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Leadership Function: Corporate Human Research Protections Program (HRPP)
Description:
McLaren’s Human Research Protections Program is a centralized system to ensure the
protection of the rights and welfare of subjects and compliance with the highest legal and ethical standards in Human Research. The Corporate HRPP covers all research involving human subjects that is under the auspices of the McLaren and has jurisdiction over all human-subjects research conducted at MHC and its subsidiary hospitals and clinics.
The HRPP is a multi layered system to ensure the protection of human subjects participating in research. The Program is comprised of the following components: Institutional Review Board (IRB), Office of Education, Training and Resources, Office of Research Compliance and Quality Improvement.
Expectations in Working Together:
Role Manager:
Role HRPP Department:
1. Take an active role in understanding and supporting the corporate HRPP.
2. Support and educate staff on human research protections program and direct them to the HRPP when questions are arising. Ensure that everyone involved in human subject research is up to date with the required training.
3. Ensure that all human subject research is submitted to the Corporate IRB and is conducted in accordance with federal, state and corporate policies.
4. Understand and support corporate policies and procedures regarding research involving human subjects. Implement new policies and procedures when applicable.
5. Understand and comply with requirements of the Research Record Retention and record Destruction as stated in the Corporate Policies for all human subject research conducted by your department.
6. Report potential serious or continuing non-compliance with applicable regulations or institutional policies to the IRB.
7. Report potential conflict of interest in Research
1. HRPP is responsible for ensuring compliance with federal regulations, state law and corporate policies. Monitor changes in regulations and policies that relate to human research protection.
2. Provide education, training and resources to everyone involved in human research. Provide support and guidance. Provide Researchers and Research Coordinators with quality improvement recommendations to ensure that research is conducted in accordance with good clinical practice guidelines
3. The IRB prospectively reviews and makes decisions concerning all human research conducted at MHC subsidiary hospitals’ facilities, by its employees or agents, or under its auspices.
4. Act as a resource to MHC and its subsidiary hospitals and clinics in the development of internal policies and procedures in regards to conducting human subject research.
5. Provide guidance and assistance when needed.
6. Perform routine on-site reviews of any study that has been approved by the IRB. Investigate allegations and findings of non-compliance.
7. Ensure any conflict of interest in research which could affect the design, conduct or reporting or educational activities be disclosed and eliminated or managed as appropriate.
8. Can provide guidance with the IRB submission, creation of regulatory binders and set-up. Face-to face meetings with new researchers as needed and/or requested