Institutional Review Board
Institutional Review Board
The United States Department of Health and Human Services (DHHS) and Ozarks Technical Community College (OTC) have established standards and guidelines to protect individuals who may be at risk as a consequence of participation in a research activity. The Institutional Review Board for the Protection of Human Participants (IRB) is responsible for insuring that adequate safeguards are established to protect any individual who may be at risk as a consequence of participation in research activities.
Standards for the committee’s review are based upon:
- Protection of Human Subjects – Code of Federal Regulations, 45 CFR 46
- Standards for Privacy of Individually Identifiable Health Information, 45 CFR 160 and 164
Researchers are encouraged to refer to these codes in planning their research.
To what does this policy apply? All research undertaken by the college personnel that involved human participants in any way, regardless of the source of funds, must be reviewed and approved by the IRB before activity is undertaken. This includes activities in which a faculty member us supervising student research activities.
According to 45 CFR 46, “Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
The Health Insurance Portability and Accountability Act (HIPAA) imposes additional requirements for those involved in the collection, use, retention and destruction of research data that includes protected health information (PHI). According to 45 CFR 165.501, protected health information is defined, in part, as individually identifiable health information transmitted or maintained in electronic or any other form or medium.
All research projects must be renewed annually. Renewals (without changes) are sent directly to the IRB chair and typically require only a brief review. Any meaningful changes in procedures must also be reviewed. Applications involving changes in approved procedures are sent to the division representative.
1. The lead OTC person for the proposed project is to complete the application in the format described in steps 1-8 of the Instructions for the Human Participates Protection Application, which appears below.
2. Additional information related to the project is to be included with the application (e.g. individual consent forms, survey instruments, flyers to be disseminated or other written information to be distributed to participants).
3. Certification of completion of required training is also to be included with the application.
a. Human Participant Protection Training: All faculty, staff, and students involved in the design, collection and/or analysis of data in projects involving human participants must complete the online training module entitled “Protecting Human Research Participants”, sponsored by the National Institute of Health: http://phrp.nihtraining.com/. The Certificate of Completion available at the completion of the training module is to be printed out and submitted with the application to the IRB. If a certificate has already been filed with a previous application, please indicate by checking the appropriate line of the Human Participants Protection Application Cover Sheet. All persons that will be involved in the design, collection and/or analysis of data must be listed on the application. If necessary, attach a separate sheet of paper to the cover page listing additional project personnel.
4. The lead OTC person should submit one application to the IRB representative for their division. This is particularly useful if the applicant has any questions about the review process. The division representatives are as follows:
|John Clayton||Research & Strategic Planningfirstname.lastname@example.org|
|Dr. John Gambon||General Educationemail@example.com|
|Celeste Johns||Business & Marketingfirstname.lastname@example.org|
|Aaron Light||Allied Healthemail@example.com|
|Kim Sutton||Technical Educationfirstname.lastname@example.org|
Applicants outside of the academic divisions should submit applications to the Institutional Research representative. It is suggested that an additional copy be retained by the applicant.
5. The IRB division representative will review the application and recommend its approval as either exempt, expedited, or requires full committee review. The recommendation and application will be forwarded to the institutional research representative who will approve the application as either exempt, expedited, or requiring full committee review. If exempt or expedited the institutional research representative will notify the applicant. If the application is recommended for full committee review, the institutional research representative will distribute copies of the application to the IRB members and schedule a meeting of the IRB.
6. The committee encourages, but does not require, investigators to submit their proposals to peer review from within their department and to include results from the peer review with the application. Applications may be submitted at any time. Time required for review depends upon the time of year and whether full committee review is necessary. Exempt and expedited proposals generally should be reviewed within 2 weeks. Full committee reviews will be conducted on an “as needed” basis, but can be expected to require one month from the date of submission.
7. If an application is to be considered by the full committee, the applicant will be notified and invited to attend the meeting at which the application will be discussed. Action of the committee will be followed by written notification to the applicant. If the application is not approved, changes recommended by the IRB must be completed before resubmission. In this case, the applicant is encouraged to work with their division representative to ensure that the proposal addresses all IRB concerns. Applicants should be aware that neither the division representative nor the institutional research representative is empowered to disapprove research. Disapproval of a research project must be done through a vote of the IRB. Hence, in discussing modifications to procedures with the division representative, disagreements may be resolved in the full committee. All applicants have the right to have applications considered by the full committee.
8. Additional information on ethical use of human participants is available in 45 CFR 46 and from the Office of Human Research Protections (OHRP) at http://www.hhs.gov/ohrp/ .
The decision of the IRB regarding the proposed activity will be based on the content of the application, so care should be exercised to ensure that it is completed carefully and completely. Approval of an application which omits substantive information regarding procedures to be used cannot be construed as approval of the research project. Any substantive changes in the project must be approved by the IRB, except those changes necessary to eliminate apparent immediate hazards to the participant which shall be promptly reported to the IRB.
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