Comments on Chapter 13 --- Human Genetic Research General

Comments on Chapter 13 --- Human Genetic Research
General comments on this chapter:
Consistent with my comments to Chapter 12, this chapter needs to be under continuing review. With the pharmacogenomics explosion (and other “omics” research), it is almost certain
from my perspective that this area of research will raise considerable issues well into the future that may require rapid revision of the guidances in this chapter. The core principles are
fine. The issue of the right “not to know” is an important concept that is insufficiently considered by many bodies.
Good chapter. I especially applaud the discussion of the implications of genetic research for families and communities.
Overall, Chapter 13 is clear and thoughtfully-written.
There is variability in the quality of chapters and some may require major streamlining (in particular, chapters 1, 8, 10, 11, 12 and 13).
Article #
Issue Raised
13.1
LIGNE 6324 : La recherche en génétique doit nécessairement faire l’objet de beaucoup de précautions. Or, les chapitres précédents multiplient les méthodes
par lesquelles il est possible de passer outre au consentement des participants (par exemple pour des utilisations secondaires d’information – Chapitre 5, articles
5.5 et 5.6). Nous ne croyons pas que cela soit approprié dans la plupart des cas.
13.1
We believe that when genetic studies are being tacked on to other clinical trials, a dedicated approach to informed consent is necessary to disclose information
particular to the genetic aspects of the study.
It should highlight the particularly sensitive nature of genetic information, as well as the way in which secondary use of previously collected and banked genetic
material will be managed, and the precautions that will be taken in relation to these.
13.1
13.1
1
For as the draft notes, “Participants in clinical trials are increasingly being asked to participate in genetic studies in addition to the primary clinical trial (TCPS
2008, 5156-8).
Article 13.1 I think the implication of research for families, groups, and genetically related communities is very important – there is a need to reinforce the
special consideration regarding Line 5179-5180 and to refer researchers to the chapters which address Free and Informed Consent, Privacy and Confidentiality,
Human Tissue , Research Involving Aboriginal Peoples and Clinical Trials for guidance as to how these principles relate to families, groups and communities
and not solely to individuals.
Par contre, je remarque aussi que le consentement est encore traité uniquement dans l'optique du consentement INDIVIDUEL (sauf pour la recherche auprès des
autochtones). C'est bien dommage, car on évince encore tous les problèmes éthiques que soulèvent notamment la recherche en génétique et dans laquelle le
13.1
13.2
13.2
13.2
13.2
consentement de l'un entraîne des conséquences pour tous les autres qui partagent son patrimoine génétique (risques de stigmatisation, etc., assurabilité,
employabilité, etc.).
• confusing/misleading/inaccurate to put human genetic research as a separate chapter, since genetic research can be done on any human tissue; as such,
genetic research is very closely linked to issues concerning research involving human tissue, and can therefore be considered derivative of chapter 12
• in particular, due to the development of tissue banks and unclear guidance from the Tri-Council on need for consent from tissue donors re future studies,
particularly since theoretically even anonymized tissue can be identifiable, and the unknown future ethical issues related to genetic research, this is an area
where TCPS could show more clear guidance, or at least emphasize the unknown aspects and difficulties in this area
Line 5201 Insert
… of the particular genetic tests intended and of the
In article 13.2, we suggest that it be further specified that only genetic information relevant to the study at hand be analyzed and recorded, in order to minimize
complications that might arise regarding handling genetic information.
This caveat will also minimize communication and disclosure issues specified in articles 13.3 and 13.4.
Ligne 6381. En parlant de résultats non identifiables, visez-vous les résultats généraux de la recherche ? À clarifier.
Genetic Duty to Warn
Lines 5211 and 5212 - Article 13.2
Recommendations:
33. In line 5211, add the term “adoption” so that the statement would read "Genetic research may also reveal information about family relationships, including
adoption and non-paternity."
34. Add the sentence to line 5214 “Consideration for disclosure of these findings is based on the clinical and ethical implications for family members involved
and should be done on a case by case basis.”
