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Past Interpretations of the TCPS

Subject Reasonably Designed Inclusion and Exclusion Criteria and Applicable Human Rights Legislation
Keywords inclusion, exclusion, competence, representation, participation, research, consent, law, discriminatory, benefits, burdens, human rights, justice
TCPS Articles 1.3, 2.5, 5.1, 5.3
Date January 2003

PDFReasonably Designed Inclusion and Exclusion Criteria and Applicable Human Rights Legislation Jan 2003.pdf

1. Thank you for your correspondence in which you requested clarification of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) of 1998 (with 2000, 2002 amendments) position on (a) the rules of inclusion in research and (b) application of the human rights laws to research conducted at universities. You ask:

  1. Is the (automatic) exclusion of the prospective research subjects based on mental disability, or diagnosis per se, consistent with the TCPS?
  2. Does the TCPS require that the university research comply with the existing human rights legislation?
2. Your questions have been referred to the Interagency Advisory Panel on Research Ethics (PRE) for advice1.

Reasonable Inclusion and Exclusion Criteria

3. Section 5 of the TCPS addresses inclusion in research. Articles 5.1 and 5.3 state:

Article 5.1: Where research is designed to survey a number of living research subjects because of their involvement in generic activities .that are not specific to particular identifiable groups, researchers shall not exclude ... research subjects on the basis of such attributes as culture, religion, race, mental or physical disability, sexual orientation .unless there is a valid reason for doing so.

Article 5.3: Subject to the provisions in Articles 2.6 to 2.8, those who are not competent to consent for themselves shall not be automatically excluded from research which is potentially beneficial to them as individuals, or to the group that they represent.

4. Articles 5.1 and 5.3 are inspired by distributive justice norms regarding the fair distribution of benefits and burdens of research.2 The societal commitment to justice in the specific context of participants involved in human research means that particular groups should neither be unjustly denied access to the potential benefits, nor bear a disproportionate burden of the research. Distributive justice norms in the TCPS thus impose a general duty on researchers and Research Ethics Boards (REBs) not to act in a discriminatory manner in the inclusion or exclusion of participants in research projects. Attention to distributive justice should help in the design of reasonable inclusion and exclusion criteria for research protocols.

5 . Benefits: Reasonably designed inclusion and exclusion criteria will thus affect access to potential benefits and the distribution of burdens. Read together, articles 5.1 and 5.3 indicate that if the research project is intended to study phenomena or processes that are not specific to any particular groups of population, then the study should likely include a breadth of groups, in the expectation that the knowledge derived may benefit diverse populations. The inclusion in research of participants representative of the general population should normally be respected, unless there is a valid reason for not doing so. Moreover, to further the purposes underlying the general TCPS preference of inclusion, those claiming a valid reason for excluding particular groups from research would bear the onus of persuading the REB of its validity.3 What qualifies as a "valid reason" for exclusion will depend on the research in question and the general context it is conducted in, as well as--on objective grounds--the scientific validity and reasonableness of the inclusion and exclusion criteria for a research protocol.

6. Burdens: Distributive justice norms further indicate that reasonable inclusion and exclusion criteria avoid unduly burdening or exploiting groups, such as those who lack the competency to consent for themselves. The concern is also expressed through the informed consent provisions of section 2 of the TCPS. Article 2.5 outlines conditions that should be met for those who are incompetent to participate in research.The commentaries to the article express (i) "the general requirement to restrict research involving incompetent subjects to questions that can not be addressed with competent subjects," and (ii) "the general moral preference for involving competent rather than incompetent research subjects, and the need to avoid selecting prospective subjects merely because of convenience." The commentary reflects a protective concern about potential exploitation.

7. Overall, then, distributive justice norms in the TCPS should help the research community to design reasonable and scientifically grounded inclusion and exclusion criteria that strike a just balance for those participating in human research.

8. Based on the foregoing, an automatic exclusion of the prospective research subjects based on mental disability, or diagnosis per se, is not consistent with the TCPS. Such an exclusion would have to be justified by the "valid" reasons recognized as such in the ethics review process.

Human Rights Laws

9. While it is beyond our mandate to provide legal advice, your question about the application of human rights laws to REB decisions implicates at least three provisions of the TCPS. First, it implicates the guiding ethical principles outlined in section C of the "Context of an Ethics Framework"4 for the TCPS. Modern human rights laws have been enacted to further some of the guiding ethical principles embraced in the TCPS Ethics Framework. These include respect for human dignity and vulnerable persons, as well as the commitment to justice.

10. Secondly, section C of the TCPS Ethics Framework also discusses the important relationship between law and ethics.5 Reasonable and responsible research must respect the law. In general, reasonable research protocols thus need to adhere to both applicable legal and ethics norms. Whether a particular law applies to an institution, to the REB or to a particular protocol, are precisely the kinds of legal issues that fall within the deliberations of a duly composed REB. Thirdly, then, TCPS article 1.3 and its supporting commentary outline the norm for including in the membership of REBs those with legal knowledge. Legal expertise on the REB is intended to help the REB to identify legal issues and requirements, such as the relevance, applicability and implications of federal or provincial human rights laws. In some instances, the REB's identification of legal issues will necessitate further scrutiny and formal legal advice from competent local legal counsel to the institution.

We hope that you will find these thoughts helpful to your human research ethics deliberations.

Sincerely,

Secretariat on Research Ethics
on behalf of
The Interagency Advisory Panel on Research Ethics
pre.ethics.gc.ca


  1. PRE provides advice on such interpretation questions to assist the research ethics community in applying the TCPS to the ethical issues it faces. While responses to TCPS interpretation questions may address ethical dimensions of legal issues in research ethics, PRE does not provide legal advice. Nor does it act as an appeal body on REB or institutional decisions.
  2. See J. Kahn, A. Mastoiainni, and J. Sugarman, Beyond Consent: Seeking Justice in Research (New York: Oxford University Press), 1998.
  3. TCPS, "Context of an Ethics Framework," page i.9.
  4. TCPS, "Context of an Ethics Framework," page i.5.
  5. TCPS, "Context of an Ethics Framework," page i.8.