Human subject protections in genetic research.
The Certificate of Confidentiality (COC) is a voluntary tool to protect researchers from being compelled to release identifying information about their subjects. Institutional review board (IRB) review and informed consent (IC) procedures are mandatory tools to protect human subjects. Although many studies reveal poor documentation of IRB and IC procurement, most published research undergoes IRB review and has appropriate IC procedures. There are no empirical data about the use of COCs. We examined the procurement and documentation of all these human subject protections in the genetics literature. A total of 112 (55%) articles documented IRB review, 108 (53%) document IC, and 82 (41%) documented both. None documented the procurement of a COC. Returned surveys provided additional information that confirmed that at least 74% (n = 150) of research had received appropriate IRB review, at least 71% (n = 143) had procured IC, and at least 10% (n = 21) had obtained a COC. An additional 22 respondents had procured COCs for other research, whereas 17 respondents were unaware of them and their purpose. In this era of public scrutiny of medical research, we recommend greater familiarity with and documentation of all human subject protections.
PubMed Abstracts
PubMed Abstracts