Protection of human research
Research with human participants proved invaluable to the promotion of knowledge in the biomedical, behavioral and social sciences. Such research is strictly regulated by legislation on the Federal, State and local levels. Further, the professional societies have developed discipline-specific standards, policies and guidelines to ensure that the rights and welfare of research participants are protected.
In the early 1970s, after a lot of publicity cases of abuse research, the National Commission for the protection of human subjects of biomedical and Behavioral Research was created to examine issues relating to the protection of humans in research. In 1979, is the Commission a report entitled ethical principles and guidelines for the protection of human subjects of research (often referred to as the Belmont report), in which the ethical framework, if the current federal legislation for the protection of human participants in research based issued.
Legislation/regulations
Below is a short list of laws and regulations that affect the conduct of research with human participants.
The public health Services Act Dept. of Health & human services (45CFR46 PDF, 149 KB) the Food and Drug Administration (21CFR50 & 21CFR56) Dept. of education (34CFR98 & 34CFR99)
HIPAA The rule on the protection of personal data Mandatory reporters: summary of State laws
NIH policy on required training in the protection of human research participants Guide
Resources that give further guidance on the various issues relating to the protection of human research:
Institutional Review Boards (IRB)
IRB guide Expedited review Categories IRBs & psychological science (APA report) 2007 APA presidential task force recommendations for IRBs and psychological science
HIPAA
The impact of HIPAA on research understand HIPAA FAQ
Research on the Internet
Psychological research Online: opportunities and challenges AAAS report on human subjects research on Internet research on the Internet-the British Psychological Society
Federal offices in research regulation
US Federal agency offices accused governance 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 supervision (Department of Veterans Affairs) Office or additional Research human research subjects Website (NIH)
Codes of ethics
Canadian psychological factors & Ergonomics Society AssociationHuman Society for research in the British Psychological Society DevelopmentThe child
Education Resources
Ethics & policy problems with research using human participants (NBAC report) ethics in research involving human participants (APA publication), national library of medicine ModulesProtecting BibliographyNIH participants and social and Behavioral Sciences Research (NRC report) research involving persons with mental disorders that can affect decision-making capacity to facilitate
(NBAC report)Resources for research ethics education: human SubjectsResponsible research: A systems approach to protecting research participants (IOM report) University of Minnesota permission module