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COVID-19 Guidance for Human Subject Research - Updated 05/29/20

As concerns about COVID-19 (“Coronavirus Disease 2019”) continue to spread, the Texas State Institutional Review Board (IRB) is reminding researchers that the protection of human participants is paramount. The amount of additional risk to participants differs across research projects and all IRB protocols will continue to be reviewed on an individual basis. Currently the IRB is only approving research projects classified as Level 0 that do not involve in person contact without additional requirements. The IRB has the following guidelines to assist researchers on minimizing participant risks that should be addressed in the Kuali system if protocols involve in person contact. It is also the expectation that all researchers follow current federal and state guidelines. (CDC guidelines, Texas Department of State Health Services, Texas State Student Health Center)

 

Please review the following:

  • Refer to the COVID-19 Research Protocol Risk Reduction Checklist, which IRB members will use to guide their review and decisions for recommendations. The “Checklist” will be updated as knowledge and national recommendations change over time.
  • Allow participants to reschedule or cancel if they feel sick or have any symptoms consistent with COVID-19 if your research involves in person interaction. Research conducted remotely (i.e. Zoom) should continue as approved in your IRB application. If you need to add remote data collection procedures to minimize risks, please submit an amendment to the IRB through Kuali.
  • Perform a risk assessment/prescreen of participants prior to visits. Example of questions can be:
  1. Have you traveled within the last 14 days to a location designated by the CDC to be an at-risk area for novel Coronavirus, COVID-19?
  2. Have you or members of your household been diagnosed with COVID-19 or asked to self-quarantine due to potential exposure to the novel Coronavirus, COVID-19?
  • Make alcohol-based hand sanitizer available to research staff and participants.
  • Consider harms to research participants who are at higher risk (older adults, people with chronic, serious medical conditions) and take action to minimize their risks. Amendments can be submitted at any time to the IRB through Kuali if protocol changes are required to minimize risks.
  • Review CDC guidance for Where You Live, Work, Learn, Pray, and Play
  • Communicate with faculty advisors, funders, sponsors, and research team members about altered timelines.
  • Contact the IRB if you are concerned whether your particular project may be associated with additional risks. For example, research projects with the following characteristics: (a) research occurring in locations with confirmed cases of COVID; (b) participants over the age of 60 years; (c) participants with compromised immunity: (d) and research involving larger gatherings of people.
  • If a funded project refer to the Office of Research and Sponsored Programs website for latest information about the COVID-19 updates that may impact your research.
  • If NIH funded clinical trial refer to the NIH Grants and Funding website for Information on NIH applicants and recipients of NIH funding.
  • Refer to The Student Health Center COVID- 19 webpage for recommendations and announcements for the Texas State community.
  • Refer to the Texas State University System Travel Policy if traveling for research.