Biobanking Research and Privacy Laws in the United States

Harrell, Heather L.; Rothstein, Mark A.

doi:10.1177/1073110516644203

Cited by 13 publications

(14 citation statements)

References 21 publications

(27 reference statements)

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“…The companies also must publicize that they are following the data protection principles, so that if they fail to do so they will be in violation of American unfair trade practice laws. 18…”

Section: Privacy and Biobanking Research Across The Nationsmentioning

confidence: 99%

Comparative Approaches to Biobanks and Privacy

Rothstein¹,

Knoppers²,

Harrell³

2016

J. Law. Med. Ethics

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Laws in the 20 jurisdictions studied for this project display many similar approaches to protecting privacy in biobank research. Although few have enacted biobank-specific legislation, many countries address biobanking within other laws. All provide for some oversight mechanisms for biobank research, even though the nature of that oversight varies between jurisdictions. Most have some sort of controlled access system in place for research with biobank specimens. While broad consent models facilitate biobanking, countries without national or federated biobanks have been slow to adopt broad consent. International guidelines have facilitated sharing and generally take a proportional risk approach, but many countries have provisions guiding international sharing and a few even limit international sharing. Although privacy laws may not prohibit international collaborations, the multi-prong approach to privacy unique to each jurisdiction can complicate international sharing. These symposium issues can serve as a resource for explaining the sometimes intricate privacy laws in each studied jurisdiction, outlining the key issues with regards to privacy and biobanking, and serving to describe a framework for the process of harmonization of privacy laws.

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Section: Privacy and Biobanking Research Across The Nationsmentioning

confidence: 99%

Comparative Approaches to Biobanks and Privacy

Rothstein¹,

Knoppers²,

Harrell³

2016

J. Law. Med. Ethics

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“…All samples are collected, stored and used in agreement with the ethical and research guidelines set by biobanking privacy laws 18 and the Institutional Review Boards (IRB) of JHUSOM and University of California, San Francisco. The methods for specimen collection for genetic studies were approved at Columbia University Irving Medical Center.…”

Section: Methodsmentioning

confidence: 99%

Specimen Collection for Translational Studies in Hidradenitis Suppurativa

Byrd

Dina

Okoh

et al. 2019

Sci Rep

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Hidradenitis suppurativa (HS) is a chronic inflammatory disorder characterized by painful nodules, sinus tracts, and scars occurring predominantly in intertriginous regions. The prevalence of HS is currently 0.053–4%, with a predominance in African-American women and has been linked to low socioeconomic status. The majority of the reported literature is retrospective, population based, epidemiologic studies. In this regard, there is a need to establish a repository of biospecimens, which represent appropriate gender and racial demographics amongst HS patients. These efforts will diminish knowledge gaps in understanding the disease pathophysiology. Hence, we sought to outline a step-by-step protocol detailing how we established our HS biobank to facilitate the formation of other HS tissue banks. Equipping researchers with carefully detailed processes for collection of HS specimens would accelerate the accumulation of well-organized human biological material. Over time, the scientific community will have access to a broad range of HS tissue biospecimens, ultimately leading to more rigorous basic and translational research. Moreover, an improved understanding of the pathophysiology is necessary for the discovery of novel therapies for this debilitating disease. We aim to provide high impact translational research methodology for cutaneous biology research and foster multidisciplinary collaboration and advancement of our understanding of cutaneous diseases.

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“…However, achieving an adequate level of privacy protection will be challenging. Privacy regulations in the United States are fragmented; they include complex, sometimes conflicting, federal and state policies; and, in any case, they focus on protecting individuals and families from state (and other external) intrusion but not on privacy concerns within families.…”

Section: The Pmi's Social Contractmentioning

confidence: 99%

The Precision Medicine Nation

Sabatello¹,

Appelbaum²

2017

Hastings Center Report

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The United States’ ambitious Precision Medicine Initiative proposes to accelerate exponentially the adoption of precision medicine, an approach to health care that tailors disease diagnosis, treatment, and prevention to individual variability in genes, environment, and lifestyle. It aims to achieve this by creating a cohort of volunteers for precision medicine research, accelerating biomedical research innovation, and adopting policies geared toward patients’ empowerment. As strategies to implement the PMI are formulated, critical consideration of the initiative's ethical and sociopolitical dimensions is needed. Drawing on scholarship of nationalism and democracy, we discuss the PMI's construction of what we term “genomic citizenship”; the possible normative obligations arising therefrom; and the ethical, legal, and social challenges that will ensue. Although the PMI is a work in progress, discussion of the existing and emerging issues can facilitate the development of policies, structures, and procedures that can maximize the initiative's ability to produce equitable and socially sensitive outcomes. Our analysis can also be applied to other population‐based, precision medicine research programs.

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Biobanking Research and Privacy Laws in the United States

Cited by 13 publications

References 21 publications

Comparative Approaches to Biobanks and Privacy

Comparative Approaches to Biobanks and Privacy

Specimen Collection for Translational Studies in Hidradenitis Suppurativa

The Precision Medicine Nation

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