UCAIHS | Tutorial | References

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Tutorial: References

Belmont Report — Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Chapter 2)
Nuremberg Code (Chapter 2)
Declaration of Helsinki (Chapters 2 and 16)
United States Department of Health & Human Services: Office for Human Research Protections (Chapter 3).
NIH policy concerning assent (Chapter 13)
NIH policy concerning parental permission (Chapter 13)
NIH Policy on the inclusion of additional categories of protected populations (Chapter 13)
Regulations governing the use of cognitively impaired subjects in research (Chapter 13)
Regulations governing the use of prisoners in research (Chapter 13)

Additional Resources

Resources on Nonconsensual Human Experimentation (material originally created for students at Georgia Perimeter (DeKalb) College and Penn State University).
Tuskegee Syphilis Study (1932-1972).
US Department of Energy: Human Radiation Experiments
University at Albany, State University of New York: Human Subjects Research.
UCLA Office for Protection of Research Subjects: Human Research
University of Michigan Institutional Review Boards.
NIH FAQ: Research on Human Specimens
Code of Federal Regulations, Title 45 Part 46: Protection of Human Subjects
Policy Guidance
Office of Human Subjects Research, National Institute of Health.
Regulations and Ethical Guidelines
Computer-Based Training
U.S. Food and Drug Administration.
Guidance for Institutional Review Boards and Clinical Investigators
Information for FDA-Regulated Industry
Applied Ethics Resources on WWW, Centre for Applied Ethics, University of British Columbia.
National Reference Center for Bioethics Literature (NRCBL), Kennedy Institute of Ethics, Georgetown University.
Center for Bioethics, University of Pennsylvania.
National Human Genome Research Institute: Ethical, Legal and Social Implication (ELSI).
NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects (March 6, 1998).
Informed Consent, Parental Permission, and Assent in Pediatric Practice. Committee on Bioethics, American Academy of Pediatrics.
Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations.

Human Subjects Tutorial

Introduction
Chapter 1: Why are human subjects research regulations necessary?
Chapter 2: What are the basic elements of the research code of ethics?
Chapter 3: What are the current regulations concerning human subjects research?
Chapter 4: Do you need to apply to the UCAIHS?
Chapter 5: What do HIPAA regulations entail and how do they relate to the regulations governing human subjects?
Chapter 6: What process does the University use for implementing the regulations?
Chapter 7: What are the investigator’s responsibilities?
Chapter 8: What are the categories of application?
Chapter 9: What information must investigators give to the UCAIHS?
Chapter 10: What criteria does the Committee use when evaluating applications?
Chapter 11: How should researchers select and recruit subjects?
Chapter 12: What is informed consent and how is it documented?
Chapter 13: How must researchers deal with protected populations?
Chapter 14: How do researchers protect subject privacy and confidentiality?
Chapter 15: What are researchers’ obligations when cooperating institutions are involved?
Chapter 16: What are researchers’ obligations when doing research in foreign countries?
Chapter 17: What types of decisions can the UCAIHS make?
Chapter 18: What should investigators do during the application process and the course of their projects?
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