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Help For Committee Members and Staff

• Are risks to subjects minimized?
• Does the researcher make adequate provisions to protect the privacy interests of participants?
• Does the researcher make adequate provisions to maintain the confidentiality of data?
• Are Risks to Subjects Reasonable in Relation to Anticipated Benefits?
• Exculpatory language
• Determining the Level of Risk
• Is selection of subjects equitable?
• Is there adequate scientific or scholarly rationale?
• Is there an adequate process for obtaining informed consent?
• Are there adequate provisions for documenting consent?

THE FLORIDA DEPARTMENT OF HEALTH ANNOUNCES ACCREDITATION OF HUMAN RESEARCH PROTECTION PROGRAM

Help for Researchers and Study Personnel

• Contracts
• Investigators serving as sponsors
• Scientific or Scholarly Rationale or Purpose
• Waiver of the Requirement to Obtain Written Documentation of the Consent Process (Option #1)
• Describe how the Investigator has the resources necessary to protect participants before conducting the research study
• Research involving data registries
• Basic Elements of Informed Consent
• Continuing Review Subject Information Questions
• Procedures used in research
• Risks and potential benefits

Rule 64H-2.002 Institutional Review Board Applications

Researchers

• Contact the Ethics and Human Research Protection Program at DOH
• Institutional Review Board Membership
• Roles and Responsibilities
• Policies
• Data Registry Research
• Online Application
• Education
• Frequently Asked Questions
• Improving Informed Consent
• Create User Account

Participants

• Contact the Ethics and Human Research Protection Program at DOH
• Research in Florida
• Ask questions, discuss problems or concerns or file a complaint, or request information, or offer suggestions.

Ethics and Human Research Protection Program

Ethics and Human Research Protection Program