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Archives to Prior Version of Revised Policies & Superseded Policies

Research Integrity

Superceeded Policies

IRB Policies & Procedures (PDF) - Entire Guide Superceeded 11/01/2008

Revised Policy & Procedures - Prior Policy Versions

Versions are listed below by effective date. Click the effective date to open the archived document.

HRPP 1.1 - Description, Principles, & Authority for MUSC HRPP

02/20/2009 (PDF) (archived 12/01/2009)

12/01/2009 (PDF) (archived 10/01/2010)

10/01/2010 (PDF) (archived 01/27/2012)

01/27/2012 (PDF) (archived 09/15/2016)

HRPP 1.2 - MUSC Organization

02/20/2009 (PDF) (archived 01/27/2012)

01/27/2012 (PDF) (archived 09/15/2016)

HRPP 1.3 - Definitions of Terms

02/20/2009 (PDF) (archived 01/27/2012)

01/27/2012 (PDF) (archived 05/08/2013)

05/08/2013 (PDF) (archived 01/21/2019)

HRPP 1.4 - Scientific/Scholarly Review of Protocols Policy & Procedures

02/20/2009 (PDF) (archived 01/27/2012)

01/27/2012 (PDF) (archived 12/01/2016)

HRPP 1.5 - State Laws Affecting Human Subjects Research

02/20/2009 (PDF) (archived 01/27/2012)

HRPP 1.6 - Communicating Conflict of Interest (COI)

09/10/2009 (PDF) (archived 01/27/2012)

HRPP 2.1 - Responsibilities Ethical Principal Authority & Independence of the IRB

02/20/2009 (PDF) (archived 01/27/2012)

HRPP 2.2 - Functions of the IRB

02/20/2009 (PDF) (archived 01/27/2012)

HRPP 2.3 - Membership of the IRB

02/20/2009 (PDF) (archived 01/27/2012)

01/27/2012 (PDF) (archived 05/15/2012)

05/15/2012 (PDF) (archived 08/01/2012)

08/01/2012 (PDF) (archived 12/01/2016)

HRPP 2.4 - Approval of Research Activities by the IRB

02/20/2009 (PDF) (archived 01/27/2012)

01/27/2012 (PDF) (archived 01/21/2019)

HRPP 2.5 - Convened Meetings of the IRB

02/20/2009 (PDF) (archived 01/27/2012)

01/27/2012 (PDF) (archived 05/15/2012)

05/15/2012 (PDF) (archived 12/01/2016)

HRPP 2.6 - Retention of Review Activities Records of the IRB

02/20/2009 (PDF) (archived 01/27/2012)

HRPP 2.7 - Management of the IRBs

02/20/2009 (PDF) (archived 01/27/2012)

HRPP 3.1 - Human & Not Human Research Policy & Procedures

02/20/2009 (PDF) (archived 12/01/2009)

12/01/2009 (PDF) (archived 01/27/2012)

01/27/2012 (PDF) (archived 01/21/2019)

HRPP 3.2 - Exempt Research Review Policy & Procedures

02/20/2009 (PDF) (archived 01/27/2012)

01/27/2012 (PDF) (archived 09/16/2013)

09/16/2013 (PDF) (archived 05/30/2014) 

05/30/2014 (PDF) (archived 10/01/2014) 

10/01/2014 (PDF) (archived 12/01/2016)

12/01/2016 (PDF) (archived 01/21/2019)

HRPP 3.3 - Expedited Research Review Policy & Procedures

02/20/2009 (PDF) (archived 12/01/2009)

12/01/2009 (PDF) (archived 01/27/2012)

01/27/2012 (PDF) (archived 05/30/2014) 

05/30/2014 (PDF) (archived 10/01/2014)

10/01/2014 (PDF) (archived 12/01/2016)

HRPP 3.4 - Full Board Initial Review Policy & Procedures

02/20/2009 (PDF) (archived 01/27/2012)

01/27/2012 (PDF) (archived 05/30/2014)

05/30/2014 (PDF) (archived 10/01/2014)

10/01/2014 (PDF) (archived 0/01/2014)

01/28/2016 (PDF) (archived 09/15/2016)

HRPP 3.5 - Full Board Continuing Review Policy & Procedures

02/20/2009 (PDF) (archived 01/27/2012)