13.2
Lines 5223 -5224 Article 13.23 (a)– Preference re Disclosure to Self
If findings are of known clinical relevance to the participant, reasonable efforts should be made to contact those individuals either directly (by the appropriate
person which likely would be the person that recruited the person for the study) and/or through a known healthcare provider for appropriate clinical follow-up. It
is not appropriate as described in the last paragraph to notify participants through a community newsletter only.
Recommendation:
35. Notification of findings that are clinically relevant to the participant should be a direct notification by the appropriate person and done in a manner that
2
permits the individual to get his or her results and counseling if required.
13.2
13.2
13.8
L5212: Should also be a comment about the participant’s right not to know.
Questions
1. With regard to biobanks that anticipate the use of their biological data and samples by a variety of research projects, who is responsible for the “information
revealed”?
2. Consider a researcher who accesses a resource such as
and who does not have the code to participants’ personal information and where the resource
containing the data and samples does not have direct access to this information but uses a third party fiduciary to hold the keys. Who will address the
“associated ethical issues”?
3. How does one judge when, how, and in what context it is necessary to recontact participants? Must there be advance consent by participants to any recontact?
4. What are the competencies required to provide genetic counselling? Are they described in an official document? Who can claim to be a provider of genetic
counselling services? Is it necessary to distinguish between research and clinical genetic counselling?
Comments
1. Page 152, Line 5286: The translation of “biological relatives” into parents biologiques is inexact. The French version of the Policy Statement should use the
phrases famille biologique or parenté biologique.
2. We believe that genetic research involves a risk of stigmatization similar to other forms of research such as social, medical or psychological or lifestyle
research.
3. Would it not be appropriate in this chapter to emphasize the principle of proportionate review? All too often, genetic research of any kind is perceived as
posing enormous risks for participants.
4. Line 6465: The Policy Statement should take into account the Canadian Association of Genetic Counsellors. Since 2007, this Association only allows
individuals who have received training in genetic counselling to sit exams and be certified as genetic counsellors. This change demonstrates their desire to
become a bona fide professional order and to prevent whomsoever to act as a genetic counsellor. Indicating in the DV-TCPS that genetic counselling services
can be provided by anyone other than a qualified counsellor or physician goes against the goal of many genetic counsellors, medical geneticists, and their
3
organizations.
Recommendation
13.3
Genetic research should be subject to the same obligations as other sensitive medical research.
Le Sous-comité croit que les plans de gestion de l’information mis en place dans le cadre de recherches en génétique devraient obligatoirement prévoir leur
communication aux participants, et il suggère de remplacer le terme « pourrait » par « doit ».
Line 5234 – change “To express” to “Express”.
13.3
Lines 5237-9 Syntax?
13.3
Line 5255-5273- point out the complicated interplay between the researchers’ obligations to disclose information and the participants’ preferences about
disclosure gathered in the informed consent process. Article 13.4 is an important reminder of the requirement for researchers to inform potential participants
about legal or ethical requirements for the researcher to disclose information which the participant did not wish disclosed.
Section B. Article 13.3 (a) raises the important issue of research participants not being interested in receiving information about themselves. Although more
acute in genetics, this is also true in some areas of social studies. This article should therefore be mentioned in Chapter 6 as well.
Lignes 6389 et suivantes – article 13.3. Votre règle en matière de communication des résultats devrait être nuancée pour la recherche pédiatrique. L’intérêt de
l’enfant devrait prévaloir et le parent ne devrait pas avoir la possibilité de refuser la communication d’un résultat significatif pour la santé des enfants lorsqu’un
traitement ou de la prévention est possible.
13.2 – 13.4
13.3
13.3
13.3
Lignes 6407 à 6410. Vous écrivez qu’un participant devrait pouvoir refuser de recevoir des renseignements dont la signification clinique n’est pas connue. Or,
les résultats dont la signification clinique n’est pas connue ne devraient jamais être communiqués aux participants. Il n’y a aucun avantage ou bienfait pour les
participants et cela peut soulever des risques importants d’anxiété, d’inquiétude et même de discrimination. Les résultats doivent être communiqués par un
médecin ou un autre professionnel compétent lorsqu’ils sont validés scientifiquement, qu’ils ont des implications significatives pour la santé du participant et
que la prévention ou un traitement est disponible. Il faut aussi tenir compte du moment de l’apparition de la maladie (maladie infantile ou apparaissant
seulement à l’âge adulte.
