7.2 Use of Human Biological Material in Research

Last Revised: 1/25/2018

1.0 Purpose

The purpose of this policy and procedure is to describe the Organizations requirements for the use of human biological material (HBM) in research.


2.0 Policy

It is the policy of the Organization that HBM be used in research in accordance to HHS regulations at 45 CFR 46; FDA regulations at 21 CFR 50, 56; HIPAA Privacy Rule, applicable HRPP policies, and Organizational requirements.


3.0 Definitions


4.0 IRB Review and Consent Requirements


DOCUMENT HISTORY:

 Written: 1/14/2016 (Approved: 1/14/2016) - original author not recorded

 Revised: 1/25/2018 - revision not documented


Revision #6
Created 24 October 2019 21:42:45 by Autumn M Eberly
Updated 17 April 2025 16:09:07 by Robert A Lewis