Research Ethics
Response by the Canadian Political Science Association To the Draft Second Edition of the Tri-Council Policy Statement on Research Ethics (TCPS II)
March 23, 2009
Summary
The Canadian Political Science Association (CPSA) is generally very encouraged by the revisions incorporated in the draft second edition of the TCPS. We are particularly pleased to see the inclusion of a chapter on qualitative methods, greater sensitivity to the particular circumstances surrounding research on political elites and the more nuanced and open approach to obtaining informed consent. As political scientists and social science researchers, we do however have several concerns regarding the current proposed revisions, particularly regarding their failure to address the growing problem of “research ethics creep” at the institutional level.
Strengths of the draft TCPS II
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.
• 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 3985-96, 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).
• 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.
• We are pleased to see the recognition in this document of the particular challenges and requirements of research involving Aboriginal peoples in Chapter 9.
• Overall, the document is greatly strengthened by the inclusion of examples and application notes to illustrate the principles of the policy.
• It is vital that these positive changes not be weakened or reversed in the final post-consultation version of the policy.
Weaknesses of the TCPS II
Research ethics creep
Our major concern with the current draft of the TCPS II is its failure to adequately address institutional tendencies towards “research ethics creep,” which pose excessive burdens on social science and humanities researchers.
Research Ethics Boards (REBs) tend to focus their overriding concern on the risks posed to the research participant. Unfortunately, this usually means that the costs of foregone research to the researcher, the university, and the society, along with the costs for researchers and universities of managing protocols and complying with the decisions and advice of the REBs, tend to be underestimated.
• Chapter 1, the Ethics Framework, does not address this problem sufficiently. None of the three core principles (concern for welfare; respect for autonomy; and respect for the equal moral status of all humans) reflects the importance of balancing risk mitigation against the social value of research. Moreover, the old section of Chapter 1 on Academic Freedom and Responsibilities, which served to provide some balance to the emphasis on participant risk, has been deleted. The discussion of proportionality (lines 163-74) is helpful but it is too brief, not sufficiently prominent in the text, and too easily ignored by REBs. Moreover, in these eleven lines of text only two phrases refer vaguely to costs: “unnecessary barriers or delays to research” and “unnecessary impediments.” Ideally, proportionality should be raised to the status of a core principle. At a minimum, it should have its own subsection and the costs to which it refers should be elaborated in more detail.
• Chapter 6 on Governance also fails to adequately address the tendency towards REBs’ “mission creep.” Universities are required to fund Research Ethics Boards and, for good reasons, their ability or authority to interfere with REB decisions is minimal. However, this poses the danger that REBs will be insufficiently accountable for their authority. Given that there is currently significant institutional variation in the application of the TCPS, it is essential that there be some reasonable mechanisms of accountability. Yet, the appeal mechanisms included in the TCPS II (Article 6.19) are supposed to be used only in “exceptionally rare circumstances,” and the bodies to which appeals are taken consist of REB members. Therefore, the appeal mechanisms as specified in Chapter 6 are unlikely to provide the necessary check on mission creep. To correct this problem Chapter 6 should include discussion of the problem of research ethics creep, and wording to encourage universities to establish mechanisms of accountability for the types of costs of mission creep mentioned above. Examples of such mechanisms could include surveys of researchers similar to student evaluations; mechanisms that allow researchers to lodge complaints about the process with universities; requirements to publish reports on complaints submitted to REBs by researchers; comparative cross-university sharing of data to measure the cost/benefit ratio of REBs (such as estimated hours spent by REBs and researchers on research ethics relative to the volume of protocols and the volume of complaints from research participants). As well, a more meaningful appeal mechanism should be specified in the chapter.
