The NIH has released its final policy on the use of central IRBs for multi-site research. Starting May 2017, in multi-site studies in the United States involving non-exempt human subjects research funded by the National Institutes of Health (NIH), research institutions will be expected to use a single Institutional Review Board (sIRB) to conduct the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subjects at 45 CFR Part 46. Limited exceptions to the rule are provided, primarily to accommodate prohibitions established by federal, tribal, or state laws, regulations, or policies.
As stated by NIH, the goal of the policy is to “enhance and streamline the IRB review process in the context of multisite research so that research can proceed as effectively and expeditiously as possible. Eliminating duplicative IRB review is expected to reduce unnecessary administrative burdens and systemic inefficiencies without diminishing human subjects protections. The shift in workload away from conducting redundant reviews is also expected to allow IRBs to concentrate more time and attention on the review of single site protocols, thereby enhancing research oversight.”
Institutions applying for grants to fund multi-site research will need to submit a plan describing the use of an sIRB that will be selected to serve as the IRB of record for all study sites. The policy outlines several other administrative responsibilities for the institution (applicant).
Participating sites also have specific responsibilities. For example, they are responsible for meeting other regulatory obligations, such as obtaining informed consent, overseeing the implementation of the approved protocol, and reporting unanticipated problems and study progress to the sIRB.
Thousands of investigators, patient advocacy groups, institutions and others filed comments with the agency during the public comment period. Some commenters expressed concerns that the proposed policy does not recognize the time and effort needed to identify and establish a single IRB of record, including negotiating and executing authorization agreements and standard operating procedures, conducting study initiation meetings, creating account activities, and modifying information technology (IT) systems.
HRP is prepared to help institutions comply with the new policy
HRP has helped institutions to establish and implement procedures to comply with regulations, policies, and accreditation standards and to ensure appropriate local oversight of research and protection of human subjects. Despite relying on an sIRB, organizations still hold overall responsibility for the oversight and conduct of the research. HRP can partner with you to develop reliance agreements that meet the needs of all parties and to develop internal processes to ensure that all organizational responsibilities are fulfilled while streamlining the process. HRP’s expertise includes:
• Development of customized policies, procedures, forms and checklists
• Evaluation and development of human research protection programs (HRPPs), policies, and processes
• Evaluation and development of IRB policies and processes
• Training and education
BRANY offers a “Connected IRB”
BRANY offers an AAHRPP-accredited IRB to institutions. BRANY IRB’s experience with a wide variety of institutions and sponsors has led to the development of the unique “Connected IRB” model. Understanding that institutions need to remain connected to the research conducted throughout their organization, BRANY includes in its processes the mechanisms to keep key institutional personnel apprised of all pertinent research matters throughout the course of a clinical research study.
This policy represents a significant shift in how protocol reviews are conducted for federally funded research. Institutions needing assistance in this transition can rely on their partners at HRP Consulting and at BRANY.