Research Ethics

Note: This memo was distributed to CPSA members in early 2008. While it provided a deadline of March 14, 2008 for feedback, comments on this memo or any other aspects of research ethics continue to be welcome.

1. Why a memo on research ethics?

Research ethics and the regulations that govern them play a necessary and important role in the work of Canadian political scientists. This memo has been written in order to provide you, as a CPSA member, with some background on the ongoing review of research ethics regulations underway in Canada at the moment, to articulate some possible concerns from a political science perspective, and to solicit feedback from you on these concerns.

The context for this memo are a series of recent reviews on research ethics that will likely have a significant impact on the way that political scientists conduct research involving human subjects. Two processes in particular are of interest: a review of the place of qualitative research in the Tri-Council Policy Statement (TCPS) on ethical conduct for research involving humans, and the proposals of the Sponsors’ Table for Human Research Participant Protection. In the discussion below, we provide a brief overview of each of these processes and discuss some potential concerns from the perspective of political science researchers.

2. Qualitative Research and the TCPS

2.1 The review currently underway

Many Canadian political science professors and students have had direct experience with the TCPS, as it is the policy that governs all funded research involving human subjects at Canadian universities. The TCPS provides the individual Research Ethics Boards at each university and college with the basis for their assessment of the ethics of research projects conducted by graduate students, for example, or by academics with SSHRC funding. There have long been debates about whether the TCPS, as a document developed by all three research councils and therefore developed in large measure to address the ethical dimensions of bio-medical research, is in fact adequately tailored for the particular demands of social science research. These debates finally led to a review of the treatment of qualitative research in the TCPS by the Interagency Panel on Research Ethics (PRE), which resulted in a report entitled, “Giving Voice to the Spectrum”. The most recent document produced by this committee, which served as the basis of consultations this past spring, was “Qualitative Research in the Context of the TCPS”.

2.2 Potential political science concerns with the TCPS

The TCPS appears to offer some flexibility in accommodating qualitative research in social sciences. It calls, for instance, for the notion of harm to be interpreted with flexibility, so that the context and nature of research are considered. The notion of minimal risks is also interpreted very broadly so that critical research in social sciences and the humanities which may have a “negative effect on public figures” or “that challenge mainstream thought” are not supposed to be blocked by Research and Ethics Boards. But despite this apparent flexibility some serious concerns about the TCPS and its application by Research Ethics Boards have been raised by social scientists. Four issues can potentially be of concern for research involving human subjects in political science:

i. Defining risk: The vague definition of harm and risk might work against qualitative research insofar as, in the absence of clear definitions, researchers have to imagine what harm there could be, and have to think of worst-case scenarios in terms of risks entailed by the research, even though these worst-case scenarios have very little probability of occurring. Such thinking might deter researchers (including graduate students) to add interviews to their projects.

ii. Anonymity: The principle of privacy and confidentiality might be the most difficult challenge for researchers in political science. The right to privacy and confidentiality is meant to protect the research subjects, while at the same time, the need to conduct research on social issues might require access to personal information. The Tri-Council statement sees the role of REBs as one of balancing the need for research and the privacy of the subjects. This kind of balancing makes sense when researchers study subjects that are vulnerable and that need protection. In political science, it is often the case however that leaders and high public figures are interviewed. And the requirement for anonymity in such cases might undermine the research itself, insofar as the disclosure of personal information about the subjects might be one of the important aspects of the research results.

iii. Power asymmetries: Biomedical models assume that the subjects of the research are vulnerable and that the ethics rules should protect these subjects from harms caused by the researcher. In political science research the research subject may be more powerful than the researcher and effects from the research that the subject may consider harmful, but that hold the powerful figure accountable, may be ethically appropriate. It is not clear that the wording of the TCPS on this issue is adequate to prevent problems for political scientists at the Research Ethics Board level.

iv. Less flexibility: The last point refers to a key challenge for political scientists. On the one hand, the flexibility of the system has allowed for research ethics to take into consideration a series of factors that require exceptions to the rules. But this same flexibility often leads REBs to search for harder and more systematic rules to avoid inconsistencies in their decisions. In such case, the hard rules of biomedical research might become the norm. There is a risk that the Tri-Council policy statement might move towards standardization, and very specific guidelines could replace the vague and flexible system that exists now.

The proposed revisions to the TCPS articulated in the consultation document (link provided above) do go a long way towards responding to many of these concerns. It is not yet clear, however, how many of these proposed changes will in fact be implemented, or how. There has already been some consultation on the TCPS review on qualitative research. We have been told, however, that there will likely be one more round of consultations sometime this winter or early spring.

Finally, it is worth noting that although many political scientists are involved in qualitative research of the kind being addressed by the PRE review, some are also engaged in other forms of research involving human subjects, most notably survey-based research. Those involved in such research have articulated a range of concerns about the TCPS that are not addressed by the current review, including REB concerns about the reliance on telephone contact, their preference for formal, written consent, and their discomfort with retaining data, when this remains essential for long-term analysis of historical trends. For a fuller analysis of these issues, see the CPSA research ethics website.

3. The Sponsors’ Table

3.1 The process currently underway

The Sponsors’ Table is a group of organizations with an interest in research involving humans, including Health Canada, the Canadian Federation for the Social Sciences and Humanities, and Canada’s Research-Based Pharmaceutical Companies, among others. This group is proposing a wide-ranging set of changes to the research ethics governance system – essentially proposing a single national system of oversight for research involving humans. The key report here is “Moving Ahead”.

3.2 Potential political science concerns

The Sponsors’ Table is proposing to integrate (and ultimately replace) the existing TCPS process into a single national regulatory framework that would cover all research involving human subjects, whether funded or not, whether conducted at a university or elsewhere, and whatever the discipline. The proposed Canadian Council for the Protection of Human Research Participants (CCRHRP) would have the powers of accreditation, policy setting and education. The idea is not to replace the REBs but rather to add a further level of supervision, by creating a mechanism for accrediting them.

This proposal raises three principal concerns for political scientists:

i. Voice: Given that there are already considerable concerns regarding the smaller voice of social scientists in the TCPS process—one that includes the three granting agencies—it is unlikely that an agency governed by a much larger number of organizations will provide political scientists with much of a say in the policies governing research ethics. Given that 10 of the 15 organizations involved represent medical research, and only two represent social science and humanities research, there is little doubt that the dominant concerns driving the policies and accreditation procedures will be biomedical in nature

ii. A one size fits all approach: Although the Sponsors’ Table report does recognize the concerns of social scientists about the specificity of their research concerns, it also makes it clear that they are seeking to develop a single approach to all disciplines, arguing that “while it is reasonable to argue that the level of scrutiny applied to research should vary by level of risk, it is not reasonable to argue that it should vary by type or discipline” (p. 40). Such an approach appears to move in an opposite direction to the TCPS qualitative review outlined above, and to seek to apply a one size fits all approach to research in Canada.

iii. Extra bureaucracy: Finally, given that the proposal is not to replace existing ethics review processes, but rather to supplement them with an additional layer of bureaucracy, it is likely that this will place additional administrative demands on already-stretched scholars. One might also ask whether the proposed annual budget of $9-10 million dollars is the best way to spend such research dollars.

iv. Relationship with the current PRE review: The relationship between the current review of the TCPS being undertaken by the Interagency Advisory Panel on Research Ethics (PRE) discussed above and the recommendations contained in the Sponsor’s Table’s report, Moving Ahead, is far from clear. It certainly appears that the two processes are moving in opposite directions, the PRE process responding to the particular requirements of research in the social sciences and the Sponsor’s Table and panel of experts seeking to standardize research ethics. This runs the risk of losing much of the significant effort expended in this years-long process, and of forcing the evaluation of research ethics in the social sciences backwards rather than “moving ahead” as the report promises.

