Henry B. Dinsdale, President of NCEHR

Let me describe how the National Council on Ethics in Human Research will do some of its work this year.

A vital and invigorating feature of Council from its inception is the diversity of backgrounds and interests of its members. That element is increasing as Council expands to meet its new mandate to encompass issues not only in the life sciences but also those in the social and physical sciences and engineering and psychological research involving humans. Council is responsible for major policy directions, and meets twice this year. It has provided input to drafts of the Tri-Council Code of Conduct and will follow closely the progress of that initiative.

NCEHR does much of its work through its committees, with support from the NCEHR office. The Executive Committee assists Council in establishing policies and priorities. It acts on behalf of Council between Council meetings. The Finance Committee oversees the NCEHR budget and prepares the business plan. The Nominating Committee reviews candidates for Council and assigns Council members and non-Council experts to four key NCEHR working committees:

The Committee on Evaluation, chaired by Dr. Gordon Crelinsten, recommends criteria for and evaluates ethics review in research with human subjects. The goal is to help Research Ethics Boards (REBs) solve problems and to propose methods for ethics review. Between 1990 and 1993, the committee organized site visits to the 16 Canadian universities with medical schools to observe the structure, work, problems and pressures dealt with by their REBs. The findings from those visits were the basis for a major NCEHR workshop, held in Ottawa in March 1995 and reported in Communiqué 1996: 7(1).

Because the expanded mandate of NCEHR now encompasses research funded by the Natural Sciences and Engineering Research Council of Canada (NSERC) and the Social Sciences and Humanities Research Council of Canada (SSHRC) as well as the Medical Research Council of Canada (MRC), site visits are planned this year to six universities without medical schools but with faculty who receive research funding from NSERC and SSHRC. NCEHR is compiling a list of REBs that consider human research protocols funded by NSERC and SSHRC. Advantage is being taken of the experience from the first series of visits to refine the site visit process for the new group of institutions, including modification of the pre-site visit questionnaire.

Many institutional REBs are stressed by rising numbers of research protocols and increasingly complex issues. NCEHR has been sensitive from the beginning to the need to avoid adding unnecessary administrative burdens on institutions. NCEHR will strive to ensure that site visits remain a value-added process. NCEHR is grateful to the volunteers who give freely of their time to undertake these visits. Information gained from this new round of site visits will enable NCEHR to make ongoing recommendations to improve the process of ethics review and the monitoring of research.

The Committee on Communications and Education is chaired by Dr. Carole Guzman. It recommends policies and strategies in these areas for Council.The need to communicate effectively has never been greater for NCEHR than with its broadened constituency and new research cultures.

The first issue of the bilingual, semi-annual newsletter, NCEHR Communiqué CNÉRH, appeared in October/November 1990. It is intended as an informative addition to existing literature on bioethics in Canada. Supplements to Communiqué are prepared periodically to deal with specific topics, like the one on Informed Consent accompanying the last issue. These publications, monographs and answering queries from REBs constitute major educational activities of NCEHR. It may be necessary to create a separate educational committee as expectations and demands on NCEHR increase across the country.

A feasibility study is under way to evaluate parameters for establishing an Internet/World Wide Web site for NCEHR. A website should accurately reflect NCEHR’s professional role in the bioethics community. A site that is not well maintained, useful and kept up-to-date is a site that will not be used by its target audience. It can also be expensive, as seen in the two-year, six-figure grant by the United States Department of Energy to three Shriver Center researchers to publish a monthly Internet newsletter on bioethics and public policy issues arising out of advances in human genetics. A number of Canadian ethics centres and groups have websites with some overlapping activities. There is an obvious need for national co-ordination of communication policy and resources.

The Committee on Consent addresses issues on consent with special populations. It organized the workshop and published the Report on Research Involving Children. Recently it produced the discussion document, Facilitating Ethical Research: Promoting Informed Choice. Many topics were before the Committee for consideration before NCEHR’s mandate was broadened, including research with cognitively impaired persons, cross-cultural issues, innovative therapy, research with terminally ill and emergency patients, epidemiological research, genetic research involving humans and substitute decision-making in research. Dr. Kathleen Glass, new committee chair, will undoubtedly receive further topics from the SSHRC and NSERC communities as she sets out with her committee to assign priorities.

The Committee on Ethics of Research Design has addressed issues relating to clinical trials and drug-related research. It organized the first workshop held by NCEHR on the subject of the Ethics of Clinical Trials for Research Ethics Boards. The proceedings were reported in Communiqué 1991: 2(2), and the topic addressed again in the issue 1993: 4(2). The committee has prepared testimony on the issue of compassionate access to experimental therapies for the House of Commons Standing Committee on Health. It also provided comment to Health Canada on the research ethics review process for use in an international harmonization initiative by Japan, Europe, the United States and Canada in pharmaceutical policy and law. A consensus conference on the use of placebos may be held later this year. However, careful consideration will be given to additional topics of concern, particularly to investigators holding grants from NSERC and SSHRC. Dr. Charles Weijer is the new chair of this committee.