01/27/2012 (PDF) (archived 01/21/2019

Renamed Continuing Review Policy & Procedures on 05/30/2014

01/27/2012 (PDF) (archived 05/30/2014)

05/30/2014 (PDF) (archived 01/28/2016)

01/28/2016 (PDF) (archived 09/15/2016)

HRPP 3.6 - Full Board Amendment Policy & Procedures

02/20/2009 (PDF) (archived 01/27/2012)

Renamed Modifications to Approved Research Policy & Procedures on 5/30/2014

 01/27/2012 (PDF) (archived 05/30/2014)

05/30/2014 (PDF) (archived 09/15/2016)

HRPP 3.8 - Quality Improvement Projects Policy & Procedures

10/01/2010 (PDF) (archived 01/27/2012)

01/27/2012 (PDF) (archived 03/04/2019)

HRPP 4.1 - Review of Research involving Drugs or Biological Drug Products

02/20/2009 (PDF) (archived 01/27/2012)

01/27/2012 (PDF) (archived 2/01/2016)

HRPP 4.2 - Single Emergency Use of an Investigational Drug

02/20/2009 (PDF) (archived 01/27/2012)

HRPP 4.3 - Review of Research Involving Medical Devices

02/20/2009 (PDF) (archived 01/27/2012)

01/27/2012 (PDF) (archived 08/01/2012)

HRPP 4.4 - Medical Devices Risk Determination Policy & Procedures

02/20/2009 (PDF) (archived 12/01/2009)

12/01/2009 (PDF) (archived 01/27/2012) 

01/27/2012 (PDF) (archived 12/01/2016)

HRPP 4.5 - Emergency Use of an Investigational Device Policy & Procedures

02/20/2009 (PDF) (archived 01/27/2012)

01/27/2012 (PDF) (archived 05/08/2013)

HRPP 4.6 - Humanitarian Use Device

02/20/2009 (PDF) (archived 01/27/2012)

01/27/2012 (PDF) (archived 05/08/2013)

HRPP 4.7 - Unanticipated Problems & Adverse Events Policy & Procedures

02/20/2009 (PDF) (archived 10/01/2010)

10/01/2010 (PDF) (archived 01/27/2012)

01/27/2012 (PDF) (archived 08/01/2012)

08/01/2012 (PDF) (archived 12/01/2016)

HRPP 4.8 - Management of Non-Compliance Policy & Procedures

02/20/2009 (PDF) (archived 01/27/2012)

HRPP 4.9 - Suspension or Termination of IRB-Approved Research

02/20/2009 (PDF) (archived 01/27/2012)

01/27/2012 (PDF) (archived 08/08/2013)

08/08/2013 (PDF) (archived 12/01/2016)

HRPP 4.10 - Data & Safety Monitoring Plans

02/20/2009 (PDF) (archived 01/27/2012)

HRPP 4.11 - Human Gene Transfer Studies Policy & Procedures

02/20/2009 (PDF) (archived 12/01/2009)

12/01/2009 (PDF) (archived 01/27/2012)

01/27/2012 (PDF) (archived 09/15/2016)

HRPP 4.12 - Clinical Trials Registration

02/20/2009 (PDF) (archived 01/27/2012)

HRPP 4.13 - Privacy & Confidentiality

02/20/2009 (PDF) (archived 12/01/2009) 

12/01/2009 (PDF) (archived 01/27/2012)

HRPP 4.14 - Protocol Deviation Policy & Procedures

11/01/2010 (PDF) (archived 01/27/2012)

HRPP 5.1 - Principal Investigator Responsibilities - Supervision of Staff & Protection of Subjects

02/20/2009 (PDF) (archived 11/15/2009)

11/15/2009 (PDF) (archived 01/27/2012)

HRPP 5.2 - Principal Investigator Responsibilities - Recordkeeping and Record Retention

02/20/2009 (PDF) (archived 01/27/2012)

01/27/2012 (PDF)  (archived 12/01/2016)

HRPP 5.3 - Education and Training Requirements for Individuals Involved in Human Research

02/20/2009 (PDF)  (archived 01/27/2012)

01/27/2012 (PDF)  (archived 08/01/2012)

08/01/2012 (PDF)  (archived 09/18/2017)

HRPP 6.1 - Informed Consent to Participate in Research Policy and Procedures

02/20/2009 (PDF)  (archived 04/27/2010)

09/26/2009 (PDF) (archived 09/22/2010)