We have forwarded our initial comments to the Moving Ahead report to the appropriate authorities. The formal consultation period on this report has passed, but given the scope of the changes proposed, we are hoping that there will be further debate on the subject.

4. What CPSA members can do

If you are interested in these questions, there are several ways in which you can get involved:

• Visit the CPSA ethics website to learn more. We have created a new site dedicated to the issue of research ethics, which provide links to all of the key reports and official documents and to academic research on the subject, and which provides a brief history of the CPSA’s work on research ethics.

• Participate directly in consultations related to these two review exercises. We will be sure to keep you informed of any new consultation processes.

• Review the relevant documents (links provided above) and send us your feedback on the concerns that we have outlined above ([email protected]) by March 14, 2008.

• Raise awareness of these issues with your own Research Ethics Board.

5. What we will do

With the help of your feedback to this memo, we plan to communicate CPSA members’ concerns to the appropriate organizations as research ethics guidelines continue to evolve in Canada.

Prepared by the CPSA Working Committee on Research Ethics (Members: Jacqueline Best (Chair), Tony Porter, Hélène Pellerin, Claire Turenne-Sjolander) and approved by the CPSA Board on December 1, 2007.

Sponsors’ Table
http://www.hrppc-pphrc.ca/english/sponsors.html

Social Sciences and Humanities Research Ethics Special Working Committee (SSHWC)
http://pre.ethics.gc.ca/english/workgroups/sshwc.cfm

Interagency Advisory Panel on Research Ethics (PRE)
http://pre.ethics.gc.ca/english/aboutus/aboutus.cfm

Tri-Council Policy Statement
http://pre.ethics.gc.ca/english/policystatement/policystatement.cfm

National Council on Ethics in Human Research (NCEHR)
NCEHR is a non-governmental organization that assists Research Ethic Boards. It maintains a list of Research Ethics Boards in Canada
http://www.ncehr-cnerh.org/english/home.php

Canadian Association of Research Ethics Boards
http://www.careb-accer.ca/

Canadian Federation for the Humanities and Social Sciences Research Ethics Project
http://www.fedcan.ca/english/projects/research/

The Economics and Social Research Council in the UK has recently revised its ethics regime
http://www.esrcsocietytoday.ac.uk/ESRCInfoCentre/opportunities/research_ethics_framework/

The US Office for Human Research Protections (OHRP) Secretary’s Advisory Committee on Human Research Protections (SACHRP) [The US Department of Health and Human Services agency responsible for research ethics]
http://www.hhs.gov/ohrp/sachrp/

The American Political Science Association’s update on the US situation
http://www.apsanet.org/content_9347.cfm

Human Research Ethics Committees (Australia)
http://www.nhmrc.gov.au/ethics/human/hrecs/index.htm

Webpage of Ted Palys, member of the Social Sciences and Humanities Research Ethics Special Working Committee (SSHWC)
http://www.sfu.ca/~palys/articles.htm

Survey research is a major component of political science research. There has been an academically-motivated and mainly SSHRC-funded Canadian Election Study in every election but one since 1965. Smaller scale work is commonly conducted in the context of provincial elections. As well, survey research is important in the realm of multicultural citizenship, as, for example, with the Equality, Security, and Community Study, funded under an MCRI. Survey research is increasingly important for policy research, especially for systematic study of discourse and framing.

1. Contact: Almost all survey research since the mid-1980s has been by telephone, although the World Wide Web is gaining ground as a mode for fieldwork. It is essentially inescapable that fieldwork initiated by random digit dialing creates an intrusion on households. Some ethical review boards might dislike this. Sometimes it is suggested that respondents first be sent a warning letter, but this raises the cost of the research and compromises the sample.

2. Consent: The biomedical model tends to require formal, written consent. This is impossible in the telephone survey context. It is reasonable to ask for the script of the “front end” of the interview (the most important element in which is a forthright indication of the identity of the sponsoring institution) and for scripts of replies to reasonable questions, e.g., about who is paying for the research or how long the interview will take. The key in telephone interviewing is that it is very hard to coerce a potential respondent. Such persons find it very easy to say no, as declining response rates attest. The situation is far less coercive than, for example, a psychology department subject pool or an in-home survey interview.

3. Content: For the most part, content issues should be covered by properly constructed consent statements. Respondents should not be blindsided. The substantive interests of the research usually dictate careful introduction of potentially difficult issues. And again, respondents do not find it hard to refuse or, indeed, to terminate the interview. But in general, review boards should not seem themselves as in the censorship business. Consent is their essential subject.

4. Confidentiality: These are potentially serious issues. The survey research firm or institution will have information, including the telephone number and, typically, the respondent’s first name that must be kept in absolute confidence. Care also has to be taken over the full complement of a respondent’s demographic and location indicators to ensure that a highly motivated third party cannot produce a vector of characteristics that enable identification of an individual respondent. It may be necessary for research purposes to have all this information. But it may be no less necessary to mask some of it in a public-use version of the data set and to put the raw individual data behind a ³wall² that a secondary analyst could only pass through by signing a confidentiality agreement.

5. Retention of data: Some review panels are confused on this and ask how the data will be kept from the public and ultimately destroyed. Of course, SSHRC requires precisely the opposite, viz., that data (anonymized as necessary) become property of the research community and do so in a timely way. Increasingly, researchers analyze merged files from multiple sources, as many survey data sets gain value as time passes and repetition becomes possible. The Canadian Election Studies are a perfect case in point.

In the Moving Ahead report of August 15, 2007, under the heading “Other International Developments” there are ten lines (934-44) devoted to the United Kingdom’s system of research ethics. However this discussion only mentions the health-related research ethics arrangements and misleadingly implies that this supports the direction for the governance of research ethics in Canada recommended in the Moving Ahead report, with its single system for all disciplines. In fact the United Kingdom has established a separate Research Ethics Framework (REF) for social sciences administered by the Economic and Social Research Council. This framework took effect in 2006 after extensive consultation. In considering reforms to Canada’s research ethics governance it is important to seriously consider alternatives to the US model, since the US model has been seen as very problematic by many social scientists. The model of the UK’s Economic and Social Research Council is one such alternative.

