Lessons from HeLa Cells: The Ethics and Policy of Biospecimens

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Abstract

Human biospecimens have played a crucial role in scientific and medical advances. Although the ethical and policy issues associated with biospecimen research have long been the subject of scholarly debate, the story of attention of a much broader audience. The story has been a catalyst for policy change, including major regulatory changes proposed in the United States surrounding informed consent. These proposals are premised in part on public opinion data, necessitating a closer look at what such data tell us. The development of biospecimen policy should be informed by many considerations—one of which is public input, robustly gathered, on acceptable approaches that optimize shared interests, including access for all to the benefits of research. There is a need for consent approaches that are guided by realistic aspirations and a balanced view of autonomy within an expanded ethical framework.

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Most cited references 137

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Identifying personal genomes by surname inference.

Melissa Gymrek, Amy L McGuire, David Golan … (2013)

Sharing sequencing data sets without identifiers has become a common practice in genomics. Here, we report that surnames can be recovered from personal genomes by profiling short tandem repeats on the Y chromosome (Y-STRs) and querying recreational genetic genealogy databases. We show that a combination of a surname with other types of metadata, such as age and state, can be used to triangulate the identity of the target. A key feature of this technique is that it entirely relies on free, publicly accessible Internet resources. We quantitatively analyze the probability of identification for U.S. males. We further demonstrate the feasibility of this technique by tracing back with high probability the identities of multiple participants in public sequencing projects.

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Interventions to improve research participants' understanding in informed consent for research: a systematic review.

James Flory, Ezekiel J. Emanuel (2004)

Available data suggest that prospective research participants may frequently not understand information disclosed to them in the informed consent process. Little is known about how understanding can be improved. To review research on interventions to improve research participants' understanding of information disclosed in the informed consent process. A search of MEDLINE was performed using the terms informed consent and clinical research and informed consent and (comprehension or understanding) from 1966 to March 2004 , which included randomized controlled trials, longitudinal trials, and controlled trials with nonrandom allocation that compared the understanding of research participants who had undergone only a standard informed consent process to that of participants who had received an intervention to improve their understanding. A comprehensive bibliography of empirical research on informed consent published in January 1999 was also reviewed, as were personal files and all issues of the journals IRB and Controlled Clinical Trials. Study design, quality criteria, population characteristics, interventions, and outcomes for each trial were extracted. The statistical significance of the interventions' effects on understanding were noted, as were mean scores for understanding for each group of each trial. For those trials that measured the secondary outcomes of satisfaction and willingness to enroll, results were also summarized. Thirty studies described 42 trials that met inclusion criteria. Of 12 trials of multimedia interventions, 3 showed significant improvement in understanding. Of 15 trials of enhanced consent forms, 6 showed significant improvement in understanding (all P<.05), but 5 of 6 trials were of limited quality, casting doubt on their practical relevance. Of 5 trials of extended discussion, 3 showed significant improvement in understanding (all P<.001) and 2 showed trends toward improvement (P=.054 and P=.08). Of 5 trials of test/feedback, all showed significant improvement in understanding (all P<.05) but were flawed in that they may have mistaken rote memorization for improvement in understanding. Another 5 trials were put into a miscellaneous category and had varying impact on understanding. Some demographic factors, particularly lower education, were associated with less understanding. Satisfaction and willingness to enroll were never significantly diminished by an intervention . Efforts to improve understanding through the use of multimedia and enhanced consent forms have had only limited success. Having a study team member or a neutral educator spend more time talking one-on-one to study participants appears to be the most effective available way of improving research participants' understanding; however, further research is needed.

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Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials

Adam Nishimura, Jantey Carey, Patricia Erwin … (2013)

Background Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified. Purpose To systematically analyze the random controlled trials testing interventions to research informed consent process. The primary outcome of interest was quantitative rates of participant understanding; secondary outcomes were rates of information retention, satisfaction, and accrual. Interventional categories included multimedia, enhanced consent documents, extended discussions, test/feedback quizzes, and miscellaneous methods. Methods The search spanned from database inception through September 2010. It was run on Ovid MEDLINE, Ovid EMBASE, Ovid CINAHL, Ovid PsycInfo and Cochrane CENTRAL, ISI Web of Science and Scopus. Five reviewers working independently and in duplicate screened full abstract text to determine eligibility. We included only RCTs. 39 out of 1523 articles fulfilled review criteria (2.6%), with a total of 54 interventions. A data extraction form was created in Distiller, an online reference management system, through an iterative process. One author collected data on study design, population, demographics, intervention, and analytical technique. Results Meta-analysis was possible on 22 interventions: multimedia, enhanced form, and extended discussion categories; all 54 interventions were assessed by review. Meta-analysis of multimedia approaches was associated with a non-significant increase in understanding scores (SMD 0.30, 95% CI, -0.23 to 0.84); enhanced consent form, with significant increase (SMD 1.73, 95% CI, 0.99 to 2.47); and extended discussion, with significant increase (SMD 0.53, 95% CI, 0.21 to 0.84). By review, 31% of multimedia interventions showed significant improvement in understanding; 41% for enhanced consent form; 50% for extended discussion; 33% for test/feedback; and 29% for miscellaneous.Multiple sources of variation existed between included studies: control processes, the presence of a human proctor, real vs. simulated protocol, and assessment formats. Conclusions Enhanced consent forms and extended discussions were most effective in improving participant understanding. Interventions of all categories had no negative impact on participant satisfaction or study accrual. Identification of best practices for studies of informed consent interventions would aid future systematic comparisons.

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Author and article information

Contributors

Laura M. Beskow

Journal

Journal ID (nlm-journal-id): 100911346

Journal ID (pubmed-jr-id): 26795

Journal ID (nlm-ta): Annu Rev Genomics Hum Genet

Journal ID (iso-abbrev): Annu Rev Genomics Hum Genet

Title: Annual review of genomics and human genetics

ISSN (Print): 1527-8204

ISSN (Electronic): 1545-293X

Publication date Nihms-submitted: 9 October 2016

Publication date (Electronic): 03 March 2016

Publication date (Print): 31 August 2016

Publication date PMC-release: 20 October 2016

Volume: 17

Pages: 395-417

Affiliations

[1 ]Program for Empirical Bioethics, Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina 27705

[2 ]Department of Medicine, Duke University School of Medicine, Durham, North Carolina 27710

Article

Manuscript ID: NIHMS821852

DOI: 10.1146/annurev-genom-083115-022536

PMC ID: 5072843

PubMed ID: 26979405

SO-VID: f4db7694-5c3b-4d07-8d97-38482216e6a8

License:

This work is licensed under a Creative Commons Attribution 4.0 International License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. See credit lines of images or other third party material in this article for license information.

Lessons from HeLa Cells: The Ethics and Policy of Biospecimens

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Most cited references 137

Identifying personal genomes by surname inference.

Interventions to improve research participants' understanding in informed consent for research: a systematic review.

Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials

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