Human Subjects Research During COVID-19 Reopening
The purpose of this guidance is to describe how researchers may request to proceed with in-person human subjects research during the COVID-19 University reopening. We must ensure that appropriate safety precautions are in place before commencing with in-person human subjects research. Safety precautions related to COVID-19 are distinct from the ethical review of human subjects research performed by the IRB. Permission to proceed with IRB submission (Step 1) must be completed in addition to IRB approval (Step 2) for your human subjects research study.
It is important to remember that human subjects are volunteers, and you may not always be aware of those in higher-risk groups. The IRB will continue to consider the risk:benefit ratio for all human subjects research studies. When activities are conducted in person, additional precautions may be required to protect both the research participants and the study team.
Permission to perform in-person human subjects research activities will be assessed on a case-by-case basis. Permissions may change based on the current county/city/state/federal situation. You are responsible for monitoring your emails and this website. Additionally, you must comply with all IRB guidelines and mandates when performing human subjects research.
Remote Research vs. In-Person Research
- All human subjects research that can be conducted remotely (via phone, Zoom, etc.) should continue to be conducted remotely.
- If you are performing remote human subjects research only (your study does not contain any in-person interaction) AND you have already received your IRB approval, then no further action is needed related to COVID-19 University reopening. For studies that contain only remote research procedures, approval can be directly obtained from the IRB via Cayuse.
Guidance for All Researchers
Obtaining Permission to Proceed with IRB Submission
- Before submitting a request to conduct in-person human subjects research, researchers must ensure proper safety precautions will be taken per institutional guidelines. If you are performing remote human subjects research only and your study does not involve any in-person interaction, you can skip Step 1 (Obtaining Permission to Proceed with IRB Submission) and go directly to Step 2 (IRB Approval).
- Please submit the Permission to Proceed with IRB Submission form. These requests must contain the following information:
- The rationale for in-person research to resume given the potential risks of COVID-19. Simply indicating there will be marginal gains in productivity will not be sufficient and compelling. Rationales are expected to bring together multiple concerns (e.g., closing of age window to collect longitudinal data, lack of alternatives to collect data remotely, funder lack of willingness to extend deadlines).
- The procedures for mitigating risk related to COVID-19, including social distancing practices, symptomatic pre-screening, use/availability of PPE (e.g., masks, face coverings, etc.), disinfecting protocols, study staffing needs, study location requirements, etc.
- Upon submission, the Research Integrity and Compliance (RIC) staff will review for completeness and send the information to the IRB Chair, or designee member of the Board with specific expertise, for review.
- The IRB Chair, or designee, will review the form submitted and make a determination if in-person research can proceed.
- Once reviewed by the IRB Chair, the RIC Office will send the researcher a formal letter regarding their study’s determination.
- If permission was granted to proceed with your IRB submission, the researcher will follow the next steps to obtain IRB approval. Human subjects research cannot proceed until IRB approval is obtained under Step 2.