Single IRB Review Jeannie Barone Director, HRPO
Presentation Agenda New NIH policy Requests for Single IRB review Investigator vs. institutional responsibilities
Current Regulations 45 CFR 46.111 (DHHS): Cooperative Research With the approval of the department or agency head, an institution participating in a cooperative project may enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for duplication of effort. 21 CFR 56.114 (FDA): Cooperative Research In complying with these regulations, institutions involved in multi institutional studies may use joint review, reliance upon the review of another qualified IRB, or similar arrangements aimed at avoidance of duplication of effort.
New NIH Policy Expectation that a single IRB of record will be used in the ethical review of non exempt human subjects research protocols funded by NIH that are multi center Effective date is May 25, 2016
New NIH Policy Scope All domestic sites of NIH funded multi site studies Research supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program Does not apply to career development, research training, or fellowship awards
Proposed Benefits (NIH FAQs on Final Policy) Streamline the IRB review process Remove redundant hurdles to the initiation of multisite studies Permit research to proceed effectively and expeditiously Reduce administrative burdens Enable IRBs to focus on single site protocols thereby enhancing research oversight
Then: One Study. Multiple sites. Review at each Institution s IRB. Now: One Study. One IRB Review. Multiple sites.
Terms you might hear Single IRB Review a legal arrangement that allows one IRB to review the research on behalf of other engaged institutions Reviewing IRB the IRB that reviews and makes required regulatory determinations (IRB of Record) Relying Institution external institution that cedes IRB responsibilities to the Reviewing IRB Reliance Agreement an agreement that outlines the responsibilities of each party
Roles and Responsibilities (Final NIH Policy) Single IRB: Conducts the initial and continuing reviews to ensure compliance with regulatory requirements. May also act as the Privacy Board for HIPAA purposes. Participating Sites: Rely on the Single IRB to carry out functions for institutional compliance. Meet other regulatory obligations obtaining informed consent, reporting unanticipated problems, communicate relevant local context and state regulations.
Roles and Responsibilities (Final NIH Policy) Single IRB Conducts the initial and continuing reviews Ensure compliance with regulatory requirements May also act as the Privacy Board for HIPAA purposes Participating Sites Rely on the Single IRB to carry out functions for institutional compliance Meet other regulatory obligations: obtaining informed consent, reporting unanticipated problems, communicate relevant local context and state regulations.
Roles and Responsibilities Applicant/Offeror (person submitting grant): Submit a plan describing the use of a Single IRB that will be the IRB of Record for all study sites. NIH acceptance will incorporate the plan into Terms and Conditions of the award. Awardees (person receiving the grant): Ensure authorization agreements are in place and ensure communication between the Single IRB and participating sites. Funding Institute or Center: Manage and oversee awards, communicate with awardee about the Single IRB compliance plan.
Exceptions to the NIH Policy Permitted when review by the proposed single IRB is prohibited by federal, tribal, or state laws, regulations or policies. Requests that are not based on legal, regulatory, or policy prohibitions will be considered if there is a compelling justification. Determination of whether an exception will be granted will take place following an assessment of the need.
Authorization and Approval Applicant/Offeror must include a plan describing the single IRB of record and a statement that the study sites will adhere to the single IRB policy Letters of support from study sites Letter of support from Human Research Protection Office Applicant/Offeror must assure that the single IRB is qualified to serve VERY IMPORTANT: Please don t commit the Pitt IRB to serve in this capacity without speaking to us first
Review Costs The primary activity of IRB review of the research protocol and template consent are covered by the grant s indirect costs. Secondary activities can be charged as direct costs with appropriate justification. Includes site specific considerations for all of the participating sites. We are currently working on a cost model.
A Note of Caution Ceding oversight only covers the IRB review piece Institutional Review Board (IRB) Office for Investigator Initiated IND/IDE Support (O3IS) Radioactive Drug Research Committee/Human Use Subcommittee (RDRC/HUSC) Institutional Biosafety Committee (IBC) Education and Compliance Office (ECO) Conflict of Interest (COI) Study Initiation Stem Cell Research Oversight Committee (SCRO)
Requesting Use of a Single IRB Contact us early in the process letter of support in RFAs if requested New request forms under A Z guidance Submit to Askirb@pitt.edu Determinations made on case by case basis Funding source Number of sites Number of studies Level of risk Approval by Institutional Official Discussions with IRB reps from sites Drafting of template agreement and SOPs
Pitt as Reviewing IRB Normal submission through OSIRIS We will work with relying sites to negotiate agreement Relying sites supply local context information Our IRB issues a template consent for all sites Consents will be watermarked once local required language is inserted
PI/Research Team Responsibilities Assisting IRB with obtaining contact information from local IRBs Presenting study to all sites and addressing any issues identified Submitting study into OSIRIS Complete workflow not yet developed Site PI/study team will need access to system Following provisions of agreement
Outside Institution is Reviewing IRB Submit a registration application through OSIRIS Research cannot begin until we provide acknowledgement Limited information is submitted to Pitt IRB Time of continuing review If the PI changes If any procedure related to an ancillary review changes If the Reviewing IRB makes a determination of serious or continuing non compliance or an unanticipated risk to subjects or others
OSIRIS EXTERNAL PATHWAY
PI/Research Team Responsibilities Complying with the reviewing IRB s policies and procedures Registering through OSIRIS Ensures completion of other institutional requirements Allows tracking of approved studies at institution Maintaining a current and accurate protocol file Including correspondence from reviewing IRB Reporting unanticipated problems to reviewing IRB
HRPO Is At Your Service askirb@pitt.edu Consultations Pre reviews General questions IRB Makes House Calls! Request on site training www.irb.pitt.edu Click on Calendar of Events irb@pitt.edu OSIRIS training/support CITI training/support IT questions