Human Research Protection Program
Ensuring medical research for patients is consistently promoted in a safe environment.
Human Research Protection Program
Ensuring medical research for patients is consistently promoted in a safe environment.
What is the Human Research Protection Program?
The Human Research Protection Program and the Broward Health IRB, together with employees and staff of Broward Health, will:
- Review and approve research proposals according to the ethical principles and guidelines of the Belmont Report, the applicable sections of the Code of Federal Regulations, and the International Conference of Harmonization Good Clinical Practice guidelines
- Safeguard the rights, welfare, and dignity of the human subjects who participate in the research process
- Promote the highest ethical standards for conducting research; and
- Provide a strong foundation of knowledge and cooperative education to facilitate the conduct of biomedical and behavioral research.
IRB Manager
IRB forms will be accessible through IRBManager, which is our web portal where study files will be maintained.
Download IRBManager User Guide Here
IRBManager is an electronic management system that supports electronic submissions of new studies and requests to the Broward Health IRB. The system will support a portal to include all study and researcher data, and storage of all documents submitted to the IRB to include:
- IRB approvals
- Informed consent documents
- IRB expirations
- Electronic signatures
- IRB notifications
- Distribution and tracking of study documents.
The system is 21 CFR, Part 11 compliant.
Other Capabilities:
- Includes audit trail history
- Smartforms which redirect users to applicable questions only
- Users can easily find documents/studies with a keyword search
