Data Governance Document
Rationale for institutional biorepository:
The research response to the COVID-19 outbreak has been overwhelming. Many investigators would like to collect biospecimens on COVID-19 patients in order to better understand and treat the disease. The research around this disease is a new frontier as investigators from multiple disciplines are interested in studying the same patients, and biological specimens from these patients pose significant issues in collection and processing. At the instruction of leadership in UPMC, a unified biospecimen repository to allow collection of blood and other samples in patients hospitalized with COVID-19 or under investigation for COVID-19 has been constructed. The goal of the repository is to allow broad access to patient samples and data to as many investigators as possible. This effort is meant to be inclusive of the research community while balancing safety and feasibility.
Overview of biorepository:
- Blood samples will be obtained from individuals with COVID-19 or who are PUIs at admission, day 5, and day 10 of hospitalization if they remain in-house. These time frames are approximate.
- Specimens for plasma, serum, DNA, and PBMCs will be obtained and aliquoted.
- Excess blood and other samples from clinical testing will be obtained.
- Urine and stool samples will be collected.
- If investigators want different samples or timing of samples, we will work with those investigators to accommodate their requests. Depending on the nature of the request, the investigator may be asked to provide supplies or assistance for collection.
Expectations of investigators:
- Participating investigators (PIs) will provide a summary of their proposal including rationale, type and volumes of sample needed (with range of minimum to ideal), funding, and certification by EH and S to receive the sample type. Number of patients, types of patients, and timing of samples must also be provided.
- PIs are encouraged to collaborate with others with similar interests to maximize use of resources and avoid duplication of assays.
- PIs will have access to all data generated from samples such as cytokine panels, genome sequencing, flow cytometry, etc. PIs will be required to state specific intentions for use of these data in order to avoid scientific overlap between investigators.
- Investigators will have access to data generated from samples that is of general interest. For example, genomics or inflammation studies will be made available to University investigators. Similarly, PIs will be expected to share data generated if requested by other investigators. A database of available studies will be maintained. Data sharing will be accomplished under a data use agreement and the oversight of the PI and the biorepository committee in order to ensure that the PI’s research is not compromised, while allowing for maximum efficiency from sample utilization.
- A comprehensive de-identified database from the electronic medical record is being developed to support investigators. The oversight committee will assist investigators seeking identifiable data.
- All COVID-related research activities involving biosamples will be covered under a global IRB and consent document. Interventional studies will require a separate IRB.
- Samples and data may not be used for non-COVID related research.
- Identified data or samples may not be shared with other investigators not on the PIs project.
- All approved proposals will send a yearly progress report as well as an end of project report. This will be a brief document detailing key scientific findings and publications.
- The PI must acknowledge the biorepository in grants and papers. Please contact the committee for appropriate language.
- The Data and Sample Oversight committee is comprised of representatives from Medicine, Critical Care Medicine, Neurology, Emergency Medicine, the CTSI, and Surgery.
- The DSOC will review applications from internal investigators for use of samples, data, and the associated EMR linking data. Any decision on the release of samples and/or data will need approval of a 2/3 majority of the DSOC. In the event of a disagreement, Steve Shapiro, MD and the Dean of the School of Medicine will be consulted.
- The DSOC committee will meet every two weeks and as necessary to review applications.
Destruction of samples:
- Samples and data will be destroyed per research participant request and consistent with all registry consent guidelines.
- If a PI decides to stop research on repository samples, remaining samples must be returned to the repository.
- If a PI leaves the university, all samples and data must be returned to the repository.