After a project has been approved, the following procedures and policies will be followed.
Approval Provisions
Project approval is provisional, conditional on the receipt of funding, the logistics of sample retrieval, and the use of samples by other approved ancillary studies. If there are other studies that have approval for the use of these samples, HRS will ensure everyone has the maximum number of samples possible. HRS may revoke approval to use biosamples if the project implementation is not conducted as described in the original application.
All approvals are time-limited. Approvals will be valid for a period of two years from the date of issuance of a HRS Letter of Support. Samples will be encumbered during that two-year period. Investigators requiring additional use of HRS Biospecimens will be required to resubmit an application.
Required Documents
The following documents must be submitted before the release and use of any biospecimens:
- The HRS Data and Material Use Agreement
- Proof of IRB approval for the proposed study
- Proof of research ethics training by all research team members
Specimen Selection
HRS will work with study investigators to select the sample according to the approved study protocol. Any post hoc changes to approved ancillary study selection criteria, sample size, or protocol must be formally proposed and approved by the HRS PI. Formal review and approval of such requests must precede sample selection.
Specimen Distribution Policies
- The cost to remove samples from the freezers and any preparation required for analysis (e.g. normalization or plating) will be paid for by the applicant. The cost to ship the aliquots to an external lab, if necessary, will be paid for by the applicant.
- If projects use partial aliquots, the project may be held until sufficient applications are approved to thaw whole aliquots for division and dissemination. Project timelines are at the discretion of the HRS.
- Aliquots ready for distribution will either be assayed at the University of Minnesota’s Advanced Diagnostic Research Laboratory (ARDL) or shipped to external labs for assaying, if necessary.
- Any remaining specimens or portion of, must be returned to HRS. External labs cannot store specimen remainders for future use.
Quality Control
Conditional on their availability, HRS may randomly interleave quality control biospecimens up to 5% of the selected participant biospecimens into the selected sample. The quality control biospecimens may include pairs of masked duplicates. For example, in a study of biospecimens from n=2000 participants, HRS will randomly interleave an additional n=100 quality control biospecimens (potentially 2 masked duplicates from each of n=50 samples). Any proposed reduction in the number of quality control biospecimens designated above must be justified in detail at the time of proposal.
HRS will use masked ancillary study IDs before shipping samples to laboratories for assay. HRS will control the crosswalk of ancillary study IDs and HRS study IDs. HRS will not identify participant assay results to ancillary study investigators until HRS receives the results and associated documentation of laboratory quality control.
Data Sharing Policy
Researchers must provide the HRS team with all data derived from HRS biosamples. HRS will then make these data publicly available.
Researchers must follow the data sharing practices outlined in the HRS Data and Materials Use Agreement. Researchers must also agree that HRS is the only party able to distribute the data derived from HRS biosamples. Data cannot be provided to any group outside of the HRS team and the study investigative team.
Results from the Use of HRS Biospecimens
HRS shall not release ancillary data resulting from the use of HRS biospecimens to the scientific community of HRS users for a period of six months beginning upon release of the final data file to the Ancillary Study PI. During this six-month period, the Study PI may create and submit manuscripts, abstracts, or presentations regarding the Study, with appropriate attribution to HRS, as specified in the HRS Data and Material Use Agreement. HRS retains the right to adjust this policy in exceptional circumstances.
Annual Progress Report
The PI is responsible for submitting annual progress reports on the status of the study to HRS until HRS has released final ancillary data. These progress reports must summarize the study’s activities, including:
- Assays and analyses in progress or completed
- Updated timeline for completion
To facilitate annual reporting, annual report forms will be sent by the HRS staff to Ancillary Study investigators on June 1 of every year in the study period. These forms must be completed and returned to HRS no later than July 1 of the same year. Ancillary studies that fail to comply with the annual reporting requirement may have their agreement terminated.
External Notification of Approved Projects
HRS will publicly list approved requesters and related project information on the HRS website.