Summer/Fall 1999

hank you, Dr. Roberge for the introduction. I would first like to talk about the University, and briefly explain the status, scope and importance of our committee within the University. The Université du Québec à Trois-Rivières (UQTR) is a general university which is part of the Université du Québec network and still fairly young at 30 years old. The UQTR does not have either a faculty of medicine or, unfortunately for us — a faculty of law — which would be useful, nor faculties of pharmacy or dentistry. We have 335 professors, close to 400 instructors and approximately 9,000 to 10,000 students, depending on the success of our recruitment campaign.

To explain the context of our committee, in July 1997 an early retirement incentive program was offered to professors, and was successful, in that 53 of 355 professors took the offer. They were replaced at that time by 48 new professors. So we found ourselves in a situation characterized by many changes, if you wish, with new and more or less in-experienced professors arriving, often having just obtained their doctorates, who immediately began submitting funding applications. The Ethics Research Board had some awareness-building work to do. One third of our university’s teaching staff turned over within 5 or 6 years. Because it is a non-faculty university, we deal with 21 departments.

I would like to draw a picture of the workload to which are submitted the members of our REB. We receive 20 to 25 applications from the psychology department each year. We think this is fairly high, but nothing like other research ethics committees. There are about 40 professors in the psychology department, and with three sites, they account for between 40% and 50% of the research applications we receive. Educational psychology is a relatively new department, and has about 10 professors teaching graduate and undergraduate courses, and represent 10% of the applications we receive. These figures are higher than last year. Educational Sciences is one of our promising clients. They have hired many young professors who work in the area of longitudinal studies, particularly for schools and school boards, and currently represent 10% of our clientele, although that figure might be slightly higher. Kinesiology, with approximately 20 professors, represents 5% to 10% of our clients. The number of applications from industrial engineering depends on the year. We receive an application from time to time and it is generally annoying for the REB. Nursing has about 12 professors, and occasionally submits an application. Approximately 10% of our applications come from biomedical sciences, and the chiropractic program, which opened six years ago, has appro- ximately 10 chiropractors and a slightly higher number of professors, because some of them teach basic sciences and do research, and submit a few applications. We have only one Research Ethics Committee. We handle between 20 and 25 cases, and that number will probably increase.

UQTR has two policies, one involving research ethics, which, I believe, makes us unique. The first policy implemented deals with research relationships among researchers, students and the university, and the sharing of responsibilities. What makes this policy interesting is that it includes a procedure for handling complaints. The policy is somewhat affected by a section of the Statement, but only in part. When the NCEHR site visit team recently visited us, we had to have two policies to show how we were meeting the requirements of the Statement as a whole. More recently, weimplemented an ethics policy  (http://www.uqtr.uquebec.ca/ DEAR/ Document/ POLDEONTHUM.pdf) titled Déontologie [Ethics], to differentiate it from the first policy on human research. The latter was approved by the Board of Directors on November 24, 1997, which, as you can see, is fairly recently. The policy was reassessed once the Statement was issued, and will have to be slightly amended. As I just mentioned, we were evaluated by the site visit team on March 5. They were quite positive about our work and asked me to talk about our policy today. I would like to thank them for giving me this opportunity.

Given the time, I will skip the objectives and principles, because I think they have been addressed fairly extensively today and you have a copy of the Policy Statement so that you are able to reach your own conclusions. Regarding the responsibilities of researchers, any research project involving humans and developed by researchers, whether eligible for funding, funded, or not funded, must be submitted to our REB for assessment. Graduate research projects for publishing or thesis purposes (these were discussed earlier in one of the workshops) are assessed by members of the graduate studies committee. Those committees have a form pre-approved by our REB. We sometimes receive applications for an opinion, and analyze it at that time. The researcher must take the committee’s comments into account. Applications may be returned for changes three or four times. The more progress we make in teaching professors about the Policy, the fewer returns we will have, but we still do have some. I am planning to meet with new professors arriving at the university. The role of past and current committee members is very important in this context — there are six professors from six different fields, and they act as mentors to researchers making their first applications, asking them to redo their work — even if this is more or less pleasant. There are some strong reactions, and the first reflex is to go see the representative and ask for an explanation, and then, after the second time, if the reasons are explained, they ask for some assistance, and the committee members thus play a mentoring role.

Committee authorization must be obtained before beginning research. At the outset, this caused some problems, but now it works very well. Moreover, any change to an approved protocol must be notified to the REB.

