In part 1 of our 2 part series, Clinical Trials Canada magazine Editors Saaqshi Sharma and Gazal Vakili sat down with Jack Corman, President of the Institutional Review Board Services in Aurora, Ontario, to discuss patient safety and research ethics.
SS: So what is an Institutional Review Board and why is it important?
JC: IRBs review the science and ethics of research projects involving human subjects. The idea was proposed initially through the Declaration of Helsinki in the 60’s that was carried through into law in the U.S. following the Tuskegee Syphilis Study scandal and the publication of the National Research Act in the U.S. History has taught us that research sponsors and researchers themselves – no matter how well intentioned – require an independent review of what they do.
The goal is to better protect subject rights and welfare, and one of the ways to do that is to ensure that the research is scientifically sound and steps are taken to minimize risk to research subjects. Subjects need to be properly informed so that they are able to make decisions in full knowledge of the risks, benefits and other relevant aspects of the research, and to make those decisions autonomously, i.e., free from coercion or undue influence.
That’s essentially what the board does, and our company exists to support the ethics. That’s the mission; that’s what we do. It’s important because this independent oversight is really necessary; history has proven it.
SS: What do ethics mean to you, as the president of IRB Services?
JC: Technically ethics is a branch of philosophy, but that’s not what it’s really about; it’s much more than a philosophical exercise. To me, ethics is a simple expression of “do the right thing.” And doing the right thing is hard to define exactly, but it is reflected in things like showing respect for persons. It’s not limited to research; it’s what we need to do every day, and how we interact with others – family, friends and co-workers.
We have a social responsibility to do good, whether it’s in social marketing, or being a part of an advocacy group looking to sustain the best practices. It’s about trying to do good, good for society. Research ethics is about good for the individual research subject, so it means a research project should be constructed in such a way that it seeks to benefit the individual while minimizing risks.
SS: In your experience, what are the main reasons for volunteering for research? And how does an IRB advocate for participant safety?
JC: The intent to carry out trials, or experiments, on humans bears with it great responsibilities that go beyond individual subjects. One of those responsibilities is to ensure that all communication with the public is truthful. One of the things that people can do in advertising is over-promise. You cannot promise a benefit.
People who are interested in participation in a research study are typically motivated by two reasons. The first motivation for patients is often self-seeking. People often think “this is something new, and I’m not doing as well as I’d like, or my child is not doing so well, if it’s new it must be something better.” Clinical research by its nature is an investigation and you cannot promise anyone that they are going to be better because you don’t know the outcome of your investigation yet. And that’s an important consideration for an ethics board – to ensure that all those communications follow the requirement to be honest and upfront with no promise of benefit. It’s not marketing, it’s not selling.
The other primary reason that people volunteer for research, at least for Phase 1 studies with healthy volunteers, is for financial reasons. The compensation that is offered to participate in those types of studies can be quite substantial. It’s unethical to “buy” a research subject; however, that doesn’t mean that financial considerations aren’t legitimate. It’s alright to use payment for participation as an incentive to encourage people to volunteer in the studies, as long as it’s not so large or structured so that it’s coercive or an inducement.
In other cases, people might volunteer for studies to gain access to treatments that are not affordable and often not covered by government programs, such as some of the newer anti-inflammatories or targeted anti-cancer treatments.
It’s also important to look at how advertising messages are going to be delivered, and it’s not only about the words on the page, it’s the images. Why is it that beer companies are advertising people having a great time? It’s not about the beer; it’s about “buy my beer and have a good time.” You can’t do that with research because you’re asking people to assume a risk, and to portray the experience in the same way that you can portray consumer goods is misleading. You don’t want to give people the wrong idea that volunteering for a research study that hasn’t been tested before is going to be a party – it’s not. It’s serious and potentially very risky business.
Sneak Peak: In the winter edition of Clinical Trials Canada magazine, Jack Corman discusses his previous interactions with concerned patients and the importance of the informed consent process in a non-threatening environment. Be sure to check it out!