The OHRA is a smaller component of the Enterprise Research Advancement Unit (ERA Unit). The OHRA is the office that maintains the IRB, the ON-RAMP portal, and the informational website. The OHRA is tasked with coordinating efforts to develop and support the research that is reviewed by the IRB. The IRB is the group of people affiliated with the OHRA who review and make final determinations about the approval of research projects. Please see the About Us page to learn more about the ERA Unit structure.
OHRA/IRB FAQ
The Office of Human Research Affairs (OHRA);
- Serves as a centralized internal office for Institutional Review Boards, Ethics and Compliance, and Research Support functions.
- Leads standardization and implementation of research protocols and research related relationships with external partners.
- Cooperates with UHG’s Information Risk Management group on research data-related issues
- Offers guidance, mentorship, education and training to research leads across the Enterprise.
The OHRA SOPs are currently being finalized. The Final version will be posted in the Resource Library.
Yes, Federal Wide Assurance: FWA00028881 with a current expiration of 10/25/2024.
Confirmation of FWA can be obtained at the following link
Yes, IRB Registration: FWA00028881 with a current expiration of 11/04/2022.
Confirmation of IRB Registration can be obtained at the following link
The OHRA will apply the Common Rule when federal funds are being used to conduct the research. Even if the federal funds come from a research partner.
The OHRA will apply aspects of the Declaration of Helsinki when appropriate, but not consistently, as this is not required to assure compliant and ethical research.
The OHRA complies with the Belmont report consistently.
The UHG IRB membership information will not be made public.
We will provide documentation upon request to confirm compliance with IRB roster requirements and conflicts of interest in lieu of an actual roster.
There is currently no cost for use of OHRA resources and services.
Project FAQ
The OHRA is currently developing the Online Regulatory Approval Management Portal. Until that system is ready, all projects should be submitted via email to ohra_uhg@uhg.com .
The OHRA commits to providing exceptional customer service to our research community and we will be sure to respond to general inquiries or needs of assistance within 24 hours.
All expedited determinations (i.e. exemptions from IRB review, minimal risk approvals, operational determinations, etc.) will be conducted within five business days of receipt.
The convened IRB meets once per month for review of research that poses greater than minimal risk, The OHRA staff will keep you apprised of when your submission is scheduled for review and if any additional information or explanation for your submission is required. Please see the Meetings Schedule page for upcoming dates.
YES. Human Subjects Protections training through the online CITI program is required. Please see our detailed guidance about CITI training in the resources library.
Documentation of completed is expected to be provided in your ON-RAMP system profile. In general, training is only required to be completed one time.
The OHRA will assist with coordination of all necessary approvals in relation to project start up. Depending on the project design, this may include:
- IRB Review
- Quality Review (Science / Operations / Methods)
- Data Governance
- Optum Operations and Privacy
- FDA Requirements Review
Please see the resource library for a protocol template as well as companion guidance for using the template.
The OHRA will also assist you with improving your protocol once we receive it for review.
Participant Engagement FAQ
- Recruiting participants & Enrollment best practices
- Consent best practices
- Ongoing participant engagement methods and expectations
Application FAQ
When the submission system is ready to be launched, quick access guidance will be posted here along with detailed instructions in the Resource Library.