Pol-Human Subjects Protection Program Policy Manual
policy Human Subjects Protection Program Manual modified Thu Nov 17 2022 09:45:34 GMT-0500 (Eastern Standard Time)
University of Louisville
OFFICIAL
UNIVERSITY
ADMINISTRATIVE
POLICY
POLICY NAME
Human Subjects Protection Program Policy Manual
EFFECTIVE DATE
September 1, 2015
POLICY NUMBER
HSPPO-4.01
POLICY APPLICABILITY
This policy applies to University Sponsors, Researchers, Research Staff, Research Participants, and Institutional Review Board.
REASON FOR POLICY
To comply with applicable federal and state laws and regulations and the Association for the Accreditation of Human Research Protection Programs (AAHRPP) standards.
POLICY STATEMENT
The University of Louisville has and follows written policies and procedures setting forth the ethical standards and practices of the Human Research Protection Program:
Policy |
Manual Location |
Action for Failure to Obtain Required Subject Authorization for the Use of Protected Health Information |
|
Authority of the UofL IRB |
HRPP Chapter 6.1 |
Institutional Review Board Membership |
HRPP Chapter 6 |
IRB Report of Findings Policy |
HRPP Chapter 3.6 |
Lapse in Approval (Continuation Review) |
HRPP Chapter 3.5 |
Local Adverse Events, External Adverse Events, UPIRTSOs |
|
Paying Human Subjects Policy |
HRPP Chapter 10.4, Guide 030 |
Suspension or Termination of Previously Approved Research |
HRPP Chapter 3.5 |
University of Louisville Non-Compliance Policy |
HRPP Chapter 3 |
University of Louisville Non-Retaliation Policy |
DEFINITIONS
See HSPP Policy Manual, Appendix 3.
ADMINISTRATIVE AUTHORITY
Executive Vice President for Research and Innovation
RESPONSIBLE UNIVERSITY DEPARTMENT/DIVISION
Human Subjects Protection Program
Med Center One, Suite 200
501 E. Broadway
Louisville, KY 40202
502-852-5188
hsppofc@louisville.edu
HISTORY
Revision Date(s): January 1, 2020
Reviewed Date(s):
The University Policy and Procedure Library is updated regularly. In order to ensure a printed copy of this document is current, please access it online at http://louisville.edu/policies.