Office of Human Research Participant Protection

Effective immediately, all Human Subject Research (HSR) activities including clinical trials are allowed to resume provided all OUHSC COVID-19 safety protocols can be met. It is expected that all personnel will adhere to the requirements in the OUHSC COVID-19 Response Plan.

If your current HSR protocol was temporarily halted due to the COVID-19 restrictions, the HRPP Office will update the study status of those protocols without any action required from you.

Also, in accordance with campus policy, our research laboratories* remain closed to K-12 students for shadowing, volunteer, and educational purposes, but open to visitors, undergraduates, graduates, and post-docs from any institution for those purposes, provided the following are observed by these individuals.  The manager of the area where these individuals will be is responsible for compliance:

• Non-HSC individuals will complete the online visitor screening tool prior to their first day on campus
  • Individuals will be required to show proof of a negative COVID test (within past 48 hours) or documentation of COVID vaccination, if required based on screening results
• All individuals will complete the HSC online COVID-19 training module in OnPoint, using their HSC credentials
• All individuals (including students, faculty, staff, and volunteers) will comply with OU’s COVID-19 vaccine policy:
  • Those with patient-facing or research participant-facing responsibilities or who will be in patient care or human research participant settings must be vaccinated against COVID-19
  • All other individuals will be strongly encouraged to be vaccinated against COVID-19
• All individuals will be informed that they must comply with and be given the link to the HSC COVID-19 Response Plan

*Rotations in clinical areas on campus and at OUMI are limited to OUHSC students, at least through July 2021.

With these changes, we are retiring the Return to Research Plan and will refer to the OUHSC COVID Response Plan for COVID protocols. If you identify a deficiency caused by this action, please email vpr@ouhsc.edu.

Phase One Reopening of Human Subjects Research will begin Monday, May 11.

All Principal Investigators (PIs) of Human Subjects Protocols and their research team must read and follow the OUHSC COVID-19 Return Plan.

The March 27, 2020 Updated Guidance for Human Subject Research at HSC will remain in effect until further notice, with the following changes:

• New patients may now be recruited into all IRB approved protocols.
• Protocols that have been halted by the IRB due to COVID-19 related issues may be reopened by the approval of a Human Subjects Research Request Worksheet process (see below).
• Newly submitted protocols that would be halted by the IRB due to the March 27 COVID-19 directive will require the approval of a Human Subjects Research Request Worksheet process (see below).

The OUHSC Institutional Review Board (IRB) remains responsible for ensuring participant safety and ethical research practices. The IRB will also determine whether a new IRB protocol needs to be halted based upon the March 27, 2020 Updated Guidance for Human Subject Research.The review of the Human Subjects Research Request Worksheet will be performed by the Restarting Human Subjects Research Review Committee, an ad hoc committee of researchers named by the Vice President for Research, to ensure that potential transmission of SARS-CoV-2 is reduced sufficiently to ensure not only participant safety, but that of research and university personnel.

PIs must follow the steps below to obtain approval for an IRB protocol halted due to COVID-19 related issues:

1. The PI will read and follow the Return to Research – Policy and Plan for Phase One Reopening of Human Subjects Research.
2. The PI will complete the Human Subjects Research Request Worksheet and submit to VPR@ouhsc.edu. This document will describe the measures that investigators are taking to reduce COVID-19 transmission and protect participants and university personnel. The PI is responsible for completing the worksheet for each protocol. If several protocols will include the same safety precautions and measures, they can be included on the same worksheet.
3. The Restarting Human Subjects Research Review Committee will review the Human Subjects Research Request Worksheet. The review committee may request additional information and clarification from the PI on precautions and safety measures. The review committee will grant approval for those protocols that demonstrate sufficient safety precautions to reduce COVID-19 transmission. Approval of the Human Subjects Research Request Worksheet will be provided to the PI.
4. The PI will submit all modifications, including the approval by the Restarting Human Subjects Research Review Committee, to the IRB via iRIS using the Modification/Notification form available at https://iris.ouhsc.edu/.
5. The IRB will review this modification. Minimal additional clarification or precautions are anticipated. Modifications will be approved as standard process once PI has sufficiently addressed stipulations.
6. Once the IRB protocol is approved the PI can begin in-person human subjects research.

Facilities for data collection and analysis for human subjects research must follow the OUHSC COVID-19 Return Plan. 

Faculty Researchers and laboratory members who have been absent from campus for 7 consecutive days or more must complete the COVID-19 self-screening questionnaire: https://covidreporting.ouhsc.edu/ and submit it before returning to work on campus. They will be notified via email of their screening results. This return to work email should be forwarded to the employee’s direct supervisor upon receipt.

Obtaining Masks

• All individuals in campus facilities, including research laboratories, must wear disposable or fabric surgical-style face masks.
• The University will make available to researchers a surgical-style mask. Researchers may wear their own mask, including a fabric mask, so long as it complies with the Return Plan.
• Instructions on how to obtain this surgical-style mask will be provided by the researcher’s college/department/center.

Effective Date: March 27, 2020
Supersedes March 17, 2020 Memo

The OUHSC HRPP, IRB, and the University are closely monitoring the COVID-19 situation, as it changes daily.  We understand that you may have questions or concerns about the impact of COVID-19 on your research participants and research staff.  

Based on the Oklahoma Governor’s March 24 Safer-at-Home executive order, and the University’s Safer-at-Home March 25^th memo, all on-campus research activities are restricted to essential research only. The following guidance will assist human subjects researchers to determine which research programs to continue.

As a reminder, the following criteria from the March 17 memo remains as described below:

1. New Participants: Recruitment of new patients into clinical trials remains stopped until further notice.  The exception is clinical trials in which the standard treatment cannot be given without personal interaction between the patient and the physician (examples include, but are not limited to: cancer chemotherapy, cardiovascular disease, stroke care), for which the study consent process and in which execution of the protocol provides no additional risk above the standard care process in terms of infection transmission.
2. Currently Enrolled Participants: Clinical trials that provide critical treatment for the life and health of currently enrolled participants (examples include, but are not limited to: cancer treatment, cardiovascular disease, stroke care), may continue, if stopping study treatment might present increased risk to the participant.

For these studies, every attempt must be made to minimize the need to interact with the participant in-person, when it is safe to do so.  For example, routine follow-up visits that do not involve administration of treatment should be done by telephone if possible.These decisions must align with the University’s Safer-at-Home March 25^th memo.

3. Studies involving no personal interactions with research participants, such as telephone interviews, web-based surveys, retrospective chart reviews, research on stored specimens, etc., may proceed in alignment with the University’s Safer-at-Home March 25^th memo.
4. Guidance for NIH-funded clinical trials and FDA-regulated research is available on the HRPP’s COVID-19 page in the 'Additional Guidance, Information & Resources' section below.

IMPORTANT: Any activities conducted by HSC employees at a location outside University offices and locations must align with University, IT, and HIPAA guidelines for telecommuting.