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 hrpp@mclaren.org.
Thank you for your cooperation!
Policies and Procedures
MHC HRPP Manual
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 (Updated)
MHC_RP0113 Changes to Currently Approved Human Subject Research
MHC_RP0121 Reportable Events and UPIRSO (Updated)
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 (Updated)
MHC_RP0120 Humanitarian Use Device (HUD)
MHC_RP0125 Investigator Responsibilities
MHC_RP0127 Expanded Access of Investigational Drugs and Devices (NEW)
MHC_RP0129 Concerns, Questions, and Complaints About Human Research Studies (NEW)
Human Research Protection Program
MHC_RP0201 Human Research Protections Program
MHC_RP0202 Annual Evaluation of the Human Research Protection Program (NEW)
MHC_RP0203 Review and Management of Conflict of Interest in Research
MHC_RP0204 Emergency Preparedness Plan (NEW)
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)