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investigational drugs or devices are used, the investigator is responsible for providing written procedures for their storage, security, dispensing and disposal.
10.7 McLaren Legal Counsel’s Office
The McLaren HRPP relies on the MHC Corporate Counsel for the interpretations and applications of State law and the laws of any other jurisdiction where research is conducted as they apply to human subjects’ research.
Legal Counsel at MHC advises on human-subjects research issues and legal requirements; research compliance matters; research integrity and related misconduct investigations; conflicts of interest questions. Their work related to human subject protection includes, for example, drafting IRB Authorization Agreements, Letters of Resolutions, Investigator Agreements, advising on project-specific issues (e.g., child, who can serve as a legally authorized representative or guardian, informed consent, confidentiality), counseling on privacy requirements, assisting in investigations of alleged noncompliance, advising on liability issues, and generally interpreting and advising on new and existing legal requirements and conflicts between applicable laws. When there are any conflicts between federal or national law and other applicable laws, the Legal Counsel will determine the appropriate resolution.
McLaren Legal Counsel has a close working relationship with McLaren’s Human Research Protections Program. Frequent conversations, meetings, and e-mail exchanges take place on a wide range of research issues on protection of human subjects.
10.8 Other Related Units:
10.8.1 McLaren Center for Research and Innovation (MCRI):
The McLaren Center for Research and Innovation has a centralized clinical trial infrastructure which streamlines operations while maintaining efficiencies and conducting research in compliance with federal and state regulations.
The MCRI is designed to provide centralized management of all the activities associated with research from pre-award to post-award and includes:
1) The centralized clinical trials office,
2) The office of research protocol feasibility,
3) The office of research contracts and budget negotiations and 4) The office of research fund management.
All clinical trials that are conducted through the MCRI are required to follow the MCRI contract review process.
Human Research Protections Program Manual McLaren Health Care
Revised 12/1/16
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