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Are research participants safe enough?

April 26, 2010
Canadian Medical Association Journal
Rules and regulations are threatening academic clinical trials in Canada which contribute to the public good, states an editorial.

Every year, millions of patients worldwide participate in randomized clinical trials hoping to benefit from an experimental treatment or potentially help someone else with the same condition.

However, rules and regulations are becoming a menace to academic clinical trials where resources are limited and risks may be much less than those associated with new experimental drugs.

"There is no question that research participants need protection," write Paul Hébert, Editor-in-Chief, CMAJ, and coauthors. "But regulations have grown so burdensome that they are overwhelming the very things they are meant to support and safeguard. Consequently, clinical research has been substantially decreased among industrialized countries."

International bodies, regulatory authorities, the academic community and major granting agencies need to work together to develop and adopt proper, study-specific standards instead of having ineffective monitoring of all clinical research.

The authors conclude that without significant changes, our academic research enterprise and eventually even commercial trials will be immobilized by increasing bureaucracy and spiraling costs.

Story Source:

Materials provided by Canadian Medical Association Journal. Note: Content may be edited for style and length.

Journal Reference:

  1. Paul C Hébert and Dean A Fergusson. Are we keeping research participants safe enough? CMAJ, 2010; DOI: 10.1503/cmaj.100404

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Canadian Medical Association Journal. "Are research participants safe enough?." ScienceDaily. ScienceDaily, 26 April 2010. <>.
Canadian Medical Association Journal. (2010, April 26). Are research participants safe enough?. ScienceDaily. Retrieved April 27, 2017 from
Canadian Medical Association Journal. "Are research participants safe enough?." ScienceDaily. (accessed April 27, 2017).