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Research Participant COVID-19 Risk Information Documents

For Tier 1 and Tier 2 research studies that are approved to continue in-person research activities and Tier 1 studies that are approved for new enrollment, researchers must provide each participant being seen with a COVID-19 Risk Information Sheet as follows:

  1. Research teams must attempt to contact each participant before their scheduled research visit to provide this information about COVID-19 risks.
  2. When participants arrive for a research-related visit, the study team must confirm that the participant has received this information. If not, then this information must be provided at that time.

For all research studies that will pause in-person activities, investigators must incorporate the COVID-19 Study Pause Guidelines into their communication with research participants.