Permission to Conduct Research Involving Human Beings - Institutional Review Board (IRB)
For both ethical and legal reasons, USF requires all researchers (including students) who conduct studies involving participation of human beings to have their projects reviewed and approved by an Institutional Review Board (IRB) for the "Protection of Human Subjects" prior to the start of their studies. Virtually all doctoral studies in the College of Education will require approval by the IRB as these studies involve the use of human subjects. Doctoral students must therefore submit an application for approval of their study to the IRB. A copy of IRB Approval must be filed with the Associate Dean for Academic Affairs.
Education in the Protection of Human Subjects
Effective April 15, 2002, all USF faculty, students, and staff who plan to conduct or participate in a research study/project are required to complete training in the "Protection of Human Subjects" prior to the start of the study and must file a copy of their Certificate of Completion (of an approved program) with USF’s Division of Research Compliance and with the COEDU Associate Dean for Academic Affairs. All doctoral students prior to the start of their dissertation research must complete the required training if their proposed research will involve participation of human subjects.
Completion of the "Courses in Human Subject Protections", available on-line at web site
http://www.research.usf.edu/dric/ will meet the USF training requirements. (Be sure to read and print off all instructions before beginning the on-line program). Save and print the Certificate of Completion that is displayed when you complete the program. The doctoral candidate will need to submit a copy of the Certificate of Completion along with the Verification of Education in Human Subjects Protection form when filing an application for human subjects review and approval of his/her proposed research study with the Institutional Review Board (IRB). This application is to be submitted to the IRB at the dissertation proposal stage and prior to the involvement of human subjects in any aspect of the research study (including pilot studies, pre-testing of instruments or interventions, etc.).
The IRB approval will be contingent upon the receipt of the Certificate of Completion of the required training in the "Protection of Human Subjects" for both the doctoral candidate and his/her major professor(s). The candidate and his/her major professor(s) will receive notification from the IRB regarding approval of the application. A copy of the IRB training certificate must be filed with the Associate Dean for Academic Affairs.
NOTE: The Certificate of Completion for both the candidate and Major Professor(s) must be current for the year in which the application for IRB approval is filed. In addition, both the candidate and his/her Major Professor(s) will be expected to meet the continuing education requirement (see below) each year until the dissertation is completed.
Continuing Education Requirements
Annual re-certification in human subjects protection will be required for all research faculty, staff, and students directly involved in research with human participants. The Division of Research Compliance will offer educational programs that will be customized and up-dated each year to ensure their relevance to current needs. (For more information, please contact John Arnaldi, Coordinator of Education at (813) 974-7363 or email@example.com.)
Institutional Review Board (IRB) Forms
The forms and other relevant information needed to complete an application for human subjects review and approval by the IRB may be accessed and downloaded from USF’s Office of Sponsored Research, Division of Research Compliance web site at http://www.research.usf.edu/cs/ (click on "Forms and Templates" in the Institutional Review Board-IRB section, and then on "Social and Behavioral Studies-IRB02").
In addition to completing the IRB application form, candidates will need to complete the following forms:
- Verification of Education in Human Subjects Protection – Signature Form
- Investigator Responsibilities Certification, and
- the necessary Consent Forms or Request for Waivers of Consent Form.
An outline of the Steps for IRB-02 Protocol Review is also available at the web site. It is recommended that you review each section of this web site carefully to familiarize yourself with all IRB requirements that pertain to your research study.
At the proposal defense, the Outside Chairperson will remind the student of the necessity of the IRB review. A copy of the Certificate of Completion of Training in Human Subjects Protection must accompany the proposal when it is submitted to the COEDU Associate Dean’s Office. The Certificate of Completion and evidence of annual re-certification must be presented with the dissertation when submitting the Request for Final Oral Defense. A copy of IRB Approval of the final research protocol must be submitted to the COEDU Associate Dean for Academic Affairs.
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