Policies & Procedures

AAHRPP seal
This section includes policies and procedures that aid investigators, researchers, Institutional Review Board members, and others involved in human subject research in fulfilling their obligation to ensure that research is conducted and approved consistently and in compliance with applicable laws, regulations and MHC’s commitment to the protection of its research participants.

Persons conducting, supporting or reviewing research throughout MHC and its subsidiary hospitals should familiarize themselves with these policies and procedures. This section should be referenced regularly as policies, procedures and guidelines are revised to stay current with evolving issues and regulations related to human research.

If you wish to provide comments or suggestions on MHC HRPP policy and procedures, organization of materials on this website, or other human subject protection issues, please contact Lana Gevorkyan at lana.gevorkyan@mclaren.org

Thank you for your cooperation!

Overview of the McLaren Health Care Human Research Protections Program
HRPP Manual
Appendix I_Definitions 
MHC_RP0201 Human Research Protections Program
MHC_RP0202 Research COI Committee Procedures 

IRB Governance and Operations
MHC_RP0101 Authority of the IRB
MHC_RP0102_FWA & IRB Registration
MHC_RP0103_IRB Membership
MHC_RP0104 Determination of Human Subject Research 
MHC_RP0114 IRB Documentation and Research Record Retention
MHC_RP0124 Reporting to Regulatory Agencies and Institutional Officials
MHC_RP0126 Conflict of Interest for IRB Members

IRB Review Process
MHC_RP0104 Determination of Human Subject Research 
MHC_RP0105 Exempt Review of Human Subject Research
MHC_RP0106 Expedited Review of Human Subject Research
MHC_RP0107 Initial Review of Human Subject Research
MHC_RP0108 Full Board Review of Human Subject Research
MHC_RP0109 Criteria for Approval of Human Subject Research
MHC_RP0110 Additional Consideration during IRB Review and Approval
MHC_RP0111 Study Suspension, Termination, and Investigator Hold
MHC_RP0112 Continuing Review of Human Subject Research
MHC_RP0113 Changes to Currently Approved Research
Appendix II_MSU Approved Projects

Informed Consent
MHC_RP0115 Obtaining Informed Consent from Research Subjects

Human Subject Participants
MHC_RP0116 Vulnerable Subjects in Research

Operational Guidelines for the IRB
MHC_RP0117 Use of Medical Devices in Human Subject Research
MHC_RP0118 Use of Drugs and Biologics in Human Subject Research
MHC_RP0119 Emergency Use of Investigational Drugs and Devices
MHC_RP0120 Humanitarian Use Device

The Research Team
MHC_RP0121 Reporting Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others (UPIRSO)
MHC_RP0122 Protocol Deviations, Violations, and Exceptions
MHC_RP0123 Non-Compliance in Human Subject Research
MHC_RP0125 Investigator Responsibility
MHC_RP0127 Investigational Drugs and Biologics Used in Clinical Research
MHC_RP0128 Relying on an external IRB as an IRB of record

EQuIP
MHC_RP0301 EQuIP Overview
MHC_RP0302 QA/QI Routine Review
MHC_RP0303 Directed For-Cause Audits
MHC_RP0304 QA/QI Review of IRB Files and Operations
MHC_RP0305 Investigator Requested Services
MHC_RP0306 Education and Training in Human Subject Research