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Revised Common Rule AddendumIRB Review of Research Subject to the Revised Common Rule
101UNC-Chapel Hill Human Research Protections Program
201Quality Assurance
301Education & Training
401Institutional Review Board
501Human Subject Research Determination
601Exempt Studies
701IRB Review Process
801Institutional, Investigator, or Sponsor-Initiated Holds
901Multicenter Research and Reliance Process
1001Documentation and Records
1101Obtaining Informed Consent from Research Subjects
1201Vulnerable Subjects in Research
1301FDA-Regulated Research
1401Reporting New Safety Information
1402Management of New Safety Information
1403Questions, Concerns, or Complaints from Research Participants or Third Parties
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
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 (CoC)
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 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
4601Trainee or Student Projects Involving Human Subjects Research
4701Transnational Research
4801Pregnancy Testing Requirements
4901Incidental Findings
Appendix AMemo: North Carolina Reporting Requirements
Appendix BMemo: North Carolina Age of Majority and Exceptions for Consent
Appendix CGuidance for Student Research and Class Projects
Appendix DIndividual Identifiability of Data (18 HIPAA Identifiers)
Appendix EPolicy: Investigational Drug Services General Description