Office for Research Subjects (ORS) & Research Administration (ORA) In-Sync to Help Make your Research Happen Stephanie Gaudreau, Sr.Research Subjects Specialist, ORS LaVonne Sumler, Sr. Research Administrator, ORA

IRB Review of Grant Proposals  Department of Health and Human Services (DHHS) regulations at 45CFR46.103(f) require that each application or proposal for HHS- supported human subject research be reviewed and approved by the Institutional Review Board.

IRB Review of Grant Proposals  JHSPH Federal Wide Assurance (FWA # ) with DHHS states that the JHSPH IRB will review all research – regardless of the funding source (private, HHS, or industry)

IRB Review of Grant Proposals  Spring 2008 – Revised NIH Policy NIH no longer requires IRB review and approval either at the time of proposal submission or within 60 days of the submission. Investigators should only proceed with IRB review when they have been assigned a “fundable” score

IRB Review of Grant Proposals  NIH WILL NOT MAKE ANY GRANT AWARDS WIHOUT IRB APPROVAL

IRB Review of Grant Proposals What portion of the grant must be Submitted for IRB review?  Investigators must submit a copy of the entire proposal (including budget pages). The IRB cannot review a protocol unless the entire grant application has been submitted.

IRB Review of Grant Proposals  What is the IRB reviewing? Overall, the grant proposal must be found to be consistent with the information contained in the research plan Specific aims and objectives Background and significance Research design and methods

IRB Review of Grant Proposals  Description of human subjects involvement: Number of subjects, age range, health status, and inclusion/exclusion criteria Sources of research material (specimens, records and/or data) Plans for recruitment of subjects

IRB Review of Grant Proposals  Description of human subjects involvement (continued)… Potential Risks Procedures for protecting and minimizing risks Risk-benefit ratio

IRB Review of Grant Proposals  Description of human subjects involvement (continued)… Consortium/Contractual Agreements Consultants

IRB Review of Grant Proposals  What will happen if the research plan is found to be inconsistent with the grant proposal? The IRB protocol must be consistent with the grant proposal. Any discrepancies will require the PI to either amend the current protocol or to submit a new protocol that is consistent with the grant application

IRB Review of Grant Proposals  What is a planning phase approval? Some projects that involve human subjects include an initial planning phase in which human subjects will not take part (45 CFR ) Development of research instruments Study design Performance of animal studies Hiring of research personnel

IRB Review of Grant Proposals  Planning phase… If you request a planning phase review, you must submit an entire copy of the grant proposal

IRB Review of Grant Proposals  Planning Phase…

IRB Review of Grant Proposals  If the IRB grants a planning phase approval, funds will be released for your proposed activities  Initiation of contact with human subjects (for research purposes) is not permitted during the approved planning phase portion of a study

IRB Review of Grant Proposals  Prior to the start of the implementation phase of your study, an amendment to the planning phase application must be submitted, and IRB approval obtained, before contact with human subjects is initiated.

Research Administration Review of Grant Proposals  Reviewer checks the Compliance Section, question #2 of the eIS. The response is verified by language in the Abstract and line items of the Proposal Budget. Discrepancies are discussed with departmental administration.

Research Administration Review of Awards  Upon receipt of the award, Reviewer requests a copy of the IRB Approval Letter. Significant differences in the Protocol title and the Proposal/Award title are discussed with the ORS Specialist. Additional documentation may be requested.

ORA Initiates Account Number Assignment Process  Appropriate documents are scanned for retrieval by Shared Services. Once the budget number is assigned the department is notified.

THE RESEARCH BEGINS!!! Questions? Comments? Stephanie Gaudreau LaVonne Sumler