Congruency between funding proposal and research protocol

1. Congruency between funding proposal and research protocol An IRB Infoshort January 2013

2. Key terms • Human Research Protocol Application (Protocol): • Description of human research activity to be conducted by a University investigator and submitted to the IRB for review. The protocol is saved in the IRB files. • Proposal/Application: • A request for financial support of a research project or activity submitted to a sponsor via Grants & Contracts Administration. The proposal is saved in the GCA database and when awarded, is administered by Grants & Contracts Financial Administration (GCFA). Congruency: A determination by the IRB that the research described in a protocol is consistent with that described in any associated proposal/application. Determination is stated in IRB approval letter and recorded in protocol database (Coeus) both for IRB purposes and for GCA to search on and record in their certification to the funding agency.

3. Protocol-proposal congruency initiative • In 2008, the University formalized the proposal-protocol congruency process between IRBs – GCA/GCFA: • Strengthened communication channels between these departments and research community • Improved upon information sharing via access to GCA proposal and IRB protocol databases (IRES and Coeus), and eRA Commons • Increased efforts to educate research community and departmental business offices on congruency requirements

4. Protocol submission/review process Human research can begin! PI submits protocol application to IRB IRB reviews protocol IRB approves protocol Yes? Federal funding? 1. The IRB ensures that the research described in the protocol and any associated sponsored project proposals are consistent (congruency) 2. Congruency noted in IRB protocol approval letter and database (Coeus) Note: If an additional/new funding source is associated with or later removed from the protocol, the PI must submit a protocol amendment to the IRB

5. Protocol review and approval: IRB must review and approve all human research protocols prior to the undertaking of the activities. Office for Human Research Protections (OHRP) - 45 CFR Part 46.103(f): Certification is required when the research is supported by a federal department or agency and not otherwise exempted or waived under §46.101(b) or (i). An institution with an approved assurance shall certify that each application or proposal for research covered by the assurance and by §46.103 of this Policy has been reviewed and approved by the IRB. Such certification must be submitted with the application or proposal or by such later date as may be prescribed by the department or agency to which the application or proposal is submitted. Under no condition shall research covered by §46.103 of the Policy be supported prior to receipt of the certification that the research has been reviewed and approved by the IRB. Regulations, guidance and policy

6. Regulations, guidance and policy OHRP's 5/31/2000 memo IRB Review of Applications for HHS Support (http://www.hhs.gov/ohrp/policy/aplrev.html) recommends that IRBs ensure that all research described in the application or proposal is entirely consistent with any corresponding protocol(s) submitted to the IRB. National Institutes of Health (NIH) Policy - Grantees must provide a certification to NIH that the research application has been approved by an appropriate IRB, consistent with 45 CFR part 46. IRB approval must have been granted within 12 months before the budget period start date to be valid.

7. challenges • Regulatory language • Proposal is often quite expansive and contains sections that are relevant to research, but not intended for IRB approval, such as animal research and budget requirements. • IRBs approve research protocols; detailed requirements of protocol review and approval criteria set forth in the IRB application are not specified sufficiently in the proposal. • OHRP Guidance contemplates a 1:1 match between the proposal and the IRB protocol; reality is that several protocols may be supported by 1 proposal, or several proposals may support 1 protocol; multi-phased research problematic with this expectation.

8. Challenges - continued “IRB Holds “on Award Set-up Holds are put on releasing funding by Grants & Contracts Financial Administration (GCFA). Most holds are due to investigator delay in either submitting the protocol to the IRB for review, or submitting an amendment request to add the funding source/proposal to an existing protocol for the IRB to review. Responsibility is on investigator to associate ALL appropriate proposal(s) with protocol(s) and to ensure that substantive changes to one are reflected in the other and reviewed/approved by the IRB. GCFA won't release funding to the investigator without confirming that we have done congruency on the award, so if the investigator hasn't associated the award with a protocol, it becomes a rather urgent request of us to review the proposal and protocol to release the funding. Changes to protocol funding source not communicated to the IRB Our records won’t be updated in a timely manner and reports that we run from our records at any given time will be inaccurate in these cases.

9. Process improvements • We are working toward getting an electronic protocol system – a fully integrated database that allows for data sharing and automatic feeds to and from GCA and IRB records, rather than the current system that relies on human interface • Increasing IRB education and outreach to departmental business managers, as well as investigators and research coordinators • Continue communication and collaboration with GCA colleagues and researchers to identify areas for improvement and to facilitate the timely approval of research.