Institutional Review Board Approval

In order to protect human subjects it is necessary for Principal Investigators to obtain Institutional Review Board approval for research involving human subjects in a timely fashion as defined below:

    1. Principal Investigators shall obtain Institutional Review Board approval prior to initiating research projects involving human subjects and maintain current approval through project completion.

    2. All investigators, research staff, and students working on such projects are required to complete the CITI protection of human subjects course (and the Responsible Conduct of Research Course [RCR] as required by the NSF or other funder) prior to engaging in the research.  A copy of the current CITI certification should be attached to the IRB application submitted to the Office of Research Compliance.  Project-specific files with documentation of current CITI training for each person engaged in the research are to be maintained by the PI. 

    3. The PI must also document providing human subjects protocol specific training to staff members engaged in research with human subjects.  The CITI and protocol verification form is attached and should be provided to the human resources office upon hire and updated accordingly prior to employees’ involvement in new protocols involving human subjects.

    4. Upon notice of award from the funder or the Office of Shared Research Services or a Just in Time (JIT) Request, the Principal Investigator shall submit an IRB application to the Texas A&M IRB Office.

    5. For projects wherein the start-up and development phases are devoted to activities which do not involve human subjects (i.e., development of protocols and instruments), the Principal Investigator is required to submit an IRB packet and receive IRB approval prior to the project start date.  In these instances, the initial IRB application should include a statement that development of instruments, protocols, and any associated consent/assent forms is part of the project‘s work plan and as these are developed, amendments will be submitted to the IRB office prior to the initiation of any data collection activities.

    6. Continuations shall be submitted within the 60 day window allowed by the IRB office.  While notices are sent electronically to the PI, it is the PI’s responsibility to monitor IRB renewals and respond upon receipt.

    7. Amendments shall be submitted to the IRB office immediately upon changes in research protocol.

    8. Project Completion:  At the completion of the project, the Principal Investigator shall notify the IRB office via a project continuation/completion form.  For student thesis or dissertation projects, the student is responsible for submitting the completion report prior to commencement or departure from SPH.  In the event the student is not available, the thesis/dissertation chair is responsible for submitting the completion report to the IRB office.

    9. The PI shall copy the SPH Office of Research with all IRB related submissions and share copy of the IRB approval documentation for retention in project files.

 Resources: The IRB application forms, guidelines, and link to IRB training are available at http://rcb.tamu.edu/humansubjects