Pol-Human Subjects Protection Program Policy Manual

policy Human Subjects Protection Program Manual modified Tue Mar 17 2020 14:12:24 GMT-0400 (Eastern Daylight Time)

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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.

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

Privacy Office Policy

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

Event Reporting

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

Duty to Report and Non-Retaliation



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.

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.