Office of Sponsored Research and Programs
Responsibilities and Actions of OSRP
Administrative Responsibilities of the OSRP Pertinent to IRB Functions:
The OSRP is administratively responsible for the implementation of the assurance to the Secretary of Health and Human Services. Procedures and actions of the OSRP with respect to implementation of the assurance include, but are not limited to the following:
- Assure that sufficient provisions have been made for staff and space needs in order to support the IRB’s functions;
- Monitor changes in federal regulations and guidelines and propose to policies and procedures to the IRB;
- Oversee initial training and continuing instruction of IRB members, University administrators, and any other personnel for whom federal regulations and University policy requires training regarding policies and procedures;
- Provide that research covered by the regulations will be reviewed, approved, and subjected to continuing review by the IRB;
- Assure prompt reporting to the IRB, appropriate University officials, OHRP, and any sponsoring federal department or agency head of any unanticipated injuries or problems involving risks to participants or others, any serious or continuing noncompliance with the regulations or requirements of the IRB, and any suspension or termination of IRB approval of research;
- Provide a statement of principles governing the institution in the discharging of its responsibilities in protection of the rights and welfare of human research participants;
- Provide of a list of IRB members to DHHS, identified by the requirements contained in 45 CFR 46.103(b)(3); and
- Provide satisfactory written assurance to the Secretary of Health and Human Services that the institution will comply with the requirements as set forth in the applicable federal regulations.
Actions of the OSRP upon Receipt of Notice of IRB Action from the Chairperson:
- For externally funded projects approved by the IRB, the OSRP will complete any documentation required by the funding agency, and send the documentation to the proper agency.
Revisions of Policies and Procedures:
The OSRP, in consultation with the IRB and with their approval, may implement changes of policy and procedures for the review of research involving human participants as may be consistent with currently applicable regulations, institutional requirements, and IRB experience. As changes occur in 45 CFR 46 and applicable portions of 21 CFR 50, they will be incorporated into University policy and procedures by reference, without requiring separate action by the OSRP. When Federal agencies issues new or revised guidelines and regulations , the IRB Chairperson will consult with the IRB and draft a recommendation to the OSRP regarding adoption. The OSRP will maintain a current master copy of University policy, will provide a copy of any changes in University policy to all IRB members and alternates, and will update the IRB website. Additionally, the OSRP shall determine the appropriate method of dissemination of policy and procedural changes to the University community.
IRB Policy document (Word and PDF):
IRB Policy manual (
PDF, 667 KB)
IRB Policy manual (
Word, 1.37 MB)
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