Rules governing the use of human subjects in science matter

We need broadly-applied ethical standards to protect the human subjects of research

//

 science
 science

[popup url=”http://marketplace.troymedia.com/2016/02/rules-governing-the-use-of-human-subjects-in-science-matter/” height=”800″ width=”800″ scrollbars=”0″]Download[/popup] this column on [popup url=”http://www.troymedia.com/tag/science/” height=”800″ width=”600″ scrollbars=”0″]science[/popup] and [popup url=”http://www.troymedia.com/tag/ethics/” height=”800″ width=”600″ scrollbars=”0″]ethics[/popup]
[popup url=”http://marketplace.troymedia.com/terms-and-conditions-of-use/” height=”800″ width=”600″ scrollbars=”0″]Terms and conditions of use[/popup]

scienceOTTAWA, Ont. Feb. 25, 2016/ Troy Media/ – The disturbing announcement recently that a man died and four others were seriously harmed in France as a result of participation in a research study is a 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 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 those of youth and other vulnerable persons, were manipulated. The intent was to see if the subjects’ emotions could be altered. The researchers found out they indeed could manipulate subscribers’ emotions.

These two seemingly disparate examples demonstrate 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 involved violated ethical standards. The Rennes study had prior review by a French ethics committee, yet things still went very wrong.

The history of research, including in Canada, shows that very serious harm may be suffered by those taking part in research. The rules are not perfect and they continue to be refined, but prior review and oversight helps make research safer for human subjects.

However, these 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 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 for vulnerable people such as children. These standards also require prior review by an independent expert board – in Canada usually called a research ethics board (REB) – to ensure that these protections are adhered to.

So what’s the concern?

In Canada, 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. Second, Health Canada and U.S. regulations prescribe rules for new drug and medical device testing carried out primarily by pharmaceutical and biotechnology companies.

Remarkably, aside from these two categories, there is no legal requirement in Canada that any human research undergo any scrutiny. This critical gap in research rules for human subjects must be addressed.

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 to have their research reviewed according to the TCPS: Health Canada, the Department of National Defence 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 private industry (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 in Canada without having to show that it is reasonably safe, that privacy is protected or that subjects are treated fairly.

Doing 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 Trudeau government made vigorous commitments to the twinned themes of science and integrity during last year’s election campaign. This priority has been echoed by many interests inside and outside the new federal government. As a start, the 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 protections to everyone who gives of themselves to promote research for the good of us all — particularly when directed and funded by our governments? Let’s learn from past tragedies and help make sure they don’t keep happening.

Gordon DuVal is part-time professor at the University of Ottawa Faculty of Law and a member of its Centre for Health Law, Policy and Ethics.

Gordon is a Troy Media [popup url=”http://marketplace.troymedia.com/our-contributors/” height=”1000″ width=”1000″ scrollbars=”0″]contributor[/popup]. [popup url=”http://www.troymedia.com/become-a-troy-media-contributor/” height=”600″ width=”600″ scrollbars=”0″] Why aren’t you?[/popup]


The views, opinions and positions expressed by all Troy Media columnists and contributors are the author’s alone. They do not inherently or expressly reflect the views, opinions and/or positions of Troy Media.

Submit a Letter to the Editor science

Troy Media Marketplace © 2016 – All Rights Reserved
Trusted editorial content provider to media outlets across Canada

You must be logged in to post a comment Login