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[ Recorded presentation ] Recorded presentation

Protection of human participants in community collaborative non-research studies

Adrienne E. Keller, PhD, Prevention Research, University of Virginia, P.O. Box 800623, Charlottesville, VA 22908, 434-924-8784, aek3a@virginia.edu and Ryan Ehrensberger, MPH, CARMA, Bon Secours Richmond Health System, 2025 East Main St., Suite 207, Richmond, VA 23223.

The protection of human subjects in research studies is generally tightly regulated, under federal mandates. Increasingly, however, public health educators and practitioners face the need to determine appropriate protection for human participants in non-research studies. Such studies frequently require formal evaluation strategies to assess effectiveness at individual, risk group and population levels. CARMA (Controlling Asthma in the Richmond Metropolitan Area) is one such federally funded project. In 2001, the Bon Secours Richmond Health System received a multi-year grant from the CDC as part of the Controlling Asthma in American Cities Project. Based on our experience over the last four years with the implementation and evaluation of CARMA, in collaboration with multiple community partners, we have developed a strategy for assessing the factors related to protection of human participants in non-research studies. We use the word “ethics” as an eponymous acronym for six essential factors. “E” for ethics, the bottom-line and ultimate arbiter: what are the ethical implications for participants? “T” for training, focused on the professional staff and lay volunteers of collaborating community organizations. “H” for HIPAA regulations and exemptions. “I” for Institutional Review Boards, including both understanding IRB requirements and the education of IRB members. “C” for concomitant requirements, which include requirements of funders, the grant management organization, collaborating groups, and requirements for dissemination. “S” for self-evident protection brings the focus back to participants. Participants must know that their welfare – and not funding, data or dissemination – is the primary concern. This presentation will describe and discuss each factor.

Learning Objectives: At the end of this presentation participants will be able to

Keywords: Ethics, Evaluation

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