The federal granting agencies -- the Medical Research Council, the Natural Sciences and Engineering Research Council, and the Social Sciences and Humanities Research Council -- have issued the third and final report of the tri-council working group on ethical conduct for research involving humans.

The final report proposes a single code of ethics for all research involving humans. The code of ethics would not only cover researchers funded by all three councils but also any other research undertaken by employees of universities. The final version of the code will be adopted by all three councils and will be enforced by local research ethics boards whose membership is also laid out in the code.

The report is the result of a complex exercise initiated by the councils in 1994 to replace the existing codes of MRC and SSHRC.

The working group began with an issues paper in 1994 followed by the first and second versions of the proposed code in 1996 and 1997. Both the 1996 and the 1997 versions produced vigorous controversy -- the 1996 version alone generated more than 2,000 pages of comment from 260 different sources.

The councils are now conducting a final consultation process before adopting a formal policy statement, concerning ethical conduct, in early 1998. The councils have asked three questions about the proposed code:

• Will the code enhance the protection of participants in research?
  
• Will the Code allow research to be carried out without unreasonable constraint?
  
• Will the Code provide effective mechanisms to review ethical requirements and enhance the accountability of universities, research councils and researchers?
  

CAUT's executive committee has reviewed the final report of the working group and has formulated a CAUT response.

The Controversy

One of the reasons for the controversy was the decision to create one code for all researchers. CAUT opposed this on the grounds that it would lead to the application of a medical code of ethics to social science, environmental and humanities research which was not only inappropriate but could lead to serious questions of censorship. Since the councils have rejected this argument CAUT has concentrated on improving the code -- in particular focusing on procedural justice and questions of academic freedom.

The CAUT response recognizes that each successive version of the report has been a considerable improvement on the earlier ones, and that the final version has incorporated some important guarantees in the section on process regarding academic freedom.

The CAUT response also congratulates the working group on restricting the scope of the code to the living (a previous version included the dead) and for stating that research based on materials in the public domain, including archives, need not be reviewed by local research ethics boards. This was a serious concern of the Canadian Historical Association.

CAUT still has concerns about the "medicalization" of the process. CAUT recognizes the need for specific procedures to govern medical research, particularly given the terrible abuses that have occurred in the twentieth century.

However, certain aspects of medical ethics have a counterproductive effect when applied elsewhere. For instance, the code endorses the view that medical research should do no harm to individuals and should do them some good either immediately or in the future. The application of these concepts to public policy research or to literary criticism would be devastating, particularly since the code applies not only to individual research subjects but to all collectivities -- including, specifically, governments and corporations.

Public policy research or environmental research may well harm those who are players in the political arena, and literary criticism is famous for its pungent attacks on living authors. Local research ethics boards would be forced by this code to enforce the "no harm" and "informed consent" rules on all researchers. CAUT has suggested wording to avoid this dilemma. It has also suggested that the code explicitly state that artistic criticism need not be reviewed by local ethics boards. Otherwise there will certainly be unreasonable constraints on research.

CAUT has been particularly concerned about the application of the code to collectivities. The CAUT response points out that the difficulty has arisen because the authors tried to generalize particular concerns about research on aboriginal peoples into a general code for all collectivities.

The result is an overwhelmingly strong tendency "...to define the rules in such a manner as to defend the status quo and the powers that be and to make it difficult to undertake critical research about these collectivities." Once again the "no harm" rule will apply as well as procedures that go a long way towards giving the collectivity a veto over the research.

CAUT argues that governments, corporations and labour organizations do not need the protection of research ethics boards and may well, in fact, try to use those boards to suppress research about their activities. Universities could block research about themselves with these provisions.

The CAUT response notes that "there seems to be a great reluctance to say explicitly that when collectivities involve themselves in the public arena, their political, economic or social positions may be the subject of research without their consent or participation and may lead to negative conclusions about them." In an earlier letter CAUT described this section as "marshmallow liberalism."

CAUT recommends that the code not apply to governments or corporations. For example, it is hard to understand why any citizen in Canada would be able to write an unofficial biography of a living person except, of course, university professors who will be tied in knots by these rules.

Nor is this approach restricted to Canada. It applies to all governments with the result that a researcher could not write a book on Sadam Hussein's dictatorship in Iraq based on private interviews with various exiles without approaching Hussein for his "informed consent" and without assuring an ethics board that no harm would come to Hussein or his government as a result. The powerful, as CAUT points out, have plenty of weapons, including libel and defamation, not to mention economic and political power. They do not need more.

In the view of CAUT, this section on collectivities should be restricted to research on aboriginal peoples and vulnerable minorities. Unless the changes suggested by CAUT are made, there will be serious and unreasonable constraints on university research.

The CAUT response recognizes that there have been significant improvements in the procedural section of the document. All universities will be required to have research ethics boards and their composition is set out in the code. CAUT notes that the authors of the code have not taken into account the problem of creating such structures in small universities. It suggests either that small universities be allowed to recruit more outsiders on these boards or to band together with other small universities to create a single board.

The main objection of CAUT is that the board members will be appointed by the university president. CAUT believes this mechanism to be ineffective. The president should nominate the members but they should be appointed (and removed) with the advice and consent of the academic senate or equivalent senior academic body. Other nominations that conform to the criteria should also be acceptable.

If such procedures are not adopted both for the boards and for any appeals body, CAUT will take the view that these boards are simply part of the administrative structure of the university and subject to the grievance and arbitration procedure of local collective agreements.

CAUT welcomed the confirmation in the code that university research should be open and that university researchers should not undertake covert action on behalf of either the Canadian or foreign governments under the guise of university research.

The CAUT response suggested an additional caveat about research under authoritarian regimes whereby local research ethics boards should ensure that researchers working in such countries should take special precautions to maintain the confidentiality of data about individuals who are citizens of such countries and which might compromise them with their governments. "It is particularly important," said CAUT, "that Canadian scholars, from the safety of their own country, not publish or otherwise disseminate research materials which could jeopardize the lives or freedom of individuals with whom they have worked on a research project under an authoritarian regime unless they have the express and verifiable consent of those involved." This change would enhance the protection of such research participants.

Peer Review

The research ethics board are supposed to review the ethical side of research projects in so far as they deal with human subjects.

Should they also review the quality of the research? There seems little disagreement that they should do so in areas of research that pose risk of harm above the threshold of normally acceptable risk.

But what about all the other research? Opinions differ by discipline, and the solution of the councils is to allow the boards to decide for themselves. CAUT disagrees. In disciplinary areas, where there is a tradition of examining scholarly quality in addition to ethical probity and professionalism, the boards should honour this tradition. Where, however, there is a tradition in a discipline whereby scholarly quality is assessed by peer evaluation separately from the board assessment of ethical probity and professionalism, that tradition should also be honoured. No change should be made in these traditions without the express consent of the members of the discipline in each university. CAUT sees no rationale for two sets of peer evaluation.

The CAUT response also notes the new procedures will impose considerable costs on the universities, particularly when the cost of the time of professional employees is considered. CAUT recommends that the councils approach the federal government for new funds to assist universities in creating these new structures.

Background: CAUT Bulletin reports September 1996, January 1997 & September 1997.