Date Published: May 13, 2008
Publisher: Public Library of Science
Author(s): David I Shalowitz, Franklin G Miller
Abstract: The authors discuss the available data on the effects of communicating aggregate and individual research results on participants, investigators, and the research enterprise.
Partial Text: Recent commentaries advocate routinely offering study results to research participants [1,2]. However, debate continues over the scope and limits of investigators’ responsibilities in this regard. A 2006 review identified 30 national and international policies and guidelines concerning the duty to return research results , of which 21 were published in the last decade. Worldwide interest in this complex issue will likely continue to rise in light of the increasing relevance of the results of biomedical research to participants’ health and well-being.
A literature search revealed 28 empirical studies concerning communication of research results (Text S1). Because these studies encompass many different participant populations and research settings, we did not pool quantitative data or conduct a formal quality assessment of studies. Of the 28 studies summarized below, 22 are primarily quantitative and six are primarily qualitative [4–9]. Sample size ranged from 13  to 8,941 . Twelve studies involved either cancer research or the attitudes of patients with cancer [7,10–20]; seven studies involved genetics research [7,9,11,20–23]. Ten studies were conducted in the United States [9,10,16–21,24,25], nine in the United Kingdom [4–8,11,26–28], four in Canada [14,15,29,30], one in France , and one in Sweden . Three studies enrolled a multinational participant population [12,13,31].
As we have conducted a narrative review of studies concerning communicating research results to participants, rather than a systematic review, definitive conclusions about findings and their ethical import cannot be drawn. Nevertheless, the data reviewed here suggest several important implications. Available data consistently indicate that research participants want aggregate and clinically significant individual study results made available to them. Participants’ desires do not necessarily determine policy, but respect for participants requires taking their preferences seriously. Though investigators appear to support the communication of aggregate study results, less is known about investigators’ attitudes towards communicating individual research results or about the costs and time required to do so. Future research should focus on these issues, including ways to facilitate communication of results by addressing investigators’ concerns.