Institutional Review Board Standard Guidance and Education

Below you’ll find a list of the most current SLHS Standard Guidelines. We review our guidelines for adherence to current FDA and Institutional regulations every three years to ensure compliance. Our guidelines are in direct accordance with SLHS policies and procedures available on the internal portal for SLHS faculty and staff.

IRB Administrative Standard Guidance

• HRPP Handbook (PDF)
• Statement of Compliance (PDF)

Training and Education

Any individual engaged in human subjects research (co-investigators, study coordinators, research nurses, etc.) conducted on behalf of SLHS must complete and maintain current certification of training for Human Subjects Research Protections.

Collaborative IRB Training Initiative (CITI) is a web-based educational program in the ethics of human subject research and may be used for core initial certification as well as continuing education requirements. The program may be accessed at the Collaborative IRB Training (CITI) website.

Investigators who come from other institutions are encouraged to achieve certification as SLHS as soon as possible. We will accept written evidence of certification in human subject protection from another institution for up to one year. Investigators at other institutions, who are named on a SLHS IRB protocol and do not obtain consent do not need to be certified.

HIPAA Privacy Rule and Research

We serve as the HIPAA Privacy Board for Research. The HIPAA Privacy Rule establishes the conditions under which Protected Health Information (PHI) may be used or disclosed by covered entities for research purposes. SLHS is a covered entity and as such, must abide by the HIPAA Rules for the use and disclosure of PHI under its jurisdiction (see 45 CRR 160 and 164).

Reliant Review

Participating institutions utilize the Reliant Review model to streamline our review process. The Reliant Review model relies on a simplified agreement that focuses on 45 CFR 46 and 21 CFR 50 and 56 (human subjects’ protections). One Consortium institution serves as the Reviewing IRB for a given protocol; also referred to as the IRB of record (IRBR). Collaborating institutions, designated as Relying IRBs (RIRB), agree to accept the research review and oversight of the IRBR for the life of the protocol. Currently, the model serves biomedical and social behavioral research, industry sponsored and investigator initiated protocols, any phase of clinical trials, and any risk determination.

The Reviewing IRB focuses on regulations regarding human subject protections, but does not review for local requirements. Local requirements, such as Key Personnel/ HSP Certification, Department Review, Conflict of Interest, Coverage Analysis, Radiation Safety, Recombinant DNA, etc. must be met and are the responsibility of the local study team.

At SLHS, a Reliant Review Form is submitted via iMEDRIS to inform us of the plan to rely on another institution and to address local requirements. Submit the application early in the process to encourage timely acceptance of a Reliant Review study.

Ongoing and regular communication during the initial Reliant Review process, and for the duration of the study, between the lead principal investigator (PI) and the Relying PI’s is crucial for the review process and to ensure that all sites are conducting the research according to the most currently approved protocol.

Definitions:

Principal Investigator (PI): The PI for the study at the Reviewing IRB institution. The PI coordinates study activity across all sites, to ensure clear communication of study related information, consistent adherence to the protocol, and regulatory compliance.

Relying Investigator: The PI at the relying institution(s). The Relying Investigator is responsible for ensuring that all local protocol requirements are met prior to acceptance, and for communicating with the local IRB.

Relying IRB(s): The IRB(s) at the collaborating site(s) for the study. The Relying IRB receives the Reliance Request from the Reviewing IRB and administratively reviews the attached documents. The Reliance is accepted or declined. If accepted, the Relying IRB agrees to accept the Reviewing IRB’s determinations for the duration of the protocol.

Reviewing IRB: The IRB at the lead site for an inter-institutional study; responsible for initial approval of the research and all subsequent review and oversight. Also sometimes called the IRB of Record.