Coverart for item
The Resource Returning individual research results to participants : guidance for a new research paradigm, Jeffrey R. Botkin, Michelle Mancher, Emily R. Busta, 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

Returning individual research results to participants : guidance for a new research paradigm, Jeffrey R. Botkin, Michelle Mancher, Emily R. Busta, 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

Label
Returning individual research results to participants : guidance for a new research paradigm
Title
Returning individual research results to participants
Title remainder
guidance for a new research paradigm
Statement of responsibility
Jeffrey R. Botkin, Michelle Mancher, Emily R. Busta, 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
Creator
Contributor
Author
Editor
Issuing body
Subject
Genre
Language
eng
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
Member of
Cataloging source
NLM
Dewey number
610.72/4
Funding information
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.
Illustrations
illustrations
Index
no index present
LC call number
R853.C55
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
  • technical reports
NLM call number
  • 2019 A-107
  • W 20.55.H9
http://bibfra.me/vocab/lite/organizationName
National Academies of Sciences, Engineering, and Medicine (U.S.)
http://library.link/vocab/relatedWorkOrContributorName
  • Botkin, Jeffrey R.
  • Mancher, Michelle
  • Busta, Emily R.
  • Downey, Autumn S.
  • National Academies of Sciences, Engineering, and Medicine (U.S.)
Series statement
Consensus study report
http://library.link/vocab/subjectName
  • Clinical trials
  • Clinical trials
  • Participant observation
  • Medicine
  • Research
  • Human experimentation in medicine
  • Outcome assessment (Medical care)
  • Ethics, Research
  • Human Experimentation
  • Biomedical Research
  • Disclosure
  • Patient Access to Records
  • Duty to Recontact
  • Research Subjects
  • HEALTH & FITNESS
  • HEALTH & FITNESS
  • MEDICAL
  • MEDICAL
  • MEDICAL
  • MEDICAL
  • MEDICAL
  • MEDICAL
  • Clinical trials
  • Human experimentation in medicine
  • Medicine
  • Outcome assessment (Medical care)
  • Research
  • United States
Label
Returning individual research results to participants : guidance for a new research paradigm, Jeffrey R. Botkin, Michelle Mancher, Emily R. Busta, 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
Instantiates
Publication
Bibliography note
Includes bibliographical references
Carrier category
online resource
Carrier category code
  • cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
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
Control code
1046985414
Dimensions
unknown
Extent
1 online resource (1 PDF file (xxvii, 370 pages))
Form of item
online
Isbn
9780309475181
Media category
computer
Media MARC source
rdamedia
Media type code
  • c
Other physical details
illustrations
Specific material designation
remote
System control number
(OCoLC)1046985414
Label
Returning individual research results to participants : guidance for a new research paradigm, Jeffrey R. Botkin, Michelle Mancher, Emily R. Busta, 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
Publication
Bibliography note
Includes bibliographical references
Carrier category
online resource
Carrier category code
  • cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
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
Control code
1046985414
Dimensions
unknown
Extent
1 online resource (1 PDF file (xxvii, 370 pages))
Form of item
online
Isbn
9780309475181
Media category
computer
Media MARC source
rdamedia
Media type code
  • c
Other physical details
illustrations
Specific material designation
remote
System control number
(OCoLC)1046985414

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