Prospective Biorepository Participants' Perspectives on Access to Research Results

Abstract

Disclosure of individual research results to research participants has been the subject of professional guidelines as well as scholarly commentary, yet controversy remains. To gather data on participant perspectives, we interviewed 40 individuals from the Durham, North Carolina area about a biorepository consent form and conducted an in-depth analysis of responses to a series of questions concerning access to research results. Cross-cutting themes emerged about (1) the nature of research; (2) the nature of research results; (3) expectations concerning access to research results; and (4) practical issues in providing access to research results. Our findings highlight the importance for sound policy development of soliciting stakeholder input, and exploring the complexities behind their evaluations. Keywordsbiorepository; biological specimen banks; informed consent; research subjects; confidentiality; disclosure of research results; access to research results Considerable controversy exists over the issue of disclosing individual research results to research participants. This topic has been the subject of guidelines from federal and international entities (Bookman et al., 2006;Knoppers et al., 2006; National Bioethics Advisory Commission, 1999) as well as ample scholarly commentary, and yet the debate continues range widely between the view that individual results should routinely be offered (Fernandez, 2008;Sharp & Foster, 2006;Shalowitz & Miller, 2005;Fernandez, Kodish, & Weijer, 2003) and the view that such results should seldom, if ever, be disclosed (Miller et al., 2008;Meltzer, 2006;Parker, 2006;Clayton & Ross, 2006). Many the same ethical principles -respect for persons, beneficence, and reciprocity-are applied in arguments both for and against disclosure of results (Haga & Beskow, 2008).Data on the opinions and preferences of stakeholders are essential for informing policy development on this issue. Surveys employing basic questions about research results appear to document participants' desire to receive such information (Kaufman et al., 2008;Wendler & Emanuel, 2002). However, the preponderance of positive responses may not accurately reflect what participants' nuanced preferences would be if they were given a more complete portrayal of the limited validity and utility of most research findings (Ormond et al., 2009 NIH-PA Author ManuscriptNIH-PA Author Manuscript NIH-PA Author Manuscript addition, many studies (as well as broader discussions on this topic) have focused on the disclosure of results generated in the context of clinical trials (Partridge et al., 2009; DixonWoods et al., 2006;Partridge et al., 2003) and other well-defined studies (Schulz et al., 2003;Richards et al., 2003). Less attention has been given to the context of a biorepository, where participants may be enrolled based simply on their membership in a particular population (e.g., geographically defined) and not because they have a particular condition of interest. Specimens and data are stored for future, unspecified use i...

Biobank Participants' Preferences for Disclosure of Genetic Research Results: Perspectives From the OurGenes, OurHealth, OurCommunity Project

“…14 We found that preferences regarding disclosure of individual genetic research results vary on the basis of the type of research result. Most participants in our study wanted genetic research results disclosed across all the hypothetical scenarios.…”

“…26,28 Only a few potential biobank participants understand these logistical barriers to disclosing research results. 14 The public believes that costs related to confirming genetic research results should be absorbed by the study budget. 15 Engaging the public in policy decisions about disclosure is important to promoting a shared responsibility for managing logistical barriers.…”

“…13 Focus groups conducted with prospective biobank participants and the public reveal that the nature of the research and type of research result affects participants’ opinions about disclosure. 14,15 …”

Views of Cohort Study Participants about Returning Research Results in the Context of Precision Medicine

“…Previous research has explored the opinions of members of the general public about return of results in several different contexts, including studies focusing on predominately African American members of the general public participating in focus groups [11], members of the general public participating in focus groups [12], an online survey of the general population [13], prospective biorepository candidates [14], and diverse members of the public in focus groups [15]. These studies of the opinions of people who had not previously participated in genetic research have tended to show similar results, including a strong interest in return of results, both because of a belief that such results could help participants improve their health and due to a sense of control that is provided.…”

Informed Consent in Genomics and Genetic Research

“…A biobanking context adds further complexity, since stored specimens and data can be used in a variety of studies that typically take place without the participant’s direct knowledge or consent (13). These studies are often conducted without any interaction with the researcher, who may be unknown to the participant.…”