Work

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

Year: 2003

Type: review

Abstract: 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.

Source: The Journal of Law Medicine & Ethics

DOI: 10.1111/j.1748-720x.2003.tb00131.x

Authors: Scott Burris, James Buehler, Zita Lazzarini

Institutions: Temple University, Emory University, Harvard University, UConn Health

Language: English

Topic: Ethics in Clinical Research

Subfield: Public Health, Environmental and Occupational Health

Field: Medicine

Domain: Health Sciences

SDGs: Good health and well-being, Peace, justice, and strong institutions

Open Access status: green

Funder: Centers for Disease Control and Prevention