The ESRC’s REF very explicitly notes that “ESRC feels that it is important that there are a set of standards and guidelines that are relevant specifically to social science research rather than drawing on those developed primarily for clinical research.”

With regard to multi-site research, which is cited by the Moving Ahead report as a reason that accreditation is needed, the REF notes: “In order to minimise bureaucracy and avoid unnecessary duplication of efforts, universities and research organisations should consider agreeing arrangements for accepting one another’s decisions following formal ethical review. Each institution would retain formal responsibility for overseeing the ethical review of research conducted under its auspices but would accept the decisions made by the REC of the institution where the Principal Investigator is based” (REF, p. 17).

The REF incorporates a useful disciplinary perspective by requiring researchers applying for funding to address ethical issues in their application (REF, p. 2). The peer reviewers of the project are then responsible to review the ethical analysis of the researcher.

On joint biomedical and social science research, which is cited by the Moving Ahead report as another reason that a single system of accreditation for all disciplines is needed, the REF sets out a more flexible arrangement:

“Researchers and their employing organisations should avoid duplication of ethics review, especially in respect of research that may fall under the rubric of other ethical frameworks – such as that of the Department of Health’s Research Governance Framework. Researchers must submit proposals either to their institution’s REC or to a Department of Health Local or Multi-site Research Ethics Committee as appropriate, but the ESRC does not require both bodies to be involved…This will apply to both single discipline and interdisciplinary research where social and biomedical scientists are working together.” (REF, p. 4)

In contrast to the Moving Ahead report’s call for a centralization of control in order to strengthen monitoring and compliance, the REF specifies a more flexible approach, noting that the ESRC will “engage in dipstick testing of institutions with awards to check that commitments to ethical review have indeed been followed through by institutions.” (REF, p. 2).

The REF allows Research Ethics Committees to be established at more than one level in a university in addition to a university-wide one. There can also be one at the faculty or department level: “A university–wide ethics committee might advise on broad strategy for ethics review, and monitor university performance overall, rather than consider applications per se. Wherever they are located, they should meet the requirements of this REF, even at department level if this is where the decision to approve a project is to be taken.” (REF, p. 9). This allows more flexibility and disciplinary input than the system in Canada.

The REF has a checklist that identifies social science research hazards. If you answer no to the eleven questions then you only need to file the form with the appropriate authority. If you answer yes to any question then you need to write up an ethical plan and get approval from the Research Ethics Committee. (REF, pp. 33-34).

The following is a list of scholarly articles that have addressed concerns about research ethics regimes. In the United States the counterpart to the Canadian Research Ethics Boards are the Institutional Review Boards (IRBs). Many of these articles address concerns with the US research ethics regime and its IRBs that are similar to concerns expressed in Canada. An upcoming issue of the American Political Science Association’s PS: Political Science and Politics will have a symposium on problems associated with research ethics which will include a contribution on the Canadian situation.

Bergeron, Michel (2001) “NOTE: L’éthique et la recherche en science sociale: Le suivi des projets de recherche: l’articulation entre une visée éthique et son application.” Les Cahiers de Droit 42, June, p. 315.

Bosk, Charles L. and Raymond G. De Vries (2004) “Bureaucracies of Mass Deception: Institutional Review Boards and the Ethics of Ethnographic Research” The Annals of the American Academy of Political and Social Science September, 595, p. 249.

Chalmers, Don (2004). “Symposium Article: Part 2: Research Ethics: Research Involving Humans: A Time for Change?” Journal of Law, Medicine & Ethics, Winter, 2004, 32 p. 583.

Grayson, J. P. and R. Myles (2005). “How research ethics boards are undermining survey research on Canadian university students” Journal of Academic Ethics 2(4): 293-314.

Haggerty, K. D. (2004). “Ethics Creep: Governing Social Science Research in the Name of Ethics.” Qualitative Sociology 27(4): 391-414.

Hamburger, Philip (2004). “The New Censorship: Institutional Review Boards,” The Supreme Court Review. 271.

Hoonaard, W. C. v. d. (2001). “Is Research-Ethics Review a Moral Panic?” Canadian Review of Sociology and Anthropology. 38(1): 19-36.

Hoonaard, W. C. v. d., Ed. (2003). Walking the Tightrope: Ethical Issues for Qualitative Researchers Toronto, University of Toronto Press.

Jacob, Marie Andrée and Annelise Riles (2007). « The New Bureaucracies of Virtue: Introduction.” PoLAR: Political and Legal Anthropology Review 30:2, pp. 181-191.

Kerr Robert L. (2006). “Unconstitutional Review Board? Considering A First Amendment Challenge to IRB Regulation of Journalistic Research Methods.” Communication Law and Policy, Summer, 11, p. 393.

Kitchin, H. A. (2003). “The Tri-Council Policy Statement and Research in Cyberspace: Research Ethics, the Internet, and Revising a ‘Living Document’ ” Journal of Academic Ethics 1(4): 397-418.

Lederman, Rena (2006). “Introduction: Anxious borders between work and life in a time of bureaucratic ethics regulation.” American Ethnologist, 33(4), pp. 477–481.

Lederman, Rena (2006). “The perils of working at home: ‘IRB “mission creep’ as context and content for an ethnography of disciplinary knowledges,” American Ethnologist, 33(4), pp. 482–491.

White, Ronald F. (2007). “The Common Rule, Social Science, and the Nanny State”, The Independent Review, v. XI, n. 4, Spring, pp. 547-564.

The following articles are from: “SYMPOSIUM: Censorship and Institutional Review Board” Northwestern University Law Review Special Issue, Volume 101, 2007. This is available without charge on the internet at http://www.law.northwestern.edu/lawreview/issues/101.2.html

Bledsoe, Caroline H., Bruce Sherin, Adam G. Galinsky, Nathalia M. Headley, Carol A. Heimer, Erik Kjeldgaard, James Lindgren, Jon D. Miller, Michael E. Roloff & David H. Uttal (2007) “Regulating Creativity: Research and Survival in the IRB Iron Cage”, Northwestern University Law Review Special Issue, Volume 101. p. 593.

Burris, Scott and Jen Welsh (2007). “Regulatory Paradox: A Review of Enforcement Letters Issued By the Office For Human Research Protection” Northwestern University Law Review Special Issue, Volume 101, p. 643.

Charrow, Robert (2007). “Protection Of Human Subjects: Is Expansive Regulation Counter-Productive?” Northwestern University Law Review Special Issue, Volume 101, p. 707.

Epstein, Richard A. (2007). “Defanging IRBs: Replacing Coercion with Information” Northwestern University Law Review Special Issue, Volume 101, p. 735.

Hamburger, Philip (2007). “Getting Permission” Northwestern University Law Review Special Issue, Volume 101, p. 405.

Hyman, David A. (2007). “Institutional Review Boards: Is this the Least Worst we can Do?” Northwestern University Law Review Special Issue, Volume 101, p. 749.

Lindgren, James, Dennis Murashko and Matthew R. Ford (2007). “Forward: (2007). On Censorship and Institutional Review Boards” Northwestern University Law Review Special Issue, Volume 101, p. 399.

