Monday, June 29, 2009

Finnish Group Warns Against Unnecessary Bureaucracy

Klaus Mäkelä and Kerstin Stenius kindly alerted me to their paper, "A New Finnish Proposal for Ethical Review in the Humanities and Social Sciences," which they presented in London in April. The paper describes a draft report by a working group of Finland's National Advisory Board on Research Ethics, which examined the need for ethics review in the humanities and social sciences.

In its draft report, issued in January, the working group adopted some principles that would be familiar to ethics committees and regulators in the United States and other countries. The report stresses the importance of voluntary participation, informed consent, the confidentiality of information, the avoidance of "undue risk and harm," and the need for special care when researching minors. It sees ethics review committees as part of a process to effect these goals.

On the other hand, the working group recognizes that too much oversight presents its own problems:

5. It is important to respect the autonomy and good sense of research subjects. In social research, participants usually are fully competent to assess the risks involved without outside expertise. Ethics committees should avoid paternalism.

8. Clear criteria should be formulated for what kinds of projects require ethical review, but it should be up to the researcher to determine whether a project meets these criteria.

10. The work of ethics committees should be as transparent and open as possible and a system of appeals should be put in place.

The second part of principle number 8 is particularly significant. U.S. regulators have, since 1995, insisted that researchers cannot be trusted to determine when their research is subject to review under the Common Rule. Recently, Jerry Menikoff of OHRP noted that institutions are not legally required to strip researchers of the power to make these determinations, but OHRP will continue to recommend that they do so.

The Finnish working group, by contrast, sees a greater danger in giving that power to committee members and staffers who will likely err on the side of too much review:

It is a matter of judgement to decide what kinds of stimuli are 'exceptionally strong'. To avoid unnecessary bureaucracy, it nevertheless should be up to individual researchers to decide whether their project falls into the categories listed above and needs to be submitted to ethical review. It is highly unlikely that this will lead to transgressions, and ex post facto sanctions will be enough to keep any exceptions under control.

In short, the working group understands that in this case, the dangers of too much bureaucracy outweigh the dangers of too little.

I should note that the London conference at which Mäkelä and Stenius presented their work was the Third Working Meeting of the International Study of Ethical Codes and Ethical Control in the Social Sciences, the previous conferences having been held in London in 2007 and 2008. The meetings have brought together scholars from several northern European countries to discuss social science ethics and regulations across international borders. It is splendid that these scholars are at work on so important a topic, and I look forward to learning more from them.

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