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[ Recorded presentation ] Recorded presentation

A framework for assessing risk in public health research

Harry Perlstadt, PhD, MPH, Bioethics, Humanities, and Society, Michigan State University, C-218 East Fee Hall, East Lansing, MI 48824-1316, 517 432-2691, perlstad@msu.edu

Public health research often involves communities and groups as the subjects of the study with the benefits often accruing to the collective rather than the individuals who participate. The current guidelines for the protection of human research participants are drawn from the theoretical-juridical model and principles enunciated in the Belmont Report (1979), which had no representatives from public health or the social/behavioral sciences. The recommendations were subsequently codified in federal regulations at 45 CFR 46. The practical interpretation and enforcement of these regulations are delegated to Institutional Review Boards (IRBs), which protect the rights of individual subjects through documented informed consent. The IRBs seldom consider societal interests in gaining new knowledge that can contribute to the public's health. If the existing guidelines for assessing research risks to human subjects are construed from an individual liberties perspective, then we need a parallel framework for assessing research threats to the common good. Such a framework (two 2x2 matrices) is presented for assessing the probability and magnitude of harm to individuals and the threats that research poses to the common good, that is communities and groups. APHA's Code of Ethics holds that one's right to make decisions for oneself must be balanced against the fact that each person's actions affects other people. The protection of individual rights regarding research should be balanced against the interests of society just as society must respect the rights of individuals.

Learning Objectives:

Keywords: Ethics, Community Research

Presenting author's disclosure statement:

Any relevant financial relationships? No

[ Recorded presentation ] Recorded presentation

Research Ethics

The 134th Annual Meeting & Exposition (November 4-8, 2006) of APHA