Other Resources

This page provides links to additional resources on human subjects protection.

Ethical Codes and Regulations for Human Subjects in Research

The Belmont Report

Report by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

The Nuremburg Code
The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the Nuremberg trials at the end of World War II. It remains a landmark document on medical ethics, stating that "the voluntary consent of the human subject is absolutely essential."

Declaration of Helsinki
The Declaration of Helsinki is a set of principles regarding human experimentation developed for the medical community by the World Medical Association. It is widely regarded as the cornerstone document on human research ethics.

U.S. Department of Health and Human Services/National Institutes of Health/Office for Human Research Protections Human Subject Regulations, 45 CFR Part 46
Code of U.S. federal regulations for the protection of human subjects.

U.S. Food and Drug Administration Regulations, Protection of Human Subjects
Guidance for IRBs, clinical investigators and research sponsors.

International Clinical Research Regulations
NIH aggregated clinical research regulations from around the globe.

Guidelines for IRB Committees

Office for Human Research Protection's IRB Guidebook
Last updated in 1993, it provides information on institutional administration, regulation and policies, research design, and an overview of biomedical and biobehavioral research.

Agencies and Organizations Involved with Human Subject Protections

Office of Human Research Protections
Leadership in the protection of the rights, welfare and well-being of human subjects.

Office of Human Research Protections Resource Page
Links to reference documents, historical materials and Common Rule departments and agencies.

Association for the Accreditation of Human Research Protection Programs
AAHRPP accredits high-quality human research protection programs in order to promote excellent, ethically sound research.

Public Responsibility in Medicine and Research
PRIM&R advances the highest ethical standards in the conduct of biomedical, behavioral and social science research.

U.S. Food and Drug Administration
The FDA is responsible for protecting our nation's public health.

Policy Development and Commissions

Informed Consent Guidance for Human Gene Transfer Trials
National Institutes of Health guidelines for research involving recombinant or synthetic nucleic acid molecules.

U.S. Food and Drug Administration Guidance for IRBs, Clinical Investigators and Sponsors
Collection of FDA information sheets that represent the agency's current thinking on protection of human subjects in research.

Final Recommendations on U.S. Genetic Testing
Recommendations from the National Institutes of Health to help ensure genetic testing in the U.S. is safe and effective.

National Bioethics Advisory Commission
Advice and recommendations on bioethical issues.

Office for Human Research Protections
Website of the OHRP covers regulations and policy, education and outreach, compliance and reporting, and more regarding the protection of human subjects in research.

NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans
National Institutes of Health (NIH) has released a clinical trial protocol template with instructional and example text for NIH funded investigators to use in writing protocols for behavioral and social sciences clinical trials.