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Human Subjects Research Re-Start Plan
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 available here. The ETSU overall plan for Return to Academic Research Activities established by the Provost is available here. Please be aware of the ETSU COVID-19 Policy on Facial Coverings available here.
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 the novel coronavirus.
Key information for human subjects researchers to keep in mind:
- Studies that involve remote or virtual study procedures may continue.
- Studies that require in-person or face-to-face research procedures must obtain institutional approval from the Vice Provost for Research by completing this form and emailing to firstname.lastname@example.org.
- Any paper-based items should be submitted via email instead of campus mail or in-person drop-off.
- Highest priority is being given to all inquiries, requests, applications, and modifications related to the impact of COVID-19 to ongoing research.
- Researchers are encouraged to email IRB@etsu.edu to obtain IRB consultations, as needed, to discuss concerns or changes to human subjects research.
- Student researchers should work closely with their Faculty Advisors to determine whether any changes are needed to facilitate their research.
Resuming in-person research activities
Effective June 15, 2020, human subjects research requiring in-person research procedures may resume with prior institutional approval from the Vice Provost for Research and Sponsored Programs. Approval is contingent upon there being no remote alternative and with appropriate safety precautions in place. Research studies that can be completed using remote procedures should continue to do so. Once a study has obtained IRB approval, the PI must email the VPR the completed ETSU Request to Initiate or Resume Face-to-Face Research Form for institutional approval.
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. Additionally, research study staff should self-screen for COVID-19 symptoms and implement appropriate safety measures as approved by the VPR.
Regarding the directive from Dr. Noland, effective March 20, 2020, all ETSU research procedures involving on-campus or face-to-face interaction with participants must be paused or modified to allow for remote study visits. Research interactions with participants such as telephone contact, remote monitoring, or remote data collection may continue. See information below about modifying your study to implement remote procedures.
Any research studies under a temporary hold initiated to comply with the request of an external funding agency, data safety monitoring group, or federal agency may not resume until the hold is lifted by that agency or group. Additional reporting for VA studies may be required; see links to resources below and contact the VA R&D office.
Investigators should establish formal plans
All studies should have a contingency plan in place that details how the study is being conducted during the the pandemic. This plan must be in writing and should be distributed to the entire research team. The plan should be maintained with the research records and made available upon request to the IRB, compliance agencies, or sponsors.
All investigators engaging in human subjects research should develop concrete and actionable plans for:
- Continuing or halting data collection.
- Modifying the protocol to decrease or eliminate in-person study interactions or implement remote visits or procedures. (see below)
- Regularly communicating with the research team, sponsor, study sites, and participants and their caregivers to ensure safety and compliance.
- Managing data accessibility and storage to facilitate ongoing research as the situation changes.
- Coordinating with data collection sites (e.g., ETSU Health, JHQVAMC, Ballad Health) to follow any new guidelines or procedures for interacting with subjects and determining whether any coronavirus cases have been identified at the site.
- Ensuring that research study staff is healthy and how to handle a reduction in study staff.
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 specific 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 risk for 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
Last updated: 7/28/2020