The Tri Council Policy Statement: Ethical Conduct for Research Involving Humans is the supreme research ethics document in Canada. Generally speaking, it is a well-intentioned, sincere, sensitive, thoughtful reflection on the problems and concerns regarding the ethical treatment of human subjects2 in research. But its birth was painful and its labor long. The first draft shocked the research community into action and individuals, professional and academic associations, and university administrators responded with an unprecedented number of critical comments and suggestions for revisions. Indeed, so activated was the community of researchers that the second draft was forced to further revision. The final document, published in July, 1997, was one that most researchers thought they could live with. However, what many of us failed to realize was that the document was not just a treatise on good, ethical practice but was also a potential blueprint for increased control over the research we could do and how we could do it.
The 1997 Statement replaced the separate ethical guidelines that had been used previously by each of our three major, federal, granting agencies. It was not obvious why it was felt that: a) medical research, b) science and engineering research, and c) social science and humanities research needed to be brought under one umbrella of ethical scrutiny. But a consideration of the reasons for the integration of the ethical review processes of the granting agencies illustrates the abstract and, sometimes, incoherent reasoning that is so evident throughout the document.
The stated reasons for the integration included the beliefs that fundamental ethical issues and principles transcend disciplines, and that a harmonizing of Research Ethics Boards (REBs, called IRBs in the US) across disciplines would be bureaucratically and educationally more effective. Oddly, the increased protection of human subjects was not mentioned as one of the reasons! Moreover, no evidence was presented that showed the old way was problematic in the first place. Indeed, true to the natural reluctance of Canadians to offend anyone, the statements on the need for harmonization and adherence to common principles were followed by a recognition that “The effective working of ethics review across the range of disciplines conducting research involving human subjects requires a reasonable flexibility in the implementation of common principles. The Policy therefore seeks to avoid imposing one disciplinary perspective on others.”
Thus, although it is not clear that the Tri-Council Statement has increased public safety, it is evident that Canadian researchers are under more scrutiny and control than ever before, because a bigger bureaucracy, with more rules, has been created. We don’t want to suggest that increased control per se was the driving motive of the Tri-Council, but we do want to suggest that that is one of the real outcomes of their new ethics statement. And therein lies a potential threat to free inquiry. We will describe four examples.
1. First, many REBs are asked to judge the scientific validity of research in order to consider whether the benefits expected outweigh the harm. In the new ethics forms developed at our university this past summer, investigators are asked to provide details on the scientific justification of the research, the strengths and weaknesses of the design, the analysis of the data, the justification of the sample size, and the sample size power calculation. This is the case even for research that has been peer reviewed and funded by one of the Tri-Councils!
Giving members of an ethics review board the authority to second guess the expert opinion of the grant review panel is not only absurd but opens the door to abuse. A study by Ceci, Peters, & Plotkin (1985) many years ago demonstrated that the decisions of ethics committees are influenced by the purpose of the research. In their study of actual IRBs, they showed that judgments of the ethical acceptability of the procedures of a study varied with the expected outcome of the study, even though the method section was held constant across conditions. Ethics review boards should concern themselves with the protection of subjects only, i.e., they should ask the question, ‘Does the research violate any of the subject’s rights?’
2. Second, we are, of course, required to provide informed consent regarding the tasks the subjects are expected to complete, anonymity guarantees, and the like. No argument. But now we are also directed to ask our subjects at the end of the experiment, after they have been fully debriefed, whether they want their data used by the researcher. Let us be clear. We are not talking about permission to reveal personal information or to identify which subject provided which data points. We are asked to obtain permission from the subject to use his or her data in the data analysis. Thus experiments that study hypotheses or theories or applications that the subjects may object to may be put in jeopardy by selective withdrawals from different experimental conditions. In extreme cases, this would be tantamount to giving subjects a veto over which research could be carried out, even though there were no ethical problems of harm associated with any of the procedures. Should investigators be obligated to match any potential or hypothetical political implication of their research with the political inclinations of their subjects?
3. Our third example is a good illustration of Lou Penner’s (2002) warning about the local REBs’ idiosyncratic interpretations of the rules. Although the Tri-Council Statement is silent on the advertising of payment for research participation, our local non-medical REB, for many years, has refused to allow investigators to advertise how much money subjects will be paid. Participants were allowed to call to find out, and payment information is part of the informed consent form, but the amount must not be placed in the ad. The REB’s rationale is that money is coercion, and coercion is bad.
