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Human Subjects Protection, Ethical Research, and Institutional Review Boards (IRBs)
Protecting privacy and confidentiality is one component of a larger mandate to individuals who collect data: protect the
well-being of data subjects. This page provides links to resources on protecting human subjects from harm, on ethical guidenlines for research, and
on the functioning of IRBs, which are committees based at research institutions that are responsible
for the protection of human subjects in research. These are vast and important topics; we only introduce them here. For more information,
see the Committee on Professional Ethics
of the American Statistical Association.
For researchers planning to collect data, we advise you to work with the IRB of your institution to ensure compliance
with protocols for protection of study subjects. Additionally, federal agencies can have different regulations
for protecting human subjects, so that researchers should consult the relevant agency to ensure compliance.
A. Summaries of ethical principles.
Belmont
Report (April 18, 1979, the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research)
The National Commission for the Protection of Human Subjects of Research's
summary of the ethical principles of research involving human subjects.
Declaration
of Helsinki (October 2000, World Medical Association)
The World Medical Association's statement of ethics in medical research.
American Statistical Association's Ethical Guidelines
for Statistical Practice
International Statistical
Institute's Declaration on Professional Ethics
B. Legal aspects of protecting human subjects in research
The "Common Rule", Code of Federal Regulations, Title 45,
Part 46
Federal code governing research conducted on human subjects from the U.S. Department of
Health and Human Services, Office for Human Research Protection.
U.S.
Department of Health and Human Services, Office for Human Research Protection
(OHRP) main page
General information about the OHRP with links to the site's 8 major content
areas: IRB Regulations and Assurances, Policy Guidelines, Compliance and
Oversight, Educational Materials, Workshops, On-line training etc.
C. Journals and other academic resources
IRB:
Ethics & Human Research.
Human Genome Project's "Ethical, Legal, and Social Issues"
"Population, Statistics, Confidentiality and War:
Essential Documents and Recent Writings" (William Seltzer and Margo
Anderson)
A collection of documents, laws, and papers regarding the misuse of population
data systems and threats to the confidentiality of statistical data during wars
and periods of civil unrest.
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