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Contracts, Grants, and Sponsor Agreements

The Department of Health works with sponsors and funding agencies to ensure that the benefits of knowledge obtained through research are realized and that the interests of current and future research participants are protected.

Section I: DOH reviews all contracts, grants, or other funding agreements agreements in their entirety.

  • All such grants, contracts, and other funding agreements must be uploaded in IRBWise.
  • Applications where research is funded will be returned if the funding agreement is not uploaded in IRBWise.
  • The IRB must review the final approved grant, contract or funding agreement, and cannot grant approval based on a draft agreements.
  • The table below outlines requirement and suggests example language; other language may meet these requirements
  • DOH determines whether contracts meet standards required by DOH as part of its commitment to AAHRPP accreditation

Section II: Requirements and sample language

The Florida Department of Health works with public, industry, and private
Sponsors to apply the requirements of the Human Research Protection Program to all participants. (AAHRPP Standard I-8)

Examples

Research in which DOH is engaged has a written agreement with the Sponsor that addresses medical care for research participants with a research-related injury, when appropriate. (AAHRPP Element I.8.A) Contracts or other funding agreements indicate:
  • who will provide care and,
  • who is responsible to pay for medical care for research participants with a research-related injur
  • This requirement may not apply to studies that do not involve clinical procedures or require medical care for injuries.
  • Example: Institution agrees to provide or arrange for prompt diagnosis and medical treatment of any Research Injury experienced by a Study subject. Sponsor agrees to pay the actual cost of diagnostic procedures and medical treatment necessary to treat a Research Injury.
  • Example: UNIVERSITY agrees to provide or arrange for diagnosis and medical treatment of research related injury in study subjects. The SPONSOR agrees that it, and not UNIVERSITY, is responsible for the costs of diagnosis, care and treatment of any undesirable side effects, adverse reactions, illness or injury to a participant in the Clinical Trial which in the reasonable judgment of the Principal Investigator or UNIVERSITY are determined to result from participation in the Clinical Trial, except for such costs that arise directly from (i) the negligent activities, reckless misconduct or intentional misconduct of UNIVERSITY, the Principal Investigator or his/her staff or (ii) their failure to adhere to the terms of the Protocol.
In studies where Sponsors conduct research site monitoring visits or conduct monitoring activities remotely, research in which DOH is engaged has a written agreement with the Sponsor that the Sponsor promptly reports to the investigator or investigator’s university findings that could affect the safety of participants or influence the conduct of the study. (AAHRPP Element I.8.B.) Contracts or other funding agreements require the Sponsor to promptly report to the university any findings that could:
  • Affect the safety of participants.
  • Influence the conduct of the study.
  • This requirement does not apply if the Sponsor does not conduct site visits or conduct remote monitoring.
  • Example: Sponsor will promptly notify Investigator [or Institution] of any monitoring findings that could affect the safety of subjects, or influence the conduct of the Study.
  • Example: Sponsor will promptly notify Investigator [or Institution]of any findings of serious or continuing non-compliance detected during the monitoring process that could affect the safety of participants or influence the conduct of the study.
  • Example: Sponsor will promptly notify Investigator [or Institution]of any monitoring findings that could affect the safety of subjects or their willingness to continue participating in the Study, influence the conduct of the Study, or alter the IRB's approval to continue the Study.
  • Example: SPONSOR agrees: (a) to promptly notify the Principal Investigator and/or the IRB directly, of (i) non-compliance with the study protocol or applicable laws, particularly those laws related to human research subjects, that could impact the safety or welfare of participating subjects, (ii) serious adverse events that have been reported to the FDA or other governmental agency in relation to the Clinical Trial at this or any other site, (iii) unanticipated problems in the Clinical Trial at this or any other site that could relate to risks to participating subjects, and (iv) circumstances that could affect subjects’ willingness to continue to participate in the Clinical Trial or the IRB’s continuing approval of the Clinical Trial.
When the Sponsor has the responsibility to conduct data and safety monitoring, DOH or the investigator’s university has a written agreement for research in which it is engaged that addresses provisions for monitoring the data to ensure the safety of participants and for providing data and safety monitoring reports to the DOH. (AAHRPP Element I.8.C.) Contracts or other funding agreements specify
  • that data and safety monitoring plans are provided prior to IRB approval of the research.
  • the time frame for providing routine and urgent data and safety monitoring reports to DOH.
  • This requirement does not apply it the sponsor does not have responsibility for conducting data and safety monitoring.
  • Example: Sponsor agrees to provide data and safety monitoring plans for review by the IRB prior to its approval of the research, and agrees to provide routine safety monitoring reports at continuing review, and urgent reports immediately.
Before initiating research, the Organization has a written agreement with the Sponsor about plans for disseminating findings from the research and the roles that Researchers and Sponsors will play in the publication or disclosure of results. (AAHRPP Element I.8.D.) Contracts or other funding agreements require the Sponsor to
  • follow the Organization’s policies and procedures regarding the publication of findings from sponsored research.
  • Example: Sponsor agrees to follow DOH agency policies concerning publication.
  • Example: Sponsor agrees to follow agency policies concerning publication of research results. Sponsor also agrees to provide DOH an opportunity to comment in advance of publication, and to include reference to DOH as a research location in any publication.
When participant safety could be directly affected by study results after the study has ended, DOH or the university has a written agreement for research in which it is engaged that the Sponsor will notify the Researcher of the results in order to consider informing participants. (AAHRPP Element I.8.E.)
  • Contracts or other funding agreements describe the steps followed to communicate findings from a closed research study to the Researcher or Organization when those findings directly affect participant safety.
  • Contracts or other funding agreements specify a time frame after closure of the study during which the Sponsor will communicate such findings (e.g., two years).
  • Example: Sponsor agrees to develop with Investigator a plan of communication to subjects that is acceptable to the DOH IRB when new findings or results of the Study might impact the willingness of subjects to continue to participate in the Study or directly affect their current or future safety or medical care.
  • Example: Sponsor agrees to notify, for a period not greater than two years, Investigator of any findings that directly affect safety of participants.
  • Example: Sponsor agrees to notify Investigator of any findings that directly affect safety of participants until test article is approved for marketing by FDA, or an application for marketing is withdrawn.

Section III: For DOH Researchers: Grant Applications must be reviewed by DOH before they can be submitted to the funding agency

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 (Access requires a DOH user account; not accessible to those outside DOH)

http://dohiws.doh.state.fl.us/Divisions/Administration/Rev_Mgt/Policies/DOHP57-01-08index.htm