Tuesday, September 6, 2011

Canadian Tortoise Beats American Hare

In the United States, human subjects regulations remained unchanged for twenty years, and almost unchanged for thirty. Then, in July, federal regulators proposed dramatic changes but gave citizens only sixty days to respond. When scholarly and professional organizations complained, that period was extended to a leisurely ninety days. Once that period closes, scholars may need to wait additional decades for such a chance to shape the regulations under which they must work.

Meanwhile, the Canadian Interagency Advisory Panel on Research Ethics has released its first responses to written requests for interpretation of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2), only eight months after the release of that document. Whereas Americans must wait years for regulators to respond to their concerns, Canadians are promised contact with a policy analyst within 48 hours and, as we have seen, may get formal interpretations within months. If the past is a guide, they can expect amendments to the TCPS every few years (the first edition was amended three times) and perhaps another full revision after twelve.

The protection of research participants should be subject to constant improvement. We will not get sensible rules from decades of inaction interrupted by brief spasms of debate.

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