The GTEx project involves potentially sensitive recruitment, Institutional Review Board (IRB), and consent issues, particularly for deceased donors and their families. The collection of biospecimens from deceased individuals is not legally classified as human subjects research under 45 CFR 46; nonetheless, the depth of the genetic information obtained from deceased donor specimens has direct implications for donor patient families. In recognition of this, sites were required to obtain written or recorded verbal authorization from next-of-kin for deceased donor participation in GTEx, typically through an addendum or modification to an existing authorization form for research donation of tissues and organs. It included statements common in consent forms such as the intention to perform genetic analyses, establish cell lines, and to share data with the scientific community. Work underway is more closely identifying familial concerns and may result in a modification to authorization. Living surgery donors participate only after full, written informed consent is obtained.
