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Standard Operating Procedures
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Standard Operating Procedures
Table of Contents
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SOP Number:
Title:
Summary of SOP changes effective August 15, 2022
101
UNC-Chapel Hill Human Research Protections Program
201
Quality Assurance
301
Education and Training
401
Institutional Review Board
501
Human Subject Research Determination
601
Exempt Studies
701
IRB Review Process
801
Institutional, Investigator, or Sponsor-Initiated Holds
901
Multicenter Research and Reliance Process
1001
IRB Documentation and Records
1101
Obtaining Informed Consent from Research Subjects
1201
Vulnerable Subjects in Research
1301
FDA-Regulated Research
1401
Promptly Reportable Information
1402
IRB Review of Promptly Reportable Information
1501
Investigator Responsibilities
1601
Sponsored Research
1701
Participant Outreach
1801
Health Insurance Portability and Accountability Act (HIPAA)
1901
Information Security
2001
Research Supported by the Department of Defense (DoD)
2101
Individual Conflict of Interest in Research
2102
IRB Member and Consultant Conflict of Interest
2103
Institutional Conflicts of Interest
2200
US Department of Justice Supported Research
2201
Research Subject to the US Environmental Protection Agency
2301
Research Subject to US Department of Education Regulations
2401
Research subject to US Department of Energy Regulations
2501
Case Reports Requiring IRB Review
2601
Certificate of Confidentiality
2701
Community Partnerships in Research
2801
Data or Biological Sample Repositories
2901
Family History Research
3001
Genetic and Stem Cell Research
3101
Research in Educational Settings
3201
Internet Research
3301
Mandatory Reporting
3401
Multi-Site Studies Where UNC is the Lead Site or Coordinating Center
3501
Oral History
3601
Pilot Studies
3701
Qualitative Research
3801
Research Involving Coded Private Information or Biological Specimens
3901
Research Involving Deception or Withholding of Information
4001
Research Involving Potentially Addictive Substances
4101
Research Involving Radiation
4201
Research Using Existing Data & Materials
4301
Review Involving Data from Voice, Video, Digital or Image Recordings
4401
Survey Research
4501
UNC-Chapel Hill Students and Employees as Research Subjects
4502
Self and Family Member Experimentation
4601
Trainee or Student Research and Course Projects Involving Human Subjects Research
4701
Transnational Research
4801
Pregnancy Testing Requirements
4901
Incidental Findings
5001
Emergency Preparedness Plan for the HRPP
6001
Definitions
Appendix A
Memo: North Carolina Reporting Requirements
Appendix B
Memo: North Carolina Age of Majority and Exceptions for Consent
Appendix C
This document has been removed.
Appendix D
Individual Identifiability of Data (18 HIPAA Identifiers)
Appendix E
Policy: Investigational Drug Services General Description