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Draft additional Protocol to the Convention on Human Rights and Biomedicine, on biomedical research
Doc. 10126
2 April 2004
Opinion[1]
Social, Health and Family Affairs Committee
Rapporteur for opinion: Mr. Claude Evin, France, Socialist Group
Introduction
1. The Rapporteur fully agrees with the conclusion of the Committee on Culture, Science and Education that the draft additional protocol to the Convention on Human Rights and Biomedicine, on biomedical research provides for a balanced and appropriate protection for those who take part in research projects without hampering the advancement of research and scientific knowledge.
2. While understanding the difficulty of agreeing a text which states general principles without entering into details of legislation, the Rapporteur wishes to draw attention to a number of points which are being left “open” for the interpretation of the member states, future parties to the protocol.
Chapter II of the draft protocol: general provisions
3. As a general remark, the draft protocol rightly refers to “research”, “research participants” and “researchers” and avoids using the terms “doctors” and “patients”, thus making a clear distinction between research undertaken for furthering scientific knowledge in the field of biology and medicine and healthcare treatment as such.
4. It is important that this distinction be kept in mind in order to provide clarity. For example in Article 5 (absence of alternatives), “comparable effectiveness” applies to scientific knowledge which is being sought through research and to the risk/benefit evaluation made with regard to the choice of methods and does not apply to the therapeutic treatment of the individual.
Chapter III: ethics committee
5. The Rapporteur welcomes the separation between the approval of research on the basis of scientific merit (articles 7 and 8) and the review of its ethical acceptability (articles 9 to 12). However, the definition of “ethical acceptability” (articles 7, 9.1, 9.2, 11.1) remains unclear and vague and calls for improvement in the current text.
6. Article 10 insists on the independence of the ethics committee and requires member states to put in place a clearly-defined procedure of appointment to the Committee which would not give rise to objections or complaints.
7. While the draft protocol focuses in Chapter III on the independence of the ethics committee (article 10), it does not specify in any way its multidisciplinary set-up (article 9.2). Yet multidisciplinarity is a fundamental element of an ethics committee, representing a strong feature which reinforces the committee’s independence.
8. The paragraph 41 in the explanatory report states that “it may be appropriate for ethics committees to consult with patients’ organisations familiar with a particular condition and/or situation”, which is a useful suggestion, giving a consultative role to patients’ organisations not represented on an ethics committee.
9. A more specific paragraph in article 9 could therefore be envisaged specifying the multidisciplinary composition of an ethics committee.
10. The Rapporteur shares the concerns expressed in Article 12 (Undue influence). It should be ensured that poor and vulnerable people who volunteer for research are not exposed to greater health risks. However, he believes that reimbursement of specific expenses borne by the person volunteering for experiments could be envisaged without breaching this principle.
Chapters IV, V and VI: information and consent
11. The Rapporteur welcomes the very precise drafting of the articles dealing with information and consent with regard to persons participating in biomedical research which cover also a variety of specific situations and groups (persons not able to consent to research, persons deprived of liberty, emergency clinical situations, pregnancy and breastfeeding, etc.).
12. It can be underlined that the term “consent” applies only to the person volunteering for research. In a case where this person has no capacity to consent to the research, the draft protocol foresees the seeking of “authorisation” and in such a case rigorously spells out a certain number of conditions.
13. The Rapporteur insists on the protection of persons not able to consent and in particular persons in emergency clinical situations (article 19.2 ii and sub-paragraph xiii in the Appendix to the draft protocol) and therefore recalls article 6.1 stating that “research shall not involve risks and burdens to the human being disproportionate to its potential benefits”.
14. Furthermore, in article 15.1, the Rapporteur would propose a switch between sub-paragraph i) and ii), thus giving higher priority to the requirement that “research of comparable effectiveness cannot be carried out on individuals capable of giving consent.”
Chapter VIII: confidentiality and the right to information
15. Article 27 (duty of care) states that “if research gives rise to information of relevance to the current or future health or quality of life of research participants, this information must be offered to them”. Yet the question arises as to who will assess the “relevance” of such information. Any given information or data may suddenly become relevant in the light of new scientific discoveries, while before it may not have been considered relevant. An example of this would be advances in the diagnosis of genetic diseases.
