How do I contact the Office of Research Administration (ORA)?
ORA is located at 865 Research Parkway, Suite 450, in Oklahoma City. The phone number is 405-271-2090. Please email any documents to HSCORA@ouhsc.edu.
When is a routing form needed and where can I find them?
Please click here to see all industry-related forms. All new industry-related contracts (clinical trial agreements, research agreements, material transfer agreements, and confidential disclosure agreements) will need to be accompanied by the correct routing form. Routing forms are not required for amendments to existing clinical trial contracts or C-account extensions.
When is a CDA (Confidentiality Disclosure Agreement) required?
CDAs are not a university requirement for incoming information. The ORA will process a CDA when a third-party or company requires a CDA to be signed and completed before they will disclose information to the Principal Investigator (PI). A CDA should be used if the PI needs to disclose any OUHSC confidential information to a third party.
Who is eligible to serve as a Principal Investigator?
The OUHSC policy on PI eligibility is located here: PI Eligibility
What if I think I might have a conflict of interest?
The OU Board of Regents policy requires that you complete a Conflict of Interest Disclosure Form if you identify a potential conflict of interest. Please click here to review the policy and forms.
I need to request an extension on my C-account. How do I do that?
In order to extend a C-account, please submit a Clinical Account Extension Request form to ORA via email to firstname.lastname@example.org. This is a separate process from extending your study with IRB.
When does my IRB board meet?
Please click here to view the IRB meeting schedule.
Does an IRB need to be submitted prior to ORA receiving a new contract?
No. Ideally, submission of a new clinical trial to the IRB would happen at the same time ORA receives the new contract.
Will I be charged an IRB fee?
According to IRB policy, a study may be charged a $2,500 fee. Please click here to view the IRB’s fees and invoicing policies.
The IRB approved my continuing review and extended the study. Why is my C-account not extended?
In order to extend a C-account, please submit a Clinical Account Extension Request form to ORA. IRB approval is a separate action and has no effect on your C-account.
There is no contract or budget for this study/project. Do I need one? Why?
A contract is a legally enforceable agreement between two or more parties. When a contract is formed it creates binding obligations and rights and duties for each party, regardless of whether money is exchanged under the contract. These duties are contained in the terms and conditions of the agreement. The University has a legal obligation to protect its personnel, assets, and resources and therefore must evaluate contracts to ensure that they contain adequate protections from liability or unnecessary risk in the event that one or more parties do not fulfill their obligations. Also, the University must ensure that it limits its liability to other parties to the extent legally allowed, and that it can comply with the terms in the contract.
Additionally, there are a plethora of state and federal laws and regulations that apply to the University, and contracts must be evaluated to determine whether the terms and conditions contained in the contract comply with those laws and regulations. Therefore, it has been determined that the best way to protect the University and its personnel from liability is to require that all contractual documents be submitted for evaluation by the Office of Legal Counsel prior to creating legal obligations.
Can I sign for the university?
No. All employees of the University are employees of the State of Oklahoma. As such, they are subject to University policy and state conflicts of interest rules. University policy prohibits employees from signing contracts individually, if the contracts bind the University or its employees in any way.
What is my indirect cost rate?
Please click here to view the applicable indirect cost rates for clinical trials, public service projects, instructional and training programs, and on/ off campus research grants. Additional indirect costs may be required by your department. Please click here for more information.
This clinical trial/ project requires tests/procedures to be completed at an outside facility. Do I need purchasing approval?
If the total amount paid to the outside facility for the study-specific tests/procedures exceeds $5,000, approval must be granted by the Purchasing Department. If the amount is under $5,000 you will still need to complete ORA’s form. Please click here for more information. The Purchasing Department’s website can be found here.
How do I get a subcontract out or an independent contract agreement prepared?
- Subcontracts and Independent Contract Agreements can be started in SoonerTrack:Agreements: https://soonertrackagreements.ouhsc.edu
- These agreements will be routed to Purchasing. (Note: this step must be completed before ORA can begin processing the agreement).