09/22/2010 (PDF) (archived 10/13/2010)

10/13/2010 (PDF)  (archived 01/27/2012)

01/27/2012 (PDF)  (archived 01/30/2015)

01/30/2015 (PDF) (archived 12/01/2016)

12/01/2016 (PDF)  (archived 01/17/2017)

01/17/2017 (PDF) (archived 07/17/2017)

07/17/2017 (PDF) (archived 01/21/2019)

HRPP 6.2 - Waiver of Alternation of the Consent Process and Waiver of Consent Documentation - Policy and Procedures

02/20/2009 (PDF) (archived 01/27/2012)

01/27/2012 (PDF) (archived 01/21/2019)

on 9/15/2016 Hyperlinks to IRB Informed Consent Information and Guidance eliminated

01/27/2012 (PDF) n/a

on 9/15/2016 HRPP 6.3. renumbered to HRPP 6.2

01/27/2012 (PDF)  (archived 9/15/2016)

HRPP 7.1 - Equitable Selection of Subjects

02/20/2009 (PDF) (archived 01/27/2012)

HRPP 7.2 - Advertisements for Research Participations Policy and Procedures

02/20/2009 (PDF) (archived 01/27/2012)

01/27/2012 (archived 09/15/2016)

HRPP 7.3 - Payments for participation Policy and Procedures

01/24/2011 (PDF)  (archived 01/24/2009)

01/27/2012 (PDF) (archived 04/01/2013)

HRPP 7.5 - Research Involving Non-English Speaking Subjects Policy and Procedures

02/20/2009 (PDF) (archived 01/27/2012)

01/27/2012 (PDF)  (archived 01/30/2015)

HRPP 7.6 - Research Subject Advocacy Policy and Procedures

02/20/2009 (PDF) (archived 01/27/2012)

01/27/2012 (PDF) (archived 09/17/2012)

09/17/2012 (archived 09/15/2016)

HRPP 7.7 - Subject Complaints, Issues, Concerns and Suggestions Policy and Procedures

02/20/2009 (PDF) (archived 01/27/2012)

HRPP 7.8 - Recruitment of Research Participants

07/01/2016 (PDF) (archived 12/01/2016)

12/01/2016 (PDF) (archived 01/21/2019)

HRPP 8.1 - Vulnerable Populations - General Guidelines

02/20/2009 (PDF) (archived 03/03/2010)

03/03/2010 (PDF) (archived 01/27/2012)

HRPP 8.2 - Research Involving Persons with impaired Decision Making Capacity

02/20/2009 (PDF) (archived 01/27/2012)

HRPP 8.3 - Research involving Prisoners

02/20/2009 (PDF)  (archived 01/27/2012)

HRPP 8.4 - Research Involving Pregnant Women, Fetuses, and Neonates

02/20/2009 (PDF) (archived 01/27/2012)

HRPP 8.5 - Research Involving Children

02/20/2009 (PDF) (archived 01/27/2012)

01/27/2012 (PDF) (archived 05/15/2012)

HRPP 9.1 - Off Campus Policy and Procedures

02/20/2009 (PDF) (archived 10/01/2010) 

10/01/2010 (PDF) (archived 01/27/2012) 

on 9/15/2016 HRPP Renamed

01/27/2012 (PDF) (archived 09/15/2016)

HRPP 9.2 - Management of Reporting events in Multi-Site Research Studies

02/20/2009 (PDF) (archived 01/27/2012)

HRPP 9.3 - Transnational Studies Policy and Procedures

01/27/2012 (PDF) (archived 05/15/2012)

05/15/2012 (PDF) (archived 08/01/2012) 

HRPP 9.4 - MUSC as Single IRB of Record

09/15/2016 (PDF) (archived 02/23/2018) 

HRPP 9.5 - Relying on an External IRB

09/15/2016 (PDF) (archived 02/06/2018) 

HRPP 10.1 - Human Research Audit

02/20/2009 (PDF) (archived 01/27/2011) 

01/27/2011 (PDF) (archived 09/15/2016)

HRPP 10.2 - Record Retention Policy

02/20/2009 (PDF) (archived 01/27/2012) 

01/27/2012 (PDF) (archived 09/15/2016) 

HRPP 10.3 - Quality Improvement Initiatives

02/20/2009 (PDF)  (archived 01/27/2012)

01/27/2012 (PDF) (archived 09/15/2016)