McLaren Health Care
Research Policies and Procedures

IRB Policies & Procedures

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 email the HRPP office at

Thank you for your cooperation!


Policies and Procedures 


MHC_RP0100 Definitions

IRB Purview

MHC_RP0101  Authority and Responsibility of the IRB

MHC_RP0102  The Federal-wide Assurance and Institutional Review Board Registrations

MHC_RP0103  IRB Membership

MHC_RP0104  Determination of Human Subject Research

MHC_RP0124  Reporting to Regulatory Agencies and Institutional Officials

MHC_RP0126  Conflict of Interest:  IRB Members

MHC_RP0128  Relying on an External IRB as an IRB of Record

Review Mechanisms

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 IRB Approval of Research

MHC_RP0110   Additional Consideration during IRB Review and Approval of Research

MHC_RP0111   Study Suspension, Termination, and Investigator Hold

MHC_RP0112   Continuing Review of Human Subject Research

MHC_RP0113   Changes to Currently Approved Human Subject Research

MHC_RP0121   Reportable Events and UPIRSO

MHC_RP0122   Protocol Violations and Exceptions

MHC_RP0123   Non-Compliance in Human Subject Research

Record Keeping

MHC_RP0114   IRB Documentation and Research Record Retention

Special Requirements

MHC_RP0115   Obtaining Informed Consent from Research Subjects

MHC_RP0116   Vulnerable Subjects in Research

MHC_RP0117   Use of Medical Devices in Human Research

MHC_RP0118  Use of Drugs and Biologics in Human Subject Research

MHC_RP0119   Emergency Use of a Test Article

MHC_RP0120   Humanitarian Use Device (HUD)

MHC_RP0125   Investigator Responsibilities

MHC_RP0127  Expanded Access of Investigational Drugs and Devices

MHC_RP0129  Concerns, Questions, and Complaints About Human Research Studies

Human Research Protection Program

MHC_RP0201  Human Research Protections Program

MHC_RP0202  Annual Evaluation of the Human Research Protection Program

MHC_RP0203  Review and Management of Conflict of Interest in Research

MHC_RP0204  Emergency Preparedness Plan

Education and Quality Improvement Program

MHC_RP0301 Education ad Quality Improvement Program-EQuIP

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

MHC_RP0500 Transition and IRB Review of Research Subject to the Revised 2018 Common Rule

Revised Common Rule

Common Rule

Pre-2018 Common Rule Policies

Example Waiver of Informed Consent (pre 2018 Common Rule)
Example Waiver of Documentation of Informed Consent (pre 2018 Common Rule)
Translation Requirements Guidance (pre 2018 Common Rule)