Manual for Conducting Human Subject Research

Available Regulations, Policies, and Educational Materials

The HRRC Support Office will make available to the UNMHSC research community the following documents relevant to human subject research, either through the Internet (by posting cites) or by hard copy if an investigator lacks such access:

Federal Regulatory & Advisory Documents

  1. "Protection of Human Research Subjects" Title 45, Code of Federal Regulations (C.F.R.), Part 46, issued by HHS.
  2. "Protection of Human Subjects" Title 21 C.F.R. Part 50, FDA.
  3. "Institutional Review Boards" Title 21 C.F.R. Part 56, issued by FDA.
  4. "Investigational Drugs" Title 21 C.F.R. Part 312, and Part 314, issued by FDA.
  5. "Investigational Devices" Title 21 C.F.R. Part 812, issued by FDA.
  6. "Federal Policy for the Protection of Human Subjects" which represents a consolidation of related regulatory policies of all federal agencies, issued by HHS.
  7. "Protecting Human Research Subjects: Institutional Review Board Guidebook" prepared by OHRP.
  8. "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research" prepared by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979). Check HS Library for additional availability
  9. "The Nuremberg Code" derived from the Trial of Criminals of World War II by the International Military Tribunal (1949).
  10. "World Medical Association Declaration of Helsinki" (adopted in 1964; most recently amended in 1989).
  11. "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" (March 6, 1998)
  12. Amendments to regulations and news releases by federal regulatory agencies.
  13. FDA Guidance Documents and Information Sheets.

University of New Mexico HRRC Documents and Materials

  1. "Federal Wide Assurance" entered into between the University of New Mexico Health Sciences Center and the National Institutes of Health (FWA #3255).
  2. HRRCs Procedures and Guidelines for the Protection of Human Subjects.
  3. HRRCs Submission Form, Expedited Review Application, Exempt Review Application, Progress Report Form, Adverse Event Reporting Form, Sample Consent Form, Consent Form Checklist, Departmental Review Form, and Final Report Form.
  4. OHRP Tapes on the following human subject research topics:
    • Evolving Concern for Human Subject Research
    • Trials and Tribulations: Legal Issues of the Institutional Review Board
    • Historical Perspective in the Evaluation of Human Subjects Protection
    • Inclusion of Women and Minorities as Research Subjects
    • Issues with Special Populations: Children, the Elderly, and Persons with Mental Retardation
    • Special Concerns in Mental Health and Behavioral Research - Strategies for Research in Community Settings and Deception in Research
    • Collaborative Research Issues and Working with Multi-Site Projects
    • Ask the IRB Administrators: A Question and Answer Session
    • Balancing Societies Mandates, IRB Review Criteria
    • The Belmont Report - Basic Ethical Principles and Their Application

Useful Websites

  1. FDA: Contains policies from all centers, regulations, guidance, latest activities, organization charts, staff numbers, etc.
  2. OHRP: Contains Belmont Report, regulations, policies, guidance, staff numbers, etc.
  3. National Bioethics Advisory Commission: Contains latest testimony, reports, etc. from NBAC.
  4. Glossary of Lay Terms: Contains glossary of lay terminology for consent forms.
  5. Public Responsibility in Medicine and Research: Home page for this organization (addresses IRB/ethical issues).