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Investigator Experiences and Attitudes About Research With Biospecimens.
Suzanne M Rivera1, Aaron Goldenberg2, Beth Rosenthal2
1Case Western Reserve University, Cleveland, OH, USA Suzanne.Rivera@case.edu.
Journal of Empirical Research on Human Research Ethics : JERHRE
|November 14, 2015
Summary
Investigator experiences with biospecimen research reveal significant variability in institutional review board (IRB) approvals and informed consent processes. Findings suggest current human research protection regulations may need reassessment for biospecimen and data sharing.
Area of Science:
- Biomedical research
- Translational science
- Human biospecimen research
Background:
- Advancing human disease knowledge requires access to biospecimens and data.
- Regulatory hurdles can hinder effective biospecimen and data sharing.
- Investigator perspectives on these challenges are underexplored.
Purpose of the Study:
- To investigate scientists' experiences and attitudes regarding biospecimen and associated data research.
- To identify barriers and facilitators in biospecimen and data sharing.
Main Methods:
- An electronic survey was distributed to 114 practicing scientists.
- Participants were from 60 university medical schools with NIH-funded CTSAs.
- Data collected focused on experiences with institutional review boards (IRBs) and informed consent.
Main Results:
- High variability observed in IRB experiences for biospecimen research.
- Diverse approaches to informed consent for specimen collection were reported.
- Investigators expressed concerns about potential overestimation of risks by IRBs.
Conclusions:
- Current regulatory frameworks for human research protections may need revision.
- Standards for biospecimen and data collection, use, and sharing require reconsideration.
- Addressing investigator concerns can improve research efficiency and data sharing.
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