The Challenge of Informed Consent and Return of Results in Translational Genomics: Empirical Analysis and Recommendations

Henderson, Gail E.; Wolf, Susan M.; Kuczynski, Kristine J.; Joffe, Steven; Sharp, Richard R.; Parsons, D. Williams; Knoppers, Bartha Maria; Yu, Joon Ho; Appelbaum, Paul S.

doi:10.1111/jlme.12151

Cited by 65 publications

(63 citation statements)

References 23 publications

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“…According to other research, this lack of clarity is not uncommon even in more recently written ICDs. 30 Thus, even when the ICD leaves open the option for returning individual genetic results, investigators may feel conflicted about returning a result that was unrelated to the original study described in the ICD, and therefore not anticipated by the participant.…”

Section: Discussionmentioning

confidence: 99%

Return of individual genomic research results: what do consent forms tell participants?

2016

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Advances in genomic technology make possible the large-scale collection of genomic data for research purposes. Many international initiatives seek to collect genomic data on large populations, often relying on existing collections to populate their databases. As these efforts progress, the debate over whether or not to return individual genetic research results to study participants remains an area of much contention. Some recommend returning results to participants only if the issue was addressed in the original study consent form. Much of the data being used in current studies, however, may have been derived from biospecimens collected years ago with consent documents that did not anticipate the possibility of returning individual level genomic results. We conducted an analysis of informed consent documents from published genome-wide association studies (GWAS) (n = 40) to explore whether future research use of biospecimens or data is anticipated, and if return of results is addressed and how it is described to better understand participants' expectations for future disclosure. The majority (70%) of the GWAS consent documents we analyzed either stated explicitly that individual genomic results would not be returned or were silent on the issue. This has implications for how researchers and members of Research Ethics Committees manage the return of results from sequencing studies using legacy samples and data.

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Section: Discussionmentioning

confidence: 99%

Return of individual genomic research results: what do consent forms tell participants?

2016

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“…This shall result in the patient consenting to the testing process as well as to the consequences the data might induce [100,101]. The patient will likely have the current disease condition in focus and take for granted that potential risks that she/he should consent to are directly connected to related findings and their immediate consequences for her-or himself.…”

Section: An Informed Consent?mentioning

confidence: 99%

Findings made in gene panel to whole genome sequencing: data, knowledge, ethics – and consequences?

Winkler

Wiemann

2016

Expert Review of Molecular Diagnostics

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“…Additional categories were derived from the federal requirements for consent form content (e.g., study purpose, risks of participation); others were derived from two prior consent form analysis projects on ''benefit'' in gene transfer research consent forms 12 and the return of research results following whole genome/exome sequencing. 13 After a detailed, preliminary list of categories was created, each consent form was reviewed and coded. Categories were reduced by grouping into broader themes.…”

Section: Creating Coding Categoriesmentioning

confidence: 99%

The Ethics of HIV “Cure” Research: What Can We Learn from Consent Forms?

Henderson

2015

AIDS Research and Human Retroviruses

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The advent of HIV ''cure'' research has generated enormous attention, but also concern about its potential to engender false hope, leading to overestimation of benefits and underestimation of risks, and about recruiting relatively healthy participants to studies with uncertain or serious risks. Currently, little is known about potential ethical problems in the ways that informed consent for HIV cure research is described to potential participants. As a first step to address this question, early phase, HIV ''cure'' research consent forms were analyzed to assess how study aims and potential risks and benefits are presented. Thirteen consent forms from a diverse group of clinical studies were selected to represent the major categories of cure research, including 11 interventional (gene transfer, vaccine intensification, treatment interruption, and latency reversing) and two observational. Consent forms were coded using seven categories, abstracting data on study purpose and design, participant selection criteria, presentation of risks and benefits of participation, and potential return of research results. Findings demonstrate variation and deficiencies that merit attention, but that can largely be addressed by turning to existing guidance about early phase research and specific study designs from other research contexts. The most challenging of these is ensuring that clear, specific, and consistent language is used to describe study aims, risks, benefits, and possible return of results. Informed consent for HIV ''cure'' research represents an opportunity to apply relevant existing guidance, measure the effectiveness of its application, and develop standardized best-practice policies for consent forms and processes.

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The Challenge of Informed Consent and Return of Results in Translational Genomics: Empirical Analysis and Recommendations

Cited by 65 publications

References 23 publications

Return of individual genomic research results: what do consent forms tell participants?

Return of individual genomic research results: what do consent forms tell participants?

Findings made in gene panel to whole genome sequencing: data, knowledge, ethics – and consequences?

The Ethics of HIV “Cure” Research: What Can We Learn from Consent Forms?

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