MSU HRPP Manual Section 5-2-A

5-2-A, Human Research Protection Program Director

The description provided below is intended to indicate the kinds of responsibilities of the Human Research Protection Program (HRPP) director. The description shall not be construed as declaring what the specific duties and responsibilities of any particular person or position shall be. It is not intended to limit or in any way modify the right of any supervisor to assign, direct, and control the work of employees under his or her supervision. The use of a particular expression or illustration describing duties shall not be held to exclude other duties not mentioned that are of similar kind or level of difficulty. The description is not intended to limit or displace applicable Michigan State University Human Resources policies and procedures for employment.

The HRPP director shall:

  1. Uphold federal, state, and local laws and regulations, university policy and procedures, and ethical standards on the protection of human research subjects.

  2. Provide administrative oversight over all aspects of the HRPP, including the Institutional Review Board (IRB) and the Compliance offices.

  3. Support oversight activities related to clinical research activities as appropriate.

  4. Maintain communications with institutions engaged in human research, external IRBs, administrators, and others as needed.  Coordinate and manage the execution of reliance agreements with institutions engaged in research.

  5. Oversee and manage the accreditation efforts for the HRPP.

  6. Prepare and manage the budget of the HRPP.

  7. Represent the HRPP in discussions with other university units.

  8. Consult with MSU Office of General Counsel when necessary.

  9. Ensure prompt reporting to the federal government and others when required.

  10. Prepare plans for education or corrective action to be applied university-wide as a result of reports from the IRB and the Compliance office.

  11. Provide reports to the assistant vice president for the Office of Regulatory Affairs as needed.

  12. Serve as a resource regarding regulatory requirements and university policies and procedures for conducting human research.

  13. Coordinate with federal and state agencies and university internal auditors during audits.

  14. Coordinate the generation, review, and distribution of metrics.

  15. Coordinate evaluation and quality improvement activities as needed.

  16. Perform other projects or tasks as assigned.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 8-22-2011. Revision 1 approved by Assistant VP Regulatory Affairs on 12-10-2015.

Related HRPP Manual Sections

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