Menikoff, Jerry (2007). “Where’s The Law? Uncovering the Truth about IRBs and Censorship” Northwestern University Law Review Special Issue, Volume 101, p. 791.

Mueller, John H. (2007). “Ignorance is Neither Bliss nor Ethical” Northwestern University Law Review Special Issue, Volume 101, p. 809.

Simmerling, Mary, Brian Schwegler, Joan E. Sieber & James Lindgren (2007). “Introducing a new Paradigm for Ethical Research in the Social, Behavioral, and Biomedical Sciences: Part I” Northwestern University Law Review Special Issue, Volume 101, p. 837.

Weinstein, James (2007). “Institutional Review Boards and the Constitution” Northwestern University Law Review Special Issue, Volume 101, p. 493.

Weinstein, James (2007). “The Dimensions Of Constitutional Analysis: A Reply to Professor Hamburger” Northwestern University Law Review Special Issue, Volume 101, p. 569.

Zywicki, Todd J. (2007). “Institutional Review Boards As Academic Bureaucracies: An Economic and Experiential Analysis” Northwestern University Law Review Special Issue, Volume 101, p. 861

Some associations, including the American Political Science Association (APSA), have codes that specify ethical conduct for their members. APSA’s ethics code is far ranging, and includes ethical guidelines for hiring, and for professor-graduate student relations, classroom ethics, sexual harassment, and publishing ethics for instance. Today in Canada many such ethical issues are governed mostly by provincial human rights codes, or by university-level rules. The broader set of issues covered by APSA’s code are all important and the CPSA may wish to consider a professional code like APSA’s in the future. At present the working group examining research ethics issues for the CPSA Board and this part of the CPSA website on research ethics are focused more specifically on the current research ethics regime and the proposals to change it and not on all the ethical issues covered by APSA’s code. APSA’s code and some other codes are provided below.

APSA, Guide to Professional Ethics in Political Science:
http://www.apsanet.org/imgtest/ethicsguideweb.pdf

Statement of Professional Ethics of the Canadian Sociology and Anthropology Association:
https://www.csa-scs.ca/files/www/csa/documents/codeofethics/2012Ethics.pdf

Society of Professional Journalists
http://www.spj.org/ethics.asp

American Association for Public Opinion Research
http://www.aapor.org/Standards-Ethics/AAPOR-Code-of-Ethics.aspx

For background see also:

Reynolds, Paul Davidson, and Mark S. Frankel (1977) “Codes of Ethics in the Social Sciences: Two Recent Surveys,” Newsletter on Science, Technology, & Human Values, No. 18 (Jan., 1977), pp. 15-19. Available through JSTOR.

Bullock, Merry and Sangeeta Panicker (2003). “Ethics for all: Differences across scientific society codes” Science and Engineering Ethics Volume 9, Number 2 / June, pp. 159-170.

The first record of CPSA involvement in ethics issues was its response in 1975 to the Canada Council’s recent establishment of a Consultative Committee on Ethics with respect to research involving human subjects. The Council had asked all associations to comment on the issues facing the Committee. Two political scientists were on that Consultative Committee – J.A. Corry (Queen’s) and Gilles Lalande (Montréal). A key question was whether the CPSA should create a Code of Ethics, which might address research ethics but other professional ethics issues were discussed, including relations with government, employers, and students. At its November 1975 meeting the CPSA Board decided to establish a research policy committee to consider these issues.

The 1978 Report

The research policy committee provided its report in February 1978. It did not take a position on the advisability of creating a CPSA code of ethics. It noted “there still exists too many divergent views as to what could constitute an acceptable code of ethics for the profession and, on the other hand, the control which the CPSA could exert on its members remain minimal in that the latter do not require a permit to exercise their profession, contrarily to lawyers and physicians, for instance.” It did briefly set out some guiding principles that could be used should such a code be created. This included, for instance, “Enlightened consent: It belongs to the political scientist to keep the subjects of research fully informed of its nature, object, risks and benefits in order to allow them to decide in full awareness whether they wish to participate in the research or not.”

The report also recommended the creation of a CPSA Standing Committee of Professional Ethics that would have an advisory and educational rather than a regulatory responsibility. The models being pursued at the American Political Science Association and the Canadian Society of Sociology and Anthropology were noted as examples.

A prominent concern in the report was with the effects of government contract research and Donald D. Rowat’s article “The Decline of Free Research in the Social Sciences”, (Canadian Journal of Political Science, December 1976) was cited. However the committee noted that scholars were divided about the costs and benefits of such research and the committee limited itself to recommending that the CPSA encourage further research on the effect of contracts on research.

The 1980s

In 1980 the CPSA Board decided that it was better to set up a mechanism to respond to ethics initiatives at the Canada Council rather than to engage in creating a broad detailed code of ethics which might overlap, for instance, with existing structures at the University level. Having such a mechanism was seen as important to ensure that the Canada Council and Social Science Federation of Canada (SSFC) initiatives would not be inconsistent with the interests of political scientists. Potential differences with other disciplines, for instance psychology, were noted. In the first half of the 1980s representatives to the relevant SSFC committee were appointed (Rianne Mahon, followed by Linda Freeman) and the linkage was seen as valuable, but over the course of the decade concern about research ethics issues waned as it was felt that the ethics research clearance rules were sufficiently simple as not to pose a problem.

The Tri-Council Initiative in the mid 1990 to 2002

In the mid 1990s social scientists raised a significant number of expressions of concern about the inappropriateness of certain elements of the draft Tri-Council guidelines for their disciplines. These concerns persisted as the Tri-Council guidelines developed. In a 2002 multidisciplinary consultation on the guidelines organized by the HSSFC and the Interagency Advisory Panel on Research Ethics (PRE) these concerns were reiterated and the possibility of restricting the Tri-Council Policy guidelines to a general statement that would be supplemented by disciplinary codes was discussed by some attendees. Problems with the application of the Tri-Council Policy Statement that were noted included variation across Research Ethics Boards (REBs), a clinical bias, the inappropriateness of written consent in some situations, the difficulty of specifying lists of questions in advance, instances of apparent excessive REB attention to methodology, timing problems for graduate students, the concern about the deterrent effect on graduate students of doing empirical research, the appropriateness of the procedures for aboriginal communities, and the concern that there would be a tendency of the mandate of the ethics regime to be unduly extended. There was, however, some optimism that these concerns would be taken up and addressed by the PRE.

Source: CPSA files

Report on consultation meeting on the Tri-Council Policy Statement on Ethical Conduct for Research Involving Human Subjects (Toronto, 29 May 2002) – by Grant Amyot (Queen’s)

1) Program speakers

The meeting was organized by the HSSFC and the Interagency Advisory Panel on Research Ethics (PRE). The latter was established late last year as a permanent body with the mandate of overseeing the maintenance, interpretation, and implementation of the Statement (known as the “TCPS”). It was encouraging to hear that the PRE is aware of the problems with the TCPS, and one Panel member who addressed us said there was a need to “overhaul” the document. This is one of their priorities, on which they are seeking input. She also said that researchers can write directly to the PRE for guidance in interpreting the TCPS. This could be extremely valuable, as I am sure they were aware of the possibility of researchers’ using this as an appeal mechanism against local Research Ethics Board (REB) decisions.

