The disturbing announcement recently that a man died and four others were seriously harmed in Rennes, France as a result of participation in a research study is a timely reminder of the importance of protecting those who volunteer to be subjects of research. The drug being tested was thought to show promise in treating a variety of disorders including mood, anxiety and pain. It was the first time this drug was given to people.
In 2014, we learned of the Facebook “Emotional Contagion” study in which, without their knowledge or consent, 690,000 subscribers’ newsfeeds, likely including the newsfeeds of youth and other vulnerable persons, were manipulated to see if their emotions, happy or sad, could be altered as a result. They found out they indeed could manipulate subscribers’ emotions in this way.
The lesson we need to learn from these two seemingly disparate examples is that rules guiding the use of human subjects in science matter profoundly. The Facebook study had no prior ethics review and the manipulation and lack of knowledge or consent by those enrolled violated ethical standards. The Rennes study did have prior review by a French ethics committee, yet things still went very wrong.
The history of research, including research in Canada, shows that very serious harms may be suffered by persons taking part in research. The rules are not perfect, and they continue to be refined when tragedies do occur, but prior review and oversight has proved a powerful corrective to make research safer for human subjects.
The problem is that these research protections don’t apply to everyone doing research on people in Canada — and they should.
In Canada, and most of the rest of the developed world, a consensus emerged during the 1970s through to the 90s, that a framework of binding rules was needed to protect research subjects. This has led to the development of internationally recognized principles requiring that people in research trials be treated ethically – that is safely, and with protections for privacy, informed consent and vulnerable persons such as children. These ethical standards also require prior review by an independent expert board – in Canada usually called a Research Ethics Board (REB) – to ensure that these vital protections are adhered to.
So what’s the concern?
In our country, key research regulations and guidelines have two sources. First – the Tri-Council Policy Statement (TCPS) prescribes rules for research conducted at universities and large hospitals funded by the federal Granting Councils; and second – Health Canada and US FDA Regulations prescribe rules for new drug and medical device testing carried out primarily by pharmaceutical and biotechnology companies.
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Remarkably, aside from these two categories of research, there is no legal requirement in Canada that any other human research undergo this or any other scrutiny. Such a critical gap in Canada’s research rules for human subjects must be addressed.
For example, there is no requirement that research undertaken by federal or provincial governments undergo such review and oversight to protect human subjects. A few individual federal government agencies have acted voluntarily to have their research reviewed according to the TCPS: Health Canada, the Department of National Defense, and the National Research Council (I am its REB Chair). These agencies do this job cheaply and with generally good results.
But all other federal government departments and agencies, provincial governments and commercial and industrial companies (aside from those doing new drug and device research) have no rules requiring prior review to ensure they meet ethical standards.
This means that plenty of research with human subjects takes place every year in Canada without having to show that it is reasonably safe, that privacy is protected or that human subjects are treated fairly.
Doing high quality research on significant medical, scientific and social questions is of surpassing importance. But research, particularly that involving human subjects, must be done ethically.
The Prime Minister and the Liberal Party made vigorous commitments to the twinned themes of science and integrity during the election campaign, and this priority has been echoed by many interests inside and outside the federal government. As a start, the new government should act promptly to ensure that all federal government research takes place with mandatory ethics oversight to protect human subjects and urge others to follow.
Should we not provide ethical protections to everyone who gives of themselves to promote research for the good of us all – particularly when directed and funded by our own elected governments? Let’s learn from past tragedies and help make sure they don’t keep happening.