Thought-Leader Perspectives on Risks in Precision Medicine Research

Beskow, Laura M.; Hammack, Catherine M.; Brelsford, Kathleen M.; McKenna, Kevin

doi:10.1017/9781108147972.016

Cited by 5 publications

(13 citation statements)

References 16 publications

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“…This could be an artifact of our study design, i.e., that the highlighting activity itself (unlikely to be replicated in an actual consent process) served to engage participants in carefully considering the information in the form. Regardless, the values questions we devised were not intended to change participation decisions per se, but rather to be as neutral as possible and based on evidence generated in empirical research with a diverse group of prominent experts and scholars in the areas of ethics, genome research, health law, historically-disadvantaged populations, informatics, and participant-centric perspectives, as well as government officials and human subjects protections leaders [5,15,16]. Our goal was to create a simple tool that would prompt prospective participants to think through their personal values and what key consent disclosures might mean for their individual context.…”

Section: Discussionmentioning

confidence: 99%

“…We developed our model consent language, which refers to a hypothetical "Million American Study," based on best practice guidelines for biobanking [6][7][8]; information required by recently revised federal regulations (45 CFR 46.116); and the results of our own series of studies to simplify biobanking consent and improve comprehension [9][10][11][12][13][14], which over time involved more than 2100 members of the general public and nearly 80 professionals with biobank-related expertise in cognitive interviews, in-depth interviews, a randomized survey, and a formal Delphi process. Notably, we also incorporated key findings from in-depth interviews we conducted with a diverse group of 60 thought leaders on the benefits, risks, harms, and protections in precision medicine research [5,15,16], as well as extensive analysis of federal and state protections available for precision medicine research [17]. In constructing our language, we followed principles of plain-language writing, such as using common, lay words; writing in first person, active voice; limiting sentence length; addressing only one main idea per paragraph; using clear organization and formatting with descriptive headings; and ensuring adequate white space [18].…”

Section: Materials Developmentmentioning

confidence: 99%

“…Nearly three-fourths (72%) of participants said the values questions were helpful, describing them as "a good encapsulation of the main areas of concern for people" [15] and an opportunity to "see how you really feel about it, and … give yourself an accurate assessment on whether or not you want to proceed" (09):…”

Section: Helpfulness Of Values Questionsmentioning

confidence: 99%

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Developing model biobanking consent language: what matters to prospective participants?

Beskow

Hammack-Aviran

Brelsford

2020

BMC Med Res Methodol

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Background Efforts to improve informed consent have led to calls for providing information a reasonable person would want to have, in a way that facilitates understanding of the reasons why one might or might not want to participate. At the same time, advances in large-scale genomic research have expanded both the opportunities and the risks for participants, families, and communities. To advance the use of effective consent materials that reflect this landscape, we used empirical data to develop model consent language, as well as brief questions to assist people in thinking about their own values relative to participation. Methods We conducted in-person interviews to gather preliminary input on these materials from a diverse sample (n = 32) of the general population in Nashville, Tennessee. We asked them to highlight information they found especially reassuring or concerning, their hypothetical willingness to participate, and their opinions about the values questions. Results Consent information most often highlighted as reassuring included the purpose of the biobank, the existence and composition of a multidisciplinary oversight committee, the importance of participants’ privacy and efforts to protect it, and controlled access to a scientific database. Information most often highlighted as concerning included the deposition of data in a publicly accessible database, the risk of unintended access to data, the potential for non-research use of data, and use of medical record information in general. Seventy-five percent of participants indicated initial willingness to participate in the hypothetical biobank; this decreased to 66% as participants more closely considered the information over the course of the interview. A large majority rated the values questions as helpful. Conclusions These results are consistent with other research on public perspectives on biobanking and genomic cohort studies, suggesting that our model language effectively captures commonly expressed reasons for and against participation. Our study enriches this literature by connecting specific consent form disclosures with qualitative data regarding what participants found especially reassuring or concerning and why. Interventions that facilitate individuals’ closer engagement with consent information may result in participation decisions more closely aligned with their values.

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Section: Discussionmentioning

confidence: 99%

Section: Materials Developmentmentioning

confidence: 99%

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Developing model biobanking consent language: what matters to prospective participants?

Beskow

Hammack-Aviran

Brelsford

2020

BMC Med Res Methodol

Self Cite

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show abstract

“…However, it is important to note that thought leaders interviewed also emphasized the risks to participants' biological relatives and to socially-identifiable groups. 10 Moreover, the likelihood of risks actually occurring and the severity of any resulting harm depends on numerous contextual factors, including characteristics of the individual participant, study design, and socio-cultural environment. 11…”

mentioning

confidence: 99%

Protecting Participants in Genomic Research: Understanding the “Web of Protections” Afforded by Federal and State Law

Wolf¹,

Hammack²,

Brown³

et al. 2020

J. Law. Med. Ethics

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Researchers now commonly collect biospecimens for genomic analysis together with information from mobile devices and electronic health records. This rich combination of data creates new opportunities for understanding and addressing important health issues, but also intensifies challenges to privacy and confidentiality. Here, we elucidate the “web” of legal protections for precision medicine research by integrating findings from qualitative interviews with structured legal research and applying them to realistic research scenarios involving various privacy threats.

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“…We asked about these risks in our qualitative research with a diverse group of nationally recognized thought leaders. They identified four broad categories of risk in a hypothetical large-scale precision medicine research endeavor: unintended access to identifying information, permitted but potentially unwanted use of information, risks based on the nature of genomic information, and risks arising from longitudinal study designs 2 -with attendant prospects for physical, dignitary, group, economic, psychological, and legal harms. 3 To understand more about the specific sources of these risks and harms, we also asked these thought lead-ers to identify which they perceived to be the riskiest aspect of the endeavor: genomic analyses of biospecimens, ongoing access to electronic health record (EHR) data, or streaming data from mobile devices.…”

mentioning

confidence: 99%

Thought Leader Comparisons of Risks in Precision Medicine Research

Beskow

Hammack-Aviran

Brelsford

2020

Ethics & Human Research

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Biomedical research is increasingly capitalizing on an array of data to illuminate the interplay between "omics, " lifestyle, and health. Leveraging this information presents opportunities to advance knowledge but also poses risks to research participants. In interviews with thought leaders, we asked which data type associated with a hypothetical precision medicine research endeavor was riskiest: 42% chose ongoing access to electronic health records, 17% chose genomic analyses of biospecimens, and 15% chose streaming data from mobile devices. Other responses included "It depends" (15%), the three types are equally risky (8%), and the combination of data types together is riskiest (3%). When asked to consider the hypothetical study overall, 60% rated the likelihood of the risks materializing as low, but 20% rated the potential consequences as severe. These results have implications for study design and informed consent, including placing appropriate emphasis on the risks and protections for the full range of data. KEYWORDS research ethics, informed consent, genomic research, electronic health records, big data

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Thought-Leader Perspectives on Risks in Precision Medicine Research

Cited by 5 publications

References 16 publications

Developing model biobanking consent language: what matters to prospective participants?

Developing model biobanking consent language: what matters to prospective participants?

Protecting Participants in Genomic Research: Understanding the “Web of Protections” Afforded by Federal and State Law

Thought Leader Comparisons of Risks in Precision Medicine Research

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