers and others more familiar with qualitative methodologies might find the representation of qualitative research
somewhat limited and the language more suited to some qualitative methodologies than others. While the revision and inclusion of a section on qualitative
research is an important step forward, the rather narrowly defined representation of qualitative research raises a significant concern. Within a contemporary
context of qualitative research methodologies, the rendition of qualitative research put forward in Chapter 10 already seems outdated. Given the time and
resources involved in revising the TCPS and given that each iteration is likely to build on the original foundation, there is a very real concern that the foundation
of Chapter 10 may not be robust enough to support subsequent revisions and that the ethical issues (particular to qualitative research) discussed will always be
33
Introduction
Introduction
wanting.
Line 3835 Insert/replace?
“dependability” with “able to be replicated”?
Similarities and differences between biomedical and social science research.
REB reviews both biomedical and social science research proposals. In, but not limited to Chapter 10, the draft revised TCPS contain a number of
provisions for social science research that are purportedly different from the provisions for biomedical research.
(a) We would urge clarification to ensure that the differences are intended (and not simply to remind REBs of provisions applicable to both biomedical
and social science research).
(b) Where a difference is intentional, the rationale for such a difference should be clearly stated.
(c) Because many biomedical projects include significant social science components, it is necessary to be attentive to the ethical implications of
conducting social science research in the context of medical care and treatment.
Introduction
Introduction
Introduction
Introduction
Introduction
Introduction
Introduction
I note that in your introduction to Qualitative Research you mention a number of disciplines that do this sort of research, but you fail to mention Socio-cultural
Anthropology. As this is a discipline that has made an enormous contribution to this research method, I find this a serious oversight. It would also help
Anthropology researchers receive fair consideration from ethics review committees if they are identified clearly with this type of research by the tri-council
policy document.
3830-3832 I would rephrase this comparison of qualitative research to biomedical research to contrast qualitative research with quantitative research. This is in
keeping with the preceding lines. This would avoid repeating the misleading dichotomy between qualitative and biomedical research.
Clarifying “the Nature of Qualitative Research”
We understand that the inclusion of Chapter 10 focussing specifically on qualitative research methods is responsive to previous critique of TCPS bias towards
the biomedical model. We also concur that “many of the research practices and methodological requirements that characterize qualitative research approaches
parallel those that characterize quantitative approaches – concerns regarding research quality (e.g., dependability and trustworthiness of data), for example”
(3832-3835). As critical knowledge social scientists using multiple method approaches, we would, however, go further with this point. We maintain that,
regardless of discipline, all research involving human participants must, “as is the case with ethics” adapt to the specific “subject matter, context and
epistemological assumptions” (3835-3837).
In the opening section, second paragraph, the medical bias of the Tri-Council ethic process still appears. More specifically, the sentence “Qualitative research
approaches are inherently dynamic and are grounded in different assumptions than those that shape the biomedical model of research.” Why is this contrasting
qualitative with biomedical research? Why not the more inclusive “quantitative research”? As social-scientists, we take exception to the implicit assumption that
biomedical research is somehow the norm.
La première page du chapitre 10 ne précise pas assez clairement les contraintes de la recherche qualitative. Dans le but d’éviter que celle-ci puisse être perçue
comme étant moins rigoureuse et d’une moins grande scientificité que la recherche quantitative, ne serait-il pas approprié d’inclure, dès l’introduction, des
exemples de recherche qui exposeraient les particularités de ce type de recherche, telles qu’elles sont énumérées, dans la section A consacrée à la Nature de la
recherche qualitative.
4643 et 4644 : Pour bien comprendre le sens de la phrase, il faut remplacer le terme «hypothèses» par celui de «prémisses».
4658 : Il conviendrait de référer le lecteur aux lignes auxquelles il est possible d’obtenir de plus amples détails.
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Introduction
Introduction
Introduction
Introduction
Line 3830-3834: Comparison between quantitative and qualitative research
‐ This seems to be suggesting, at least indirectly, that quantitative research is based on a bio-medical model which is not accurate. Could this be
clarified? At the very least, the impression should not be given that quantitative research and clinical trials are directly comparable.
Line 3821. Other forms of history research, such as oral history should be included.
3820 : “Researchers in HEALTH, social sciences and humanities, such as sociology, psychology, criminology, business administration, political science,
communications, education and history, have a common belief in the desirability of trying to understand human action through systematic study and analysis.
Some researchers use quantitative research approaches, others opt for qualitative research methods, and some use a combination of both.”
It is important to include health researchers. The examples of disciplines should be deleted as they add length but are not essential to list.
3825-3828 : “Qualitative research has a long history in many well-established disciplines in the social sciences and humanities, as well as many areas in the
health sciences (e.g., nursing). Research developments point to an increasing prevalence of qualitative approaches, whether in health research or in social
sciences and humanities disciplines.”
Introduction
This text is redundant and should be deleted for reasons of length.
3843-3845 : “Researchers and research ethics boards (REBs) should also consult other relevant chapters of the Policy for additional details on principles, norms
and practices applicable to qualitative research.”
Introduction
These other sections should be specified. There are a number of relevant details spread through out the Draft but it seems impractical to expect researchers to
read the Policy from start to finish to find them all.
• overall, happy to see inclusion of this chapter, but it still seems to stigmatize and dissociate qualitative research from other types of research (e.g. at line
3826, states that qualitative research is used by some disciplines [e.g. nursing] – this seems pejorative); better linkages with quantitative approaches
throughout the chapter would be helpful, as the two approaches should work in tandem!
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