Investigators affiliated with OU should submit application materials to the IRB on the campus of their academic program. This applies to all campus locations, including Norman, Oklahoma City, Tulsa, Lawton, and more. If your academic program is tied to OUHSC, then you will submit to the HSC IRB. If your academic program is tied to OU-Norman, you will submit to the Norman Campus IRB.
One exception to this rule is based on the nature and degree of the research. All medical, clinical, and FDA-regulated, as well as VA research involving human participants, is reviewed by the OUHSC IRB. Therefore, Norman and OUHSC IRBs maintain a reciprocal authorization agreement allowing OUHSC IRB to review such research conducted by Norman investigators.
Investigators affiliated with the VA Health Care System in Oklahoma City or Muskogee, Dean McGee Eye Institute, and OU Health submit to OUHSC IRB.
Research activities that involve human participants requires IRB review. Investigators are frequently unsure whether or not their proposed project or activity meets the definition of research involving human subjects. Understanding the regulatory definitions of research and human subjects can help distinguish between activities that require IRB review and activities that fall outside the IRB's scope. When there is uncertainty, the IRB should be consulted.
What is Research?
Many proposed activities fail to meet the definition of research and therefore, do not require IRB review. The IRB may review these activities via the Determination of Human Research Worksheet in iRIS to assure that they are not research and do not fall under the IRB's purview. These reviews and determinations by the IRB may be necessary to satisfy journal or conference requirements.
- Research: a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
An activity must be both a 'systematic investigation' and contribute to or develop 'generalizable knowledge' to meet the definition of research. These terms are not defined in the regulations. OU IRBs define these terms as follows:
- Systematic Investigation: an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question.
- Generalizable Knowledge: investigations designed to generate new knowledge and expand the knowledge base of a scientific discipline or other scholarly field and yield one or both of the following:
- Results that are applicable to a larger population beyond the site of data collection or the specific subjects studied.
- Results that are intended to be used to develop, test, or support theories, principles, and statements of relationships, or to inform policy beyond the study or internal program.
Note: for FDA-regulated research, the FDA uses the term "clinical investigation" which is defined as any experiment that involves a test article and one or more human subjects...where the test article is regulated by the FDA. The FDA considers the term "clinical investigation" as being synonymous with research, clinical research, study, and clinical study.
What is Research Involving Human Subjects?
The definition of who is a human subject determines whether or not the research must be submitted to the IRB for review and approval.
- Human Subject: a living individual about whom an investigator conducting research:
- obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
- Intervention: includes both physical procedures by which information or biospecimens are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.
- Interaction: includes communication and interpersonal contact between investigator and subject.
- Private Information: includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., medical record).
- Identifiable Private Information / Identifiable Biospecimen: private information or biospecimen for which the identity of the subject is or may readily be ascertained by the investigator associated with the information or biospecimen.
Note: the FDA defines "human subject" as an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a health human or a patient.
Submit the Determination of Human Research Worksheet to the IRB in iRIS if you are unsure whether your proposed project/activity involves human subjects, requiring IRB review and approval.
By design, many QI projects do not meet the regulatory definition of research because even though they may be systematic, they are not usually designed to be generalizable. There are exceptions though and some QI projects do meet the regulatory definition of research and human subjects which requires IRB review.
The IRB has developed guidance on this topic to help investigators understand the overall differences between research activities and non-research QI activities. Visit the QI Project vs. Research page for more information.
If you require or would like to request an official determination from the IRB, you must submit a Determination of Human Research Worksheet in iRIS.
It is University policy that only full-time and part-time paid faculty and staff may serve PI or Co-PI on research studies submitted to OU. Unpaid adjunct faculty and Emeritus faculty cannot serve as PI or Co-PI.
Students, residents, fellows, unpaid faculty positions, Emeritus faculty, and volunteers may serve as a sub-investigator or in other research support roles as key study personnel.
Investigators and staff who are affiliated with other sites for which HSC serves as the IRB of record, such as the VA, Dean McGee Eye Institute, and OU Health, may serve as PI or Co-PI.
IMPORTANT: PIs assume the responsibility of the entire research study, including any responsibilities delegated to study coordinators and key study personnel.
A detailed score of PI responsibilities is described in the PI Qualifications and Responsibilities policy.
Additional responsibilities are taken on when the PI is also a sponsor of the research study. These responsibilities are detailed in the Sponsor Responsibilities policy.
All key study personnel (KSP) who are engaged in human participant research must complete the required training listed below before the IRB will approve a new study, continuing review or annual report; and before adding new KSP to an ongoing study. KSP are also responsible for maintaining current training.
HSC IRB requires individuals complete the Human Subjects Research course in CITI. Multiple options are available and individuals must complete the appropriate training based on the nature of research the individual will engage in or conduct.
