Additional Info - IRB-HRPP
Single IRB Review
To facilitate the review and approval of multi-site human subjects research, USF may agree to rely on the review and approval of another IRB of another institution. Or another institution may seek to rely on the USF IRB. Such arrangements must be made via an IRB Authorization Agreement (AA) or similar document to outline the roles and responsibilities of the reviewing IRB and the relying institution.
USF Reliance on external IRBs:
Reliance on commercial IRBs: USF relies on the review and approval of WIRB (including the following WIRB affiliate IRBs: Aspire, New England, Copernicus and Midlands), Quorum Review IRB and Advarra IRB for the review and approval of industry-sponsored clinical trials. While these IRBs serve as the IRBs of record for certain research, the USF IRB performs an administrative review of the applications to ensure that they meet the criteria for external review. Additionally, although the reviewing IRB is responsible for conducting the ethical review of studies approved to proceed to a commercial IRB, USF is responsible for ensuring that any local context issues are addressed. Local context issues include ensuring that the study team has the appropriate expertise and experience and has completed human subjects protections training, managing any local conflicts of interest and ensuring that USF's HIPAA authorization and subject injury language is included in the consent template that will be used locally, if appropriate. The administrative review of applications to commercial IRBs allows the USF IRB to ensure that local context issues have been addressed before the study is submitted to the reviewing IRB.
Effective October 1, 2014, all industry-sponsored/FDA regulated research must be reviewed by one of the contracted independent IRBs. The USF IRB will only review FDA-regulated research for investigator-initiated studies and research requiring review by the USF Biosafety Committee (i.e. studies involving recombinant DNA).
The following is a list of research studies eligible for review by commercial IRBs:
- Phase 2, 3, and 4 industry sponsored multicenter clinical trials involving drugs and devices, registry studies or observational trials
- All research projects in which there is an institutional conflict of interest must be reviewed by Western IRB, regardless of funding
The following is a list of research studies which are not eligible for review by an external IRB:
- Investigator-initiated trials where USF faculty/staff hold the Investigational New Drug (IND) or Investigational Device Exemption (IDE) for the test article and USF investigator-initiated trials which have been determined by the FDA to be IND exempt
- Research which involves rDNA or other biological agents which must be reviewed and approved by the USF Biosafety Committee
- Studies that are sponsored by or conducted at the James A Haley Veterans Hospital
- Studies that are exempt from review or that meet the criteria for expedited review
Research eligible for review and approval by an independent commercial IRB must first be submitted to the USF IRB via ARC (eIRB) by submitting an external application (PDF). USF IRB administration will conduct an administrative review of the application and materials and will provide a letter of approval to proceed to the Principal Investigator. This letter of approval to proceed must be submitted to the reviewing commercial IRB along with that IRB's required application.
Reliance on other external IRBs (e.g. IRBs at other academic institutions): In certain instances, USF will also rely on the review and approval of other external IRBs, such as IRBs at other academic institutions. To review the criteria USF IRB administration considers in determining whether or not to rely on an external IRB, please see the USF HRPP Policy and Procedure Manual, Section 10.3, Single IRB Review (PDF). To request reliance on an IRB other than a commercial IRB, please submit an external IRB application (PDF) via ARC (eIRB). Such applications will be reviewed by USF IRB administration, who will determine whether reliance is acceptable based on the research proposed and the IRB proposed to review and provide oversight for the research.
Reliance on the Johns Hopkins All Children's Hospital (JHACH) IRB: USF can agree to cede review to the JHACH IRB for research conducted by USF researchers at JHACH. USF researchers seeking to rely on the JHACH IRB must, prior to submitting an application to the JHACH IRB, submit an external IRB application (PDF) via ARC, which will undergo an administrative review by USF IRB administration to determine whether USF can agree to cede review for the proposed research.
NIH-funded multi-site research subject to the NIH Policy on the Use of a Single IRB for Multi-Site Research: Effective January 25, 2018, all NIH-funded multi-site studies involving non-exempt human subjects research will be required to use a single IRB of record (sIRB) to conduct the ethical review of the research. USF is not currently serving as the IRB of record for NIH-funded multi-site studies. Thus, if USF is the lead site on an NIH grant, the USF IRB cannot serve as the single IRB; USF will cede the ethical review of NIH-funded multi-site studies to Western IRB (WIRB). At proposal, USF IRB administration will facilitate communication with WIRB to obtain a quote for the IRB fees portion of the budget. If USF is a subcontracting (participating site), study teams will need to consult with USF IRB administration to determine whether USF can rely on the proposed sIRB. Please see the Single IRB Guidelines (PDF) posted on ARC for more information about this process.
Another Institution's Reliance on the USF IRB:
Currently, USF is not serving as a reviewing IRB for multi-site research. If another institution wants to rely on the USF IRB, the USF PI is responsible for consulting with USF IRB administration prior to submitting an external IRB application to discuss the research and the role the relying institution's faculty will have in the research. USF IRB administration will consider reliance based on the nature of the research and the role the relying institution's faculty will have in the research. USF IRB administration reserves the right to refuse to allow another institution to rely on the USF IRB's review and approval of research.
For more information, contact the USF IRB Office at (813) 974-5638.