** HRPP and OU/OUHSC IRBs Fully Operational - Working Remotely **


The HSC Campus has resumed on-site HRPP and IRB operations. IRB meeting information is addressed in the FAQ section below. 

*Norman Campus continues to work remotely: Click here for information about Norman IRB operations. 

Office of Human Research Participant Protection

Page last updated: 6/11/2020

COVID-19 (Coronavirus) and Human Subject Research

As the COVID-19 pandemic expands and the situation continues to evolve, the Office of Human Research Participant Protection (HRPP) and IRB are working closely with University officials and the Vice President for Research to establish guidance for human research operations. This guidance is intended to help the research community limit the potential risks and impact to active research protocols as they relate to COVID-19. 

We will continue to update this information as it becomes available; but we encourage you to visit research.ouhsc.edu for research-related information and coronavirus.ou.edu for the University's resources, latest news, and information.

Please contact your responsible campus IRB office if you have specific questions related to your research protocol. 

Click here to jump to the FAQ section below. 

 

5/6/2020: Phase One Plan for Reopening Human Subjects Research


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.

3/27/2020: UPDATED GUIDANCE FOR HUMAN SUBJECT RESEARCH AT HSC

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 25th 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 25th memo.

  1. 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 25th memo.
  2. 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.

FAQs and Local Guidance


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?

HRPP and IRB have resumed on-site operations. In-person meetings are being conducted via Zoom, telephone, or teleconference. 

IRB meetings will continue as previously scheduled via Zoom and teleconference. 

Phone: 405-271-2045 | Email: irb@ouhsc.edu 

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: karen-beckman@ouhsc.edu; HRPP Director: donna-hogan@ouhsc.edu.]

 

 

ADDITIONAL GUIDANCE, INFORMATION, & RESOURCES


NEW! OHRP Guidance 4/9/2020:
OHRP Guidance on COVID-19 


VA RESEARCH:
Click here to view COVID-19 announcements and guidance. 


FDA GUIDANCE - [UPDATED 3/27/2020]
FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic


NIH - March 16, 2020: 
Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19


CITI: Helpful COVID-19 Resources


* HIPAA Reminder for Researchers Conducting Human Research:
As it pertains to COVID-19 and potential impacts on your research, researchers must continue to implement reasonable safeguards to protect patient information against intentional or unintentional impermissible uses and disclosures. Furthermore, researchers (and their business associates) must apply the administrative, physical, and technical safeguards of the HIPAA Security Rule to electronic protected health information (ePHI); including ensuring any teleconferencing and electronic transmissions have been reviewed and approved for use by University IT Security.


WIRB-Copernicus Group (WCG) Free Webinar

Title: Clinical Trials in the Era of COVID-19: Changes You Need to Make Now 

When: Wednesday, March 18 @ 1:00pm - 2:30pm CT

Click here to register for the webinar

OUHSC Contact

865 Research Parkway, Suite 400
Oklahoma City, OK 73104

ph: (405) 271-2045
fax: (405) 271-1677


Email Us: irb@ouhsc.edu

Norman Contact

Five Partners Place
201 Stephenson Parkway, Suite 4200
Norman, OK 73109

ph: (405) 325-8110


Email Us: irb@ou.edu