13.3
Lines 5234-5234 – Article 13.3 (b)–Preference re Disclosure to Others
This section deals with the expression of preferences about whether information will be disclosed to biological relatives or others with whom the participant
shares a family or group relationship.
Recommendations:
4
36. The Consent Form needs to clearly outline the circumstances and rationale for disclosure to relatives and how this would be done.
13.3
13.4
13.4
13.4
13.4
13.4
13.4
13.4
13.4
5
37. If information may be disclosed to others, notwithstanding that the participant indicates that he or she does not wish such disclosure to others, this must be
clearly specified in the consent, along with the circumstances in which this will be done.
Lines 5253 & 5254 Article 13.3
The current language is that provision of results to individuals "may" give rise to a need for genetic counselling.
Recommendation:
38. All individuals for whom individual results involve genetic issues, “…should be accompanied by access to genetic counseling.”
Les enjeux éthiques fondamentaux de la recherche en génétique humaine sont identifiés. L’article 13.4, portant sur une supposée obligation du chercheur de
divulguer certains renseignements pose des difficultés du point de vue des droits au secret professionnel et à la vie privée. Ces droits sont des droits
fondamentaux. La supposée obligation du chercheur est énoncée, mais elle ne fait l’objet d’aucune démonstration.
LIGNE 6425 : Il nous semble que ce n’est pas l’état du droit partout au Canada. De plus, l’impératif (mentionné à la ligne 644) devrait être d’ordre juridique et
non éthique. Lorsque le participant a exprimé sa volonté de ne pas être informé des résultats de recherche, comment ignorer cette volonté sur le simple plan
éthique, sans être appuyé par des arguments juridiques ? Par ailleurs, jusqu’où va l’obligation du chercheur quant à la communication de renseignements
pouvant avoir un impact sur la santé des participants et de leur famille ?
Article 13.4, “…researchers may have a moral obligation to disclose…” More detail ought to be given here: it would be appropriate to emphasize that this
seems only reasonable in very exceptional circumstances, viz. if there is: a clear and identifiable risk of harm; which can be prevented; which is imminent (if
there is time, more effort seems appropriate to ask the research participant to contact his/her family member); and identifiable person or group of persons.
It seems appropriate to mention here also the tension between the clear obligation of confidentiality, and the exceptional ‘option’ to breach confidentiality. The
TCPS2 could introduce here as a rule that researchers ought to consult with the REB when they are confronted with such a situation.
Section B. Article 13.4: there may be exceptional circumstances where health issues might outweigh privacy issues and such knowledge should be part of the
public domain.
Section B. In line 5269 a reference should be added to those who may face crucial reproductive decisions based on the information.
5259: Disclosure of genetic information to relatives: Please provide guidance, especially when the participant may have expressed a wish about non-disclosure
of information to family members.
Lignes 6433 et suivantes. Ce chapitre d’application répète l’article 13.4 et n’ajoute rien.
Lines 5259 -5265 Article 13.4 – Disclosure of information to biological relatives
This paragraph has a more lenient standard than the typical legal and clinical statements outlining the standards necessary to breach confidentiality to tell others
of potential risk.
Lines 5266 – 5273- Application
Recommendations:
39. Given that the researchers will be breaching confidentiality, the clinical standard as set out in the recommendation below should be the standard for such
disclosure.
40. The accepted clinical standard in clinical genetics and other professions used for determining if confidentiality can be breached should be used as a
guideline. The clinical standard used to determine that confidentiality can be breached requires a) Imminence, b) Seriousness & Irreversibility as well as c)
Unavoidability. This standard should be specified in the Consent, as well as in Lines 5266 to 5273 of the new TCPS.
13.4
Lines 5266 to 5273.
