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 PDF, 149KB) 

• Food and Drug Administration (21CFR50 & 21CFR56)

Dept. of Education (34CFR98 & 34CFR99)

HIPAA

• The Privacy Rule

Mandatory Reporters: Summary of State Laws

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)

• IRB Guidebook 

• Expedited Review Categories 

• IRBs & Psychological Science (APA Report) 

• Recommendations of the 2007 APA Presidential Task Force on IRBs and Psychological Science 

HIPAA

• Impact of HIPAA on Research 

• Understanding HIPAA 

• FAQ

Research on the Internet

• Psychological Research Online: Opportunities and Challenges  

• AAAS Report on Human Subjects Research on the Internet  

• Conducting Research on the Internet - British Psychological Society

Federal Offices of Research Regulation

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

• Office for Human Research Protections (DHHS)

• Family Policy Compliance Office (Dept. of Ed)

• Human Subjects’ Protection Program (Dept. of Energy)

• Office of Research Oversight (Dept. of Veterans Affairs)

• Office of Extramural Research Human Subjects Website (NIH)

Ethics Codes

• Canadian Psychological Association

• Human Factors & Ergonomics Society

• Society for Research in Child Development

• The British Psychological Society

Training Resources

• Ethical & Policy Issues in Research Involving Human Participants (NBAC report)

• Ethics in Research with Human Participants (APA publication)

• National Library of Medicine Bibliography

• NIH Modules

• Protecting Participants and Facilitating Social and Behavioral Sciences Research (NRC report)

• Research Involving Persons with Mental Disorders that Might Affect Decision-making Capacity
  (NBAC report)

• Resources for Research Ethics Education: Human Subjects

• Responsible Research: A Systems Approach to Protecting Research Participants (IOM report)

• University of Minnesota Consent Module