IRB Roles & Responsibilities
Rice University, the Institution
Has instituted a Human Participant Protection Program for all faculty, staff, and students at Rice University and affiliated institutions. The program is designed to achieve and maintain regulatory compliance and ensure the safety and welfare of human participants in research.
Institutional Official (IO)
The president of Rice University has appointed the Executive Vice President for Research (EVPR) as the Institutional Official (IO) responsible for the Human Participant Protection Program. Administratively, the IRB reports to the IO. The Chair of the IRB also reports the IO. The final authority for decisions pertaining to the conduct of research and research compliance is the IO; however the institution cannot approve research that has not been approved by the IRB.
Institutional Review Board (IRB)
The IRB is composed of faculty and staff in the Rice community. Board members are Rice affiliates, persons not affiliated with Rice, and members of the surrounding community. The IRB is governed by the Office of Human Research Protections (45 CFR 46) and the Food and Drug Administration Federal Policy (21 CFR 50, 21 CFR 56, etc). The IRB has the authority to review, approve, require modifications, disapproved, suspend, or terminate all human participant research that falls under its jurisdiction. The jurisdiction of the Rice IRB is defined in its Federal Wide Assurance, FWA00003890. Rice University has one registered IRB under this assurance, IRB00003061.
Chair of the IRB
The Chair of the IRB presides at all meetings of the IRB and may assign additional duties to members as needed. The Chair acts as the IRB representative in determining research to be exempt and reviews and approves research under the expedited categories or assigns this responsibility to others on the IRB.
Office of Research Integrity
The Office of Research Integrity is responsible for the day-to-day functions of Rice's Human Research Participant Protection Program (HRPPP), which provides regulatory oversight and administrative support to the IRB. In addition this office ensures that all research is compliant with regulations that govern human participant research.
Principal Investigators (PI) and Co-Investigators (Co-I)
Per Rice University Policy 301, PI status is a “privilege granted to faculty members who hold an academic appointment in the tenure-track or research ranks. Instructional or special rank appointments do not have PI/PD Eligibility status.” Under certain circumstances, exceptions to this policy are granted, with approval by the Vice Provost for Research. A request for an exception should be made by the academic/administrative unit leader using the PI Eligibility Request Form.
The PI is the individual on the study that is responsible for the study and is the primary agent responsible to ensure that research is conducted ethically. PI responsibilities include proper documentation and reporting to the IRB, ensuring proper training for all researchers involved in the research, and maintaining information security for all study data. The PI is ultimately responsible for the oversight of the consent process to ensure all participants are properly informed to ensure that meaningful consent has been provided by all participants. The PI assumes all responsibility for compliance with federal, state, local and institutional policies. The PI is also responsible for ensuring that research is not initiated prior to IRB approval.
Before you decide to participate in research, know the facts.
Key Questions to ask
- What will happen to me in this research?
- Will there be any unpleasant side effects?
- Will the research help me personally?
- What other options do I have?
- Can I leave the study at any time?
- Will it cost me anything personally?
Your Rights as a Research Participant
Participation is voluntary and you can stop participation at any time. Your decision to stop participation will not affect any opportunity or privileges to which you are otherwise entitled. If you have any concerns about participation in a research project at Rice, please contact an IRB Compliance Administrator. To report anonymously, submit via the Ethicspoint Hotline.