Principles, Guidance & Resources
Overarching Ethical Principles (including International Guidance and Regulations)
- The Belmont Report, Ethical Principals and Guidelines for the Protection of Human Subjects of Research
- Declaration of Helsinki, World Medical Association
- Nuremberg Code
Additional Guidance
Cornell Guidance
- Protocol Principal Investigator Responsibilities
- Required Components of Informed Consent
- Secondary Data Analyses Requiring Review
- Research Involving Cognitively Impaired Adults
- HIPAA and Potential Impact on Research Studies
- Suspension/Termination of Approval to Use Human Subjects
- Studies Conducted Without IRB Approval
Other Guidance
- IRB Guidebook, Office for Human Research Protections
- Office for Human Research Protections (OHRP)
- Conflict of Interest in Clinical Research, OHRP guidance
- Research Involving Persons with Mental Disorders That May Affect Decision Making Capacity, National Bioethics Advisory Commission
- Research Involving Individuals with Questionable Capacity to Consent: Points to Consider, NIH Office of Extramural Research
- HIPAA Privacy Rule
- Human Participant Protections Education for Research Teams, National Institutes of Health
- Association of Internet Researchers
- Journal of Medical Ethics
- NHRPAC, National Human Research Protections Advisory Committee
- The Secretary's Advisory Committee on Human Subject Protections (SACHRP, chartered on October 1, 2002)
- International Compilation of Human Subject Research Protections
Additional Resources for Responsible Conduct of Research
- Office of Research Integrity (ORI - DHHS)
- Certificates of Confidentiality, National Institutes of Health
- The President's Council on Bioethics, created November 28, 2001
- "On Being A Scientist: Responsible Conduct In Research," from the National Academies Press
- Ethical, Legal, and Social Implications Research Program, National Institutes of Health, Division of Extramural Research
- National Bioethics Advisory Commission: Reports
- National Human Research Protections Advisory Committee
- Protecting Human Beings: Institutional Review Boards and Social Science Research, American Association of University Professors
- The Online Ethics Center for Engineering and & Science (highly recommended for researchers using human biological materials)
- Safeguarding Healthy Research Subjects: Protecting Volunteers from Harm, New York State Dept of Health, March 1999