Although this section outlines the obligation to inform participants of a future possibility of disclosure to a third party (family members), there is the practical
problem of how researchers will find these persons and how to contact these potentially affected people with no guidelines for this contact.
Recommendations:
41. It would be helpful to have more guidance as to the appropriate procedures for finding relatives and contacting them, as well as what would constitute
“reasonable efforts” in this re-contacting process.
A more detailed definition of what “genetic counseling” is should be included in this section. One suggestion definition from the literature is as follows:
13.5
13.5
13.5
13.5
6
Genetic Counselling
“• Interpretation of family and medical histories to assess the chance of disease occurrence or recurrence.
• Education about inheritance, testing, management, prevention, resources and research.
• Counseling to promote informed choices and adaptation to the risk or condition.”
Line 5277 – add at end “and available”.
For Article 13.5, we suggest that language be included to require that researchers assure the REB that they have the budget for genetic counseling.
In the application section of article 13.5, we suggest that the qualification, “While the service provider need not necessarily be a genetic counselor, he or she
must have the experience or training to provide genetic counseling (TCPS 2008, 5288-90) be removed, and the phrase ‘by a genetic counselor be added to
the previous sentence.
In order to accurately and appropriately communicate sensitive genetic information, we believe that experience as a genetic counselor is necessary.
6445 à 6467 : L’application de l’article 13.5 devrait sensibiliser le chercheur à la nécessité de prévoir le budget de recherche nécessaire lorsque son projet inclut
13.5
13.6
13.6
13.6
13.6
13.6
13.6
13.7
13.7
13.7
13.7
13.7
7
une communication des résultats individuels aux participants par le biais des services en conseil génétique, et que ces derniers sont difficilement accessibles
dans son institution.
Ligne 6646 et 6647 – article 13.5. On prévoit, fort à-propos, que si des résultats personnels sont communiqués, la prestation de services génétiques doit être
prévue. Lignes 6451 à 6453. Vous écrivez de façon contradictoire qu’il faudra peut-être qu’il y a la prestation de conseils en génétique.
Line 5299 Correct
Alternatively (not, alternately)
Line 5313 Correct
Alternatively
Line 5319 Insert
… in regard to the voluntariness of …
In article 13.6, we propose that it be specified that children (and possibly members of other vulnerable groups, such as the mentally incapacitated) should not be
included in genetic studies, unless the condition being studied is of particular relevance to children (or members of those groups).
As information revealed may be difficult for children (&) to understand and appreciate,
Lignes 6493 à 6497. Il y aurait lieu de modifier le texte. Ce n’est pas le chercheur qui communique avec les autres membres de la famille, mais bien le
participant et il faut écrire « Il est nécessaire que le participant établisse le premier contact avec le membre de la famille ».
Ligne 6480 à 6482. Cette procédure va à l’encontre des normes provinciales québécoises qui, par respect pour la vie privée des individus, interdit une équipe de
contacter les autres membres d’une famille sans la permission de ces derniers. Autrement, le propositus approche lui-même les autres membres de sa famille et
ceux-ci contactent le chercheur. Ce commentaire vaut aussi pour les lignes 6493 à 6497.
Lines 5324-6 Public consultation
Again, this is reiterated and the emphasis on this does not match the lack of specifics on success criteria and principles to promote the integrity of a consultation.
Line 5349 Insert
… examples of the inappropriate …
Line 5353 Insert
< Ch. 9) >
6520 à 6522 : L’obligation du chercheur d’obtenir la participation des dirigeants ou des représentants de la communauté (prise ici au sens général) aux prises
avec des conflits ou des désaccords exige de lui des aptitudes de négociation particulières pour mener à bien une consultation, et obtenir un engagement libre et
éclairé des membres de la communauté dans ce contexte. Il serait important de le souligner.
Lignes 6506 et suivantes – article 13.7. La collaboration avec la communauté impliquée devrait être exigée afin de maximiser les bienfaits de la recherche pour
la communauté.
13.8
LIGNE 6550 : Article 13.8 : Cet article nous apparaît très bref en regard de tous les défis qui sont présentement soulevés par la multiplication des biobanques de
large envergures ou de petits projets. Le Rapport final du Groupe-conseil sur l’encadrement des banques de données et des banques de matériel biologique à
des fins de recherche en santé offre des pistes supplémentaires de réflexion à ce sujet.
