Some clinical studies involve in-person study visits in order to conduct safety monitoring of the participants. For example, participants in a drug treatment study may need to have regular examinations, interviews, or laboratory tests for specific possible side effects.
Researchers should plan for alternatives to in-person monitoring visits, if possible. If appropriate for the study, this might include:
- Delay, postpone, or modify the visits
- Phone or email check-in calls
- Photos taken and delivered by cell phone (e.g., of wound healing)
- Visits to participants’ for exams or specimen collection
- Use (or establishment) of a mobile specimen collection service
These modifications to safety monitoring procedures should be approved in advance by the IRB, except when necessary to eliminate apparent hazards to a participant and there is not sufficient time to obtain IRB approval. Consult with your HSD team or email@example.com if you have questions. If you do need to change an approved monitoring procedure to eliminate immediate possible danger, please report it to the UW IRB within 10 days, following the Reports of New Information (RNI) procedures described at this HSD website. Contact firstname.lastname@example.org if you have questions or your study’s IRB application is paper-based (i.e., not in Zipline).