7.1 Banking Human Biological Material

Last Revised: 1/25/2018

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for banking human biological material (HBM) for future research. Subsequent use of stored HBM in research is addressed in HRPP policy 7.2 (Use of Human Biological Material in Research).


2.0 Policy

It is the policy of the Organization that excess or additional HBM may be collected for future unspecified research as part of an addendum study attached to another protocol, or as a free standing tissue banking protocol, in accordance to HHS regulations at 45 CFR 46, HIPAA Privacy Rule, other applicable HRPP policies and Organizational requirements.


3.0 Definitions


4.0 IRB Review and Consent Requirements


5.0 Commercialization of Banked Human Biological Material


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 21:42:31 by Autumn M Eberly
Updated 17 April 2025 16:08:56 by Robert A Lewis