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

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