About CYFAR Common Measures and Human Subjects Protection
Where can I get more information about sections of my CYFAR grant application addressing whether my research is considered research on human subjects?
Does the University of Minnesota’s Institutional Review Board (IRB) provide overall Human Subjects approval for all participating CYFAR SCP grantees to collect Common Measures data?
No, the University of Minnesota’s IRB will not provide overall Human Subjects approval for the Common Measures data collection process.
According to the University of Minnesota’s IRB, and in compliance with the United States Department of Health and Human Services, Office for Human Research Protections (OHRP), the CYFAR Common Measures data collection process does not constitute human subjects research because:
- CYFAR Common Measures data will be collected as part of routine program evaluation and is not part of a specific intervention (program or activity) proposed by the University of Minnesota;
- CYFAR Common Measures data will be de-identified (stripped of personal information and coded with a unique identifier provided by the site) before it is submitted by CYFAR SCP grantees to the University of Minnesota; therefore, the University of Minnesota will not be able to trace data back to specific individuals and will not be able to identify individual persons based on their data
Does my CYFAR program need to obtain Human Subjects approval from my own university's Institutional Review Board in order to collect CYFAR Common Measures data?
Each university's Institutional Review Board mandates different requirements and may have varying interpretations of the federal guidance related to Human Subjects protection requirements. It is always advisable to consult your university's Human Subjects Protection Program for university -specific requirements.
Do all CYFAR SCP grantees need to collect CYFAR Common Measures data?
Yes, all CYFAR SCP grantees are required to collect CYFAR Common Measure data from participants and staff. The CYFAR PDTA Center provides copies of the Common Measures to all grantees, and can give grantees access to a copy of the measures in Qualtrics if desired. In addition, the PDTA Center provides tracking sheets to all grantees to facilitate complete data collection.
Can I collect any other data from participants in my CYFAR program?
Yes, and in fact we encourage grantees to consider additional data sources that they may include in their logic model to measure progress towards program goals. As with Common Measures data collection, it is the grantee's responsibility to ensure compliance with their institution's Human Subjects Protection Program for any additional data collection.
Where will my CYFAR program send the CYFAR Common Measures data?
Once grantees collect their CYFAR Common Measures data, the data should be uploaded/submitted using the CYFAR Suite website that is currently housed at the University of Minnesota. The University of Minnesota staff will store the data in a private database housed on a secure server. Aggregate-level analysis of data across all CYFAR programs nationally will be performed by CYFAR PDTA Center staff at the University of Minnesota.
Does my CYFAR program still need to complete site-level data analysis or will all of the data be analyzed by the University of Minnesota?
Each CYFAR program will still be required to run their own site-level data analysis (in conjunction with their program evaluator) and submit their data findings using the approved CYFAR reporting system (e.g., REEport).
I have additional questions not answered here. Who can I contact to receive more support?
The CYFAR PDTA Center is available to support potential applicants and grantees who need more information. You can contact us at email@example.com.