Immortal Life of the Common Rule: Ethics, Consent, and the Future of Cancer Research

Smith, Joshua D.; Birkeland, Andrew C.; Goldman, Edward B.; Brenner, J. Chad; Carey, Thomas E.; Spector‐Bagdady, Kayte; Shuman, Andrew G.

doi:10.1200/jco.2016.68.4522

Cited by 19 publications

(29 citation statements)

References 14 publications

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“…Recently, individual cell line genetic drift was shown in the breast cancer cell line MCF7 to result in highly disparate drug response in different laboratory isolates (125). Finally, concerns over adequate patient consent for creating cell lines have arisen most notably from HeLa cells (126)(127)(128)(129)(130).…”

Section: Cellular Models In Cancer Researchmentioning

confidence: 99%

An Interactive Resource to Probe Genetic Diversity and Estimated Ancestry in Cancer Cell Lines

et al. 2019

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Recent work points to a lack of diversity in genomics studies from genome-wide association studies to somatic (tumor) genome analyses. Yet, population-specific genetic variation has been shown to contribute to health disparities in cancer risk and outcomes. Immortalized cancer cell lines are widely used in cancer research, from mechanistic studies to drug screening. Larger collections of cancer cell lines better represent the genomic heterogeneity found in primary tumors. Yet, the genetic ancestral origin of cancer cell lines is rarely acknowledged and often unknown. Using genome-wide genotyping data from 1,393 cancer cell lines from the Catalogue of Somatic Mutations in Cancer (COSMIC) and Cancer Cell Line Encyclopedia (CCLE), we estimated the genetic ancestral origin for each cell line. Our data indicate that cancer cell line collections are not representative of the diverse ancestry and admixture characterizing human populations. We discuss the implications of genetic ancestry and diversity of cellular models for cancer research and present an interactive tool, Estimated Cell Line Ancestry (ECLA), where ancestry can be visualized with reference populations of the 1000 Genomes Project. Cancer researchers can use this resource to identify cell line models for their studies by taking ancestral origins into consideration.

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Section: Cellular Models In Cancer Researchmentioning

confidence: 99%

An Interactive Resource to Probe Genetic Diversity and Estimated Ancestry in Cancer Cell Lines

et al. 2019

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“…11 It has also been recommended for secondary research on unidentified biospecimens in the revised Common Rule that guides research in the United States. 12 While a growing body of evidence suggests that African research participants recognize broad consent as the "best compromise," 13,14,15 it has also been argued that broad consent increases the risk of exploitation of African research populations, 16 which suggests that a decision to use broad consent is context dependent and that there might be particular instances when its use is inappropriate.…”

Section: Challenges Of Obtaining Informed Consentmentioning

confidence: 99%

How Should Biobanking Be Governed in Low-Resource Settings?

Yakubu¹,

Munung²,

Vries

2020

AMA Journal of Ethics

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Development of biobanks in Africa raises ethical questions related to particular features of African cancer research contexts, such as underresourced health care and research infrastructures and low-average research literacy. This article describes ethical challenges of informed consent, benefit sharing, and stigmatization and proposes navigating these challenges by developing a comprehensive governance framework to ensure African leadership in biobanking research programs in Africa. Biobanking in African Research Recent years have seen increased efforts to capture global genetic diversity in an attempt to ensure that the benefits of genomic innovation filter down to all people around the globe, including Africans. 1,2,3 Efforts such as the Human Heredity and Health in Africa (H3Africa) Consortium 2 and the Bridging Biobanking and Biomedical Research Across Europe and Africa (B3Africa) Consortium 4 are aimed at achieving this diversity, increasingly through the inclusion of African researchers and populations in genomics studies. These initiatives either set up new biobanks or strengthen the capacity of already existing ones. 4,5 Biobanking-the practice of collecting, curating, and archiving biospecimens for research purposes-is one key tool that is available to scientists to accelerate genomic cancer research. A biobank stores large numbers of samples and associated data and makes these resources available for further research. To serve its purpose as a research resource, biobanks are expected to (1) have defined mechanisms for accessing biospecimens, (2) ensure that the use of biospecimens is in accordance with the informed consent of the participants who donated the samples, (3) have policies for biospecimens disposal, and (4) have a benefit sharing plan.

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“…This was the first major revision of regulations initially conceived in the 1970s as a response to federally funded research scandals, most notably the Tuskegee syphilis experiments (in which PHS researchers observed poor black sharecroppers with syphilis in Macon County, Alabama, for decades and prevented them from receiving treatment) . The most significant controversy surrounding the revisions to these research regulations involved informed consent to research with human specimens …”

Section: Key Players In the Biospecimen Experimentsmentioning

confidence: 99%

“…Programs such as the Precision Medicine Initiative, which promise individually tailored therapies, require vast amounts of data and health information from hundreds of thousands of people in order to advance medical science . The banking of biospecimens and data for future research has become almost as important as conventional clinical trials and provides a springboard for thousands of secondary research protocols . Despite the value of human biospecimens, however, our ethical and regulatory response to their use has struggled to keep up with the public's normative expectations.…”

Section: Policy Implications For Contemporary Biospecimen Researchmentioning

confidence: 99%

“…In January 2017, the Department of Health and Human Services and other major stakeholders released the first comprehensive update to the US human subjects research regulations’ “Common Rule” since its codification in 1991 . These revisions grew out of an almost 6‐year process, which is still ongoing, with one of the major points of controversy being informed consent to biospecimen research …”

Section: Policy Implications For Contemporary Biospecimen Researchmentioning

confidence: 99%

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From in vivo to in vitro: How the Guatemala STD Experiments Transformed Bodies Into Biospecimens

Spector‐Bagdady

Lombardo

2018

Milbank Quarterly

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Immortal Life of the Common Rule: Ethics, Consent, and the Future of Cancer Research

Cited by 19 publications

References 14 publications

An Interactive Resource to Probe Genetic Diversity and Estimated Ancestry in Cancer Cell Lines

An Interactive Resource to Probe Genetic Diversity and Estimated Ancestry in Cancer Cell Lines

How Should Biobanking Be Governed in Low-Resource Settings?

From in vivo to in vitro: How the Guatemala STD Experiments Transformed Bodies Into Biospecimens

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