In the presentations, which took most of the morning, members of the Panel and other invited speakers mentioned several problems with the TCPS. They were very well aware of the “resistance” to the document on the part of researchers in the humanities and social sciences, who see it as imposing a clinical model on their very different research projects. Many of them spoke of the need to “fill gaps”, which of course we may not necessarily welcome if it means extending the document’s reach even farther. Among the problems highlighted were the vagueness or imprecision of many parts of the document: e.g. what research is subject to ethics review and what is not, who makes this determination, what qualifies for expedited review, and who is a “public figure”. Other issues identified as “gaps” included the secondary use of data, research involving communities or groups, action research (used in education), internet research, and creative work (e.g. film-making). The diversity of standards applied by local REBs was also mentioned, as well as the small-c “conservative” bias of many of them. Refreshingly, one speaker noted that the passages which allow research on public figures and issues regardless of the balance of benefit and harm for the public figures involved are important and should be given greater prominence.

2) Discussion

Most of the speakers here were officers or representatives of disciplinary associations. The overwhelming direction of their remarks, supported by Philosophy, Medicine, and others, and opposed by no one (I also spoke to this, but only for myself) was that to amend the TCPS to fit all disciplines and fill all identified “gaps” was a fruitless task which would at best produce an unmanageable document. It would be better to keep the TCPS as a statement of principles and then have each discipline work out its own code of ethics. As the president of the Canadian Philosophical Association noted, some professions already have these, but most disciplinary associations in the SSHFC do not. Many of the other speakers had some of the same complaints about the process as it exists as we have heard from political scientists.

3) Possible direction for CPSA

The model of a general statement supplemented by disciplinary codes seems a good idea, but the CPSA should consider all the alternatives before adopting it. If we do adopt it, we could probably find broad support from many other associations in the HSSFC and beyond, and bring pressure to bear on the PRE and the Councils. The PRE or the Councils would likely want to vet the disciplinary codes first. There is also the problem that there are likely to be one or two “laggard” associations that don’t draft codes, or don’t do so in time. Apart from this issue, we might want to take a stand on the procedures: e.g. should the REBs be at the university level, or should we have national disciplinary REBs instead? If the REBs remain at the university level, how can they be made more sensitive to the needs of all disciplines? I think a well drafted disciplinary code could address some, but not all, of the complaints about the procedures by making the criteria to be applied by the REBs clearer. In any case, I suppose we should consult with other associations on this too.

It may be premature to begin work on a political science disciplinary code until we know whether this orientation will be adopted. Nevertheless, we might think of doing some preparatory work. I’ve always thought we should look at whatever journalists have, just as a point of reference. As a basis for reflection, I’ve added the next section outlining some of the issues for consideration. Most of them have been suggested by my own experience as a researcher and graduate chair in my department, but some arose at the meeting and others were reported to me by colleagues or graduate students at other universities.

4) Some of the issues

a) Vagueness of the TCPS: besides the examples raised by the program speakers, there are others of special relevance to us, such as the unclear exemption for “public policy issues”.

b) REB discretion: Partly because of this vagueness, REBs in different institutions apply the TCPS differently, but often with a conservative bias (examples of the same project being treated differently by different universities’ boards were given in the discussion). This is linked to the problem that REBs often contain no one from the discipline in question, and sometimes have a marked clinical or positivistic bias. (The PRE representatives, to their credit, mostly refrained from pointing to the elements of flexibility in the document, which are of little use if local REBs choose not to use them.)

c) Graduate students have often remarked that there is no clarity about the sanctions for non-compliance with the TCPS or the REB’s directives, either (i.e. Article 1.2 of the TCPS has been imperfectly implemented at the university level). I suspect the outcome of a grievance on this issue might vary from institution to institution, depending on the wording of collective agreements, university policies, etc.

d) The TCPS’s preference for consent in writing from subjects raises problems: first, in many cultures where political scientists do research, a request for written consent is considered inappropriate or insulting, and could prejudice the success of the interview. Even in Canada, such a request may often have an unnecessarily chilling effect on the interviewee.

e) The requirement that researchers prepare a list of questions for interviewees in advance for the REB to vet is at variance with the open-ended interview procedure often adopted by political scientists, particularly when researching public policy questions.

f) REBs often exceed their mandate in various ways, making comments on the academic substance of the research proposal (methodology, theoretical framework, etc.), as well as other issues such as field research safety, etc. They have also been known to ignore the explicit restrictions contained in the TCPS (e.g. that consent from organizations, employers, etc., is not required). Graduate students, in particular, are not able to distinguish the REB comments they must address from those they should ignore, and there have been no clear lines of appeal. If REBs do wish to add helpful suggestions, these should be clearly distinguished from the changes they are requiring in order to satisfy the ethical requirements of the TCPS.

g) For graduate students in particular, the timing of the ethics review is of crucial importance. They are on grants awarded for a limited period (typically a year at a time), and hence for them to spend two or three months awaiting a response from an REB and, possibly, having to address its concerns and wait again, is an unacceptable cost. While this is a “nitty-gritty” procedural issue, it should not be lost from sight amid the broad questions of principle that are also involved in the TCPS. Some way to speed up approvals (especially where expedited review is not appropriate) must be found. Face-to-face meetings between the researcher and the REB are one possibility, but can be only one part of the solution. One idea often suggested is for grad students to make ethics submissions before the project is approved by their academic unit (thesis proposal board or similar), but the disadvantages of this solution are obvious, since the process may need to be repeated if the proposal board asks for revisions (and, in any case, grad students are unlikely to be able to make an ethics submission much in advance of the thesis proposal proper).

h) An unfortunate consequence of these problems, which are often magnified by the rumour mill, is a kind of “ethics review chill” which may lead graduate students to opt for theoretical topics, even when empirical research is much more appropriate given their interests and capabilities. This could lead to a general decline in the quality of work done in our graduate departments, with more rehash-type theoretical theses and less interesting original research. Apart from action at the national level, we should all do what we can as faculty members to counteract this chilling effect, by pointing out that most political science research gets expedited review, and by trying to introduce even simpler standard procedures for interviewing that the researcher only has to “sign on” to (provided for in Article 3.1 of the TCPS).

i) There is a potential conflict between the principle of free and informed consent and that of limiting harm to subjects. We could propose that the TCPS clarify that in most cases the calculation of the balance of benefit and harm should be left to the research subject rather than the REB.

j) In the discussion, a representative from the Native Studies Association spoke in a way that suggested that for aboriginal groups the major issue here is jurisdiction: some aboriginal communities are drafting their own research ethics guidelines. This raises a whole series of issues, of course, including e.g. individual vs. community consent and the territorial ambit of the TCPS (it appears to apply to Canadian university researchers everywhere in the world, but not to foreign researchers in Canada – or to private sector researchers – since it is not a law, regulation, or governmental policy). At any rate, I am just flagging this as an issue that will require careful thought (cf. Sec. 6 of the TCPS).

