Returning individual research results to participants : guidance for a new research paradigm / Jeffrey R. Botkin, Michelle Mancher, Emily R. Busta, and Autumn S. Downey, editors ; Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories ; Board on Health Sciences Policy, Health and Medicine Division.
By: National Academies of Sciences, Engineering, and Medicine (U.S.). Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories [author.].
Contributor(s): Botkin, Jeffrey R [editor.] | Mancher, Michelle [editor.] | Busta, Emily R [editor.] | Downey, Autumn S [editor.] | National Academies of Sciences, Engineering, and Medicine (U.S.). Board on Health Sciences Policy [issuing body.] | National Academies of Sciences, Engineering, and Medicine (U.S.). Health and Medicine Division [issuing body.].
Series: Consensus study report: Publisher: Washington, DC : The National Academies Press, ©2018Description: 370 pages ; illustrations (some color) ; 23 cm.Content type: text Media type: unmediated Carrier type: volumeISBN: 9780309475174.Subject(s): Clinical trials -- Reporting -- United States | Clinical trials -- Research -- United States | Participant observation -- Moral and ethical aspects -- United States | Medicine -- Research -- United States | Research -- Moral and ethical aspects -- United States | Human experimentation in medicine -- Law and legislation -- United States | Outcome assessment (Medical care) -- United States | Clinical Trials as Topic | United StatesGenre/Form: Print books.| Current location | Call number | Status | Date due | Barcode | Item holds |
|---|---|---|---|---|---|
| On Shelf | R853 .C55 N38 2018 (Browse shelf) | Available | AU00000000014286 |
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| R853.C55 M37 2018 The sourcebook for clinical research : a practical guide for study conduct / | R853.C55 M45 2012 Clinical trials : design, conduct, and analysis / | R853.C55 M48 2015 Field trials of health interventions : a toolbox. | R853 .C55 N38 2018 Returning individual research results to participants : guidance for a new research paradigm / | R853.C55 O94 2016 Oxford handbook of clinical and healthcare research / | R853.C55 P484 2017 A practical guide to managing clinical trials / | R853.C55 P67 2020 Foundations of clinical research : applications to evidence-based practice / |
Includes bibliographical references.
Summary -- Introduction -- Principles for the return of individual research results : ethical and societal considerations -- Laboratory quality systems for research testing of human biospecimens -- Processes to enable appropriate decision making -- Regarding the return of individual research results -- Advancing practices for returning individual research results -- Reshaping the legal and regulatory landscape to support return of individual research results -- Appendices. Study approach and methods -- Public agendas -- Analysis of legal and regulatory landscape relevant to return of individual results generated from biospecimens in research -- The return of individual-specific research results from laboratories : perspectives and ethical underpinnings -- Biographical sketches of committee members, consultants, and staff
"There is a long-standing tension in biomedical research arising from a conflict in core values--the desire to respect the interests and desires of research participants by communicating results contrasted with the responsibility to protect participants from uncertain, perhaps poorly validated information. Traditionally, the balance has been tipped toward the latter resulting in what has been termed "helicopter research." The notion here is that investigators drop into communities or people's lives, engage with them in often very personal ways, and then take off, never to be heard from again. Yet people are curious about themselves, particularly about their health and their family's health, leaving a sense of frustration and loss when investigators take but do not share"--
"When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research results--such as results with unknown validity--and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholders--investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participants--and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations"--