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Applying the Common Rule to Public Health Agencies: Questions and Tentative Answers about a Separate Regulatory Regime

Published online by Cambridge University Press:  01 January 2021

Scott Burris ,
James Buehler  and
Zita Lazzarini
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Extract

No one questions the importance of protecting human subjects of research, but over the past few years dissatisfaction has surfaced with the manner in which the protection is conferred by the federal regulatory system referred to as “The Common Rule. ” Some of the criticism surfaces in print. Some bubbles out anecdotally in conversations among researchers, with complaints about the review process being virtually inevitable whenever the topic arises. Like those in other disciplines that differ more or less dramatically from the world of clinical medical research around which the Common Rule was conceptualized, public health researchers, particularly those working in official public health agencies, have experienced some tension and difficulty in adapting to the rules. The Centers For Disease Control and Prevention (CDC) has adopted guidelines that require Common Rule review for “research” but not “practice” activities.

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Article
Information
Journal of Law, Medicine & Ethics , Volume 31 , Issue 4 , Winter 2003 , pp. 638 - 653
Copyright
Copyright © American Society of Law, Medicine and Ethics 2003

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