Katrina A Bramstedt1. 1. Bioethics Department, General Clinical Research Center, Research Subject Advocate Program, Cleveland Clinic Lerner College of Medicine, 9500 Euclid Ave, Mailcode JJ-60, Cleveland, OH 44195, USA. txbioethics@yahoo.com
Abstract
OBJECTIVE: The Internet is frequently used as a tool to recruit research subjects, and the US Food and Drug Administration (FDA) provides general guidance regarding such advertising. The goal of this study was to explore the incidence and nature of ethically inappropriate recruiting advertisements on the Internet and to provide descriptive guidance to researchers for responsible Internet recruiting. METHODS: In this study, 119 advertisements recruiting health volunteers and listed on the CenterWatch Clinical Trials Listing Service website were reviewed for content as well as text style and visual effects. RESULTS: The majority of advertisements satisfied FDA guidance. However, 21 (18%) were ethically troubling with regard to font size, font style, and/or verbiage. In many advertisements, it was unclear if "medication" meant "investigational drug," "over-the-counter medication" or US FDA approved "prescription medication." Nearly 30% of the 119 advertisements used the terms "free," "no charge" or "no cost" as lures. CONCLUSION: Ethically problematic recruiting advertisements can be coercive and misleading. Descriptive guidance provided in this paper can help clinical researchers create ethically appropriate recruiting advertisements.
OBJECTIVE: The Internet is frequently used as a tool to recruit research subjects, and the US Food and Drug Administration (FDA) provides general guidance regarding such advertising. The goal of this study was to explore the incidence and nature of ethically inappropriate recruiting advertisements on the Internet and to provide descriptive guidance to researchers for responsible Internet recruiting. METHODS: In this study, 119 advertisements recruiting health volunteers and listed on the CenterWatch Clinical Trials Listing Service website were reviewed for content as well as text style and visual effects. RESULTS: The majority of advertisements satisfied FDA guidance. However, 21 (18%) were ethically troubling with regard to font size, font style, and/or verbiage. In many advertisements, it was unclear if "medication" meant "investigational drug," "over-the-counter medication" or US FDA approved "prescription medication." Nearly 30% of the 119 advertisements used the terms "free," "no charge" or "no cost" as lures. CONCLUSION: Ethically problematic recruiting advertisements can be coercive and misleading. Descriptive guidance provided in this paper can help clinical researchers create ethically appropriate recruiting advertisements.
Authors: Ganesh Suntharalingam; Meghan R Perry; Stephen Ward; Stephen J Brett; Andrew Castello-Cortes; Michael D Brunner; Nicki Panoskaltsis Journal: N Engl J Med Date: 2006-08-14 Impact factor: 91.245