February 2009

Assurance of Protection of Human Subjects' Safety and Privacy

Author Affiliations

Copyright 2009 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2009

Arch Dermatol. 2009;145(2):193-194. doi:10.1001/archdermatol.2008.528

The conduct of human participant research and reporting the results of that research in medical journals relies upon the public trust of those who perform the research and publish the research to safeguard the safety and dignity of the individuals. Protection of the welfare, rights, and privacy of human subjects requires review and approval of the research plan by an institutional review board (IRB) or a human subjects committee (HSC). The investigator, who has a vested interest in the research, cannot decide what is exempt from review. An independent IRB or HSC offers protection for human participants and investigators. Human participants are defined as living individuals about whom an investigator conducting research obtains either data through intervention or interaction with the individual or identifiable private information.

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