13.8
13.8
13.8
13.8
8
À l’article 13.8, la formulation suivante : « aborder les questions d’éthique connexes, c’est-à-dire la confidentialité des données, la protection de la vie privée
[…] » (lignes 6553-6557) devrait être remplacée par « aborder les questions d’éthiques relatives à la confidentialité des données, la protection de la vie privée
[…] ».
6561 : Il faudrait plutôt dire : « aborder les questions d’éthique en lien à cette utilisation», plutôt que «aborder les questions d’éthique connexes».
5355: Genetic material banks: Please provide guidance on future contact with participants or family members.
Research may occur many years after the tissue has been collected. Please provide guidance on the obligation to return results to participants and
relatives when time passes between collection and testing.
Ligne 6550 – article 13.8 a). Il faudrait ajouter la possibilité de la commercialisation des résultats de la recherche et la communication des résultats personnels
parmi les items devant être abordés avec les participants.
13.8
Ligne 6552. Il faudrait lire : « informer les participants ». Pourquoi utiliser le terme « proposition » qui n’est pas un terme couramment utilisé en recherche ?
Pourquoi ne pas parler de protocole ?
13.8
Lignes 6558 – article 13.8 b). Les chercheurs doivent aussi s’assurer que la question des utilisations secondaires de matériel génétique se reflète dans le
formulaire de consentement et non seulement dans leur proposition
13.8
Ligne 6560. Pourquoi utiliser le terme « proposition » qui n’est pas un terme couramment utilisé en recherche ? Pourquoi ne pas parler de protocole ?
13.8
Ligne 6564. « ...constitueront une ressource de plus en plus importante aux fins de la recherche ». De par notre expérience sur le terrain, il ne faut pas parler au
futur mais bien au présent.
13.9
Line 5389 – What are these “other research situations”?
13.9
Procréation assistée : Nous souhaitons porter à l’attention du groupe que plusieurs des dispositions prévues à la Loi sur la procréation assistée sont présentement
l’objet d’une contestation en Cour suprême par le Québec et d’autres provinces. Compte tenu de la contestation judiciaire, on devrait s’abstenir d’y faire
référence en attendant l’issue du litige. (lignes 6190, 6242, 6279, 6586).
13.9
Lines 5374-5399 Gene therapy
13.9
13.9
13.9
13.9
13.9
13.9
Section B.
This passage seems somewhat superficial and lacking in details and specifics and only calls for more attention really.
Recommendation: Bring more detailed guidance for the conduct of gene transfer trials (e.g., criteria that need to be considered for initiation, monitoring, public
health concerns, cessation rules).
Line 5393 Reword
… processes for the long-term …
Line 5395 Insert
… lack the capacity to …
Line 5397 Reword
Because scientific research … rapidly, researchers must be aware of current law, and should be guided …
In the application section of article 13.9, we propose that a caution regarding which conditions merit gene transfer research be provided.
The attempt to eradicate some specific conditions or disabilities through gene transfer treatments may have controversial social implications. Disability rights
advocacy groups argue that disability is more properly located in social constructions that tend to exclude, discriminate, and fuel a demand for normalcy, than in
the actual disabled individuals. Some ethical guidance for researchers to sensitize them to the existence of social assumptions about disability and to raise
awareness about the diversity of what a valuable human life can be, would help address this issue.
Line 5397-5403- The reminder to researchers to be aware of ongoing ethical debate and evolving current law is made without judgement or engagement with
the moral issues which is helpful. In addition I anticipate the references at the end of the chapter will be helpful to researchers.
Enfin, le Sous-comité suggère qu’à la section G (Transfert génique), une partie importante de l’application de l’article 13.9 soit plutôt intégrée au préambule
(lignes 6578-6585) puisque les propos semblent davantage exposer la problématique que clarifier l’application de l’article lui-même.
