IRB Policies & Procedures

UCF Research Policy 4-202

ORC Conflict of Interest Policies & Disclosures

SUBJECT:

University of Central Florida
Institutional Review Board
(UCFIRB)
Policies and Procedures Manual

Effective Date:
6-09-08

Policy Number:

Supersedes:
4-26-06

Page 1 Of 47

Responsible Authority:

Associate Vice President for Research

APPLICABILITY/ACCOUNTABILITY:

This policy applies to all employees and students of the University of Central Florida who are involved in research, development, and other activities involving human participants, whether funded or not, for which the University of Central Florida is responsible.

POLICY STATEMENT:

All research, development, and other activities involving human participants, whether funded or not, for which the University of Central Florida is responsible must have a protocol that is submitted to and approved by the University of Central Florida Institutional Review Board (IRB) before any research activity is conducted. All projects involving human participants must be conducted by, or under the supervision of, a faculty member or other acceptable researcher. The UCFIRB will establish its own policies and procedures to receive and review research protocols, to approve those protocols, and to monitor the projects defined in those protocols.

INSTITUTIONAL ASSURANCE AND IRB REGISTRATION:

UCF maintains one Institutional Review Board which operates under FWA#00000351 approved by the Office for Human Research Protections (OHRP). All collaborators on federally-conducted or – supported human subjects research that is not otherwise exempt, will have an assurance of compliance approved by OHRP or another OHRP acceptable means of assuring compliance (e.g., Independent Investigator Agreement). Where appropriate a Department of Defense assurance will substitute for a federalwide assurance. The Federalwide Assurance will be renewed every three years.

IRB is registered by the federal government under IRB#00001138, IORG#0000781. This registration requires renewal every three years by the Department of Health and Human Services (DHHS).

PROCEDURES:

Principal Investigators will submit research protocols to the IRB in the format directed by the IRB. Principal Investigators will provide all necessary information for the IRB to evaluate the research protocol, to assess any approved projects under the protocol, and to monitor the compliance of any approved projects with both the protocol and federal, state, and university regulations governing research.

INITIATING AUTHORITY:

Thomas O’Neal, Associate Vice President for Research