In conversation with Kathleen Glass

Kathleen Glass is director of the Faculty of Medicine's Biomedical Ethics Unit and principal investigator of the unit's Clinical Trials Research Group (CTRG), which examines ethical questions about human experimentation. She is Clinical Ethicist at the Montreal Children's Hospital site of the McGill University Health Centre and former Chair of McGill's unique, interdisciplinary Bioethics Master's Program. Dr. Glass serves on a number of national and provincial research ethics committees and was director of the Ottawa-based National Council on Ethics in Human Research in 1993, 1994 and again in 1996.

How did you become an ethicist?

The route that I took was that I studied and was practising law, and I decided to look for work that involved more human values. So I went back to university and did graduate work in health law and ethics.

Is there a clear-cut job description for ethicists?

Ethics is really a consideration of how one ought to act or what kind of choice one ought to make in a particular set of circumstances. We all face that in our daily lives, but you can actually study ethics; it is a branch of moral philosophy which looks at those kinds of considerations, and we develop various tools for evaluating and analyzing particular situations. When we teach ethics, for example, our students come from all walks of life, and as part of their training, we try to give them an idea of how to recognize the moral dimensions of the kind of work they will be doing.

Can you briefly explain the structure of McGill's Biomedical Ethics Unit and the Clinical Trials Research Group?

The Biomedical Ethics Unit is part of the Faculty of Medicine. Within that unit, there are four faculty members: one from law, from philosophy, from religious studies, and one physician. These four people form the Clinical Trials Research Group, of which I am director and principal investigator. We each have an appointment as a clinical ethicist at a McGill hospital, where we do consultations with health care professionals who seek our advice, and sometimes with patients and families as well. All four of us also teach in the Bioethics Master's Program -- which we administer- in the medical school, and in hospitals.

How does one teach something like ethics?

There is a classroom approach, in which we examine how classical ethical ideas apply today, for example those of Bentham, Mill and Kant. In the hospitals, we often use cases as a teaching approach. We examine the facts, asking what are the key issues, why does the doctor or researcher want to talk to an ethicist, what are the values of the parties, both the health care professionals and the patients?

Is your role in society to be a moral authority -- providing answers to dilemmas -- or is it more to raise questions?

I think it's both. The person who is trained and experienced in ethical reasoning can be a resource for society. We have a role to play in public education and policy formation. Bodies like governments and committees are often looking for someone to give them ethical guidance when forming new policy.

Do scientists have greater obligations today? Are they responsible for the ways their discoveries are used?

I think governments, institutions, and the lay public do demand more accountability. At the same time, there are still strong notions of academic freedom that exist within universities; we ought to be able to study what we want. Many areas of research involve developing a technique that carries a load of public accountability.

For example, when Dr. Wilmut cloned Dolly the sheep, he had already done the cloning before the announcement came, and there was a lot of talk about what kind of accountability he might have for developing a technique which could be used in humans. There are good reasons for increasing public accountability, but we don't want to make it so burdensome that progress grinds to a halt. We need a balanced notion of accountability.

What is the function of the CTRG?

The CTRG was founded in 1990 with the philosophy that there is no aspect of clinical trials or research involving humans that doesn't raise ethical issues. In one current project, we're asking when it is ethical to start a clinical trial, considering that no one should be disadvantaged -- especially a sick person -- by being a research subject. When is it appropriate to make someone part of a trial in which they will get no treatment because they receive placebos?

How can research interests be reconciled with patients' needs for treatment?

In the case of placebos, if an effective treatment doesn't currently exist, I think it is an ethical proposition to offer a patient a chance to participate in a study in which he or she may end up taking the new treatment, or a placebo. You're not disadvantaging the ones who take the placebo because there is no effective, tested treatment available.

On the other hand, if you already have a treatment that works, and someone comes along with a new treatment, you can do a trial in which the current treatment is up against the new one. If you put the new treatment up against a placebo, that would be unethical because the patient is disadvantaged.

How do ethics boards wrestle with issues raised by trials involving research they may not fully understand, like cutting-edge gene therapy?

You may need to pool your expertise in cases like that. Very rarely would any one research ethics board have the expertise necessary to review a protocol, but within the university community or the broader Montreal community, we probably do. So you could bring in a specialist on an ad hoc basis, or a university could decide to set up a specialized board for specific kinds of protocols.

Are there other issues the CTRG is studying?

We are looking at issues of competence, and how to evaluate the competence of someone who has a dementing disease, for example. When are they competent enough to make a choice to participate in a research trial, and when do they need someone to represent them? This has been an increasing concern for the past 10 or 15 years.

In the past the assumption was if the subject consents, that's all researchers need?

That's right. We have a sad history of abuse of some very vulnerable people in the course of 20th century medical trials. Today, people are looking at the quality of the consent. They are asking whether the person really understood what they were getting involved in. In order to be competent to consent, the person only needs to understand the particular task you're asking of them. Someone could have a mental disorder, but still understand perfectly well what is involved in the research study. They might be unable to handle their finances, but still be able to say, "I know what that drug will do to me, and I want to be in the trial."

Decades ago, people were considered either entirely competent or entirely incompetent, with nothing in between. Now we think of it more as a continuum, with competence at one end, incompetence at the other, and many points along the way.

You have written about the importance of accuracy in the reporting of clinical trials. Why is that a concern?

I looked at the discrepancy between actual trial results and what is written in journal articles. If strict accuracy is not adhered to, researchers can decide to present their data in a particular way, depending on what they wanted to emphasize. Another concern is that if the patients in the trial are not described accurately enough in the journal article, doctors may make a mistake in prescribing the drug to their patients.

So strict rules of accuracy may help eliminate bias in reporting trial results?

That is the ideal. I think scientific journals are now requiring researchers to disclose whether they have any financial interests in a particular trial. For example, was it sponsored by a particular company, and does the researcher own shares in the company?

Are ethicists filling a void created by the absence of laws addressing the ethics of new technology?

In some cases, that is true. We haven't had significant discussions and debates at the grassroots level on a lot of emerging issues. There are areas in which the law hasn't acted yet, and others in which the law would be too blunt an instrument -- or is not detailed enough to deal with every case. In cases where we don't have laws yet, there are various ethical guidelines that people may follow. In that sense, ethicists can fill a void.

So researchers constantly push the frontiers of science, while ethicists are forced to play catch-up?

That certainly can happen. If you're asking whether, as a society, we sit back and consider all the implications well before we fund the research, I would say no. However, we have made progress in that we are operating side by side; we have people working on a project in the labs, and at the same time we have people considering the ethical and social implications of the research.

Can that kind of evaluation rein in unbridled technology?

I hope that what we're able to do is look at issues of importance, and consider what is the best thing to do. If we start off thinking that new technology is bad, we will always be at loggerheads with researchers. We have to take an open perspective -- we may decide that a new technology is objectionable, or we may decide that it will be very beneficial.

I don't see the ethics community as some kind of police to keep technology and scientists in line.

Kathleen Glass was interviewed by Montreal freelance writer Sylvain Comeau.