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Informed consent for re-use of stored specimens and data in intramural NIH clinical research

Thursday, November 07, 2013 — Poster Session II

12:00 p.m. – 2:00 p.m.

FAES Academic Center (Upper-Level Terrace)




  • X. Pan
  • V. Huser
  • E.J. Ayres
  • J.J. Cimino


Clinical research increasingly relies on clinical data repositories and biobanks to answer research questions. We sought to study how the topic of re-use of stored specimens and data is addressed in consent forms associated with intramural NIH clinical research. We selected protocols from the NIH Biomedical Translational Information System which began in 2006 or later and had enrolled at least 20 subjects in the previous 6 months. We examined their consent forms to identify elements that addressed specimens or data storage, information sharing, and future use. Of the 600 active protocols, 37 met our inclusion criteria. We identified two consent methods, default and categorical, for future research use of specimens or data. The method choice was strongly associated with factors, including disease studied, type of research, and benefits of research. Given the imperative for increased data sharing and changing regulation related to patient privacy, obtaining clear, informed consent from research subjects has never been more important. Consideration needs to be made as to whether subjects must allow full reuse of their data and specimens, or can express a variety of preferences. A mechanism for communicating subject preferences must accompany any data or specimens transferred to repositories or biobanks.

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