My research requires study participant visits on campus. Should I consider temporarily halting these visits?
If the research is minimal risk, provides no benefit to the participants, or is not part of a participant’s clinical care, the investigator is encouraged to temporarily halt study activities that require visiting the study site until further notice.Some of these activities may include focus group sessions, exercise physiology studies, on site interviews, etc.
If I need to stop study participants from coming in for study visits outside their clinical care, do I need to submit a modification to the IRB to do so?
Some studies are voluntarily halting or delaying enrollment because of public health recommendations, facility requirements or higher risk to participants. Such voluntary actions by the PI or sponsor do NOT have to be reported to the IRB.
Do I need IRB approval in order to contact research participants to determine COVID-19 exposure or symptoms?
No. If you implement procedures to identify participants whose visits should be postponed, modified or delayed, this is not a research procedure you do not have to submit a modification to the IRB to do so.
Do I need to modify my study to make changes for alternatives to in-person study visits?
Any changes to IRB approved research must be approved in advance by the IRB unless the change is necessary to eliminate immediate apparent hazard to participants.If the change is to eliminate an immediate hazard, the investigator should submit a modification to the IRB within 5 days after making this change.
What if a research participant reports possible COVID-19 exposure or symptoms during a study visit?
Please follow institutional policy.
Does my COVID-19 related project require prior IRB review?
If you plan to conduct a COVID-19 project, please contact the HRPP Office immediately to discuss. Some activities may fall under public health surveillance and/or FDA emergency authorizations.
Has the process for single patient emergency use been affected?
The procedure for single patient emergency use of an experimental drug or device remains unchanged. Emergency use must be reported to the IRB by submitting the Emergency Use application into iRIS within 5 days of use.
Are OUHSC IRBs operating as usual?
On-site HRPP and IRB operations are currently suspended. HRPP and IRB staff are working remotely and are available via email and phone. IRB meetings will be conducted as previously scheduled via Zoom and teleconference. Staff members are checking email and voicemail regularly. If you leave us a voicemail, your inquiry will be answered by the next business day.
Phone: 405-271-2045 | Email: firstname.lastname@example.org
If you have a question for a particular staff member, please contact them directly via email. Contact information is available on the HRPP Contacts page.
The OUHSC IRB #5 has the capacity to meet on short notice and may be called to review urgent items if necessary. Investigators who have an urgent matter for IRB review should email the Board 5 Chair and HRPP Director directly to discuss the matter.
[Contacts: IRB Chair: email@example.com; HRPP Director: firstname.lastname@example.org.]