16. This issue would therefore merit further debate.
Chapter IX: research in States not parties to this protocol
17. The Rapporteur welcomes the clarity of article 29 which resolves the problem of research which is being initiated in countries with strict jurisdiction but completed in other states with less stringent rules. The provision of this article requires member states, parties to the Protocol, to ensure that the same ethical criteria be respected for the part of the research undertaken outside their jurisdiction.
Conclusion
18. The Social, Health and Family Affairs Committee considers the draft additional protocol to the Convention on Human Rights and Biomedicine, on biomedical research to be of high quality. It strikes the right balance in outlining measures that are necessary to safeguard human dignity and the fundamental rights and freedoms of individuals without hampering progress in biomedical research.
19. The Committee therefore recommends that the Committee of Ministers adopt the draft additional protocol and invite member states to adhere to its provisions by signing and ratifying the Oviedo Convention and its future additional protocol on biomedical research. It would be desirable if the observer states subscribe to the principles of this Protocol.
Amendments proposed:
Amendment 1
In the draft opinion, at the end of paragraph 5, insert the following sentence:
“While understanding the difficulty of agreeing a text which states general principles without entering into details of legislation, the Assembly wishes to draw attention to a number of points which are being left “open” for the interpretation of the member states, future parties to the protocol.”
Amendment 2
In the draft opinion, after paragraph 5, insert the following paragraph:
“The Assembly welcomes the separation between the approval of research on the basis of scientific merit (articles 7 and 8) and the review of its ethical acceptability (articles 9 to 12). However, the definition of “ethical acceptability” (articles 7, 9.1, 9.2, 11.1) remains unclear and vague.”
Amendment 3
In the draft opinion, after paragraph 5, insert the following paragraph:
“While the draft protocol focuses in Chapter III on the independence of the ethics committee (article 10), it does not specify in any way its multidisciplinary set-up (article 9.2). Yet multidisciplinarity is a fundamental element of an ethics committee, representing a strong feature which reinforces the committee’s independence.”
Amendment 4
In the draft opinion, after paragraph 5, insert the following paragraph:
“The Assembly also insists on the protection of persons not able to consent, and in particular persons in emergency clinical situations (article 19.2 ii and sub-paragraph xiii in the Appendix to the draft protocol) and therefore recalls article 6.1 stating that “research shall not involve risks and burdens to the human being disproportionate to its potential benefits.”.
Amendment 5
In the draft opinion, after paragraph 5, insert the following paragraph:
“Article 27 (duty of care) states that “if research gives rise to information of relevance to the current or future health or quality of life of research participants, this information must be offered to them”. Yet the question arises as to who will assess the “relevance” of such information. Any given information or data may suddenly become relevant in the light of new scientific discoveries, while before it may not have been considered relevant. An example of this would be advances in the diagnosis of genetic diseases. The Assembly believes that this issue merits further debate.”
Amendment 6
In the draft opinion, after paragraph 5, insert the following paragraph:
“The Assembly welcomes the clarity of article 29 which resolves the problem of research which is being initiated in countries with strict jurisdiction but completed in other states with less stringent rules. The provision of this article requires member states, parties to the Protocol, to ensure that the same ethical criteria be respected for the part of the research undertaken outside their jurisdiction.”
Amendment 7
In the draft opinion, at the end of paragraph 7, add the following phrase:
“In addition, it would encourage observer states also to adhere to the principles of the Convention and its additional protocols.”
Reporting committee: Committee on Culture, Science and Education.
Committee for opinion: Social, Health and Family Affairs Committee.
Reference to committee: Doc. 9924, Reference 2877 of 29.09.03
Opinion approved by the committee on 25 March 2004.
Secretaries to the committee: Mr Mezei, Mrs Meunier, Mrs Karanjac, Mr Chahbazian.
[1] See Doc. 10121 tabled by the Committee on Culture, Science and Education.