Section 7: Human Biologic Materials and Data Registries

7.1 Banking Human Biological Material

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

7.2 Use of Human Biological Material in Research

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

7.3 Data Registries

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for creation and operation of a data registry, and for research use of data from a registry.


2.0 Policy


3.0 Definitions


4.0 IRB Review and Consent Requirements for Internal Data Registries


5.0 ORA Review and Consent Requirements for External Data Registries


6.0 Research Use of Data from a Registry


DOCUMENT HISTORY:

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

 Revised: 3/2/2018 - revision not documented