SOPs and Guidance - UNC Research

UNC-Chapel Hill has established a Human Research Protection Program (HRPP). The UNC‐Chapel Hill HRPP, in partnership with its research community, is responsible for ensuring the ethical and equitable treatment of all human subjects in research conducted under its auspices. The research may be externally funded, funded from internal sources, or conducted without direct funding. The UNC‐Chapel Hill HRPP is administered by the Office of Human Research Ethics (OHRE).

SOP Number:	Title:
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