k) In the presentations and discussion, there were a number of proposals to “extend” the TCPS, “fill gaps”, etc., that I think we should view with some scepticism. (For example, one of the program speakers suggested some limits on the use of material already in the public domain, such as theses.) We should remain vigilant against the tendency for an emerging “ethics review bureaucracy” to attempt to widen its mandate and enter areas where it does not belong or has no expertise. The freedom to research – a key component of academic freedom – should remain the fundamental assumption, any proposed limits on it must be “reasonable and justified” (to borrow a phrase), and we should be ready to oppose any limitations that go farther than that.

l) Following from the previous point, one speaker in the discussion noted that the TCPS is based on a series of ethical principles, such as respecting human dignity, free and informed consent, etc. (Sec. i.5). There is, quite properly, no reference to limiting the legal liability of universities or researchers, and this should not be allowed to creep in as a subsidiary goal (already, many faculty believe this is the real purpose). This is the job, at the limit, of the university’s legal advisers, not the REB. This is just a list of problems, in no particular order, and with no particular solutions, in most cases. Some may have to be dealt with at the PRE level, while others might be addressed in our own code of ethics, should we decide to go that way.

5) Concluding comments

I and other participants were pleasantly surprised by the intelligent, reasonable, and non-bureaucratic approach that the PRE members took. I think they will listen to well thought-out representations from associations and researchers. I shall forward the materials (overheads) distributed at the meeting to the CPSA office.

September 16, 2008

(by Tony Porter, CPSA representative on the Federation Ethics Committee)

Two parallel processes are unfolding currently at the national level in Canadian research ethics governance. The first is the creation of a revised Tri-Council Policy Statement (TCPS) by its guardian committee, the Panel on Research Ethics (PRE) and the PRE’s secretariat. The second is the Sponsors’ Table initiatives that have included the Moving Ahead report. The two processes are summarized in turn.

The PRE’s Revision of the TCPS (TCPS II)

The TCPS is the policy statement that guides research ethics boards across the country and which has been seen as problematic for its biomedical bias by social sciences and humanities SSH) scholars. The PRE plans to release a draft of TCPS II by early 2009 with a public consultation period of about four months. The PRE created a number of working committees to advise it on changes needed to the TCPS. The most important of these committees from the CPSA point of view appears to be the Social Sciences and Humanities Research Ethics Special Working Committee (SSHWC), which on the basis of hundreds of submissions from SSH scholars produced a very critical report entitled Giving Voice to the Spectrum in 2004 and a follow up report in 2007. Like the other working committees it has produced a report with specific recommendations for rewording the TCPS in the form of a draft chapter on qualitative research (“Qualitative Research: A Chapter for Inclusion in the TCPS”, February 2008, at http://www.pre.ethics.gc.ca/english/publicationsandreports/publicationsandreports.cfm). The SSHWC report to does a very good job in addressing concerns about qualitative research, especially ethnographic research. There is perhaps, however, more that could be said about two concerns that are more serious in Political Science than in other SSH research: the distinctive practical and ethical problems of burdening elite research with excessive ethics rules and the distinctive problems of survey research. As well the SSWHC report did not recommend actual specific rules for implementing its more conceptual points.

It also isn’t clear whether the PRE will make clearer its apparent intention to have public policy research treated differently than other research. The following two excerpts from the TCPS suggest this intention but in practice REBs seem not to have actually treated public policy research any differently than other research.

Research about a living individual involved in the public arena, or about an artist, based exclusively on publicly available information, documents, records, works, performances, archival materials or third-party interviews, is not required to undergo ethics review. Such research only requires ethics review if the subject is approached directly for interviews or for access to private papers, and then only to ensure that such approaches are conducted according to professional protocols and to Article 2.3 of this Policy” (TCPS 1.1)

Researchers and REBs should also be aware that some research may be deliberately and legitimately opposed to the interests of the research subjects. This is particularly true of research in the social sciences and humanities that may be critical of public personalities or organizations. Such research should, of course be carried out according to professional standards, but it should not be blocked through the use of harms-benefit analysis or because it may not involve collaboration with the research subjects.” (TCPS i.7).

Left unclear in the TCPS is the meaning of “professional standards” and “professional protocols” in these statements. It isn’t certain that the TCPS II will clarify these terms.

A prevailing view among participants in research ethics governance appears to be that the idea of having separate documents for SSH research and for biomedical research is not one that has any realistic chance of succeeding. It isn’t yet clear whether a separate qualitative chapter in the TCPS II will satisfy SSH critics. It may be useful to keep in mind that journalists in Canada, when writing about public policy issues or actors, are not subject to ethical regulation. The UK’s Economic and Social Research Council’s Research Ethics Framework (REF), established in 2006, also has taken a different path than the TCPS. It states: “Other ethical frameworks for research on human subjects, such as that which addresses biomedical research, may not be appropriate, which is why a framework specific to social science is necessary.” Although more investigation would be needed to see how it is working in practice, the wording of the REF suggests that research ethics governance in the UK is much more decentralized and flexible that in Canada. For instance it references a checklist that identifies social science research hazards. If you answer no to the eleven questions then you only need to file the form with the appropriate authority. Only if you answer yes to any question do you then need to write up an ethical plan and get approval from the Research Ethics Committee. In other words, although participants in Canadian research ethics governance seem to set limits around the degree to which the distinctive concerns of social scientists feasibly can be reflected in textual exemptions of SSH research from biomedically-inspired rules these limits do not appear to be a problem in other settings.

The Sponsors’ Table and the Experts Committee

The Sponsors’ Table for Human Research Participant Protection includes 14 research sponsors such as the Alberta Ministry of Health and Wellness, the Association of Canadian Academic Healthcare Organizations, and Canada’s Research-Based Pharmaceutical Companies, ten of which are health-related. The other four include the Canadian Federation for the Humanities and Social Sciences, the Association of Universities and Colleges of Canada and the Natural Sciences and Engineering Research Council and the Social Sciences and Humanities Research Council. The Sponsors’ Table created an Experts Committee that issued a report, Moving Ahead, that appeared in draft form in August 2007 and in final form in 2008. This report proposed the replacement of the TCPS with a drastically reworked and strengthened set of governance arrangements. The CPSA submitted concerns to the Experts Committee about the August 2007 draft of the Moving Ahead report. Other critical responses were submitted. For instance the SSHWC stated:

we believe that this structure will actually entrench – rather than reverse – the problems…We have worked tirelessly to identify the problems with the imposition of just this type of biomedical ethics model on the SSH in Canada, so we are saddened and frustrated that this is the model presented here for ‘solving’ our existing problems.

The Association of Universities and Colleges of Canada (AUCC) was also very critical of the report, probably in part because they feared having to fund the new Council that the report proposed and the Council’s 51 staff, estimated at $9-10 million. The need for the proposed system of accreditation, which in effect would be required to be applied to all research, was also seen as unsubstantiated.

