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Policies & Procedures

ORI

 

Section 1 - Overview of the MUSC Human Research Protection Program

Section 1.1 - Description, Principles, and Authority for MUSC HRPP (PDF) (Effective 09/15/2016)
Section 1.2 - Organizational Charts (PDF) (Effective 09/15/2016)
Section 1.3 - Definitions of Terms (PDF) (Effective 01/21/2019)
Section 1.4 - Scientific/Scholarly Review of Protocols Policy and Procedures (PDF) (Effective 12/01/2016)
Section 1.5 - State Laws Affecting Human Subjects Research (PDF) (Effective 01/27/2012)
Section 1.6 - Communicating Conflict of Interest (COI) among IRB, ORSP, and University COI Committees (PDF) (Effective 09/15/2016)
Section 1.7 - Mentor Department and Ancillary Reviews (PDF) (Effective 10/01/2014)

Section 2 - IRB Governance & Operations

Section 2.1 - Responsibilities, Ethnical Principles, Authority, and Independence (PDF) (Effective 01/27/2012)
Section 2.2 - Functions of the IRB (PDF) (Effective 01/27/2012)
Section 2.3 - Membership of the IRB (PDF) (Effective 12/01/2016)
Section 2.4 - Approval of Research Activities by the IRB (PDF) (Effective 01/21/2019)
Section 2.5 - Convened Meetings of the IRB (PDF) (Effective 12/01/2016)
Section 2.6 - Retention of Review Activities Records of the IRB (PDF) (Effective 01/27/2012)
Section 2.7 - Management of the IRBs (PDF) (Effective 01/27/2012)

Section 3 - IRB Review Process

Section 3.1 - Human and Not Human Research Policy and Procedures (PDF) (Effective 01/21/2019)
Section 3.2 - Exempt Research Review Policy and Procedures (PDF) (Effective 01/21/2019)
Section 3.3 - Expedited Research Review Policy and Procedures (PDF) (Effective 12/01/2016)
Section 3.4 - Full Board Initial Review Policy and Procedures (PDF) (Effective 09/15/2016)
Section 3.5 - Continuing Review and Annual Status Update Policy and Procedures (PDF) (Effective 01/21/2019)
Section 3.6 - Amendment Policy and Procedures (PDF) (Effective 09/15/2016)
Section 3.7 - Case Reports Policy (PDF) (Effective 02/20/2009)
Section 3.8 - Quality Improvement Projects Policy and Procedures (PDF) (Effective 01/27/12)

Section 4 - Operational Guidelines for Human Research Protocols

Section 4.1 - Review of Research Involving Drugs or Biological Drug Products Policy and Procedures (PDF) (Effective 12/01/2016)
Section 4.2 - Single Emergency Use of an Investigational Drug Policy and Procedures (PDF) (Effective 01/27/2012)
Section 4.3 - Review of Research Involving Medical Devices Policy and Procedures (PDF) (Effective 09/15/2012)
Section 4.4 - Medical Devices Risk Determination Policy and Procedures (PDF) (Effective 12/01/2016)
Section 4.5 - Emergency Use of an Investigational Device Policy and Procedures (PDF) (Effective 05/08/2013)
Section 4.6 - Humanitarian Use Device Policy and Procedures (PDF) (Effective 05/08/2013)
Section 4.7 - Unanticipated Problems and Adverse Events Policy and Procedures (PDF) (Effective 12/01/2016)
Section 4.8 - Management of Non-Compliance Policy and Procedures (PDF) (Effective 08/08/2013)
Section 4.9 - Suspension or Termination of IRB-Approved Research (PDF) (Effective 12/01/2016)
Section 4.10 - Data and Safety Monitoring Plans (PDF) (Effective 01/27/2012)
Section 4.11 - Human Subjects Exposed to Recombinant Nucleic Acid Molecules, Biological Toxins or Microorganisms Policy and Procedures (PDF) (Effective 09/15/2016)
Section 4.12 - Clinical Trials Registration Policy and Procedures - Currently under revision
Section 4.13 - Privacy and Confidentiality (PDF) (Effective 01/27/2012)
Section 4.14 - Protocol Deviation - Policy and Procedures (PDF) (Effective 01/27/2012)
Section 4.15 - Application of Industry E6 Good Clinical Practice Requirements (PDF) (Effective 01/31/2012)

Section 5 - The Research Team

Section 5.1 - Principal Investigator Responsibilities - Supervision of Staff and Protection of Subjects (PDF) (Effective 09/15/2016)
Section 5.2 - Principal Investigator Responsibilities - Recordkeeping and Record Retention Requirements (PDF) (Effective 12/01/2016)
Section 5.3 - Education and Training Requirements for Individuals Involved in Human Research (PDF) (Effective 09/18/2017)

Section 6 - Informed Consent

Section 6.1 - Informed Consent to Participate in Research Policy and Procedures (PDF) (Effective 01/21/2019)
Section 6.2 - Waiver or Alteration of the Consent Process and Waiver of Consent Documentation - Policy and Procedures (PDF) (Effective 09/15/2016)

Section 7 - Human Subject Participation

Section 7.1 - Equitable Selection of Subjects (PDF) (Effective 01/27/2012)
Section 7.2 - Advertisements for Research Participants Policy and Procedures (PDF) (Effective 09/15/2016)
Section 7.3 - Payment for Participation Policy and Procedures (PDF) (Effective 04/01/2013)
Section 7.4 - Recruitment Incentives Policy and Procedures (PDF) (Effective 02/20/2009)
Section 7.5 - Research Involving Non-English-Speaking Subjects Policy and Procedures (PDF) (Effective 01/30/2015)
Section 7.6 - Research Subject Advocacy Policy and Procedures (PDF) (Effective 09/15/2016)
Section 7.7 - Subject Complaints, Issues, Concerns and Suggestions Policy and Procedures (PDF) (Effective 01/27/2012)
Section 7.8 - Recruitment of Research Participants (PDF) (Effective 01/21/2019)

Section 8 - Vulnerable Populations

Section 8.1 - General Guidelines (PDF) (Effective 01/27/2012)
Section 8.2 - Research Involving Persons with Impaired Decision Making Capability (PDF) (Cognitively Impaired) (Effective 01/27/2012)
Section 8.3 - Research Involving Prisoners (PDF) (Effective 01/27/2012)
Section 8.4 - Research Involving Pregnant Women, Fetuses, and Neonates (PDF) (Effective 01/27/2012)
Section 8.5 - Research Involving Children (PDF) (Effective 01/30/2015)
Section 8.6 - Research Involving MUSC Employees or MUSC Students (PDF) (Effective 02/20/2009)

Section 9 - Human Subjects Research Conducted at Multiple Sites

Section 9.1 - Off Campus Research Studies (PDF) (Effective 09/15/2016)
Section 9.2 - Management of Reporting Events in Multi-Site Research Studies Policy and Procedures (PDF) (Effective 01/27/2012)
Section 9.3 - Transnational Studies Policy and Procedures (PDF) (Effective 08/01/2012)
Section 9.4 - MUSC as Single IRB of Record (PDF) (Effective 02/23/2018)
Section 9.5 - Relying on an External IRB (PDF) (Effective 02/06/2018)

Section 10 - Quality Assurance

Section 10.1 - Human Research Audit Policy and Procedures (PDF) (Effective 09/15/2016)
Section 10.2 - Record Retention Policy (PDF) (Effective 09/15/2016)
Section 10.3 - Quality Improvement Initiatives (PDF) (Effective 09/15/2016)

Entire HRPP Guide - (PDF) (Effective 02/17/2017)
Archives to Superseded Policies and Procedure