Review by the DOH IRB is required for all research involving human subjects in which the Department of Health is engaged. Researchers (employees and agents of the Department, including external researchers like people at universities) should create an application in the Department's online system, IRBWise, when they are proposing to be engaged in any of the following:

• Receiving federal funding for research passed through the Department of Health
• Interacting or intervening with human subjects, or manipulating their environment
• Using DOH facilities for research purposes, including recruitment
• Using DOH non-public individually-identifiable data for research
• Whenever the proposed activities are otherwise determined by the Department to be research requiring review under regulation and policy

The Department of Health has terminated its formal memorandum of understanding providing for its service as the Institutional Review Board for the Department of Children and Families. Research conducted at, or supported by the Department of Children and Families no longer requires review by the DOH IRB (unless the research otherwise meets the above criteria).

See DOHP-400-1.2-07 Activities Subject to IRB Jurisdiction (opens in new window)

The Food and Drug Administration now provides Information Sheets in Spanish as well as English. Go to the Resources page for the link to FDA's Information Sheets.

DOH's required research ethics training is now available in Spanish, and other languages. For more information see the CITI Program website.

Study materials read by research subjects (brochures, instructions, informed consent documents) should be written at the 6th-8th grade level. Limited
literacy has been shown to be an independent risk factor for worse health status, hospitalization and mortality. Researchers should write so that individuals with limited health literacy are able to make informed decisions.

Use this form to test the reading level. Copy the text you want to check and you will get a report of the reading level of the material.
Governor Crist signed Executive Order 07-01 directing all of Florida’s state agencies to use plain language. Writing simply and clearly helps research subjects understand what the researcher is asking them to do, and helps insure participation in research is voluntary.

Learn more about improving consent on our website and learn more about plain language at www.plainlanguage.gov

Researchers are responsible for applying for continuing review at least 60 days prior to study expiration. The DOH IRB reviews research under requirements in state law and federal regulation. Federal regulation allows no "grace period" or extensions to the requirement for continuing review. According to the Office of Human Research Protections updated Guidance from January 15, 2007:

"The IRB and investigators must plan ahead to meet required continuing
review dates. If an investigator has failed to provide continuing
review information to the IRB or the IRB has not reviewed and approved
a research study by the continuing review date specified by the IRB,
the research must stop, unless the IRB finds that it is in the best
interests of individual subjects to continue participating in the
research interventions or interactions. Enrollment of new subjects
cannot occur after the expiration of IRB approval. When continuing
review of a research protocol does not occur prior to the end of the
approval period specified by the IRB, IRB approval expires
automatically." See OHRP's Guidance on Continuing Review

The IRBWise electronic systems sends out reminders as a courtesy at 90, 60 and 30 days prior to expiration. However, researchers are responsible for securing continuing review.

Closing a study is actually a kind of continuing review. Guidance from federal officials indicates that continuing review should be "substantive and meaningful." Criteria for review of research are provided in federal regulation, and they apply even to requests to close studies. This means that IRBs are required to review requests to close studies using the criteria, which include:

• Risks to participants are minimized
• Risks are reasonable in relation to anticipated benefits

In order to make a determination that risks to participants are minimized, the IRB needs answers to questions posed in the IRBWise application.

Example: A researcher requests to close a social/behavioral study, observational in nature, that the IRB determined did not involve greater than minimal risk at time of original review. In such a case, it will be a relatively simple matter for the researcher to demonstrate to the IRB that risks to participants are minimized (because the study was originally determined to be not greater than minimal risk). Additionally, since the study design is observational (rather than an intervention study) closing the study will not end an intervention that might put participants at a disadvantage.

Example: A researcher reports that a pharmaceutical company is closing a study of an investigational drug. Assuming the IRB, at time of original review, determined the study posed greater than minimal risk, then the IRB will need information sufficient to allow it to determine that closing the study will not increase risks to participants. The research could demonstrate this by clarifying that patients are being transferred to another therapy (one that is covered by insurance, or covered by federal drug-assistance programs). Or the researcher might indicate that the study is being closed because of unanticipated problems to participants or other issues requiring prompt reporting to the IRB. The IRB may concur that closing the study indeed minimizes risks.

As these examples suggest, the level of detail the researcher needs to provide for the IRB to make a determination about study closure depends on a number of factors, including the level of risk posed by the study, and the reasons the study is being closed. It is for these reasons that the application must be detailed. Researchers are encouraged to contact the Ethics and Human Research Protection Program for technical assistance with specific questions about study closures. It's always better to create an application rather than wait until the study's aproval period has nearly expired.