I made a recommendation to include the formal definition of genetic counseling in its section - I have attached the
publication which contains this definition. It is broadly accepted within the genetic counselling professional community internationally.
(See attached file: A new definition of genetic counseling - NSGC Task Force Report 2006.pdf)
In addition to this item I also raised concerns about genome wide associations studies being done and hoped that you could include a section in the "Human
Genetics Research" chapter about these types of studies. I do feel that they are different than other genetics studies due to the amount of information they collect
about not only the patient but their family as well as the implications for that information. There are now thousands of genes know to be associated with
disease/an inherited condition scattered throughout the genome. Given the increasingly more dense examinations (scanning using microarrays) that are
occurring of the genome it is a given that researchers will be looking at these areas regardless of the reasons for which they are collecting the data.
9
As a member
REB we struggle with what safeguards should be put in place in these kinds of studies. I do see that in the current draft presented
that there are sections about unforeseen results and being able to communicate them back to families - I worry that with the volume of data that is being
collected on so many genes that valuable information about a patient and the potential health risks for them and other family members will not make it back to
them. Given that all people probably have some type of genetic condition predisposing them to something, I feel that the chances of finding this type of
information is quite high and it will only get greater as more and more genes are discovered. I do feel that this type of research is very important and that it can
occur, but I don't feel it is ethical to do in an anonymized way given the probability that they will have to contact the patient/family to share information about
their genetic predisposition. Given the other parts of the document you have created it seems clear to me that it would be unethical to do this type of research
without being able to recontact patients for the reasons sited above. I have attached a few Canadian publications which talk about these issues is greater detail. I
encourage you to think about my concerns in the context of some of the issues presented in the attached papers and to think about inherited cardiomyopathy
which is polygenic, but is estimated to affect 1 in 500 people and is associated with sudden death which can be preventable in many cases with lifestyle changes,
medication, use of medical devices and surgery.
(See attached file: Is gene discovery research or clinical diaqnosis.pdf)
(See attached file: Research Ethics Recommendations for whole genome research - consensus statement.pdf)
(See attached file: Genetic knowledge and moral responsibility - ambiguity at the interface of genetic research and clinical practice.pdf)
Section B.
Section B.
Section F.
Section F.
10
Please feel free to contact me at any time if you wish to discuss these or other issues further.
Section B – Plans for Handling Information Revealed through Genetic Research. This section should be applauded. The US “Common Rule” does not refer to
this ethical obligation and this makes the TCPS very progressive.
Section B. The term “disclose results” and not “return results” should be maintained throughout the chapter.
The fiduciary nature of research
o The document ought to be explicit and emphatic about the fiduciary nature of the roles and responsibilities of researchers and the research enterprise,
including research governance. Along with our requirement to acknowledge the value of research, comes the obligation to recognize that the liberties that
might be taken to advance knowledge entail responsibilities to practice in a manner that respects the interests of participants, communities and the
environment. Researchers may be given certain rights and liberties to advance knowledge, but these are accompanied by obligations to respect best interests
by eg proper balance of benefits and risks/harms, through appropriate use of resources etc.
o It is worthwhile repeating the reference to the fiduciary obligations in different sections, especially ch 12 & 13 relative to bio-banking. Such a resource
ought to be characterized less as ownership of tissue and more as a fiduciary obligation to those whose tissue is collected. These are resources where
obligations to individual confidentiality interests ought to be balanced with obligations to make appropriate use of the samples collected and not allow them
to languish in storage.
Consent to store tissue and genetic material banks: Institutions and REBs would benefit from greater guidance regarding the stored tissue and genetic material
Section F.
banks.
Other General Comments re. Chapters 12 and 13
The issue of tissue banks has been an issue of concern for
, particularly with respect to the NASBP clinical trials from the U.S.
where a consent for use of leftover tissue is tagged onto the end of a complex and lengthy oncology protocol consent form. Our REC feels that this is a
manipulative “tissue grab” that takes advantage of vulnerable oncology patients. Furthermore, as an REC, we do not feel that blanket consents for future
research are ethical, given that there may be health benefits derived from the research and the fact that there are many unknowns re. genetic research. We have
asked the NSABP to make completely separate consent forms for storing leftover tissue and making it more clear that the purpose of keeping the research
participant’s leftover tissue is to create a tissue bank, but the NSABP officials have refused to make any changes whatsoever to their consent forms. As a result,
the REC feels undue pressure to approve these protocols, since the oncology trials themselves are valid and valuable, but that undue coercion is exercised over
the captive research participant in agreeing to allow the NSABP to keep leftover tissues for future research.
