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1.11 HRPP Access to Legal Counsel

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for HRPP access to legal counsel for the purpose of interpreting federal, state, and local law as needed.

2.0 Policy

It is the policy of the Organization that the HRPP will have ready access to legal counsel in order to ensure the correct interpretation and application of federal, state, and local law. When laws or regulations are issued or amended, the appropriate component of the HRPP will be advised in a timely manner and any necessary actions taken in accordance with effective dates.

3.0 Procedures

  • 3.1. The IRB and ORA have immediate access to legal counsel. Depending upon the issue, consultation will be obtained from one or more of the following individuals:
    • 3.1.1. UNMC Chief Compliance Officer
    • 3.1.2. UNMC Associate General Counsel
    • 3.1.3. UN Senior Associate General Counsel
    • 3.1.4. UN Associate General Counsel
    • 3.1.5. CHMC General Counsel and Assistant General Counsel
    • 3.1.6. CHMC Compliance Officer / Privacy Officer
  • 3.2. The UNMC Chief Compliance Officer regularly attends meetings of IRB-01 and IRB-02 and is, therefore, available to address legal issues which arise during the meeting.
  • 3.3. The CHMC Assistant General Counsel attends meetings of IRB-04 as often as possible, and is available by telephone to address legal issues which arise during the meeting.
  • 3.4. The Assistant Vice-Chancellor for Regulatory Affairs and the UNMC Chief Compliance Officer are responsible for advising the IO, the IRB and other HRPP components of new applicable legislation, as well as changes in interpretation of laws that impact human subject protection.

DOCUMENT

ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:HISTORY:

REVISEDWritten: FEBRUARY5/6/2016 2,(Approved: 20185/6/2016) - original author not recorded

INITIALRevised: MAY2/2/2018 6,- 2016revision not documented

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