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Canada Tightens Ethics Rules for Human Subjects

OTTAWA--Canadian scientists have new ethical guidelines for research involving humans. The document, to be unveiled tomorrow, ends a 4-year struggle among the country's three research granting councils to draw up new guidelines that would raise ethical standards without stifling science (Science, 5 June, p. 1521).

The new regimen is intended to standardize wildly divergent ethics review processes within the several hundred Research Ethics Boards (REB) affiliated with Canadian universities, hospitals, and research institutions. For the first time, any researcher or institution failing to abide by the new rules would face a cutoff in funding. At the same time, the final guidelines go a long way to alleviate academe's concerns that the new regime would excessively hamper the conduct of research.

Begun in 1994 to preempt the possibility of federal legislation, the guidelines are the product of protracted negotiations among the Medical Research Council (MRC), Natural Sciences and Engineering Research Council (NSERC), and Social Sciences and Humanities Research Council (SSHRC), which fund most of the country's academic research. The councils easily agreed on rules governing clinical trials and research involving human gametes, embryos, or fetuses. For example, the new guidelines outlaw research involving "cloning human beings by any means," the use of commercially obtained human ova and sperm, and the creation of embryos for research purposes.

The area of informed consent proved contentious, however. Social scientists lobbied hard for a looser definition, while medical researchers demanded airtight rules. The final statement allows for a "limited and/or temporary exception" to full disclosure during the course of an experiment where such disclosure would "be likely to color the responses of the subjects and thus invalidate the research."

The new policy will be posted on the Web sites of the MRC, the NSERC, and the SSHRC.