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01 Processing a Proposal
01 Introduction 06/29/2004
02 Processing a Proposal 04/28/2004
03 IRB Submission Process 04/28/2004
04 Obtaining Authorized Signatures 09/28/2006
05 Instructions for Completing the IRB Application 06/29/2005
06 Instructions for Completing the IRB Modification Request 06/29/2005
07 Instructions for Completing the AE Report Form 06/29/2005
08 Instructions for Completing the Privacy Application 07/13/2005
09 IRB Flow Diagram 06/29/2005
10 Organization Chart 09/18/2006
02 IRB Policy and Procedures
01 Investigator Info on IRB Policy and Procedures 08/03/2002
02 IRB Policy and Procedures 10/18/2005
03 Writing a Protocol
01 Developing a Clinical Research Protocol 04/24/2006
02 Appendix A - Outline for Writing a Non-Clinical Protocol 04/24/2006
03 Appendix B - Outline for Writing a Clinical Protocol 04/24/2006
04 OHSR Information Sheet No. 5 04/24/2006
04 Development of Informed Consent
01 Informed Consent Instructions 08/24/2007
02 Template for the Development of Informed Consent for Research 08/24/2007
03 Consent Checklist Federal and Local Requirements 08/24/2007
05 Reporting of Adverse Events
01 PHA IRB AE Reporting Policy 08/03/2002
02 PHA IRB Adverse Event Report Form 11/16/2006
06 Educational Requirements
01 Research Personnel-CITI Training Deadlined Extended to 6-1-2007 02/02/2007
02 CITI Training Announcement to Research Personnel 8-7-2006 02/02/2007
03 Verification of Research Personnel Training Form 02/02/2007
04 IRB Members-CITI Training Deadline Extended to 6-1-2007 02/02/2007
05 CITI Training Announcement to IRB Members 8-7-2006 02/02/2007
06 IRB Member Training Verification Form 02/02/2007
07 Palmetto Health IRB Training & Education Policy 8-7-2006 02/02/2007
08 Palmetto Health IRB Participant Outreach Policy 8-7-2006 02/02/2007
09 OHRP Brochure-Becoming A Research Volunteer 02/02/2007
10 FDA Brochure-Why Volunteer? 02/02/2007
11 NCI Brochure-What You Should Know About Clinical Trials 02/02/2007
12 NCI Booklet-Taking Part In Clinical Trials 02/02/2007
13 NIH Required Education Mandate 02/02/2007
14 Questions Regarding NIH Education Mandate 02/02/2007
15 NIH Clarification Announcement 9-14-2000 02/02/2007
16 OHRP FWA Statements on Education Terms 02/02/2007
07 Federalwide Assurance with OHRP
01 Federalwide Assurance FWA00000128 with OHRP 10/22/2007
08 The Belmont Report
01 The Belmont Report 08/03/2002
09 DHHS Regulations
01 45 CFR 46 Protection of Human Subjects 08/03/2002
02 45 CFR 46 101 Exempt Categories 08/03/2002
03 45 CFR 46 101(i) Emergency Research Consenting 08/03/2002
04 45 CFR 46 101(i) Emergency Research Consent Waiver 08/03/2002
05 45 CFR 46 102 Definitions 08/03/2002
06 45 CFR 46 110 Expedited Review Categories 08/03/2002
07 45 CFR 46 116 Informed Consent Requirements 04/15/2004
08 45 CFR 46 117 Informed Consent Documentation 08/03/2002
09 45 CFR 46 201 to 46 207 Subpart B revised 12-13-2001 08/03/2002
10 45 CFR 160; 162; 164; Final Modifications to the Privacy Rule 8-14-2002 02/24/2003
10 FDA Regulations
01 21 CFR 50 Protection of Human Subjects 08/03/2002
02 21 CFR 56 Institutional Review Boards 08/03/2002
03 21 CFR 312 Investigational New Drug Application 08/03/2002
04 21 CFR 600 Biological Products General 08/03/2002
05 21 CFR 812 Investigational Device Exemptions 08/03/2002
06 Differences between FDA and HHS Regulations 08/03/2002
07 FDA Guidance on Drugs and Biologics 08/03/2002