- Group 1: Biomedical Research
- Group 2: Social/Behavioral Research
- Group 3: Both Biomedical and Social/Behavioral
What About Norman Researchers Submitting to OUHSC or serving as KSP on OUHSC studies?
Norman-based investigators submitting to OUHSC IRB shall affiliate with OUHSC in CITI and complete either Group 1 or Group 3 if the research is biomedical (e.g., medical, clinical, or FDA-regulated) in nature.
The social/behavioral course through OU-Norman in CITI is accepted for Norman-based individuals who are collaborating with OUHSC researchers on social/behavioral research.
IMPORTANT NOTES ABOUT CITI TRAINING:
- Good Clinical Practice (GCP) and Responsible Conduct of Research (RCR) are also available to individuals in CITI. These courses alone will NOT satisfy IRB training requirements. Individuals must complete the Human Subjects Research course to satisfy IRB requirements.
- OU has more than one organization in CITI. Select or affiliate with University of Oklahoma Health Sciences Center to access the correct course(s).
- CITI training can link to your account in iRIS via your OU or OUHSC email. Your email must be formatted in CITI correctly for iRIS to receive your training information. Be sure your email in CITI follows this format: firstname-lastname@ouhsc.edu.
Principal Investigator
- Understand federal, IRB, and institutional policies and regulations applicable to the research
- Understand reporting obligations to funding sources, FDA, and IRB
- Understand scope of responsibilities for multi-site studies, PI-initiated studies, and federally-funded studies
- Hold complete knowledge of protocol, investigator brochure(s), and consent form(s)
- Maintain appropriate research-related records for review by federal regulatory agencies, the sponsor, University officials - including the Office of Compliance, and the IRB.
- Select qualified individuals study team roles
- Personally conduct the research and supervise all key study personnel
- Review and attest to the accuracy of all forms and documents submitted to the IRB prior to applying your electronic signature to submissions
- Develop and maintain procedure for monitoring participant safety and data collection
For more information, refer to the following OU HRPP Policies and Procedures (SOPs):
Study Team
- Understand federal, IRB, and institutional policies and regulations applicable to the research
- Maintain appropriate knowledge (according to role) of the study's purpose(s), activities, risks, and benefits (maintain, for example, for modifications and updates/training on new protocol procedures)
- Hold thorough understanding of individual role on the study and its relation to regulations and policies
- Understand reporting obligations to the PI, IRB, and institution
In iRIS there are 3 application types to choose from when adding/creating a new study or form.
- HSC Application: select this form to submit to OUHSC IRB.
- Norman Application: select this form to submit to the Norman IRB.
- Relying on an External IRB: select this form to submit an abbreviated application when your research falls under a reliance agreement and will undergo full IRB review by an external (outside, non-OU) IRB.
The HSC Application provides 5 different types of submission forms to choose from, including:
- Study Application / Research Application
- Determination of Human Research Worksheet
- HIPAA Form 7 - Investigator Representation for Research on PHI of Decedents
- HIPAA Form 6 - Investigator Representation for Review of PHI - Preparatory to Research
- One-Time Emergency Use of a Test Article
Ancillary reviews are completed by other University offices and committees for research involving human participants. These reviews may be required by federal regulations, state law, HRPP policy, or University requirements, when applicable to individual research studies.
As for the timing of ancillary reviews, some reviews and approvals are required prior to IRB review. Some reviews may take place at the same time as IRB review, but final IRB approval will not be issued until evidence of ancillary committee approval is submitted to the IRB.
For studies that involve grants, contracts, or other agreements that are processed through Office of Research Administration, those reviews may take place at the same time as IRB review and may not be completed until after IRB approval is granted.
VA Research: The R&DC will not perform a comprehensive review or issue approval until after the IRB has approved your research. However, you must work with R&DC and/or the Privacy Official at the VA to obtain approval of the VA HIPAA Form before you submit to the IRB. Evidence (documentation) of Privacy Official review and approval must accompany your submission to the IRB.
Links to the ancillary offices and committees are available in the Researcher's Toolkit.
Yes. A new iRIS resource page has been added to this website for information about iRIS, including a link to access help guides and instructions.
Login to the page containing the help guides is required using your OUHSC or OU credentials.
The help guides are also available in the Help section in iRIS.
The PI and study team must conduct the research study in accordance with the OUHSC IRB-approved protocol, determinations, and OU HRPP policies. Please be aware of reporting requirements and expiration or check-in due dates noted in the IRB approval letter and in iRIS. The following activities require further submission to the IRB:
- Modifications/Amendments
- Continuing Review
- Annual Check-In
- Reportable Events (e.g., protocol deviations, unanticipated problems)
- Study Closure
All studies must maintain appropriate research-related records for evaluation by federal regulatory agencies, the sponsor, University officials and administrative offices - such the Office of Compliance - and the IRB.