COVID-19 Investigator Requirements, Investigator Guidance, and FAQs
The safety of both Wright State researchers and the human subjects they interact or intervene with must be managed and monitored as we continue to navigate how to conduct research during the pandemic. To that end, a new Wright State institutional review requirement has been added to all human subject research involving interventions and interactions on the Wright State campus These requirements apply for both non-COVID-19 research and research studies focused on COVID-19. Please review the topics below for more information.
IRB-approved research that involves face-to-face interactions to be conducted outside of Wright State campus (i.e. Premier, Dayton VA Medical Center) must not commence until the external entity has also given approval to conduct such activities. Wright State IRB approval does not override local facility, sponsor, and/or state requirements/prohibitions. Investigators conducting this type of research are responsible for obtaining and confirming such approval prior to starting or restarting research involving face-to-face interactions/interventions.
IRB-approved research that involves face-to-face interactions to be conducted on campus must go through an additional institutional review and approval process at this time to ensure tha appropriate protections are in place related to COVID-19. . The IRB Office will be responsible for coordinating this additional review by the Wright State COVID-19 Research Committee and Environmental Health & Safety (EHS) Office. If you are submitting a new IRB application, this process will be included as part of initial processing of your application via Cayuse. If your study has previously been approved, you will need to file an amendment via Cayuse that includes an updated local protocol and consent form(s), when applicable.
You must include a COVID-19 Safety Plan in your local protocol. This plan needs to address the following: justification of necessity of in-person research procedures, health screening procedures, social distancing procedures, hygiene and disinfecting procedures, use of personal protective equipment (PPE), and contact tracing procedures. Your consent form will need to be updated to include the new procedures. Be sure to include tracked-changed and clean versions of any revised documents with your amendment form.
COVID-19 Consent Form Language Template
COVID-19 Contact Tracing Form Template
Investigator Guidance - May 4, 2020
Research Not Involving Face-to-face Interactions
Studies conducted electronically, via telephone, or involving secondary data analysis may continue.
Is the IRB still reviewing submissions?
Yes, the IRB is still reviewing and approving IRB submissions. Please note, IRB approval does not supercede site approval.
My research requires study participant visits on campus. Can I conduct on-campus, in-person research?
As of August 3, 2020, on-campus activities may resume after social distancing and cleaning measures are implemented per Wright State guidelines (See COVID-19 Response Page). Projects must be approved by by the COVID-19 Research Committee and Environmental Health & Safety. You will need to file an amendment for your study to incorporate these new procedures into your protocol. Please include your COVID-19 Safety Plan as part of this amendment. The IRB Office will coordinate the necessary permissions needed as part of the amendment process.
If your existing or new study involves on-campus, in-person activities, please still consider whether it is feasible to modify to use remote interaction such as telephone or Zoom/WebEx.
Can I conduct off-campus, in-person research at Premier, Dayton VA Medical Center, or other off-campus locations?
Wright State recommends that any off-campus, in-person interactions with study participants be done sparingly, and with appropriate safety procedures in place. The external site must give permission for the research project. Wright State IRB approval does not override external site permissions.
Can I still conduct research via phone, or virtual interfaces (e.g. Zoom, Web-Ex)?
Yes, you can continue to engage in any research-related activities (e.g., recruitment, consent, data collection) that do not require in-person interaction. If you already have IRB approval to conduct these types of activities, then there is no need for any further action.
If your current IRB-approved study involves in-person activities, consider whether it is feasible to modify to use remote or virtual interaction. Amendments to currently approved protocols may be required.
Is the Wright State IRB operating as usual?
Yes. The Wright State Human Research Protection Program (HRPP) staff (a.k.a., IRB Staff) are telecommuting and will continue to process IRB submissions. IRB meetings are on schedule at this time and are being conducted virtually. Phone calls and email communications sent to the Wright State IRB e-mail box (email@example.com) or to individual IRB staff members will continue to be monitored and processed during normal Wright State business hours Monday-Friday 8-5 p.m.