The Data Office for Clinical and Translational Research (Data Office) is committed to continuing to facilitate your research despite the challenging climate.
Here is what the Data Office can help with:
- Feasibility: DataDirect starting population of COVID-19 positive patients.
- Data Access: Self-serve (DataDirect) or custom data extract with appropriate IRB approval.
- Consultations: E-Mail the Data Office for an in-depth consultation here.
- Biospecimens: Search DataDirect for available serum and plasma on COVID-19-positive patients.
With the self-serve tool, DataDirect (DD), researchers can answer these questions:
COVID-19 Research and the Data Sharing Policy
Does your COVID-19-related study fall in scope of the University of Michigan Medical School Policy Governing Human Data and Biospecimen Transfers to Industry or Non-Academic and Non-Governmental Entities?
NOT IN SCOPE if the study involves:
- Transfer of patient level data and/or biospecimens to governmental agencies, other academic medical centers or universities
- Transfer of aggregate counts or summary level data to commercial entities
- Sharing of data for purposes of patient care
- Transfer of data for purposes of clinical trial* site activity.
*to be considered a clinical trial, the study must meet the NIH definition of a clinical trial
IN SCOPE and requires review by the Medical School Human Data and Biospecimen Release Committee if the study involves the transfer of patient level data (including de-identified) and/or biospecimens to a for profit or commercial entity, non-academic foundation, or professional society.
How to have the study reviewed:
- Complete the checklist form, and:
- It isn’t necessary to have IRB approval before having your study reviewed by the Data Release Committee.
- You may not be able to complete all sections of the checklist if in early stages of study planning. Provide as much detail as you can, including a detailed description of the project in the Transfer Overview section, a clear description of the data to be sent (is it coded? limited data set?), and the draft budget.
- The Data Office will facilitate review. Contact Sheryl Flanagan or Erin Kaleba by sending the checklist to OoR-DataRelease-All@med.umich.edu.
- Questions? Call 734-764-9318 and leave a voice message or send an email to OoR-DataRelease-All@med.umich.edu
What will an approval include?
- Patient Consent Required - The main goal of the policy is to ensure that data and biospecimens shared with industry are collected under transparent informed consent. The Committee will provide instruction on what must be included in the patient consent.
- Agreement Terms - specific contract terms to be included in the final agreement. These can be found in the policy. You can view the policy here. You must login.
- Budget – Committee will review the proposed budget to ensure cost recovery is satisfied
- Medical School fees – a one- time $5,000 Medical School transfer fee applies to all projects in scope of the policy.
- Requirement to disclose COI - if the PI has a COI with the sponsor, it must be disclosed and an appropriate management plan prepared.
Available Data for Access
In anticipation of COVID-19 data need for research, the Data Office built COVID-19 Research Cohorts to serve as a starting point for COVID-19-related custom data requests. It is updated daily and intended to be used for retrospective studies. Currently, it has the following cohorts and data (and we can pull additional data elements based on your custom request):
Stay up-to-date on the latest COVID-19 research and updates from the Office of Research here.
Contact us for more information or questions.