Proposed ethics board unpopular

Jan 09, 2003, vol. 26, no. 1
By Carol Thorbes

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University researchers across Canada, including at Simon Fraser University, are concerned about the potential creation of a national accreditation system for ethics boards that approve research on humans.

A task force created by the National Council on Ethics in Human Research (NCEHR) is recommending that a non-government body with an arms-length relationship to research ethics boards (REB) nationally accredit the boards.

Health Canada, the Medical Research Council and the Royal College of Physicians established the council in 1989.

The non-governmental, voluntary organization promotes the protection of human research participants and the maintenance of high ethical standards in research involving humans.

The NCEHR is a national educational resource on research ethics for ethics boards at hospitals, universities, clinics and other sites.

The NCEHR feels that a national accreditation system, based on voluntary participation and developed in consultation with stakeholders, would improve the work of ethics boards, better protect human research participants and boost Canadians' trust in research.

The accreditation body would emphasize education and be accountable to the public and government through audits, possibly by the auditor general of Canada.

The NCEHR task force cites several reasons why Canada should have a national accreditation system.

For one, controversial research involving human subjects has sparked numerous lawsuits worldwide.

Secondly, the growing number of ethics boards at pharmaceutical companies doing drug research involving humans makes the creation of a fox guarding the henhouse situation more likely.

The NCEHR favours a system that regularly reviews its members' compliance with national regulations.

In a final report the agency also suggests, “the federal government may find it necessary to introduce legislation, regulations or other oversight mechanisms to ensure” the protection of human research participants. “It may want to ensure that accreditation is required to fulfill certain functions, or to ensure efficient sanctions.”

The taskforce says the buy-in of REBs is paramount to the success of a voluntary accreditation program.

Judging from the reaction of researchers at SFU and elsewhere that buy-in will be hard won.

SFU's Bruce Clayman, VP-research, and Hal Weinberg, REB director, are uneasy about any accreditation system based on fixed, national standards and policies.

“SFU and virtually all other universities in Canada have concluded a memorandum of understanding that obligates them to ensure their research is in accordance with the Tri-Council's policies on research ethics,” says Clayman. (The Tri-Council is the university research funding arm of the federal government. It is made up of three funding agencies: the Canadian Institutes for Health Research, the Natural Sciences and Engineering Research Council and the Social Sciences and Humanities Research Council.)

“If they're not in compliance, their funding from those granting agencies can be withdrawn. So I see no need for an accreditation system, which could lead to unnecessary bureaucratic interference and consequent cost and delay.”

Weinberg shares that view and adds, “What would make more sense is to set up an independent committee that changes from time to time, with representatives from universities and industry. It could look at the way ethics is handled in different research contexts.”

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