08 FDA Guidance on Medical Devices 08/03/2002
09 Important Note on Emergency Use of Test Articles 08/03/2002
10 List of FDA Regulations Relating to the Protection of Human Subjects 08/03/2002
11 Off Label and Investigational Use of Drugs Biologics and Devices 08/03/2002
12 Use of Investigational Products When Subjects Enter a Second Institution 08/03/2002
13 FDA Information Sheets 1998 10/02/2003
11 PHA Research Policies
01 PHA Research Grants Application Process Policy F.1 04/15/2004
02 PHA Billing of Research Charges Policy F.2 04/15/2004
03 PHA Debarment Suspension Policy F.3 04/15/2004
04 PHA Misconduct in Science Policy F.4 04/15/2004
05 PHA Objectivity in Research Policy F.5 04/15/2004
06 PHA Research Use and Disclosure of PHI for Research Policy F.6 06/29/2005
12 Forms
01 IRB Application (New Protocols & Renewals) 07/26/2007
02 Template for Development of Informed Consent for Research 08/24/2007
03 IRB Application for Exemption (Surveys & Chart Reviews) 07/26/2007
04 Privacy Application for Access to PHI for Research 07/26/2007
05 Template for Development of Authorization for Research 11/17/2006
06 IRB Modification Request Form (Amendments & Revisions) 05/25/2006
07 IRB Adverse Event Report Form 11/16/2006
08 Verification of Research Personnel Training Form 02/02/2007
09 Template for the Development of a Data Use Agreement 04/11/2006
10 Template for the Development of a Sponsor Contract Provision 04/11/2006
11 Request for Research Billing 04/11/2006
12 Financial Disclosure Form 04/11/2006
13 Impacted Services Agreement for Research 05/31/2006
14 IRB Member Training Verification Form 10/04/2006
15 Application for Waiver of Informed Consent 04/19/2007
16 Student-Intern IRB Application. 07/31/2007
17 Pregnant Women, Fetuses & Neonates IRB Application. 08/09/2007
13 IRB Membership Lists
01 IRB #1 Membership List 07-06-2007 07/06/2007
02 IRB #2 Membership List 07-06-2007 07/06/2007
03 IRB Membership Update with OHRP 07-06-2007 07/06/2007
14 Submission Deadline Schedule
01 IRB Submission Deadline Schedule 09/12/2008
15 Glossary and Helpful Resources
01 Glossary of Research Terms 08/03/2002
02 Lay Language Medical Terms 08/03/2002
03 Helpful Resources 08/03/2002
16 Use and Disclosure of Protected Health Information for Research Purposes
01 Announcement to Investigators regarding HIPAA and Research 06/29/2005
02 PHA Research Uses and Disclosures of PHI Policy F.6 06/29/2005
03 Instructions for Completing the Privacy Application 07/13/2005
04 Privacy Application for Access to PHI for Research 07/26/2007
05 Template for Development of Authorization for Research 11/17/2006
06 Template for Development of Informed Consent for Research 06/29/2005
07 Template for Development of Data Use Agreement 06/29/2005
08 Template for Development of Sponsor Contract Provision 06/29/2005
09 Accounting of Disclosures Tracking Log IndPt 02/27/2007
10 Accounting of Disclosures Tracking Log MultPt 02/27/2007
17 Clinical Research Handbook
01 Clinical Research Handbook 06/02/2008
18 Accepting IRB Approval
01 IRB Policy on Accepting External IRB Approvals 02/27/2007
02 Guidelines for Accepting External IRB Approvals 02/27/2007
03 External IRB Acceptance Application 02/27/2007
19 Submission Guidelines for Humanitarian Use Devices
09/12/2008
01 PH IRB HUD Information Sheet 09/12/2008
02 FDA Humanitarian Use Device Regulations 09/12/2008
03 FDA HDE Regulation - Questions & Answers 09/12/2008