Roles and Responsibilities for the Protection of Human Participants in Research at the Florida Department of Health

Researchers

Assures all Investigators and key study personnel complete initial and continuing education in human research protections annually effective October 1, 2003, to remain up-to-date on Federal regulations, Department of Health policies and procedures, and compliance expectations. This entails completing the 3 to 4 required CITI modules initially, then 1 additional module or human research protection educational session annually and will provide documentation of completion to the IRB.
Adheres to Federal regulations, state and local laws, Institutional policies, and IRB policies and procedures regarding the safety and protection of human participants and Good Clinical Practice (GCP) guidelines.
Reports adverse events and unexpected problems involving risk to participants and others to the IRB according to Institutional policy, IRB policies and procedures, DSMB/Cs, sponsors and appropriate Federal agencies as required.
Assures continuing review applications are submitted in a timely manner so that their review occurs prior to their expiration date. The Investigator acknowledges that the Federal regulations do not allow a grace period. The Investigator is responsible for being aware of the current literature in his/her field of study to assure participants are no longer placed at risk if additional risks have been identified or no benefit has been proven. The Investigator should build off previously conducted research to decrease the potential for participants to be needlessly placed at risk.
Acts as a liaison between the IRB and the sponsor.
Supervises the research process. Takes responsibility for assuring key study personnel are properly trained, qualified and have appropriate facilities and resources to conduct the research. Assures adherence to the study protocol. Monitors the informed consent process. Communicates regularly and effectively with their research staff. Responsible for protection of the safety and welfare of research participants.
Assures the IRB protocol is reflected in the grant proposal for extramural or intramural support, informs the IRB of any updates or modifications to the protocol prior to their implementation and in compliance with Federal and institutional regulations.
Assures proper performance of the informed consent process. Where applicable, retains a copy of the signed and dated informed consent document in the study file and provides a copy to the research participant.
Promotes compliance and maintains documents in accordance with Federal and state regulations, and sponsor and institutional policies and procedures regarding the safety and welfare of human participants.
Reviews and approves IRB applications, amendments and adverse events prior to their submission to the IRB, as documented by their signature on the IRB application.
Assures participant privacy and confidentiality according to HIPAA guidelines, Institutional and IRB policies and procedures.

Study Coordinators and Research Staff

Under proposed policy, all key study personnel will complete initial and continuing education in human research protections annually, to remain up-to-date on Federal regulations, DOH policies and procedures, and compliance expectations. This entails completing the 3 to 4 required CITI modules initially, then 1 additional module or human research protection educational session annually and will provide documentation of completion to the IRB.
Adheres to Federal regulations, state and local laws, Institutional policies, IRB policies and procedures regarding the safety and protection of human participants and Good Clinical Practice (GCP) guidelines.
Reports adverse events and unanticipated problems involving risks to the participants and others to the IRB according to Institutional policy, IRB policies and procedures, DSMB/Cs, sponsors and appropriate Federal agencies as required.
Acts as a liaison between the IRB, the Investigator and the sponsor.
Promotes compliance and maintains documents in accordance with Federal and state regulations, and sponsor and institutional policies and procedures.
Assures participant privacy and confidentiality according to HIPAA guidelines, Institutional and IRB policies and procedures.

County Health Department Directors and Administrators, Program Directors and others who supervise researchers

Promotes compliance with Federal and state regulations, and sponsor and institutional policies and procedures regarding the safety and welfare of human participants involved in research studies initiated from their department.
Reviews and approves IRB applications prior to submission to assure the soundness of the research design, scientific and scholarly merit in relation to the departmental capacities, and adequate staff and resources to conduct the study.

Ethics and Human Research Protection Program

Assures compliance with the Department of Health's Assurance of compliance with federal regulations ("FederalWide Assurance" or "FWA")
Assures Department of Health policies and procedures are effectively applied in compliance with State and Federal laws and regulations, the FWA, OHRP, FDA, NIH, OCR and any other applicable Federal agencies.
Provides interpretation and application of Federal regulations.
Develops, implements, and interprets IRB policies and procedures.
Investigates and response to non-compliance according to IRB policies and procedures, as necessary.
Ensures adequate resource allocation and annual review of resources.
Supports and facilitates the IRB process.
Maintains ongoing educational programs for Investigators, key study personnel, IRB Committee members and IRB staff.
Participates in mandatory training as well as other ongoing educational activities to keep abreast of current events.
Provides regular training and education to IRB Committee members, and keeps the Committees abreast of current events.
Mentors and trains new staff as needed, including IRB staff, Investigators and their research staff on human subject protection and the IRB process.
Performs and documents quality assurance activities to assure compliance.
Provides internal and external monitoring which is designed to assess compliance and safety in human subjects research.
Performs directed audits and random compliance reviews. Formulates and implements, as needed, recommendations for the PI and their research staff.
Determines whether activities fall under the definition of "research" in regulation and DOH policy.

Institutional Review Board Committees

Reviews all proposed human subject research to determine that:
Risks to participants are minimized by (a) using procedures which are consistent with sound research design and which do not unnecessarily expose participants to risk, and (b) when appropriate, by using procedures already being performed on participants for diagnostic or treatment purposes;
Risks to participants are reasonable in relation to anticipated benefits, if any, to participants and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB Committee should consider only those risks and benefits that result from the research (as distinguished from risks and benefits of therapies participants would receive if not participating in the research). The IRB Committee should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility;
Selection of participants is equitable considering the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations and the potential need for additional protections, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons;
Informed consent will be sought from each prospective participant or the participant’s legally authorized representative, in accordance with, and to the extent required by Federal and State regulations and institutional policies and procedures including the IRB;
Informed consent will be appropriately documented, in accordance with, and to the extent required by the Federal and State regulations and institutional policies and procedures including the IRB;
When appropriate, the research plan makes adequate provisions for monitoring data collected to assure the safety of participants;
When appropriate, there are adequate provisions to protect privacy of participants and to maintain the confidentiality of data;
There are adequate provisions to protect the rights and welfare of vulnerable populations from coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. The IRB Committee must determine if additional safeguards need to be included in the study to protect the rights and welfare of these participants;
When appropriate, the need for ancillary care, additional monitoring, counseling, and social support are provided; and
When appropriate, the informed consent document includes the additional elements of informed consent.
Conducts timely continuing reviews of approved research, as appropriate.
Reviews all proposed human subject research in accordance with the basic ethical principals (respect for persons, beneficence, justice) of The Belmont Report.
Reviews, and has the authority to approve, require modification in, or disapprove all research activities the fall within their jurisdiction.
Participates in mandatory annual training including the required CITI training modules and keeps abreast of current events.

Revision Date: 07/22/2005