Purpose Return of individual research results from genomic studies is a hotly debated ethical issue in genomic research. However, the perspective of key stakeholders—Institutional Review Board (IRB) reviewers—has been missing from this dialogue. This study explores the positions and experiences of IRB members and staff regarding this issue. Methods In depth interviews with 31 IRB professionals at six sites across the United States. Results IRB professionals agreed that research results should be returned to research participants when results are medically actionable but only if the participants wanted to know the result. Many respondents expected researchers to address the issue of return of results (ROR) in the IRB application and informed-consent document. Many respondents were not comfortable with their expertise in genomics research, and only a few described actual experiences in addressing ROR. Although participants agreed that guidelines would be helpful, most were reticent to develop them in isolation. Even where IRB guidance exists (e.g., CLIA lab certification required for return), in practice, the guidance has been overruled to allow return (e.g., no CLIA lab performs the assay). Conclusion An IRB-researcher partnership is needed to help inform responsible and feasible institutional approaches to returning research results.

First proposed by Mueller, the theory of the "rally effect" predicts that public support for government officials will increase when an event occurs that (1) is international; (2) involves the United States; and (3) is specific, dramatic, and sharply focused (Mueller 1973, p. 209). Using the natural experiment of a large (N=15,127) survey of young adults ages 18-27 that was in the field during the September 11, 2001, terrorist attacks, we confirm the existence of a rally effect on trust in government as well as its subsequent decay. We then use a predictive modeling approach to investigate individual-level dynamics of rallying around the flag and anti-rallying in the face of the national threat. By disaggregating predictors of rallying, we demonstrate remarkably different patterns of response to the attacks based on sex and, particularly, race. The results confirm expectations of national threat inciting a rally effect, but indicate that the dynamics of this rally effect are complex and race and gender-dependent. The article offers previously-unavailable insights into the dynamics of rallying and trust in government. Keywords trust; September 11; rally effect; race; gender Extant theory and research suggest that, in the face of a broadly-experienced national threat, citizens' trust in the federal government tends to increase (Doty, Peterson, and Winter 1997; Feldman and Stenner 1991;Sales 1972Sales , 1973)--a version of the so-called "rally effect" (Mueller 1973). This effect has been demonstrated empirically in the case of the September 11, 2001, terrorist attacks by repeated cross-sectional studies (Gaines 2002;Newport 2001;Chanley 2002;Schubert, Stewart, and Curran 2002). We examine the rally effect more closely using an unusual data source and methodological approach. We use predictive modeling to estimate individuals' probability of rallying around the federal government in the wake of the September 11, 2001, terrorist attacks using a large, nationally-representative survey of young adults that was in the field at the time of the attacks. This approach allows us to identify the kinds of people who tend to rally in response to perceived threats. Our data also allow us to focus on an often neglected population: young adults, whose attitudes toward government and citizenship may be in formation and for whom historical memory may be particularly acute (Schuman and Scott 1989). We find remarkable gender and race differences in pre-9/11 trust in government as well as in responses to the 9/11 attacks. We also document the presence and dynamics of an antiAddress correspondence to Andrew J. Perrin. (919) 962-6876 -Fax (919) 962-7568 andrew_perrin@unc.edu. Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during th...

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...

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