Ethical research in human studies
Most of my research over the years has involved working with rats to study the biological basis of human mental and behavioural disorders. The rat models I have studied may tell us something about addiction and anorexia nervosa. Such pre-clinical models are valuable in the study of the causes of illness and may help suggest treatments.
Currently I have a PhD student who wants to explore whether a theoretical approach to addiction and feeding suggested by animal research also can be studied in humans. Specifically, our animal models indicate a distinction between things animals crave and things they like. Craving is what causes them to search out a reward, measured by how hard animals will work to get the reward. Liking is the affective reaction they experience when they obtain the reward, measured by how they respond when consuming the reward – rats show a yum response to sweets (and also a yuck response to bitters).
My student would like to see if we can study craving and liking in humans. She believes that one factor leading to eating disorders and obesity is specific cravings that increase over time. Thus I may be en route to doing some human studies with her.
Before we can carry out any human studies, however, we need ethics approval from the university’s Research Ethics Board (REB). No research at Laurier (or any university for that matter) can be carried out without ethics approval, whether it is research with animals or humans. I have worked with the animal ethics process for years and for a time was Chair of the Laurier Animal Care Committee. I know these ethical issues well.
Human ethics approval has a completely different set of issues. One major difference is that you do not need to get consent from the rats you study, but you do need it from the human participants in your research. In Canada research ethics requirements have become consistent across all the funding agencies under the Tri-Council Policy Statement version 2 (TPCS 2). In addition, before anyone can even seek ethics approval for a specific project under these guidelines, they must take an online course offered by the panel on research ethics, the TPCS 2 Course on Research Ethics (CORE tutorial).
Rules and respect
Thus last week I spent three evenings completing my CORE tutorial. In total it took me about seven hours to complete all eight modules, but it was interesting, and I went slowly, looking at many of the connected sites. (Anyone can take this course. Find it by choosing the English or French site at pre.ethics.gc.ca, then look for the CORE tutorial in the menu bar on the left.)
The modules covered many of the ethical issues around research: core principles behind the ethical rules; definitions of research, consent, privacy, risks and benefits, fairness, conflict of interest; and the process that an REB follows. Each module ended with a short test to ensure that I had mastered the concepts introduced. Along the way there were examples, often Canadian, of research projects that had raised ethical issues. At the end I was able to print off an electronic certificate saying I had completed the CORE tutorial.
Having completed the tutorial, I can now submit a research proposal to the Laurier REB with my student (with her own tutorial certificate in hand) around her research on craving and liking. Preparing the multiple-page human ethics forms will take some time. After that, the proposal goes to the committee for review and comment.
Anyone who has looked at the conduct of scientists in the past recognises why we need a process like this to govern our research process. We are all aware of abuses that have happened in past research – the administration of LSD to psychiatric patients in the Allen Memorial Hospital at McGill, for example. Is the Canadian system perfect? No. Just because one knows the rules does not mean they will be followed. However, if I break the rules there will be consequences, and they can be severe both for me and for my institution.
At the heart of ethics for human research is respect for the research participants, consistent with our Lord’s command to love our neighbour as ourselves. I’m thankful that research in Canada tries to follow Christ-like principles.
