Thought Leader Perspectives on Participant Protections in Precision Medicine Research

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

doi:10.1177/1073110519840493

Cited by 19 publications

(32 citation statements)

References 14 publications

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“…09Public database can be hacked easier than a scientific database, so I don't like that. (16) What are the risks and how will I be protected? Commonly highlighted sentences in this section included disclosures about:…”

Section: Will I Get the Results Of Studies On My Sample And Information?mentioning

confidence: 99%

“…Are they going to try to attach me to somebody who has committed crimes or take my DNA or something like that? (16) … including by insurance companies in particular:…”

Section: Will I Get the Results Of Studies On My Sample And Information?mentioning

confidence: 99%

“…Until better laws are in place to protect those things, it raises a lot of questions. (16) After thinking more specifically about what they found reassuring and concerning via the highlighting activity (Time 2), a smaller proportion (66%) of participants rated themselves somewhat to very likely to participate (Table 5). Although half rated their willingness the same as they had at Time 1, one-fourth of participants rated their willingness more negatively by one to four points, and one-fourth rated their willingness one point more positively on the 6-point scale (Additional file 1: Appendix S3).…”

Section: Will I Get the Results Of Studies On My Sample And Information?mentioning

confidence: 99%

“…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%

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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: Will I Get the Results Of Studies On My Sample And Information?mentioning

confidence: 99%

“…Are they going to try to attach me to somebody who has committed crimes or take my DNA or something like that? (16) … including by insurance companies in particular:…”

Section: Will I Get the Results Of Studies On My Sample And Information?mentioning

confidence: 99%

Section: Will I Get the Results Of Studies On My Sample And Information?mentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Materials Developmentmentioning

confidence: 99%

See 3 more Smart Citations

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

Beskow

Hammack-Aviran

Brelsford

2020

BMC Med Res Methodol

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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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Ethical, Legal, and Social Implications of Gene‐Environment Interaction Research

Calluori,

Heimke,

Caga‐anan

et al. 2024

Genetic Epidemiology

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Many complex disorders are impacted by the interplay of genetic and environmental factors. In gene‐environment interactions (GxE), an individual's genetic and epigenetic makeup impacts the response to environmental exposures. Understanding GxE can impact health at the individual, community, and population levels. The rapid expansion of GxE research in biomedical studies for complex diseases raises many unique ethical, legal, and social implications (ELSIs) that have not been extensively explored and addressed. This review article builds on discussions originating from a workshop held by the National Institute of Environmental Health Sciences (NIEHS) and the National Human Genome Research Institute (NHGRI) in January 2022, entitled: “Ethical, Legal, and Social Implications of Gene‐Environment Interaction Research.” We expand upon multiple key themes to inform broad recommendations and general guidance for addressing some of the most unique and challenging ELSI in GxE research. Key takeaways include strategies and approaches for establishing sustainable community partnerships, incorporating social determinants of health and environmental justice considerations into GxE research, effectively communicating and translating GxE findings, and addressing privacy and discrimination concerns in all GxE research going forward. Additional guidelines, resources, approaches, training, and capacity building are required to further support innovative GxE research and multidisciplinary GxE research teams.

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Thought Leader Perspectives on Participant Protections in Precision Medicine Research

Cited by 19 publications

References 14 publications

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

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

Thought Leader Comparisons of Risks in Precision Medicine Research

Ethical, Legal, and Social Implications of Gene‐Environment Interaction Research

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