Consent for genetic research at CDC: Storage and future use of specimens

Biological specimens collected during public health investigations are often stored for future use. Now, with increased availability of low-cost technology, such use may include research involving human genetics. To preserve the potential value of sample collections for future research while protecting research participants requires careful attention to informed consent procedures. We reviewed 47 research protocols and consent forms approved by the Centers for Disease Control and Prevention (CDC) IRB. We used the CDC's Human Research Protections Office's database to identify all active protocols as of October 2009 that involved the collection of human genetic material either for direct analysis or for future storage and testing. We summarize and present specific examples of how researchers addressed the question of storage and future use of collected specimens. Twenty-six study protocols (55%) requested explicit consent for sample storage separately from consent for research participation; in 3 other studies, these consent requests were combined. Eight protocols did not include specific genetic research questions but requested consent to store participant samples for possible future genetic studies. One protocol stated that the samples would be destroyed when the study was completed. The remaining nine protocols did not state what would be done with samples after the initial study. We are working with the CDC's Public Health Ethics Committee and Office of Public Health Genomics to develop best practices for IRBs and researchers who conduct human genetic research in the public health setting, including development of recommendations on storage and future use.