Dual IRB Review

Review by the DOH IRB is required when researchers are engaged in research involving the Florida Department of Health. Many universities and other organizations also require their own review, even if the research is conducted at the Florida Department of Health.

Multiple IRB review

When researchers have to apply for review by the DOH IRB, and their own institution's IRB--even when the research only involves the Florida Department of Health--this is called multiple IRB review, or dual IRB review. Review by multiple IRBs:

can result in delays, and
requires additional administrative time completing applications for IRB review at multiple institutions, and
can lead to compliance violations (for example, if researchers do not maintain a single consent form approved by both IRBs, and do not obtain approval from both IRBs prior to making changes in research), and
can delay the start of industry-sponsored research and cause sponsors to withdraw research, or reduce the number of participants that can be enrolled at the local site

The Florida Department of Health reviews all research involving the Department; no research may occur involving the Department without initial review and approval, and continuing approval from the DOH IRB. The Department is not able to recognize review by external IRBs.

University	Dual IRB required (University requires its own review in addition to DOH's when University researchers conduct research at DOH)	For more information
Florida Atlantic University	Yes	NA
Florida International University	Yes	NA
Florida State University	Yes; FSU's IRB opted to continue dual IRB review	NA
Nova Southeastern University	Yes	NA
University of Central Florida	Dual IRB review NOT required--UCF researchers only need review by the DOH IRB	Researchers should contact the University of Central Florida Institutional Review Board
University of Florida - Gainsville	Yes	NA
University of Florida - Jacksonville	Yes	NA
University of Miami	Dual IRB review NOT required--UM researchers only need review by the DOH IRB	Researchers should contact the University of Miami Human Subjects Research Office
University of North Florida	Yes	NA
University of South Florida	Dual IRB review NOT required--USF researchers only need review by the DOH IRB	Researchers should contact the Division of Research Integrity and Compliance

Options for coordinating IRB review

Institutions have flexibility in how they can recognizing DOH's review when their personnel (for example, faculty, students and other researchers) conduct research involving DOH. This only applies for researchers conducting research involving DOH--these agreements do not involve DOH agreeing to take over IRB functions for another institution.

Single project agreement: A University or other organization can recognize DOH's review of a particular project (for example, if the researcher is requesting review by the DOH IRB to access birth data or other registry data). This reduces duplicate review for at least a single project; the organization needs to update information with OHRP.
Agreement based on type of research: A University or other organization can agree to recognize DOH's review for a type of research--for example, research not greater than minimal risk, or social and behavioral research. This is an intermediate option in terms of reducing duplicate review and the administrative work of updating information with OHRP.
Agreement to rely on DOH's review for all research where the University's researchers are conducting research at DOH. This provides the highest level of coordination, and the greatest reduction in administrative overhead. This option makes researchers more competitive because it reduces the time required for IRB review.

Case study: University of South Florida researchers: multiple IRB review no long required
The University of South Florida agreed to recognize DOH's review for all research whenever their researchers conduct research involving the Department, appreciating the fact that review by DOH's fully accredited IRB can be trusted. This includes studies involving DOH data (for example, birth records), interviews and surveys, and FDA-regulated drug and device studies. USF's decision is an example of how DOH's full accreditation from the Association for Accreditation of Human Research Protection Program benefits researchers.

USF researchers no longer need to wait for review by both USF and DOH, and do not require duplicate IRB review.
USF researchers should continue to apply for review by the Florida Department of Health IRB when engaged research involving the Florida Department of Health
USF researchers no longer need to apply for IRB review from the USF IRB when engaged in research involving the Florida Department of Health