As of August 24, 2020, we are entering the third phase of a three-phase plan to resume research and creative activities that were interrupted because of the COVID-19 pandemic and to continue with new ones. The plan, “Ramping up Research and Creative Activity at App State”, approved by Chancellor Everts, mirrors an approach many other universities in the nation are taking and expands allowable research and creative activities in a phased manner.
During this phase, all on campus and field research and creative activity that don’t require in-person interactions with human subjects are allowed to resume. However, please note that out-of-state travel on university business, including research-related travel, is currently not allowed. Faculty do not need to register for approval to resume research and creative activity unless the research involves in-person human subjects research. Faculty do not need to receive approval from the VPR to engage students in research and creative activity which does not involve in-person human subjects research; however, we strongly recommend that faculty endeavor to provide remote options for students that are interested in research and creative activities. Access to shared facilities continue to be allowed at reduced capacity (Vivarium, microscopy facility, etc.). Please contact the facility directors for more information. The library is open via card swipe access. Please see the library continuity of services guide for more information. Human subjects research that requires in-person interaction (being in the same physical space) with direct involvement of Appalachian faculty, staff, or students is being phased in.
All researchers must abide by the guiding principles described in the Ramping up Research and Creative Activity at App State Plan. It is important to emphasize that one of the guiding principles, safety of the participants and the research team, is of utmost importance especially in the context of research involving in-person interactions with participants. Therefore, it is imperative that research protocols be designed or adapted to minimize risk of exposure to participants, the research team, and everyone else that these groups may come into contact with. All research team members must remain cognizant of and minimize their potential exposure to SARS-CoV-2 at all times (i.e. during professional and personal time).
Guidelines for restarting human subjects research (here is a flowchart of the process):
- These guidelines are relevant for research that cannot be carried out remotely, in a virtual environment, or by digital means and covers both new protocols and those that were paused in April 2020. They do not apply to protocols that were not paused or to non-research activities.
- Please read the Ramping up Research and Creative Activity at App State Plan.
- Please read the “Guidance for restarting HSR at App” document for detailed information.
- In order to restart already-existing in-person human subjects research or start new in-person human subjects research, researchers must register through the InfoReady system. This registration is separate from the IRB review process described here and is intended to address COVID-19 specific plans for conducting human subjects research (HSR). These registrations will be reviewed first by Department Chairs, then Deans or designated Associate Deans, and finally, the Vice Provost for Research (VPR) in consultation with members of the human subjects research task force.
- Researchers will be allowed to ramp up in-person HSR in a phased manner according to the risk of exposure to SARS-CoV-2, starting with low exposure risk studies (Tier 1), followed by medium (Tier 2), and high (Tier 3) exposure risk studies. Guidelines for determining exposure risk are provided in the Tiers information document.
Target dates for approval to start protocols (please note that these are tentative dates and are subject to change).
Tier 1 research: August 25, 2020
Tier 2 research: September 8, 2020
Tier 3 research: October 2, 2020 (case by case)
Documents required for the registration (below is a summary, please consult the Guidance for Resarting HSR at App for further details):
- Description of the research and research protocols: Please include enough detail for the decision makers to be able to determine the relevant risks associated with COVID-19.
- Tier selection and justification: Please use this guidance to determine which tier your project fits and provide justification. Projects may be considered for a lower tier if they have aspects of both the lower and higher tiers. Please provide justification for why your project should be considered in the lower tier. Please use this template.
- Risk mitigation and contingency plan: Please use this template to prepare an extensive risk mitigation and contingency plan.
- Participant health screening form: Please use this form to screen participants prior to each in-person interaction. You may also prepare your own form as long as it has at minimum the information covered by the form at the link above.
- COVID-19 information sheet for research participants: We anticipate that research participants will have questions about how researchers are mitigating the spread of COVID-19. Please use this template to prepare your document. The information on this document must be verbally communicated to research participants.
- Certification for return to research for students: Students need to sign and submit a document stating they are willingly participating as a member of the research team and that they can contact their Department Chair, the Graduate Dean (for graduate students) or the Director of the Office of Student Research (for undergraduate students) should a conflict arise. Please use this document for graduate students and this document for undergraduate students.
- Please submit your registration for approval in InfoReady using this link.
- Registrations are project specific. Please submit a new registration for each project.
- Only the research team leader should submit a registration.
- Research team leaders must certify in the registration that all personnel (faculty, staff, and students involved) will abide by the safety precautions in the risk mitigation plan.
Registration to resume human subjects research will be reviewed and approved by the Department Chair, Dean of the College or designated Associate Dean, and by the VPR with input from members of the HSR Task force. Once approved, VPR will notify the faculty member, Department Chair and the Dean/designated Associate Dean.
- Please allow 2-3 weeks for approval. If a decision regarding approval has not been received within this timeframe, please contact email@example.com.