5118.0: Wednesday, November 15, 2000 - 12:50 PM

Abstract #12305

Protecting human subjects in non-research and non-traditional research programs: Balancing ethical, legal and pragmatic requirements

Marc A. Safran, MD, Carl Caspersen, PhD, and Robert E. Lieb, MS. Division of Diabetes Translation, Centers for Disease Control and Prevention, Mail Stop K-10, Atlanta, GA 30041, (770) 488-5011, mas9@cdc.gov

Greater emphasis has been placed on human subjects protection in recent years. Policies originally developed to protect the public from biomedical research risks are now applied to a wide range of public health activities, at the Federal, state and local levels. The Centers for Disease Control and Prevention (CDC) works with the health departments of 50 states, the District of Columbia and 8 island jurisdictions in the Atlantic and Pacific to prevent and control diabetes and reduce diabetes-related health disparities. CDC provides funding for a diabetes control program in each of those states and jurisdictions. The programs are designed to work with public and private sector partners in health systems and communities to improve the health of the populations they serve. With just a few exceptions, they are not funded to conduct any research. This presentation will explore ethical issues that have arisen in applying standard human subjects protection procedures to non-research projects and to non-traditional research projects involving diabetes community interventions and health systems interventions. Pragmatic challenges, such as initial resistence and misperceptions among non-research public health workers at the Federal, state and local levels will also be discussed, along with strategies that have been useful in overcoming such challenges. At the conclusion of the presentation, members of the audience will be invited to share their own thoughts and comments on the ethical, legal and pragmatic issues raised.

Learning Objectives: At the conclusion of this presentation, the participant should be able to: (1)describe three ethical requirements, three legal requirements and three pragmatic requirements for protecting human subjects from research risks; (2)discuss three challenges in applying such ethical, legal and pragmatic requirements to non-research public health programs; (3)articulate three potential strategies for overcoming such challenges;

Keywords: Challenges and Opportunities, Special Issues

Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: None
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.

The 128th Annual Meeting of APHA