Policies & Procedures
Section 1 - Overview of the MUSC Human Research Protection Program
Section
1.1 - Description, Principles and Authority for MUSC HRPP (Effective
02/20/09)
Section
1.2 - Organizational Charts (Effective 02/20/09)
Section
1.3 - Definitions of Terms (Effective 02/20/09)
Section
1.4 - Scientific/Scholarly Review of Protocols Policy and Procedures (Effective
02/20/09)
Section
1.5 - State Laws Affecting Human Subjects Research (Effective
02/20/09)
Section
1.6 - Communicating Conflict of Interest (COI) among IRB, ORSP and University COI Committees
Section 2 - IRB Governance and Operations
Section 2.1 - Responsibilities, Ethnical Principles, Authority and Independence
Section 2.2 - Functions of the IRB
Section 2.3 - Membership of the IRB
Section 2.4 - Approval of Research Activities by the IRB
Section 2.5 - Convened Meetings of the IRB
Section 2.6 - Retention of Review Activities Records of the IRB
Section 2.7 - Management of the IRBs
Section 3 - IRB Review Process
Section
3.1 - Human and Not Human Research Policy and Procedures (Effective
02/20/09)
Section
3.2 - Exempt Research Review Policy and Procedures (Effective
02/20/09)
Section
3.3 - Expedited Research Review Policy and Procedures (Effective
02/20/09)
Section
3.4 - Full Board Initial Review Policy and Procedures (Effective
02/20/09)
Section
3.5 - Full Board Continuing Review Policy and Procedures (Effective
02/20/09)
Section
3.6 - Full Board Amendment Policy and Procedures (Effective
02/20/09)
Section
3.7 - Case Reports Policy (Effective 02/20/09)
Section
4 - Operational Guidelines for Human Research Protocols
Section
4.1 - Review of Research Involving Drugs or Biological Drug Products Policy and Procedures (Effective 02/20/09)
Section
4.2 - Single Emergency Use of an Investigational Drug Policy
and Procedures (Effective 02/20/09)
Section
4.3 - Review of Research Involving Medical Devices Policy and
Procedures (Effective 02/20/09)
Section
4.4 - Medical Devices Risk Determination Policy and Procedures (Effective 02/20/09)
Section
4.5 - Emergency Use of an Investigational Device Policy and Procedures (Effective
02/20/09)
Section
4.6 - Humanitarian Use Device Policy and Procedures (Effective
02/20/09)
Section
4.7 - Unanticipated Problems and Adverse Events Policy and Procedures (Effective 02/20/09)
Section
4.8 - Management of Non-Compliance Policy and Procedures (Effective
02/20/09)
Section
4.9 - Suspension or Termination of IRB-Approved Research (Effective
02/20/09)
Section
4.10 - Data and Safety Monitoring Plans (Effective
02/20/09)
Section
4.11 - Human Gene Transfer Studies Policy and Procedures (Effective
02/20/09)
Section
4.12 - Clinical Trials Registration Policy and Procedures (Effective
02/20/09)
Section
4.13 - Privacy and Confidentiality(Effective
02/20/09)
Section
5 - The Research Team
Section
5.1 - Principal Investigator Responsibilities - Supervision of
Staff and Protection of Subjects (Effective 02/20/09)
Section
5.2 - Principal Investigator Responsibilities - Recordkeeping
and Record Retention Requirements (Effective 02/20/09)
Section
5.3 - Education and Training Requirements for Individuals Involved
in Human Research (Effective 02/20/09)
Section
6 - Informed Consent
Section
6.1 - Informed Consent to Participate in Research Policy and
Procedures (Effective 02/20/09)
Section
6.2 - Hyperlinks to IRB Informed Consent Information and Guidance (Effective
02/20/09)
Section
7 - Human Subject Participation
Section
7.1 - Equitable Selection of Subjects (Effective
02/20/09)
Section
7.2 - Advertisements for Research Participants Policy and Procedures (Effective
02/20/09)
Section
7.3 - Payment for Participation Policy and Procedures (Effective
02/20/09)
Section
7.4 - Recruitment Incentives Policy
and Procedures (Effective 02/20/09)
Section
7.5 - Research Involving Non-English-Speaking Subjects Policy and Procedures (Effective 02/20/09)
Section
7.6 - Research Subject Advocacy Policy and Procedures (Effective 02/20/09)
Section 7.7 - Subject Complaints, Issues, Concerns and Suggestions Policy and Procedures
Section
8 - Vulnerable Populations
Section 8.1 - General Guidelines
Section 8.2 - Research Involving Persons with Impaired Decision Making Capability (Cognitively Impaired)
Section 8.3 - Research Involving Prisoners
Section 8.4 - Research Involving Pregnant Women, Fetuses, and Neonates
Section 8.5 - Research Involving Children
Section 8.6 - Research Involving MUSC Employees or MUSC Students
Section 9 - Human Subjects
Research Conducted at Multiple Sites
Section
9.1 - Multi-Site Research Studies Policy and Procedures (Effective
02/20/09)
Section
9.2 - Management of Reporting Events in Multi-Site Research Studies
Policy and Procedures (Effective 02/20/09)
Section
10 - Quality Assurance
Section
10.1 - Human Research Audit Policy and Procedures (Effective
02/20/09)
Section
10.2 - Record Retention Policy (Effective 02/20/09)
Section
10.3 - Quality Improvement Initiatives (Effective 02/20/09)
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