Human Subjects (IRB)
All studies that involve humans are potentially subject to federal government regulations. This includes everything from clinical trials to surveys, interviews, and observation. Any research -- including masters and doctoral projects -- that calls for participation by people must be reviewed and approved by the Institutional Review Board (IRB) before the project can begin. All researchers who conduct human subjects research must complete the required CITI training.
***** See details below regarding upcoming IRB training sessions in Microsoft Teams! *****
Announcement concerning COVID-19 and human subjects research
The Office of the Vice President for Research and Office of Research Compliance are providing guidance related to human subjects research in response to the global coronavirus pandemic. This guidance is effective immediately (3/17/2020) for all human subjects research reviewed by an Ohio University IRB and will be revised as appropriate based on new information in this evolving environment.
Human Subjects Research Involving Physical Contact with Study Participants
At this time, research protocols that involve being in the physical presence of research participants (e.g., medical procedures, study drug administration, in-person interviews, in-person focus groups, in-person cognitive/behavioral therapeutic services) in Ohio University facilities should be discontinued until further notice. If remote procedures, such as online questionnaires, phone, Skype, Zoom, or other means are already approved by the IRB, investigators are encouraged to implement them. If remote procedures are not currently approved by the IRB and an investigator would like to utilize them, an amendment request must be submitted to the IRB and approved prior to such implementation. The IRB is available for amendment reviews and the Office of Research Compliance can assist in expediting the review.
Studies with in-person contact that are conducted outside of Ohio University facilities should also be discontinued, unless the location is a clinical or hospital healthcare setting where infection protection practices are routine.
If you need to make a modification immediately in order to eliminate potential hazards to the subject or have questions, contact the Office of Research Compliance by email, email@example.com or by phone, (740) 593-0664, for guidance.
Human Subjects Research Not Involving Physical Contact with Study Participants
Research activities may continue as approved in the IRB protocol.
Thank you for your understanding in these rapidly evolving times. Please continue to monitor the Research Compliance website for updates regarding this situation.
The Office of Research Compliance will hold an IRB training session on Thursday, July 9, 2020 from 1:30 - 3:30 PM using Microsoft Teams. This session is intended to help faculty, staff and students with any questions they may have about the IRB review process and / or the LEO electronic IRB system.
The session will begin with an introduction to the foundations of IRB review, including regulations / OU policy, and review levels followed by a brief demonstration of the LEO electronic IRB system. There will be time devoted at the end to assisting attendees seeking guidance with their protocol submissions and answering any questions regarding the IRB review process. If you wish to attend, please email firstname.lastname@example.org for details on joining the session.
- Resources Regarding Changes to the Human Subjects Regulations
- IRB Submission Procedures and Consent Form Templates
- IRB Meeting Schedule
- Ohio University's Policy on Human Subjects Research
- Office of Research Compliance Policy / Procedure Guidelines [PDF]
- Standard Operating Procedures
- Authorization Agreements
- Guidance Documents
- Frequently Asked Questions - Human Subjects Research
- Required CITI Training
- IRB Training Videos
Need help? For more information on research involving human subjects, email email@example.com or call 740-593-0664.