Consideration and Disclosure of Group Risks in Genomics and Other Data-Centric Research: Does the Common Rule Need Revision?

Chapman, Carolyn Riley; Quinn, Gwendolyn P.; Natri, Heini M.; Berrios, Courtney; Dwyer, Patrick; Owens, Kellie; Heraty, Síofra; Caplan, Arthur L.

doi:10.1080/15265161.2023.2276161

Cited by 3 publications

(4 citation statements)

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“…There is an extensive debate on genomics and consent in the literature that addresses the challenges that consent faces and suggests novel types of consent (Chapman et al 2023;Chow-White et al 2015;Fisher and Layman 2018;Horton and Lucassen 2019). These alternative approaches to consent may well be able to address important issues of consent, but at the same time they often operate within the realm of consent, aiming to revise consent rather than replace it (Chow-White et al 2015).…”

Section: Limits Of Informed Consent For Genomic Data In Different Soc...mentioning

confidence: 99%

“…All these different types and uses of genomic data give rise to varying ethical issues. One significant overarching ethical issue is the potential implications for groups and communities (Chapman et al 2023;Uffelmann et al 2021), that vary depending on the context. In the next section, the advantage of contextual integrity's sensitivity to group interests will be discussed.…”

Section: Sensitive To Group Interestsmentioning

confidence: 99%

“…Furthermore, novel developments in genomics can reinforce potential group-based harms (Chapman et al 2023;Leib-Neri and Prince 2022). These may align with groups that are socially regarded as a group, such as particular ethnic groups.…”

Section: Sensitive To Group Interestsmentioning

confidence: 99%

“…But genomics could also establish groups based on untransparent algorithmic analysis of genomic data, whose members have no idea they have been categorized as being part of this group (Hallinan and De Hert 2017). Artificial intelligence or machine learning analysis of genomic data may accelerate the creation of these groups and may lead to consequences that far extend beyond the initial research (Chapman et al 2023). An example of this could be capturing human genomic data from environmental samples, which may also result in group harms (De Groot 2023a).…”

Section: Sensitive To Group Interestsmentioning

confidence: 99%

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A contextual integrity approach to genomic information: what bioethics can learn from big data ethics

de Groot

2024

Med Health Care and Philos

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Genomic data is generated, processed and analysed at an increasingly rapid pace. This data is not limited to the medical context, but plays an important role in other contexts in society, such as commercial DNA testing, the forensic setting, archaeological research, and genetic surveillance. Genomic information also crosses the borders of these domains, e.g. forensic use of medical genetic information, insurance use of medical genomic information, or research use of commercial genomic data. This paper (1) argues that an informed consent approach for genomic information has limitations in many societal contexts, and (2) seeks to broaden the bioethical debate on genomic information by suggesting an approach that is applicable across multiple societal contexts. I argue that the contextual integrity framework, a theory rooted in information technology and big data ethics, is an effective tool to explore ethical challenges that arise from genomic information within a variety of different contexts. Rather than focusing on individual control over information, the contextual integrity approach holds that information should be shared and protected according to the norms that govern certain distinct social contexts. Several advantages of this contextual integrity approach will be discussed. The paper concludes that the contextual integrity framework helps to articulate and address a broad spectrum of ethical, social, and political factors in a variety of different societal contexts, while giving consideration to the interests of individuals, groups, and society at large.

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Section: Limits Of Informed Consent For Genomic Data In Different Soc...mentioning

confidence: 99%

Section: Sensitive To Group Interestsmentioning

confidence: 99%

Section: Sensitive To Group Interestsmentioning

confidence: 99%

Section: Sensitive To Group Interestsmentioning

confidence: 99%

See 2 more Smart Citations

A contextual integrity approach to genomic information: what bioethics can learn from big data ethics

de Groot

2024

Med Health Care and Philos

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Toward Justice and Community Empowerment in Genomics Studies on Sensitive Traits

Natri,

Chapman

2024

Hastings Center Report

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Community engagement and participatory research have been appropriately employed to increase the relevance, rigor, and acceptability of all types of research, but these approaches may be particularly important in genomics and biomedical research on sensitive traits such as neurodevelopmental, psychiatric, and behavioral ones. Here, we provide an overview of past and ongoing efforts in community engagement in genomics studies and consider successes and opportunities for further improvement. Informed by this knowledge as well as one of the author's experiences, we set out a vision for a more equitable and collaborative genomics where wider communities, including social, ethnic, and other communities that share a particular trait, are included in the research as peers and collaborators, not solely as objects of study.

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Current Trends in AI Ethics for Software as a Medical Device (SaMD)

Vu,

Throne

2024

Advances in Data Mining and Database Management

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Past scholarship has noted the growing concerns and complex challenges surrounding the emergent use of ubiquitous digital technologies in medicine and healthcare, including artificial intelligence (AI) and machine learning (ML). The scholarship has also noted the challenges that human research protection programs (HRPP) and institutional review boards (IRB) have faced in an evolving regulatory climate to review human subjects research involving AI and ML for medical devices. This chapter presents the results of a trends analysis of the current scholarship surrounding compliance trends for AI ethics specific to the use of protected health information (PHI) and compliance trends specifically surrounding AI ethics in software as a medical device (SaMD) for new investigators seeking IRB review for AI/ML research activities. The trends offered in the current scholarship also present many opportunities for policy implications needed to assure ethical oversight for the protection of human subjects in research involving AI/ML for IRBs and HRPPs to review this research.

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Consideration and Disclosure of Group Risks in Genomics and Other Data-Centric Research: Does the Common Rule Need Revision?

Cited by 3 publications

References 87 publications

A contextual integrity approach to genomic information: what bioethics can learn from big data ethics

A contextual integrity approach to genomic information: what bioethics can learn from big data ethics

Toward Justice and Community Empowerment in Genomics Studies on Sensitive Traits

Current Trends in AI Ethics for Software as a Medical Device (SaMD)

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