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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 | Guidance | Federal Offices of Research Regulation
Ethics Codes | Training Resources | Conferences

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)


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

Institutional Review Boards (IRB)
- IRB Guidebook
- Expedited Review Categories
- IRBs & Psychological Science


HIPAA
- Impact of HIPAA on Research
- Understanding HIPAA
- FAQ


Research on the Internet
- AAAS Report on Human Subjects Research on the Internet
- Psychological Research on the Internet (APA report)
- Conducting Research on the Internet (British Psychological Society)
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Federal Offices of Research Regulation
US federal agency offices charged with regulating research with human participants

Office of 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)
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Ethics Codes
American Psychological Association

Canadian Psychological Association

Human Factors & Ergonomics Society

Society for Research in Child Development

The British Psychological Society
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Training Resources
University of Minnesota Consent Module

National Library of Medicine Bibliography

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

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

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

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

NIH Modules

Ethics in Research with Human Participants (APA publication)
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Conferences
APA - ORI Workshop (2004)

Conference on Minimal Risk (2005)

Defining Vulnerability in Minimal Risk Behavioral and Psychological Research (2007)
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