One concern about the Moving Ahead proposals of August 2007 was that they appeared to advocate the abolition of the PRE without making clear how the process described above would be incorporated in the new system.

Six hundred pages of feedback in response to the draft report were received and they were summed up by a consulting company. The consultant’s report on the feedback has been posted at http://www.hrppc-pphrc.ca/english/consultationreport.pdf. After considering the feedback it received, the Experts Committee submitted a final version of Moving Ahead to the Sponsors’ Table (available at http://www.hrppc-pphrc.ca/english/movingahead.html). The changes made by the Experts Committee in response to this feedback were relatively marginal. The Sponsors’ Table met in June 2008 to consider what to do with the Moving Ahead report. In a July 2008 press release (at http://www.hrppc-pphrc.ca/english/communiquejuly182008.html) the Sponsors’ Table indicated that its four priorities were (a) to recognize the Tri-Council Policy Statement as Canada’s basic policy framework and to create a subcommittee to discuss further governance issues; (b) to work on a strategy for better education about research ethics; (c) to launch a pilot voluntary accreditation system; and (d) to emphasize and develop the notion of “proportionate review.” While the exact implications of this will only become apparent over time, it seems clear that the Sponsors’ Table has chosen at present not to implement some of the more controversial directions that were stated in or implied by the Moving Ahead report, such as the replacement of the TCPS by a large and expensive new bureaucratic structure.

Next steps

For CPSA members concerned about research ethics issues the most important upcoming development will be the call for consultations on the revised Tri-Council Policy Statement in the fall of 2008. It will also be important to monitor developments at the Sponsors’ Table. The Sponsors’ Table subcommittee reports that will set out proposals for implementing the priorities listed above are scheduled to be completed in June 2009 so it is unlikely that there will be significant public developments before then.

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.

The Canadian Political Science Association (CPSA) continues to be generally very encouraged by the revisions incorporated in the draft second edition of the TCPS (TCPS II). TCPS II has attempted to address many of our concerns with research ethics rules, especially with its inclusion of a chapter on qualitative methods, its greater sensitivity to the particular circumstances surrounding research on political elites and its more nuanced and open approach to obtaining informed consent. The December 2009 draft of TCPS II includes some further improvements. It is important that the improvements that have been made in TCPS II not be removed or weakened in the final version.

At the same time, despite the significant improvements in TCPS II the CPSA remains concerned that excessive burdens will be imposed on social sciences and humanities researchers as a result of “research ethics creep”. Some further alterations in the text of TCPS II could help alleviate this, but it will also be important to be alert to this problem as the new rules are implemented. There are a number of reasons that research ethics creep is likely to continue to be a problem. As we noted in our response to the previous draft of TCPS II,

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.

TCPS II presently reinforces this tendency through its almost exclusive emphasis on the protection of research participants. While such protection is its primary purpose, research ethics governance should balance this appropriately against the burdens that rules place on research. Combined with the REBs’ institutional autonomy, relative lack of accountability, power to prohibit research, and tendency to recruit members who are engaged in higher risk research, the almost exclusive emphasis of TCPS II on participant protection will encourage REBs to continue to be too zealous in trying to anticipate and eliminate risks in low risk research.

The CPSA notes that in the most recent draft of TCPS II a reference to academic freedom has been added in the third paragraph of Chapter 1. The placement of this, so close to the beginning, helps emphasize its importance, and this is good, and will help in alerting REBs to this issue. However the qualification of this statement in the last sentence of that paragraph, along with the absence in the larger document of much further discussion of the challenge of balancing this against the need to protect participants, reinforces the document’s implication that the protection of academic freedom is not something that the REBs have any responsibility to promote.

The main way that TCPS II addresses the problem of research ethics creep is through its discussion of proportionate review. The addition of a subhead on proportionate review at line 231 is helpful. However, this subsection could be strengthened to address more clearly the risk that REBs will be overzealous in implementing the policy, and the costs to research and to society that this can involve. The CPSA acknowledges that discussions of proportionate review appear throughout the document, and these will certainly be useful in restraining the problem of research ethics creep. However there will need to be significant ongoing exercise of judgment and interpretation in applying the proportionality provisions of the TCPS on the part of REBs, and in doing this they will be likely to err too far on the side of controlling risk and burdening research, for the reasons noted above. Strengthening the discussion of this problem in the proportionality section of Chapter 1 will help prevent this. The following two paragraphs are illustrative of the type of discussion that should be added to this section:

REBs are granted a significant degree of institutional autonomy, arrive at key decisions behind closed doors, are subject to an appeal process that is rarely used, and have the power to prohibit research. These powers are important in allowing REBs to act to reduce risk to research participants, free of external pressures that may be motivated by commercial gain or other interests that may not be aligned with the well-being of research participants. They also help provide the REBs with the credibility that is important in inspiring potential research participants to trust that if they agree to participate in REB approved research they will be appropriately informed, and risks will be appropriately mitigated. At the same time these powers may lead REBs to exercise their control too aggressively. For researchers, who have no alternative but to submit their research to their REB, these powers provide the REBs with a daunting ability to change or terminate their research plans or impose costly delays. For society the cost of foregone research is usually invisible, and REBs may underestimate these costs.

There are a number of reasons that REBs may tend not to adequately consider these costs. Their primary purpose is to protect research participants, as is the primary purpose of this policy, which governs their deliberations. Their power and autonomy may insulate them from expressions of concern about these costs. Researchers may not have the expertise or time to challenge REB decisions. In the case of research that is not initiated in anticipation of the difficulty it would experience in getting REB approval, there may be nobody with an interest or ability to make this cost visible. For these costs to be balanced appropriately against the risks involved in research it is important for REBs to be alert to them and to consider them in their deliberations, and to be sensitive to the consequences of power and autonomy that they are granted.

The definition of research as “an undertaking designed to extend knowledge through a disciplined inquiry or systematic investigation” (lines 61-2) is too broad, and it would be useful to add “and disseminate” after “extend” to reinforce the boundaries of the policy. For instance, the policy should not apply to quality assurance and improvement, or other knowledge producing activities that are not intended to lead to the dissemination of results, even if such knowledge producing activities involve systematic investigation.

The new language in lines 363-368 which exempts discussions with authorized spokespeople or personnel tasked with public communications from REB review is very welcome and should be retained. Some REBs likely will reduce the positive effect of this by treating questions that solicit the views of professionals or officials as involving personal risks that REBs have a responsibility to mitigate, even if those professionals or officials are providing these views in the ordinary course of their employment. Often the terms of their employment or appointment may include offering controversial opinions on behalf of the profession or organization that they represent, and thus these too should not lead to them being considered research participants. It would be helpful to make this clearer in the application notes.

The placing of the onus on the researcher to explain why any of the 12 elements of informed consent that appear at lines 821-62 should not be included may lead to unnecessary time spent discussing these in the submission of protocols to REBs, and may lead REBs to be overly cautious in judging which of these must be included. The following phrase, at lines 817-18, should therefore be deleted: “It is up to the researcher to explain to the REB why, in a particular project, some of the listed disclosure requirements do not apply”.

