The Department of Health works with sponsors to ensure that the benefits of knowledge obtained through research are realized and that the interests of current and future research participants are protected.
Before initiating research, DOH insures there is a written agreement with the Sponsor about plans for disseminating findings from the research and the roles that investigators and sponsors will play in publication or disclosure of results. Contracts or other funding agreements require the Sponsor to follow DOH's policies and procedures regarding the publication of findings from sponsored research.
When participant safety or medical care could be directly affected by study results, DOH addresses in the written agreement with the Sponsor how results will be communicated to study participants. Contracts and other funding agreements are required to describe the steps followed to communicate results from a research study to participants when those results directly affect their safety or medical care.
The document, "Approved Additions to Clinical Trial Agreements" satisfies all DOH requirements about agreements with Sponsors.
The Bureau of Revenue Management at the Florida Department of Health maintains a policy on grants, including grants for research. Before a grant involving research involving human subjects can be approved by the Department and sent to the funding agency, the applicant must complete an application with the DOH IRB. The application does not have to be approved by the IRB prior to grant submission, but the IRB application must be submitted.
The policy is located on the DOH intranet, available to DOH employees, at the following address (not accessible to those outside DOH)
http://dohiws.doh.state.fl.us/Divisions/Administration/Rev_Mgt/Policies/DOHP57-01-08index.htm