There were no anticipated problems with Material Transfer Agreements (MTAs) and consent forms; all were either approved or under review.
A GTEx brochure and a general GTEx website (genome.gov/gtex) are being developed at NHGRI. The purpose is to educate the public about donating tissues and organs for research.
Donor Inclusion/Exclusion criteria were discussed and tentative decisions were made (e.g., age 21-70). Inclusion/exclusion criteria can be modified over time as experience is gained, being driven by the subsequent lab and informational quality of the data.
The use of the standard major medical rule-out criteria used for clinical transplant donors was discussed and approved with some exception.
Body Mass Index (BMI) inclusion criteria (18.5 – 35) were set.
Sampling of brain was discussed and criteria still need to be set.
The Case Report Form (CRF) was discussed and the group decided to capture all the data collected on each BSS’s existing CRF and harmonize it to the degree possible.
Draft SOPs for Tissues processing were distributed and comments received. Revisions to SOP are to be released in late January.
Tissue collection and shipping kits were available for viewing and hands-on practice.
caTissue was chosen as the biospecimen inventory management, tracking, and annotation tool. It permits users to enter and retrieve data concerning the collection, storage, quality assurance, and distribution of biospecimens.
caTissue forms may be customized according to user. A permanent and secure caTissue interface was targeted for set up within 3-4 months.
GTEx timeline were presented and discussed. Enrollment of 10 donors by March 15 was set as an aggressive target, but one that needed to be reached in order to start active enrollment within 7 months of awarding of contracts.