Mapping the inputs, analyses, and outputs of biobank research systems to identify sources of incidental findings and individual research results for potential return to participants

Bemmels, Heather; Wolf, Susan M.; Ness, Brian G. Van

doi:10.1038/gim.2011.69

Cited by 10 publications

(8 citation statements)

References 7 publications

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“…For example, professional organizations 4 and government initiatives 5 are important resources. Nevertheless, there is extensive variation among biobanks with respect to initial motivation to create the biobank, settings of biobanks (e.g., academic, clinical, or commercial), data and biospecimen inventories, 6 data management and security, scope (e.g., single institution samples versus regional or national sample contributions), and sharing policies. As a result of the diverse motivations and goals, context matters.…”

Section: Surveys Of Biobank Managers’ Views On Return Of Resultsmentioning

confidence: 99%

Returning a Research Participant's Genomic Results to Relatives: Perspectives from Managers of Two Distinct Research Biobanks

Petersen

Ness

2015

J. Law. Med. Ethics

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Given the nature of scientific inquiry, biomedical and genomic researchers have forged innumerable ways to advance our understanding of human disease. In many cases, research requires the involvement of human subjects, and in a subset of these studies, the researcher may collect data and biospecimens from many participants, and even serially collect additional materials over time and across a number of geographically dispersed centers. The organized data and biospecimens are collectively known as research biobanks. Researchers have an obligation to disseminate findings from their research through publications and presentations to other professionals, and when possible, to the public. Sharing genomic data is increasingly being mandated; access to data can be obtained through collaborative or state-funded entities. For example, the database of Genotypes and Phenotypes (dbGAP) and the International Cancer Genome Consortium will grant approved research applicants access to de-identified individual level genomic data with accompanying demographic/clinical information.

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Section: Surveys Of Biobank Managers’ Views On Return Of Resultsmentioning

confidence: 99%

Returning a Research Participant's Genomic Results to Relatives: Perspectives from Managers of Two Distinct Research Biobanks

Petersen

Ness

2015

J. Law. Med. Ethics

Self Cite

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“…Fully engaging researchers in deliberative processes to develop strategies to respond to ethical issues in their human subject research may also prove to benefi t the process of research design generally. Further, as new technologies, such as next generation sequencing become more common, complicated issues about how to respond to incidental fi ndings will more common, 11 and REC services may be well positioned to provide advice and guidance. 12 Th ese collaborative eff orts may be increasingly important as emerging informatics capabilities, the rapid pace of technology development, and greater involvement of communities in the research process have made the ethical issues in clinical and translational research more visible and perhaps even more complicated than previously.…”

Section: Discussionmentioning

confidence: 99%

“…Most services reported that several areas of expertise were represented on their RECS. Backgrounds of RECS consultants included bioethics (31), medicine (26), humanities (19), law (14), epidemiology/public health (11), biological sciences (9), and social sciences (9).…”

Section: Consultant Staffi Ngmentioning

confidence: 99%

The Establishment of Research Ethics Consultation Services (RECS): An Emerging Research Resource

McCormick

Sharp

Ottenberg

et al. 2012

Clinical Translational Sci

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Emphasis on translational research to facilitate progression from the laboratory into the community also creates a dynamic in which ethics and social policy questions and solutions are ever pressing. In response, academic institutions are creating Research Ethics Consultation Services (RECS). All Clinical Translational Science Award (CTSA) institutions were surveyed in early 2010 to determine which institutions have a RECS in operation and what is their composition and function. Of the 46 institutions surveyed, 33 (70%) have a RECS. Only 15 RECS have received any consult requests in the last year. Issues that are common among these relatively nascent services include relationships with institutional oversight committees, balancing requestor concerns about confidentiality with research integrity and human subjects protection priorities, tracking consult data and outcomes, and developing systems for internal evaluation. There is variability in how these issues are approached. It will be important to be attentive to the institutional context to develop an appropriate approach. Further data about the issues raised by requestors and the recommendations provided are necessary to build a community of scholars who can navigate and resolve ethical issues encountered along the translational research pathway.

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“…First, ''financial and logistical complications'' (Samuel et al, 2012) can be minimized, thanks to scientific advances. Technical solutions exist, for example, tools to compare and manage results and the process of returning them to participants' treating physicians (Bemmels et al, 2012).…”

Section: In Favor Of a Pragmatic And Honest Solutionmentioning

confidence: 99%

Returning Results: Let's Be Honest!

Elger

Clercq

2017

Genetic Testing and Molecular Biomarkers

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Biobank research has the potential to return results that could have beneficial and even life-saving consequences for participants. This possibility raises some important questions, not only about the ethical duty to return results within a research setting, but also about participants' right to refuse results and researchers' responsibility to respect that choice. This article argues in favor of adopting a return-of-results policy that limits participants' ability to refuse clinically relevant and actionable results. We state that biobanks should allow donors only if they are aware of and agree to this return policy. If they do not agree to this, they retain the option not to participate in the biobank research. The aim of this article is to discuss the practical and ethical reasons in favor of this return-of-result policy and, thus, to underline the importance of ''honesty'' in biobanking regulations.

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Mapping the inputs, analyses, and outputs of biobank research systems to identify sources of incidental findings and individual research results for potential return to participants

Cited by 10 publications

References 7 publications

Returning a Research Participant's Genomic Results to Relatives: Perspectives from Managers of Two Distinct Research Biobanks

Returning a Research Participant's Genomic Results to Relatives: Perspectives from Managers of Two Distinct Research Biobanks

The Establishment of Research Ethics Consultation Services (RECS): An Emerging Research Resource

Returning Results: Let's Be Honest!

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