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Human subject protections in genetic research.
1Pritzker School of Medicine, University of Chicago, Chicago, IL 60637.
Genetic Testing
|September 4, 2004
Summary
Researchers often overlook Certificates of Confidentiality (COC), a voluntary tool for protecting human subject data. This study found no documented COC use in genetics literature, despite their proven utility in protecting sensitive research information.
Area of Science:
- Human Subject Protection
- Genetics Research Ethics
- Research Compliance
Background:
- Certificates of Confidentiality (COC) are voluntary tools protecting identifiable subject information.
- Institutional Review Board (IRB) review and informed consent (IC) are mandatory human subject protections.
- Limited data exists on the procurement and documentation of COCs in research.
Purpose of the Study:
- To examine the procurement and documentation of human subject protections, including COCs, in the genetics literature.
- To assess researcher awareness and utilization of COCs.
Main Methods:
- Systematic review of genetics research articles for documentation of IRB review, IC, and COC.
- Survey of researchers to gather additional data on human subject protection procurement.
Main Results:
- Only 41% of articles documented both IRB review and IC.
- No articles documented the procurement of a Certificate of Confidentiality (COC).
- Surveys indicated at least 10% of research had obtained a COC, with others obtaining them for different studies or unaware of their purpose.
Conclusions:
- There is a need for greater familiarity with and documentation of Certificates of Confidentiality (COC) in human subject research.
- Enhanced awareness and consistent documentation of all human subject protections are recommended.
- Addressing gaps in COC utilization can strengthen research integrity and public trust.