The disclosure of material incidental findings that is discussed in Article 3.4, lines 950-70, should not apply to critical research that is focused on organizations or powerful officials.

The paragraph “Respect for Communities and Minimizing Social Disruption” (lines 1599-1608), which instructs REBs to require researchers to “demonstrate respect for communities they engage in research by exercising due diligence to anticipate and minimize any risk and social disruption that might be created by research” is unacceptable and must be deleted. Much political science research, as in many other fields, may very legitimately contribute to social disruption, for instance where it challenges structures of inequality. Aside from the ethically problematic character of this paragraph it will create practical problems for REBs that are called upon to enforce it.

The discussion in lines 2049-2074 appears to extend the authority of the REBs to include all research involving human participants done by faculty members or students in other organizations. For instance, the current wording states:

Members of an institution, that is its faculty, staff and students, may be affiliated with other institutions or may be engaged in consulting or other professional activities in a separate enterprise. To enable the consistent application of this Policy, members of the institution should obtain REB approval of the ethical responsibility of their research if they engage in research involving humans related to one of their other organizational affiliations or their supplemental professional activities.

This would appear to apply, for instance, to a political scientist who carries out polling for a political party, or who is hired by a government to conduct a research project requiring the solicitation of views from officials. This extends the reach of the REBS too far. If applied as written it could seriously restrict the ability of faculty and students to become involved with activities outside the university (including internships), at a time when such involvement is rightly viewed as increasingly important by the granting councils and others. The wording of this article should be changed to make clear that only activities that are closely related to the REB’s institution should be included.

The CPSA notes that the revised appeal process, lines 2586-2625, is significantly improved and should be retained. Even if this is only rarely used it will provide a mechanism of accountability that did not previously exist.

Chapter 8 on multi-jurisdictional research, continues to impose excessive burdens on low risk social sciences and humanities research in multiple jurisdictions. The inclusion of categories d-f at lines 3120-3128, even with the qualifier “may” at line 3111, is likely to lead REBs to err too far in the direction of requiring researchers to involve REBs in other jurisdictions or to explain why they are not. Category (f), for instance, refers to research conducted in another country by a researcher at a Canadian university. If the researcher is interviewing government officials in ten European countries the policy appears to require the approval of an REB in each country. Additionally, the chapter appears to require the Canadian REB to enforce foreign rules that may not be consistent with the TCPS. For instance, if Canadian REBs require US Institutional Review Board approval of all research done in the US then this chapter also appears to put the Canadian REBs in the position of enforcing US research ethics rules on Canadian researchers for that portion of their research. In some cases this may be reasonable, but in others it will undermine the advances that the TCPS II has made in developing greater sensitivity to social sciences and humanities research, where the US rules have not. The wording of this chapter should be changed to exempt all low risk research from foreign REB review.

Research Involving Aboriginal Peoples

The December 2009 draft of Chapter 9, regarding Aboriginal peoples, is an improvement over the 2008 draft. It pays greater attention to ethical issues arising in social science research, with more nuance, and it offers greater clarity on certain questions. However, after consulting some of our members with expertise in this area – Aboriginal and non-Aboriginal – we believe that serious problems remain, in terms of both conceptual approach and operational details.

These comments should be read in the context of our observations above about the overall improvements in the most recent draft regarding research involving or about political elites and other potential subjects of political science research. As noted, however, we still have important concerns in this regard.

While we strongly support the chapter’s emphasis on respect for Aboriginal peoples, their communities and their knowledge systems, we have four significant conceptual concerns.

First, in several places (lines 3388, 3407-11, 3515-7, 4039-41) the draft appears to equate ethical research with politically engaged research that supports the political aspirations and agendas of Aboriginal peoples. This is an important issue of academic freedom: while many political scientists are supportive of the objectives of Aboriginal peoples, such a political stance should not be made a requirement for ethical approval.

Second, while we recognize the importance of community in Aboriginal societies, the overwhelming emphasis in the draft is upon securing authorization from communities (the definition of which, as discussed below, is problematic). In our opinion, insufficient allowance is made for the possibility of individuals agreeing to take part in a research project that may not be acceptable to the community or the community leaders.

Third, given the key role assigned to ‘the community’ in the ethical approval process, we find the definition of community at once too vague and too limiting. The draft stipulates that a community is “a collectivity with shared identity or interests that has the capacity to act or express itself as a group” (lines 3451-2). Among the unanswered questions this definition poses are: who decides that there is a shared identity or interest, those in the community or an outside observer? What does it mean to have “the capacity to act or express itself” and who decides whether this capacity exists? Lines 3453-61, which elaborate on the definition, do refer to “informal communities” but emphasize formal institutions. Would the single mothers on a First Nations reserve who rarely if ever come together in any formal way but who have an extensive informal network qualify as a community? What happens if they are prepared to endorse a research project but the formal reserve leadership is not?

Fourth, although sections 9.5, 9.6 and 9.7 go some way to addressing the problem, we remain of the view that too much leeway exists for those in positions of authority within the community to block research that may prove critical of them or of the status quo.

In terms of the practicalities, we are concerned that the many complex and potentially contentious issues arising from the draft will cause difficulty for REBs in evaluating specific projects. Some REBs may have only limited expertise in these areas but even those with call on substantive expertise will encounter interpretive uncertainties. In turn, this could encourage the sort of ‘ethics creep’ discussed earlier, and a consequent reduction in the willingness of researchers to undertake work relating to Aboriginal people.

Some of these uncertainties could be resolved by minor wording amendments; a few are listed below. Others, however, arising from the conceptual issues discussed above – for example, precisely who should be recognized as having authority to approve a project on behalf of ‘the community’? – require further reflection and refinement.

$ at lines 3606-8, the draft observes “In some situations, the determination may be that the welfare of relevant communities is not affected, and consent of individuals is sufficient.” The phrase “welfare of relevant communities” is extremely amorphous; moreover, there is the question of who is to decide what constitutes “welfare” and how it might be affected.

$ the hypothetical example at lines 3624-3632 indicates that “permission of the land claims organization that carries authority to approve research in Nunavut is required”. No land claim organization in Nunavut has authority to approve research involving human subjects.

$ Article 9.3 requires researchers to seek formal engagement of community leaders “on lands subject to a claim as defined by the community”. This provision needs to be revisited as it is far too broad. Much of the land on which the City of Toronto sits on land that is subject to an unresolved claim; the present wording implies that all research in that part of Toronto requires engagement of the leaders of the First Nation pursuing the claim?

The emphasis in this memo on the shortcomings of the most recent draft of the second edition of the TCPS is not intended to suggest that there are not also a great many positive changes that have been made, relative to the first edition. As noted at the beginning of this memo, the CPSA strongly supports the retention of these positive changes and appreciates the efforts that have been made to address the concerns of political scientists and other social science researchers.