1.1 Human Research Protection Program (HRPP)

Last Revised: 1/16/2023

1.0 Purpose

The purpose of this policy and procedure is to provide a basic description of the Organization’s Human Research Protection Program (HRPP) through: 1) the Organization’s stated mission, 2) application of ethical principles to guide all human subject research under the oversight of the Organization, and 3) regulatory compliance with all applicable federal, state and local laws.


2.0 Policy

It is the policy of the Organization that the HRPP will ensure the rights and welfare of human subjects are protected, will evaluate and continually improve the protection of human research subjects, and will foster important human subject research in accordance with its mission.


3.0 Organization


4.0 HRPP Mission


5.0 Ethical Principles


6.0 Regulatory Compliance


7.0 Federalwide Assurance (FWA)


8.0 Written Policies and Procedures

The HRPP Policies detail the policies of the Organization and regulations governing conduct of research involving human subjects under the auspices of the Organization. Review and revision of these policies and procedures will be conducted in accordance with HRPP policy 1.18 (Review and Approval of HRPP Policies and Procedures).


9.0 Description of the HRPP

The HRPP is a comprehensive system to ensure the protection of human subjects participating in research. The HRPP consists of the IRBs listed in section 7.0 above, other review committees, administrative offices, and administrative officials as described in this policy.


DOCUMENT HISTORY:

 Written: 4/4/2016 (Approved: 4/4/2016) - original author not recorded

 Revised: 3/27/2018 - revision not documented

 Revised: 9/4/2018 - revision not documented

 Revised: 5/3/2021 - Added IRB-05 (SIRB) (IRB00012770) in section 7.2.5; revised sections 6.1.1.3 and 6.1.1.6 to delete and clarify references to transition to Revised Common Rule; cClarified that section 9.6.1 does not represent a complete list of ancillary committees; clarified that the Pharmacy Manager or other representative of the CHMC Pharmacy is a member of the Joint Pediatric IRB (section 9.7.3.2.2); deleted specifics of job requirements for IRB Administrators and ORA Staff (redundant to job descriptions); simplified and clarified training requirements for IRB Administrators and ORA Staff. Notification: not documented

 Revised: 1/16/2023 - Added IRB-06; specified Children’s Hospital & Medical Center (CHMC) includes Children’s Physician practice offices; clarified that Children’s Hospital and Medical Center and it’s wholly owned Children’s Physician’s Practice offices operates under the authority of the FWA held by that legal entity; deleted comment that IO is the Associate Vice-Chancellor for Clinical Research; specified that the IO is an official with sufficient standing, authority, and independence to ensure implementation and maintenance of the program; replaced “Administrator” with “Analyst”; minor stylistic changes.


Revision #30
Created 14 October 2019 14:41:29 by James Geiger
Updated 17 April 2025 15:14:20 by Robert A Lewis