The ETSU Human Research Protection Program remains committed to providing services to maintain and protect the health and welfare of its students, staff, faculty, and research participants. ETSU has identified a plan to inform the campus of the re-entry process across many domains, and the plan is outlined at www.etsu.edu/bucs-are-back. The Academic Research Activities & COVID-19 guidance, updated August 9, 2021 should be adhered to by the research community.
This webpage provides guidance to researchers as ETSU begins the gradual expansion of research activities with required safety precautions in place. We assure the research community that our primary concern is the safety of our researchers and research participants while also preserving the scientific integrity of research protocols. We recommend that researchers take steps to decrease the likelihood that they will put themselves, members of their study teams, or their study participants at risk of becoming infected with or spreading COVID-19.
Human Subjects Research Re-Start Plan
- PIs must implement COVID-19 pre-screening procedures with any potential in-person research participants and may only enroll participants that are presumed COVID-19 negative.
- Research participants should be provided a copy of the ETSU Research Safety Guidelines and must agree to appropriate PPE before arriving to the research visit.
- Research study staff should self-screen for COVID-19 symptoms and implement appropriate safety measures as approved by the VPR.
- Submit a Modification Request to the IRB for approval before initiating any changes to the approved protocol, consent process, or study procedures - even if the changes are due to COVID-19 safety precautions.
Screening study participants
Research conducted in clinical facilities (e.g., ETSU Health, Ballad Health, JHQVAMC) may be required to complete clinical screening procedures for exposure to COVID-19 before patients are scheduled for study-related visits. Similarly, ETSU may require that participants be screen prior to in-person or on campus research activities. These are institutional policies rather than IRB policies. Changes made to research protocols to comply with institutional requirements do not require prior ETSU IRB approval. You may refer to this template screening tool. This safety screening procedure does not require IRB approval unless the participants' responses are recorded for research purposes.
In addition, ETSU researchers should:
- Follow directives from ETSU in accordance with guidance from the CDC, Tennessee Department of Health, and local county health departments.
- Follow instructions from the specific facility where participation interaction would occur.
- Consider the participant population (e.g., are they at gearter risk for contracting COVID-19) and the setting in which the interaction would occur.
- Develop possible alternatives to in-person study visits that are important for subject safety and monitoring.
Modifying study procedures to occur remotely
Research studies may consider modifying their procedures to replace in-person study visits with “remote” options for questionnaires, surveys, check-ins, screening, and consenting. Researchers may consider alternatives to in-person research or monitoring visits, such as email, telephone or videoconference interactions. Remember that these changes must be approved in advance by the IRB as a Modification to the study, unless the changes are necessary to eliminate immediate apparent hazards to participants. If you do need to change an approved research procedure to eliminate immediate hazards, it must be reported to the IRB within 10 days (VA research within 5 days). If you have any questions about whether a remote option is possible or approveable (especially for consent), contact the IRB. The ETSU IRBs are prioritizing these modifications.
Contact us with questions
The IRB Chairs and staff are available to discuss human subject research concerns and offer advice on how to handle modifications. Please do not hesitate to reach us via telephone or email. Please continue to visit the ETSU IRB website for the most up-to-date information.
- Department of Veterans Affairs Memorandum: ORD-funded HSR Administrative Hold
- VA COVID-19 FAQs
- VHA ORD Guidance Related to COVID-19 Concerns
- USAMRAA COVID-19 Resources
- ORSPA Federal Agency Guidance in Response to COVID-19
- Ballad Health policies regarding access to facilities
- Ballad Health Academic Professional Student COVID-19 Update
- CITI Program Coronavirus (COVID-19) Resources
- FDA Guidance for Conduct of Clinical Trials during COVID-19
- NIH Coronavirus Resources for Researchers
Last updated: 8/13/2021