Research Involving Human Subjects
It is the goal of the University's Human Research Protections Program (HRPP) to be a national model for excellence, innovation, and the advancement of knowledge while providing the highest level of protections to research participants.
The USF HRPP applies to all research involving human subjects, if:
- the research is conducted by or under the direction of any employee, student, or agent of USF (full-time, part-time, visiting, consulting, and/or without compensation) in connection with his/her USF assignment; or
- the research is conducted using any property or facility of USF or affiliated institution.
AAHRPP Accreditation
The University has received full accreditation for its Human Research Protections Program, which consists of its Institutional Review Boards, research compliance staff and administrators, and all investigators and research personnel who are responsible for the protection of human participants in research. Accreditation is the gold standard for assuring sponsors, the research community and especially human subjects participants that the university’s Human Research Protections Program is committed to operating a program that is responsible and ethical.
On June 13, 2008, the University was notified by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) that it had achieved full accreditation status. Congratulations to the IRB, the individual investigators and all of the other stakeholders within the Human Research Protections Program who participated in this challenging and ultimately rewarding process.
If you would like to learn more about the accreditation process and its significance you may also visit the AAHRPP website at www.aahrpp.org.
University Resources
- Quick Start Guide for Investigators
- Mandatory Investigator Education
- Documentation Required for Human Subjects Research Studies
- USF Institutional Review Board
- Information for Western Institutional Review Board (WIRB)
- Policies & Procedures, USF Human Research Protections Program
Excerpts:
University Federalwide Assurance
This contract between USF and the Office of Human Research Protection (OHRP) of the Department of Health and Human Services assures that Investigators conducting human subject research at USF will follow the ethical principles outlined in the Belmont report.
Ethical Principles and Guidelines for the Protection of Human Subjects of Research
- *The Belmont Report
- Declaration of Helsinki, World Medical Association
- The Nuremburg Code
Federal Regulations
- *DHHS Regulations: Policy for Protection of Human Research Subjects (Title 45 CFR Part 46, Subparts A-D)
- *FDA Regulations: Policy on Protection of Human Subjects (Title 21 CFR Part 50, Subparts A, B, D)
- *FDA Regulations: Institutional Review Boards (Title 21 CFR Part 56)
- *VA Regulations: Protection of Human Subjects (Title 38 CFR Part16)(for VA studies only)
Other Resources
- *ICMJE Requires Registration of Clinical Trials - Sept 13th 2005
As of September 13, 2005, the International Committee of Medical Journal Editors (ICMJE) requires that clinical trials be listed in a public registry before subject enrollment begins. ICMJE has determined that this requirement must be met as a condition for publication in medical journals. To register a clinical trial or to find more information about this requirement, please go to: http://prsinfo.clinicaltrials.gov/
- Human Research Participants Protections (HRPP) Online Library
- Guidelines for Human Embryonic Stem Cell Research
- Office for Human Research Protections