Overview

Prior to initiation of any research project that involves the use of human subjects conducted at or by researchers, faculty, staff or students of the University of Oklahoma-Norman Campus (OU-NC), OU-Tulsa Campus (non-medical) or Cameron University, the proposed research protocol must be reviewed and approved by the OU-NC Institutional Review Board (OU-NC IRB). The OU-NC IRB has jurisdiction to review and approve human subjects research conducted at the University of Oklahoma-Norman Campus and University of Oklahoma-Tulsa Campus(non-medical), and Cameron University.

The OU-NC IRB reviews research protocols in an effort to safeguard the rights and welfare of human subjects involved in research and to assist researchers and the University in our mutual obligation to comply with all federal, state, and OU-NC regulations and policies with respect to protection of human subjects in research. All research which may result in publication or public presentation, involving human subjects or use of data on human subjects that will be performed by faculty, staff or students of OU-NC, OU-Tulsa (non-medical) or Cameron University must be review by the OU-NC IRB.

The following definitions are applicable to the procedures outlined here.

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Human Subject means a living individual about whom an investigator conducting research obtains

1. data through intervention or interaction with the individual, or
2. identifiable private information*

*non-identifiable private information used in research must be reviewed under the exempt process and therefore must also be submitted to the IRB.

Classroom Projects with no intent to publish the findings do not require OU-NC IRB review except when the study population includes members of vulnerable populations/protected groups or poses risk to participants beyond what may be encountered in everyday life.

Vulnerable Populations/Protected Classes

• Pregnant Women (as a target population)
• Fetuses
• Children (under the age of 18)
• Cognitively/Mentally Impaired
• Prisoners
• Traumatized Individuals
• Teminally Ill
• Elderly/Aged
• Native American Tribes and/or Tribal Organizations
• Students enrolled in a class in which the Instructor is the investigator

The Submission Process

The application form, protocol, and supporting documents should be sent or delivered to the Office of Research Services, Buchanan Hall, Room 314. A cover letter that documents consideration for expedited or exempt review status is recommended. The IRB Application should include the following:

1. IRB APPLICATION FORM WITH SIGNATURES
2. CONSENT FORM(S)
3. DATA COLLECTION INSTRUMENTS/QUESTIONNAIRES/SURVEYS
4. SOLICITATION ANNOUNCEMENTS/RECRUITMENT FLYERS
5. ADDITIONAL DOCUMENTS AS REQUIRED

The Review Process

The initial review is conducted by the IRB Manager. This individual is experienced in reviewing submissions and will determine the level of review required. Administrative review should not be interpreted to mean that approval is guaranteed; only that major problems that could result in Board deferral will be addressed. The most common error found on administrative reviews is the absence of required documentation and/or information.

Applications that qualify for expedited review are reviewed by at least one (1) board member. If full board review is required, review will be conducted by a quorum of the Board members. IRB members receive applications seven (7) days prior to the meeting so that they can give studies a complete review. The scientific merit of the study is determined. Federal regulations require a review on the scientific merit of the proposal by the Institutional Review Board. Review of scientific merit is relevant and important as it is a factor in deciding if the risks/benefit ratio is appropriate. The risks to subjects are compared to the direct benefits of the research. The involvement of protected groups is assessed. Consent forms/documents are to ensure that the general purpose of the research is conveyed accurately, the risks and benefits are accurately portrayed and the study is described in sufficient detail for the prospective subjects to make an informed choice about participating. The consent form must be written in language appropriate to the study population. Regulatory agencies recommend a reading level of no higher than eighth grade for all consent forms.

Several outcomes are possible: outright approval, study approvable upon changes or clarifications, deferral (the protocol and/or the consent form must have significant revision before the submission can be reviewed again by the full Board), and disapproval (given when the Board is not convinced that the submission can be salvaged into an approved protocol).

Within one week of the Board meeting, an email message outlining the Board's decisions concerning the study are prepared. This message will address the steps/changes needed to re-submit the study to the Board.

At times the Board may make suggestions that are unsuitable or inappropriate due to not fully understanding the protocol or not grasping the precise details of the science. The principal investigator must therefore review the information to be sure that the recommended changes will not misrepresent the study to participants.

Initial Approval

If the study was found to be approvable upon minor changes, timely submission of revisions will be followed by review by the Chair or Administrative Officer. If adequate changes have been made and all questions answered, immediate Board approval will be granted. If the study was deferred, resubmission to the entire Board is required. The deferral cannot be overruled by the Chair. In the case of a deferral, the Board Chair or Administrative Officer may also speak with the PI personally to facilitate the resubmission process.

Continuing Compliance

Approval is granted for a period determined appropriate to the risks involved in the study, this period cannot exceed one year (365 days). Once initial approval is granted, continued interaction with the Board is required on several occasions. These occasions are listed and covered in detail in the section Continuing Compliance.

Exempt Studies

The IRB Chair or IRB Manager and/or Administrative Officer determine whether studies meet the criteria for exemption. In this case, the PI is notified by letter. Exempt studies are filed in the IRB office with all other active studies. The investigator is responsible for reporting amendments to the protocol and closure of the study to the IRB chair. If the research extends beyond the 12 month approval, the PI must notify the IRB, in writing.

Expedited Studies

Federal regulations permit the IRB Chair or designated member to grant expedited review to those studies which qualify. This means that this IRB representative may solely approve the study and report that action to the Board. Therefore, requests for expedited review are received and processed by the IRB office on an ongoing basis. If the IRB representative determines that Full Board review is necessary, the PI is notified and the study will be on the agenda for the next Board meeting. Expedited studies are reviewed on periodic basis and have the same reporting requirements as Full Board studies.

Studies Conducted in Collaboration with OUHSC Faculty and/or Staff

The Office for Human Research Protections (OHRP) approved a cooperative agreement between the OUHSC-OKC and Norman campus IRBs. The goal of this agreement is to facilitate IRB review and avoid unnecessary duplication of effort. In most cases, review and approval by only one IRB will be necessary. Determination of which (OUHSC, Norman or both IRBs) must review and approve the project is based on several factors, including: where subjects are recruited, where the subject participation occurs, if the protocol includes medical testing and/or procedures and if a graduate thesis is involved. An investigator who plans to conduct human subjects research with an OUHSC faculty member, an OUHSC graduate student or use OUHSC facilities or other resources, is urged to contact the OU-NC IRB office here so that we can begin working with the OUHSC IRB office to facilitate the approval process.

Compliance Hotline:

To submit an anonymous complaint, contact the OU Compliance Hotline at (405) 271-2223 or
1-866-836-3150.

Contact Information: