Public preferences regarding informed consent models for participation in population-based genomic research

1] Life Sciences and Society Program, University of Michigan School of Public Health, Ann Arbor, Michigan, USA [2] Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor, Michigan, USA.
Genetics in medicine: official journal of the American College of Medical Genetics (Impact Factor: 7.33). 05/2013; 16(1). DOI: 10.1038/gim.2013.59
Source: PubMed


Some large population biobanks that house biospecimens and health information for research seek broad consent from participants, whereas others reconsent for specific new studies. Understanding research participants' attitudes and preferences about broad and narrow consent may improve recruitment, retention, and public support.

An online survey was conducted among a representative sample of 4,659 US adults to examine relationships between consent preferences and demographic factors, beliefs about privacy and the value of research, and the perceived trustworthiness of researchers.

Participants preferred broad consent (52%) over study-by-study consent models (48%). Higher preferences for study-by-study consent observed among black non-Hispanic respondents and respondents with lower income and education were explained by differences in the prevalence of one or more beliefs about the study. Respondents with fears about research and those who would feel respected if asked for permission for each research use preferred study-by-study consent. Preference for broad consent was related to the desire not to be bothered with multiple requests and the belief that the study could lead to improved treatments, cures, and lives saved.

These data suggest that support for broad consent is contingent on sufficient information about data use. Work with research participants and community leaders to understand, respond to, and influence opinions about a given, ongoing study may improve uptake of broad consent.

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    • "It would be more productive to pay attention to potential differences among donors'' (2010: 346). For example, in some societies certain ethnic groups may be more concerned than others about access to their biological samples by law-enforcing institutions (Kaufman et al. 2009; other studies looking at the influence of demographic and cultural variables include Platt et al. 2014; Hull et al. 2008; Fong et al. 2004; Goldenberg et al. 2011; Wendler and Emanuel 2002; Ma et al. 2012; see also Hoeyer 2010; Hussain-Gambles et al. 2004). We believe that there is a need to conduct more empirical research on what considerations are potentially relevant to research participants. "
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    ABSTRACT: In this article, we seek to contribute to the debate on the requirement of disclosure in the context of informed consent for research. We defend the subjective standard of disclosure and describe ways to implement this standard in research practice. We claim that the researcher should make an effort to find out what kinds of information are likely to be relevant for those consenting to research. This invites researchers to take empirical survey information seriously, attempt to understand the cultural context, talk to patients to be better able to understand what can be potentially different concerns and interests prevalent in the target population. The subjective standard of disclosure should be seen as a moral ideal that perhaps can never be perfectly implemented but still can and should be used as a normative ideal guiding research practice. In the light of these discussions, we call for more empirical research on what considerations are likely to be perceived as relevant by potential research participants recruited from different socio-economic and cultural groups.
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    • "In this study, the study-specific model was the second most preferred, with some participants noting that they felt in control with this model and that it provided the most amount of information about secondary research uses. However, some participants also viewed the study-specific model as time-consuming , wasteful, and burdensome, as also observed in prior studies (Hoeyer et al. 2004; Master et al. 2013; Murphy et al. 2009; Platt et al. 2013). We found some differences in qualitative themes about the study-specific model by race, with White participants in particular believing that this model would lead to too much contact, while having specific information about secondary research uses and being asked permission for each study were particularly important among Black participants. "
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    ABSTRACT: Biobanks are essential resources, and participation by individuals from diverse groups is needed. Various models of consent have been proposed for secondary research use of biospecimens, differing in level of donor control and information received. Data are needed regarding participant preferences for models of consent, particularly among minorities. We conducted qualitative semi-structured interviews with 60 women to examine their attitudes about different models of consent. Recruitment was stratified by race (Black/White) and prior biobank participation (yes/no). Two coders independently coded interview transcripts. Qualitative thematic analysis was conducted using NVivo 10. The majority of Black and White participants preferred "broad" consent (i.e., blanket permission for secondary research use of biospecimens), and the second most preferred model for both groups was "study-specific" consent (i.e., consent for each future research study). The qualitative analysis showed that participants selected their most preferred model for 3 major reasons: having enough information, having control over their sample, and being asked for permission. Least preferred was notice model (i.e., participants notified that biospecimens may be used in future research). Attitudes toward models of consent differed somewhat by race and prior biobank participation. Participants preferred models of consent for secondary research use of biospecimens that provided them with both specific and general information, control over their biospecimens, and asked them to give permission for use. Our findings suggest that it will be important for researchers to provide information about future uses of biospecimens to the extent possible and have an explicit permission step for secondary research use.
    No preview · Article · Aug 2015 · Journal of community genetics
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    • "They also have the capacity to make trade-offs between the benefits of sharing private information and the resulting risks to their privacy, that institutions holding their data do not possess. Studies have repeatedly shown that individuals differ widely in how they weigh such risks and benefits [Genetics & Public Policy Center, 2007; Institute of Medicine (US) Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule, 2009; Kaufman et al., 2009, 2012; Platt, 2014] and judgments about the trade-offs they make may change over time as circumstances change. A governance system that empowered individuals to make decisions about whether or not they wanted to assume such risks, and that permitted them to change their preferences over time, would capitalize on individuals' ability to share additional information and introduce a capacity for sharing far beyond what would be permissible legally, or even ethically, in the absence of such a mechanism. "
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    ABSTRACT: Whole genome and whole exome sequencing are increasingly useful diagnostic tools for novel monogenic conditions. In order to confirm diagnoses made using these technologies, genomic matchmaking - the matching of cases with similar phenotypic and/and genotypic profiles, to narrow the number of candidate genes or ascertain a condition's etiology with greater certainty - is essential. Yet, due to current limitations on the size of matchmaking networks and data sets available to support them, identifying a match can be difficult. We argue that matchmaking efforts led by affected individuals and their families - participant-led efforts - offer a two-fold solution to this need, in that participants both have the capacity to access larger networks and to provide more detailed sets of phenotypic and genotypic data. These features of participant-led efforts have the potential to increase the value of matchmaking networks, both in terms of number of matches and in terms of the overall energy of the network. We provide two examples of participant-led matchmaking, and propose a model for scaling these efforts. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.
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