• One factor that contributes to research ethics creep is the lack of clarity in the distinction between the educational and regulatory functions of REBs. Research ethics boards are an invaluable storehouse of knowledge about research ethics and it is important for them to be able to share their insights with researchers. However since at present the REB has virtually unconstrained power to define which aspects of its communications with researchers are advice and which part are mandatory, and because the structure of the REB-researcher relationship means that it can be difficult for the researcher to know whether communications they perceive as mandatory are in fact intended by the REB or the spirit of the TCPS to be mandatory, there is an inherent risk that the boundary between voluntary and mandatory communications will shift too far towards the mandatory side. To address this problem wording should be added, perhaps in the application notes for Article 6.13 (lines 2208-2229), calling upon REBs to exercise care in distinguishing between their regulatory and educational functions.
• We are also concerned about the potential for overly legalistic interpretations of the TCPS by research ethics boards. Article 6.4, which outlines the composition of REBs states that it is necessary that “At least one member is knowledgeable in the law (but that member should not be the institution’s legal counsel or risk manager).” It is not clear what “the law” means here; does it mean that every REB should have someone trained in law or legal studies? This requirement would be both unnecessary and problematic for REBs dealing with social science research, as it would tend to create ethics boards that were more included towards narrowly legal, and thus more conservative, interpretations of research ethics guidelines. While this requirement may make sense for REBs overseeing medical research, it should not be a requirement for REBs involved in research in social science.
Other concerns
• We are concerned about the apparent need to get permission from research ethics authorities in every country for international research (Chapter 8, especially Article 8.4). This could unnecessarily burden and deter research involving interviews in multiple countries or with international organizations with members from multiple countries. It would be unfeasible and often inappropriate to have to obtain permission from governments and/or REBs in multiple countries. The exemption for “critical inquiry about organizations and institutions” (lines 2995-7) is important and must be preserved in the final draft. Additionally Canadian REBs should be authorized and encouraged not to require foreign REB review of minimal risk research in foreign jurisdictions or international organizations. This should be added to Article 8.4.
• We are also concerned about the need to satisfy the requirement on line 1348 (Chapter 4, Inclusion) that “language proficiency should not bar inclusion in research.” Does this require the hiring of translators in all local languages when conducting research internationally? Again, this would be prohibitively expensive and unrealistic.
In conclusion, we are very pleased to see that the process of revising the TCPS is approaching a conclusion and welcome many of the positive changes introduced in the current draft. We do urge the Interagency Advisory Panel on Research Ethics, however, to take more comprehensive steps to ensure that the tendency towards research ethics creep is minimized in order to preserve the right balance between mitigating risk and supporting the social value of research.
Research involving Aboriginal peoples
While it is very positive that this critically important topic has been included in the proposal, we have some concerns that we would like to bring to your attention. After consulting with some of our members who are specialists in the area, we think that more thought should be given to particular issues regarding social science research in Aboriginal communities. Many of the examples in Chapter 9 are drawn from medicine or the natural sciences. Some of the challenging issues in social science research are not mentioned and, therefore, will fall to the adjudication of the REBs.
• While we recognize the past history of unethical research practices in Aboriginal communities, we think it is important to respect the capacity of First Nations to make their own views known regarding research in their communities and that, especially for non-Aboriginal researchers, it is the researcher’s responsibility to seek information and knowledge from Aboriginal communities.
• It is also important to recognize that Aboriginal communities are not homogenous. The CPSA is concerned that local ethics boards will be left to adjudicate claims from researchers who may be concerned about having to seek the consent of the community’s formal leaders or about sharing their research with those leaders. There should be more reflection about how the community is defined in this document and about how to handle community consent when there are disagreements within Aboriginal communities.
• Moreover, the CPSA wonders how land claims mandates, such as those referenced in the document (i.e. the Nunavik and Nunatasiavut agreements), would affect political science research. It is our understanding that those agreements entail research approvals for environmental and wildlife management. We feel that the remit of these agreements should be clearly specified in the guidelines.
• Most importantly, the CPSA feels that it is of the utmost importance that Aboriginal scholars and non-Aboriginal scholars who work on Aboriginal issues should be consulted directly regarding the development of ethics guidelines and regarding the role of the local research ethics’ boards in relation to these complex issues. These consultations should take into consideration the specific issues that affect social science research, rather than assuming a medical or natural science research model.
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