When students, staff, and/or faculty conduct research at Â鶹´«Ã½ City University that involves human participants, an application to the Institutional Review Board (IRB) is required by University policy. IRB approval is required PRIOR to the initiation of any research project that includes human subjects.
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized 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.
The IRB performs the review to protect the rights and welfare of human subjects involved in research and to assist the investigator and the University in the mutual obligation to comply with all federal, state and Â鶹´«Ã½ policies with respect to these subjects. IRB approval must be obtained if any of the following circumstances apply:
- The research is sponsored by Â鶹´«Ã½;
- The research is conducted by or under the direction of any Â鶹´«Ã½ employee or student in connection with his or her responsibilities;
- The research is conducted by or under the direction of any Â鶹´«Ã½ employee or student using any subjects, property or facility at Â鶹´«Ã½ or any location identified with the University; and
- The research involves the use of Â鶹´«Ã½â€™s non-public information to identify or contact human research subjects or prospective subjects.
Graduate student research involving human subjects conducted in conjunction with a thesis or other graduation requirement must be reviewed by this committee. Graduate and undergraduate student research projects that are for educational purposes only and that involve human subjects may require IRB review. Such classroom projects that involve human participants are not subject to review if and only if: (1) the research does not include topics of a sensitive or personal nature; (2) the participants in the study will be limited to Â鶹´«Ã½ students who volunteer to participate; (3) no minors (individuals under 18 years of age) or other protected groups are involved in the research; and (4) the project will not involve dissemination of any kind (including but not limited to public presentation outside of the classroom, publication, posting of findings on a webpage, etc. are ordinarily exempt from this process. When IRB review is not required it is recommended that faculty members who assign such projects require the students to complete a similar application and serve as the review board for the students’ projects, in order to educate students about the process of completing and submitting an application to the IRB.
The Office of Human Research Protections, an office within the U.S. Department of Health and Human Service (HHS), offers comprehensive training on human research protections based on the requirements of the revised Common Rule (or 2018 Requirements). A printable completion certificate is available at the conclusion of each lesson. Note that OHRP does not collect information about who accesses or completes this training. It is incumbent upon the researcher to maintain their certificate.
For the purposes of student research at Â鶹´«Ã½: Certificates from Lessons 1, 2, and 3 are the minimum requirements to accompany an IRB application, although faculty may require all 5 modules as a part of coursework. Students and faculty with Human Subjects Certificates that are less than 5 years since certification will be considered valid until the five year renewal date or 2029 (whichever comes first).
Faculty requirements are the completion of all 5 modules for purposes of supervising or the conducting of research.
All modules will need to be printed and scanned for submission with the IRB application.
Certification from other certificate-granting bodies (example: CITI) will be honored until renewal date or 2029 (whichever comes first).
A completed Institutional Review Board Application Form along with a copy of the protocol and consent form (if necessary), and any supporting documentation should be submitted to:
Mark McClendon
Director for Assessment and Institutional Research
[email protected]
(405)208-5088
The application must include the following:
- Institutional Review Board Application Form () ()
- Research Protocol
- Consent Form () ()
- Questionnaires/surveys (required if used)
- Advertisements (required if used)
- Copy of certificate(s) of completion of Protecting Human Research Participants (PHRP) course for each Project Director and Co-Project Director named on the application form.
The chairperson of the IRB will perform the initial review of the application to see if there are problems easily found and corrected, and to determine whether the proposed research meets the criteria for exempt or expedited review status (see the following sections), or whether the proposed research must be reviewed by the full IRB. After this review the chairperson of the IRB will notify the Project Director (PD) of any action, or of any need for revision.
For any proposed research that requires full IRB review the appropriateness of the protocol will be examined in relationship to the research question. The risks to the subjects will be compared to the direct benefit. The involvement of protected groups will be assessed. The consent form will be assessed in detail to ensure that the purpose is conveyed accurately, the study is described in sufficient detail for the subject to decide what is involved, and the risks and benefits are outlined. The PD may be invited to attend the IRB meeting. Four outcomes are possible:
- Approval
- Approval contingent upon changes or clarifications
- Deferral with the protocol and/or consent form needing significant revision before submission can be reviewed again by the Committee.
- Disapproval.
Following full IRB review a letter to the PD outlining the IRB’s decision concerning the study will be prepared. If applicable, the letter will address the steps and changes needed to re-submit the study to the IRB. The letter will be ordinarily be available 48 hours after the IRB’s meeting.
