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The 130th Annual Meeting of APHA |
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The 130th Annual Meeting of APHA |
Kerri McGowan Lowrey, JD, MPH1, Mark Parascandola, PhD, MPH2, Susan Nayfield, MD, MSc3, and Daniel Swaja3. (1) Cancer Prevention Fellow, Office of Preventive Oncology, National Cancer Institute, 6130 Executive Blvd., Room 5133-B, MSC 7393, Bethesda, MD 20892, 301-435-4908, mcgowank@mail.nih.gov, (2) Cancer Prevention Fellowship Program, National Cancer Institute, 6130 Executive Blvd., Suite 3109, Bethesda, MD 20892, (3) Epidemiology and Genetics Research Program, National Cancer Institute, 6130 Executive Blvd., MSC 7393, Bethesda, MD 20982
Most investigators praise media advertising as a successful, undemanding and cost-effective method for recruiting subjects from the community for health research. However, this practice has received scant ethical review, and even less legal review. Because recruitment advertisements tap motivations and create expectations that influence research participation in ethically significant ways, some have considered them to be the beginning of the informed consent process. Advertisements' accuracy regarding clinical research protocols, the nature of the compensation offered and the way it is offered raise ethical and potential legal issues pertaining to human subjects protection. In this study, we followed health study recruitment advertisements that appeared in two free area newspapers selected for their high volume of health study advertisements and their readership-the Baltimore City Paper and the Washington City Paper. The health study advertisements in both papers were collected from March 2000 through May 2000. Based on a coding scheme developed for the purposes of this study, the advertisements were assessed by three independent reviewers to analyze them for compliance with FDA guidelines regarding health research advertising, principles of ethics, the Common Rule, consumer protection law and the Office of the Inspector General's June 2000 report, "Recruiting Human Subjects." This presentation will discuss study findings, provide an ethical and legal review of the practice of advertising for health research participation, and make policy recommendations to safeguard potential research participants during this first step of the informed consent process.
Learning Objectives:
Keywords: Consumer Protection, Research Ethics
Presenting author's disclosure statement:
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.