The Dean of Advanced Studies and Research is responsible for monitoring the progress of a research project and following up. He reports to the Board of Directors, and must ensure that students understand the principles of ethics and the scope of those principles, thus playing an awareness-building and administrative role. He has the authority to suspend work on the recommendation of the Research Ethics Board if there is a reasonable doubt, which to date has not yet happened. The REB is responsible for the following: staying abreast of discussions and other policies on ethics in research, proposing the necessary updates and seeking out informed researchers. I must thank them, because I came on the scene belatedly and did not implement policies, which is a lot of work. The information you have before you is the result of a long period of brainstorming, and fairly intensive work for a year or two, involving numerous meetings and discussions. I would like to thank those involved for all of their work.

The REB assesses protocols and monitors the application of its decisions by researchers. As I said earlier, graduate studies programs educate their students about their programs, and although we do not meet frequently, we do meet at least once a year with the people responsible for graduate studies pro- grams. They use the same principles and approaches as the REB, and, as I said, the protocols they implement are validated by the REB.

The How-Tos — Any students involved must consult the policy and complete the research protocol submission form. The protocol is then submitted for approval by the graduate studies committee. Their findings and recommendations are conveyed to the student, and the REB provides on-going support to the graduate studies committee, as stated earlier.

The REB is made up of a chairperson who is the Dean of Graduate Studies and Research, and six professors who are, or have recently been, actively involved in research. There is at least one department director, one director of the graduate studies committee, and one professor who has expertise in the area of ethics. Currently, the REB has a repre- sentative from the psychology department, one from the social sciences department (a historian), and one from industrial engineering. This person has a very interesting background — he was one of the first applicants, and was shocked when his application was turned down. In fact, he was so shocked that he protested vigorously, but was finally persuaded by the arguments presented to him and is now a member of the committee. He is an extraordinary resource person for us when it comes to refusing an application. The committee also has a representative from the nursing faculty, who is a department head and a philosopher, who helps us consider issues from a philosophical point of view, and a representative from kinesiology. We also have a student representing graduate studies who is currently doing a doctorate in materials energy sciences, a very interesting person who makes a valuable contribution to the committee. We also have a representative from industrial engineering acting as an ergonomics laboratory technician. We need a person with legal training whom we can call on when needed — this is a weak point of our committee. Up to now, when we have to address specific legal issues, we consult someone from the legal affairs office who has experience in this area. We have been criticized for this lack, and it is perhaps something that a number of universities within the Université du Québec network should address. The problem is finding someone in the area who has legal experience. I know other universities in the regions have the same problem. I mention it in passing because it is a reality. There is another person from outside the university, a student interested in ethics who works in a local social service centre. She is not typical of people from outside the university community, but she takes to heart the opinions of theparticipants and encourages them to think in interesting directions. Finally, we have a secretary who is here today, who is not only our secretary but also secretary for the

Committee on Animal Care. Committee members serve a two-year rather than a three-year mandate on the recommendation of the advanced research subcommittee. To discuss findings, we meet regularly, every six to eight weeks. Otherwise, the process is less informal: when applications are received, they are reviewed on site and go through an accelerated process via e-mail. Because there are not a lot of committee members, we are able to work by consensus. If consensus cannot be reached, the application is submitted for plenary review. However, all applications are validated by the REB.

We were very pleased by the visiting team’s positive reaction to our policy on March 5. The policy has been well received by the community over time. There were some reactions at the outset but understanding of the REB’s role has grown. There is also an understanding that the committee is a necessity and that the role of the REB and the dean in particular is to establish a climate of confidence. We are not there to act as policemen, but to demonstrate as clearly as possible that it is in their interest to look at ethical issues. There are improvements to be made, I won’t deny it.

We do not have an appeal process, but are looking into the possibility of such a process throughout the Université du Québec network, and how it would operate.

Consent forms also need to be improved. The committee spends a lot of time on consent forms submitted to us. Currently, we are looking into how the forms can be improved and whether researchers could come up with their own forms. My personal belief is that we are not a large university, and with better informed researchers and an improved consent form, we will have better results. However, at this time, we have to return applications even from experienced researchers, not because of the project, but because of the consent form. The consent forms are still causing problems, and we need to educate researchers in this area. I want to stress that our committees does not monitor the projects they approve and, as was raised by the visiting committee, it would be a good idea to know about any problems researchers have during their projects. This is currently not being done, and is an area for improvement. Another area for improvement, for the reasons I explained earlier, is to add a committee member with legal expertise.