Section G.
Line 5377 Avert or overt?
Section G.
Section G – Gene Transfer: there should be a complete distinction between genetic alterations in somatic cells and in germ line, since they raise distinct ethical
issues. The wording of the application section is confusing: what does it mean to have a “germ line alteration in the embryo”? Either the alteration is done on
the sperm or the ovum, or it is done on all the cells of the embryo.
We applaud the draft’s replacement of the term “gene therapy” with “gene transfer.” We further applaud the reference in chapter 13, article G, to “therapeutic
misconception.” We also appreciate reasons why the TCPS might devote an article to human gene transfer within a chapter on genetic research, and support
much of what is said in this article.
Section G.
Section G.
Nevertheless, the guidance in this article pertaining to somatic gene transfer (that is, interventions that do not target reproductive tissue) seems somewhat
vestigial and does not entirely cohere. Specifically, concerns about therapeutic misconception, latent risk, long-term follow up, involvement of children, and
rapid evolution of ethical issues apply to many other areas of cutting edge translational clinical research. Examples of other research areas raising similar issues
include tissue engineering, cell transplantation, immunotherapies, and electronic brain devices. Consistent with item 12 below, we would recommend that the
moral concerns surrounding somatic gene transfer be moved to a new section in Chapter 11 that addresses early phase clinical trials involving highly innovative
interventions.
Ligne 6577 et suivantes – Transfert génique.
ƒ
ƒ
11
Aucune prise de décision dans la révision de cette section sur le transfert génique. Il faudrait que les 3 Conseils prennent position. Cela est essentiel
sinon, on dirait que vous esquivez la question. Une prise de position est fondamentale pour un sujet aussi délicat au niveau éthique et scientifique.
Cela pourrait être l’occasion de recommander un suivi à long terme des participants aux essais de thérapie génique et de prévoir un système rigoureux de
divulgation des effets secondaires.
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).
Introduction
Genetic research. 5153. I believe that the definition is too general. Eg ‘the functions of genes’ encompasses all biological based medical research.
Introduction
Introduction
I believe it is more helpful to define it as …Research in this area can be defined broadly as ‘Identification of genes that comprise the human genome …as well
as studies involving gene therapy.’. However a practical definition of genetic research is biological research that intends or can be reasonably anticipated to
discover features that can predict the risk of future disease for the donor or donor’s relatives.
Introduction : ne serait-il pas utile de distinguer différents types de recherche faisant appel à la génétique : pharmacogénomique, études familiales, etc ?
Pourquoi ne pas amalgamer la section sur les tissus et la section sur la génétique et n’en faire qu’un chapitre ?
In reviewing chapter 13 of the 2008 TCPS draft, “Human Genetic Research, we appreciate the majority of the changes that have been made to the 1998
version. We find the clarification that in genetic research, “the function of each gene and its relationship to disease conditions or other characteristics may not be
clear (TCPS 2008, 5161-2) to be particularly important.
Recommendations
– In the introduction to the chapter, we suggest that a justification for why genetic research merits a separate section from other types of medical research be
specified.
Making note of the particularly sensitive nature of genetic information, in terms of the potentially damaging effect it can have on specific social relationships
and on individual sense of self. The purpose of this is to emphasize to researchers the extra care that should be taken in regulating who has access to genetic
information collected in research studies, and in communicating such information to research subjects.
12
Introduction
Lignes 6307 et 6308. Le terme « exploitation » est peut-être un peu fort. Suggestion de le remplacer par « discrimination ».
Title
Should the heading for Chapter 13 not be HUMAN GENETICS RESEARCH? That is: “GENETICS” (plural)?