Human Research Protections

Research with human participants has proven invaluable, in advancing knowledge in the biomedical, behavioral and social sciences. Such research is strictly regulated, with laws at the federal, state and local levels. Further, professional societies have developed discipline-specific standards, policies and guidelines for ensuring that the rights and welfare of research participants is protected.

In the early 1970s, following widely publicized cases of research abuse, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was created to study issues surrounding the protection of humans in research. In 1979 the Commission issued a report entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research (commonly called the Belmont Report), which provided the ethical framework on which current federal regulations for the protection of human participants in research are based.

Legislation/Regulations

Below is a brief listing of legislation and regulations that affect the conduct of research with human participants.

Public Health Services Act

  • Dept. of Health & Human Services — 45CFR46 

  • Food and Drug Administration — 21CFR50 & 21CFR56 (PDF, 106KB)

Dept. of Education (34CFR98 & 34CFR99)

HIPAA

Mandatory Reporters: Summary of State Laws (PDF, 493KB)

NIH Policy on Required Education in the Protection of Human Research Participants

Guidance

Resources that provide additional guidance on various human research protection issues:

Institutional Review Boards (IRB)

HIPAA

Research on the Internet

Federal Offices of Research Regulation

US federal agency offices charged with regulating research with human participants:

Ethics Codes

Training Resources