| Description |
1 online resource (1 PDF file (xxvii, 370 pages)) : illustrations. |
|
text file |
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PDF |
| Physical Medium |
polychrome |
| Series |
Consensus study report
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Consensus study report.
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| Bibliography |
Includes bibliographical references. |
| Summary |
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. |
| Funding |
This activity was supported by contracts between the National Academy of Sciences and the Centers for Medicare & Medicaid Services, the Food and Drug Administration, and the National Institutes of Health (HHSN26300117). Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project. |
| Contents |
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 |
| Local Note |
eBooks on EBSCOhost EBSCO eBook Subscription Academic Collection - North America |
| Subject |
Clinical trials -- Reporting -- United States.
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Clinical trials -- Reporting. |
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United States. |
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Clinical trials -- Research -- United States.
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Clinical trials. |
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Research. |
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Participant observation -- Moral and ethical aspects -- United States.
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Participant observation. |
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Medicine -- Research -- United States.
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Medicine -- Research. |
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Research -- Moral and ethical aspects -- United States.
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Research -- Moral and ethical aspects. |
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Human experimentation in medicine -- Law and legislation -- United States.
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Human experimentation in medicine -- Law and legislation. |
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Outcome assessment (Medical care) -- United States.
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Outcome assessment (Medical care) |
| Genre/Form |
Electronic books.
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Guideline.
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Technical reports.
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Technical reports.
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| Added Author |
Botkin, Jeffrey R., editor.
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Mancher, Michelle, editor.
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Busta, Emily R., editor.
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Downey, Autumn S., editor.
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National Academies of Sciences, Engineering, and Medicine (U.S.). Board on Health Sciences Policy, issuing body.
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| Other Form: |
Print version: National Academies of Sciences, Engineering, and Medicine (U.S.). Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories. Returning individual research results to participants. Washington, D.C. : National Academies Press, [2018] 9780309475174 (OCoLC)1048937277 |
| ISBN |
9780309475204 |
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0309475201 |
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9780309475181 |
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030947518X |
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9780309475174 |
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0309475171 |
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