BME 314 Lecture 23 2012

Httpohrposophsdhhsgovhumansubjectsguidance45cfr46

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Unformatted text preview: should be conducted where there is an a priori reason to believe that death or disabling injury will occur. 6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. 7. Proper preparations should be made and adequate facilities provided. 8. The experiment should be conducted only by scientifically qualified persons. 9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end. 10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage. Federal regulations: Resources Federal regulations: Resources DHHS regulations: Protection of human subjects. http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46 NIH Office of protection from Research Risks: Protecting Human Research Subjects: IRB Guidebook. http://ohrp.osophs.dhhs.gov/irb/irb_guidebook.htm FDA 21 CFR 50 and 56. http://www.fda.gov/oc/ohrt/irbs/ National bioethics advisory commission (NBAC). https://bioethics.gov Informed consent Informed consent Must be obtained BEFORE any research involving human subjects As a researcher, it is YOUR responsibility to “adequately educate” the subject about the risks, benefits, conflicts etc. about the research involving them, obtain their voluntary consent and keep them informed Informed consent Informed consent The purpose of informed consent is not just to obtain a signature in a form. It is YOUR ethical obligation to make sure that the subject has understood and is willing to voluntarily participate in your study It is YOUR duty to ensure that participants are thoroughly informed about the purpose of the study, the procedures to be performed, potential risks and benefits to them, any conflicts of interest that the researchers might have and what are their alternatives to participating in your study. They must have the opportunity and time to consult with other researchers, physicians, advisors, friends and family before making any decision They should know that their decision is completely voluntary and they can withdraw at any time Difficulty: What constitutes disclosure of information sufficient to ensure informed consent? Ref: University of Minnesota, Informed consent overview http://www.research.umn.edu/consent/mod1med/mod1sec2.html A Historical Case of Failure to A Historical Case of Failure to Obtain Informed Consent: The Tuskegee Syphilis Study History: From 1932 to 1972, 399 poor sharecroppers in Macon County, Alabama were denied treatment for syphilis and deceived by physicians of the Unites States Public Health Service. As part of the Tuskegee Syphilis Study, designed to document the natural history of the disease, these men were told that they were being treated for "bad blood." However, they deliberately denied treatment to the men with syphilis and they went to extreme lengths to ensure that they would not receive...
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