Resources Related to UNC Research

The links below provide useful resources on IRB and related issues.

Other Links at UNC-CH Related to Human Subjects Research

• Carolinas Collaborative Research Guidance Document
• Required Costs – UNC Research
• Clinical Translational Research Center (CTRC) Orientation and Training
• Environment, Health and Safety
  • Radiation Safety and the Radiation Safety Committee
    • Five or fewer FDA approved or cleared scans/xrays do not need Radiation Safety Committee approval
  • Biological Safety and the Institutional Biosafety Committee
• Oncology Protocol Review Committee
• Investigational Drug Service (IDS)
  • Note: You must be logged into UNC Health Care to access this site.
• Research Billing Compliance : Investigational Products
  • Note: You must be logged into UNC Health Care to access this site.
• Office of Clinical Trials
• Registering an Investigator-Initiated Clinical Trial in a Public Registry
• Conflict of Interest:
  • Policy on Individual Conflits of Interest and Commitment
  • Policy on Institutional Conflict of Interest
• UNC-CH NC TraCS Institute DSMB
• Information for Researchers from Research at Carolina
• HIPAA Research Policy
  • HIPAA and Research presentation, June 2021
• Data Use Agreement Guidance
• UNCHC System Office of Research Support & Compliance
  • Note: You must be logged into UNC Health Care to access this site.

Ethical Basis, Historical Documents, International Protections

• Nuremberg Code
• The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research
• The Declaration of Helsinki (the World Medical Association)
• Federal Office for Human Research Protections‘ International Compilation of Human Subject Research Protections, a listing of the laws, regulations, and guidelines that govern human subjects research in many countries around the world.
• Presidential Commission for the Study of Bioethical Issues (Meeting reports, 2010-present)
• Reports from past national bioethics commissions (1974-2009)

Federal Office for Human Research Protections

• Office for Human Research Protections. Federal agency that regulates IRBs and human subjects research.
• The Code of Federal Regulations (45CFR46). Federal regulations governing protection of human subjects
• OHRP Guidance on Unanticipated Problems and Adverse Events
• OHRP’s Frequently Asked Questions
• Expedited Review Categories of Research
• IRB Guidebook
• OHRP Policy Guidance by Topic
• OHRP Guidance on Coded Private Information and Biological Specimens
• NIH Decision Chart on Applying OHRP Guidance on Coded Info/Specimens
• Engagement of Institutions in Research
• Links to reference documents, historical materials and Common Rule departments/agencies. A list maintained by OHRP.

Other Federal Agencies

• Centers for Disease Control and Prevention
• Department of Education
• Department of Health and Human Services
  • Office for Civil Rights – HIPAA
  • Office of Research Integrity
  • Office of Minority Health announces the release of a new resource to aid researchers: The Compendium of Publicly Available Datasets and Other Data-Related Resources (Compendium). This is a free resource that compiles in one place descriptions of and links to 132 public datasets.
• Food and Drug Administration
  • 21CFR50. FDA regulations for protection of human subjects
  • 21CFR56. FDA regulations governing IRBs
  • FDA Information Sheets: Guidance for IRBs, and Clinical Investigators and Sponsors
  • FDA Guidance on Adverse Event Reporting to IRBs
  • FDA Guidance on IND Safety Reports
  • Investigational Device Exemption (IDE)
  • Drug Approval Application Process
  • Expedited Review List
  • Frequently Requested ORA Documents under FOIA
  • Index of Categories of Documents for Electronic Reading Room
  • Information for Clinical Investigators
  • Regulatory Guidance
  • FAQs about Medical Devices
  • In Vitro Diagnostic Studies Using Leftover Specimens
• National Institutes of Health
  • IRBs and HIPAA Privacy Rule
  • Protecting Personal Health Information in Research Understanding the HIPAA Privacy Rule
• Ethical Issues in Research Involving Human Participants
• Office of Biotechnology Activities
• National Cancer Institute
• National Human Genome Research Institute
• National Institutes of Environmental Health Sciences
• National Library of Medicine
• Information about the Certificate of Confidentiality

Non-Governmental Organizations

• American Council on Science and Health
• Public Responsibility in Medicine and Research (PRIM&R)
• Association for the Accreditation of Human Research Protection Programs (AAHRPP)
• “Reaching Beyond Regulations: The Pursuit of Accreditation for Human Research Protection Programs.” Lynn E. Smith, JC. CIM, CIP. Monitor, June 2008, 67-70.
• Association of American Medical Colleges
• Association of American Universities
• Children’s Hospital Boston’s Interactive Parents’ Guide to Medical Research
• Family Health International. See their Research Ethics Training Curriculum
• Harvard Program on Ethical Issues in International Health Research
• The Hastings Center
• Kennedy Institute of Ethics
• National Academy of Sciences
• Institute of Medicine
• National Research Council
• Poynter Center for the Study of Ethics and American Institutions, Indiana University
• Prisoners as Human Subjects: Researcher Reference Guide, University of Louisville School of Medicine
• University of Southern California, “Is Your Project Human Subjects Research?”

Newsletters and Additional Materials

• Article from American Nurse Today: Nurse research and the institutional review board
  Learn how the IRB process works to ensure participant safety and quality research.
  By Amy Marzinsky, BSN, RN, OCN, and Cheryl A. Smith-Miller, PhD, RN-BC
• Clinical Trials Advisor (Current issue) (archive)
• Human Research Report
• IRB: Ethics and Human Research. From the Hastings Institute
• The IRB Forum. Discussion and news forum for IRB members, staff and others
• Resources for IRB “Community” Members from the U.S. Department of Energy