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.
The president of Rice University has appointed the vice president for research (VPR) 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.
The IRB is composed of faculty and staff in the Rice community. Members are affiliated, non-affiliated and members of the surrounding community. The IRB is governed by the Department of Health and Human Services (DHHS) Federal Policy 45 CFR 46 and the Food and Drug Administration Federal Policy 21 CFR 56. 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, FWA (00003890). Rice University has one registered IRB under this assurance, IORG0002390.
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 approved research under the expedited categories.
The Human Participant Protection Plan provides regulatory oversight and administrative support to the IRB. In addition this office ensures that all research is compliant to the regulations that govern Human research.
The PI is the individual on the study that is responsible for ethical conduction of the study. These responsibilities include proper documentation and reporting to the IRB, ensuring all researchers involved in the research are adequately and properly trained. The PI is ultimately responsible for the oversight of the consent process to ensure all participants are informed properly for adequate consent to participate. The PI assumes all responsibility for compliance of federal, state, local and institutional policies. The PI may not initiate any research involving the interaction with human participants prior to the IRB approval.
Before you decide to participate in research, know the facts.
Key Quâ€‹estions to ask
YourÂ Rights as a Research Participant
Participation is voluntary and you can stop participation at any time. Your decision to stop participation will not affect services or status in which you are entitled. To report a concern, please contact the IRB Compliance Administrator.Â To report anonymously, submitÂ via the Ethicspoint Hotline.