Risk Evaluation in Occupational Safety and Health Research: Results From a Benchmarking Exercise of Federal and Academic IRBs.

Abstract

Research involving working populations can pose unique ethical and risk evaluation challenges. The purpose of this benchmarking project was to assess how federal agencies and academic institutions approach the interpretation and application of key risk evaluation concepts in research involving workers in their places of employment. Key informant interviews were conducted to ascertain current practices related to assessing soundness of research design, determining risk reasonableness and research relatedness of risks, and evaluating the risk of noninvasive clinical tests in occupational settings. There were noteworthy commonalities among the approaches described to review and address critical aspects of risk evaluation for occupational safety and health research involving human participants. The insights gleaned may help guide institutional review boards and Human Research Protection Programs as they consider the ethical issues of human subjects research in occupational settings.