Office of Research Integrity and Outreach

HRPP Policies and Procedures

The Human Research Protection Program (HRPP) Policies and Procedures listed on this site are subject to change while the Office of Research Integrity and Outreach is in the process of becoming accredited by the Association for the Accreditation of Human Research Protection Program (AHHRP). Any approved changes and edits to any of the HRPP Policies and Procedures will be uploaded to the website.  

HRPP 001 Student Classroom Projects (pdf)

HRPP 002 Protocol Violations (pdf)

HRPP 003 External Human Subjects Research conducted within the USM Community (pdf)

HRPP 004 Non-Compliance (pdf)

HRPP 005 Departing Primary Investigator (PI) (pdf)

HRPP 006 Unanticipated Problems & Adverse Events (pdf)

HRPP 007 Social Work Undergraduate Student Projects (pdf)

HRPP 008 Determination of Activities Requiring IRB Review (pdf)

HRPP 009 Conduct of IRB Meetings (pdf)

HRPP 010 Exempt Determinations (pdf)

HRPP 011 Ethical and Legal Principles (pdf)

HRPP 012 Authority of the Human Research Protection Program and Institutional Official (pdf)

HRPP 014 Humanitarian Use Devices (pdf)

HRPP 015 Emergency Use (of drug, biologic, or device) (pdf)

HRPP 016 USM as Business Associate Component (pdf)

HRPP 017 HIPAA in Research (pdf)

HRPP 018 IBC Coordination (pdf)

HRPP 019 IRB Minutes (pdf)

HRPP 020 Anonymous and De-identified Data (pdf)

HRPP 021 IRB [Board] Composition and Membership (pdf)

HRPP 022 IRB Use of Additional Expertise (Consultants) (pdf)

HRPP 023 IRB Member and IRB Staff Conflict of Interest (pdf)

HRPP 024 Registration and Maintenance of Clinical Trials.gov (pdf)

HRPP 025 Initial and Continuing Review at IRB Meetings (pdf)

HRPP 026 Study Closure (pdf)

HRPP 027 Expedited Initial Review (pdf)

HRPP 028 IRB Reliance (pdf)

HRPP 029 Informed Consent (pdf)

HRPP 030 Continuing Review (pdf)

HRPP 031 Education Requirements (pdf)

HRPP 032 Vulnerable Subjects (pdf)

HRPP 033 IRB Member Evaluation (pdf)

HRPP 034 Mandated Reporting to External Agencies (pdf)

HRPP 035 Roles and Responsibilities of Investigators (pdf)

HRPP 036 Standard Operating Procedures (pdf)

HRPP 037 Scientific Review (pdf)

HRPP 038 International Research (pdf)

HRPP 039 Research Concerns (pdf)

HRPP 040 IRB Review of Modifications (pdf)

HRPP 041 Termination or Suspension of Research (pdf)

HRPP 042 Data & Safety Monitoring (pdf)

HRPP 043 Recordkeeping (pdf)

HRPP 044 Quality Improvement (pdf)

HRPP 045 Financial Conflict of Interest (pdf)

HRPP 046 Outreach Activities (pdf)

HRPP 047 Recruitment and Screening (pdf)

HRPP 048 Privacy and Confidentiality (pdf)

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University of Maine System HIPAA Policies

University of Southern Maine HIPAA Policies

Exemption to UMS W-9 Policy (pdf)

University of Maine System Institutional Review Policy – IRB Review of UMS Cooperative Research (UMS 601.1)

Information Security Policies & Standards