Memorandum - MVP COVID-19 Survey - Request for Emergency PRA Clearance

Department of
Veterans Affairs

Memorandum

Date:

October 30, 2020

From:

Mary M Klote, M.D., Director of Research Protections, Policy and Education

Subj:

Request for OMB review and consideration of emergency clearance for “Million
Veteran Program (MVP) COVID-19 Response Survey”

To:

Paul J. Ray
Administrator, Office of Information and Regulatory Affairs (OIRA)

Cc:

VA Desk Officer, James Crowe
Office of Management and Budget (OMB)
The Million Veteran Program in a national, voluntary, medical research program. MVP
establishes an ongoing partnership with Veteran participants who give their informed
consent to authorize access to electronic health record data, provide biospecimens for
further analysis, and/or provide self-reported data through methods such as personal
logs and surveys.
In response to the COVID-19 pandemic, all MVP participants are invited to complete the
MVP COVID-19 survey. The survey collects demographics, COVID-19 symptoms and
treatment, comorbidity, healthcare utilization, well-being, and psychosocial outcomes.
Survey data analyzed in conjunction with biospecimens will assist with identification of
potential biomarkers and also allow researchers to analyze the incidence and outcomes
of COVID-19 using genomic data.
The VA Office of Research and Development has funded this research study based on
its originality in addressing the health care needs of veterans. This decision was based
upon coordination with the ORD COVID-19 Steering Committee review and the program
manager’s examination of other research supported by VA and other organizations. The
survey is not duplicative of any other survey with this population.
Emergency clearance is requested in order to timely gather data related to the COVID19 pandemic and provide valuable data on COVID-19 outcomes using genomic data.
OMB PRA approval is respectfully requested by November 10, 2020.
Questions may be addressed to Lori Churby via phone at (650) 814-8552 or via email at
[email protected]
Thank you for your consideration of this matter.

signed by
Mary Klote Digitally
Mary Klote 1714085
Date: 2020.10.30
1714085
15:13:51 -04'00'
____________________________________

Mary M Klote, M.D.
SES Equivalent, Title 38
Director, Office of Research Protections
Office of Research and Development