As a member of the local REB, and wanting evidence to argue with the REB, Dick Sorrentino wrote to members of the SPSP list to canvass their opinions and university’s policies on this issue. All of the 26 respondents who replied were in favor of advertising the amount paid to participants, and many were quite emphatic about it. All disagreed that money is, by definition, coercion. Only one person said that their university’s IRB looked upon money as coercion, but even so they were still allowed to advertise the amount.
Most of the arguments centered on informed consent. That is, participants should be fully informed about the payment amount and should not have to take extra steps to find out. For example, one respondent wrote, “I believe that most people would like to know how much they will be paid before they call for further information. As researchers we have an ethical obligation to avoid wasting people's time, and flyers with insufficient information have the potential to waste the time of everyone who would consider the compensation insufficient.”
Many respondents disagreed that money is coercion. For example, one person said, “this seems utterly absurd. By these standards, if I pay a college student as a babysitter I'm coercing her into babysitting. It is just fair payment for services rendered. Coercion refers to the use of excessive compensation intended to entice people to do something they would not otherwise be willing to do (out of fear, moral objection, or essentially any other reason beyond ‘it's not worth my time’).”
4. As a final example, two of our colleagues in the sociology department were engaged in a health research project in which one of their goals was to assess the adequacy of the current method for calculating life expectancy for native Canadians. The research was funded by the Social Sciences and Humanities Research Council (one of the tri-councils) and one of the partners in the research was the federal Department of Indian Affairs. The investigators’ idea was to match death statistics with persons listed on the Indian Register. These data are kept by another federal agency, Statistics Canada, which initially was also interested in the accuracy of life expectancy figures.
The research got hung up because Statistics Canada felt that it would be unethical to check whether newly dead people were listed on the Indian Register, without obtaining permission. Permission! From whom? Unless the silence of the dead is taken as agreement, there is a problem. Apparently, it was not possible to budge Statistics Canada on this point.
As the “negotiations” between the researchers and Statistics Canada unfolded, the researchers began to realize that the issue was hypersensitivity on the part of Statistics Canada to doing research with native populations. One need only read the Tri-Council Statement section on research with aboriginal communities to realize the political sensitivity of such investigations. The researchers ultimately decided against conducting this aspect of their research.
Unfortunately the situation may worsen in the future. The Tri-Council has now decided that the implementation of the 1997 Statement must be systematically policed and standardized across all institutions where research is conducted. Working behind the scenes without the full knowledge of the research community, various federal agencies, vying with each other for control of the research ethics industry, are making plans for accrediting the REBs.
According to The Society for Academic Freedom and Scholarship which has examined the available documents the current plan:
- does not establish any need for a national governance system
- does not make it clear that there will be any benefits to researchers
- provides no assessment scheme to document the benefits to public safety
- uses a medical research model which is not applicable to research in general
- is unclear on even the mechanics of accreditation and national governance
- aims to extend coverage to private sector research, again with no justification
- suggests that socially desirable outcomes are the aim of research
- has been developed by a top down process driven by insiders and bioethicists
- has had no meaningful input from the community of individual scholars
- continues to download the expenses to the local institutional review boards
- seems guided by the premise that more control is inherently good
- Order of authorship is alphabetical.
- The Tri-Council deliberated on what to call the people who sign up for experiments, and chose the term subjects over participants. It is tempting to conclude that the real purpose here was to reaffirm that Canadians really are different from Americans.
- >Ceci, S.J., Peters, D., & Plotkin, J. (1985). Human subjects review, personal values, and the regulation of social science research. American Psychologist, 40, 994-1002.
- Penner, L. (Spring, 2002). IRB and U. Dialogue: The official Newsletter of the Society for Personality and Social Psychology.
- Society for Academic Freedom and Scholarship (2002). Response to Interagency Advisory Panel on Research Ethics. http://www.safs.niagara.com/issuescases/pre.html
- Social Sciences and Humanities Research Council of Canada (1997). Tri-council policy statement: Ethical conduct for research involving humans. http://www.sshrc.ca/english/programinfo/policies/Index.htm