Resuming In-Person Human Subjects Research with IRB Approval
Plans to resume or initiate in-person human research activities on previously approved projects must be submitted as an amendment for IRB review and approval before such activities may begin.
Prior to seeking approval to initiate or resume in-person activities, efforts should be made to modify existing procedures to incorporate remote interactions to the greatest extent feasible. Such modifications include, but are not limited to:
- The use of questionnaires, interviews or surveys delivered online, by telephone or Zoom rather than in-person.
- Emailing or mailing to participants screening, consent documents, and other study material.
- Consider requesting a waiver of documentation of signed consent (i.e. consent is obtained orally or by means other than a formal signed document).
- Changes to methods of payment to subjects.
Before bringing study subjects to campus, the Principal Investigator must submit an amendment that includes a plan that addresses how safety measures will be implemented. At minimum, the plan should include:
- A screening process to determine the COVID-19 risk status of volunteers and staff (e.g. questionnaire regarding health status, recent travels, body temperature etc.) CDC Symptoms of Coronavirus
- Procedures for:
- maintaining social distancing requirements,
- PPE, including what is required and how it will be obtained,
- proper cleaning of materials, equipment, and commonly touched areas where the activities will take place.
- Plan for scheduling visits to avoid overlap in appointments
- If included in the subject population, plans for handling visits by participants in high-risk categories (older adults and anyone with serious underlying medical conditions). Refer to CDC guidance for a full list.
For IRB-approved off-campus research that only can be conducted in-person, the revised research plan should follow the requirements of the location in which the research will be conducted, but must not be less than those recommended above. Off-campus research also may be subject to additional USC restrictions and/or requirements (e.g. travel).
Any changes to current research projects that are made without prior IRB approval must be reported to the IRB as a Protocol Deviation using the Reportable Event mechanism in eIRB.