Evidence map›Paper›PMID 25953109›Full record

ArticleBMC medical ethics2015

IRB practices and policies regarding the secondary research use of biospecimens.

Aaron J Goldenberg, Karen J Maschke, Steven Joffe, Jeffrey R Botkin, Erin Rothwell, Thomas H Murray, Rebecca Anderson, Nicole Deming, Beth F Rosenthal, Suzanne M Rivera

Abstract read
In one paragraph

Article in BMC medical ethics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

  1. Article
  2. Review
  3. Establishing a Pregnancy Lyme Disease Biobank.Methods in molecular biology (Clifton, N.J.) · 2024
    Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Review
  13. Article
  14. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Aaron J GoldenbergDepartment of Bioethics, TA212 School of Medicine, Case Western Reserve University, 10900 Euclid Ave., Cleveland, OH, 44106, USA. aaron.goldenberg@case.edu.
Karen J MaschkeThe Hastings Center and the Centre for Biomedical Ethics, Garrison, New York, USA. maschkek@thehastingscenter.org.
Steven JoffeDepartment of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA. Joffes@upen.edu.
Jeffrey R BotkinDepartment of Pediatrics, University of Utah, Salt Lake City, Utah, USA. jeffrey.botkin@hsc.utah.edu.
Erin RothwellDepartment of Pediatrics, University of Utah, Salt Lake City, Utah, USA. Erin.Rothwell@nurs.utah.edu.
Thomas H MurrayThe Hastings Center and the Centre for Biomedical Ethics, Garrison, New York, USA. thmurray46@gmail.com.
Rebecca AndersonDepartment of Pediatrics, University of Utah, Salt Lake City, Utah, USA. Rebecca.Anderson@hsc.utah.edu.
Nicole DemingDepartment of Bioethics, TA212 School of Medicine, Case Western Reserve University, 10900 Euclid Ave., Cleveland, OH, 44106, USA. nmd11@case.edu.
Beth F RosenthalDepartment of Bioethics, TA212 School of Medicine, Case Western Reserve University, 10900 Euclid Ave., Cleveland, OH, 44106, USA. bsf3@case.edu.
Suzanne M RiveraDepartment of Bioethics, TA212 School of Medicine, Case Western Reserve University, 10900 Euclid Ave., Cleveland, OH, 44106, USA. smr140@case.edu.

Funding

ADVANCING COLLABORATIVE GENETIC RESEARCH: ETHICAL AND POLICY CHALLENGESR01HG005691 · NHGRI · CASE WESTERN RESERVE UNIVERSITY · PI RIVERA, SUZANNE · 2011 to 2013
$1.7M
NHGRI NIH HHS 5R01HG005691-03NHGRI NIH HHS R01 HG005691
6 · The paper itself

Abstract

backgroundAs sharing and secondary research use of biospecimens increases, IRBs and researchers face the challenge of protecting and respecting donors without comprehensive regulations addressing the human subject protection issues posed by biobanking. Variation in IRB biobanking policies about these issues has not been well documented.

methodsThis paper reports on data from a survey of IRB Administrative Directors from 60 institutions affiliated with the Clinical and Translation Science Awards (CTSAs) about their policies and practices regarding secondary use and sharing of biospecimens. Specifically, IRB ADs were asked about consent for future use of biospecimens, assignment of risk for studies using biobanked specimens, and sharing of biospecimens/data.

resultsOur data indicate that IRBs take varying approaches to protocol review, risk assessment, and data sharing, especially when specimens are not anonymized.

conclusionUnclear or divergent policies regarding biospecimen research among IRBs may constitute a barrier to advancing genetic studies and to inter-institutional collaboration, given different institutional requirements for human subjects protections.

Indexed as

Ethics Committees, ResearchPolicyTissue DonorsBiological Specimen BanksBiomedical ResearchConfidentialityCooperative BehaviorHumansInformation DisseminationInformed ConsentResearch PersonnelSurveys and Questionnaires

Identifiers

PMID25953109
PMCPMC4426182

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.