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Unformatted text preview: atient is adequately informed if the physician/researcher disseminates all information that a reasonable and prudent “peer” (physician/researcher) practicing in the same field would have disseminated (English rule) This is what is typically observed But do you think this is adequate? What constitutes “adequate” What constitutes “adequate” information? Informational disclosure is adequately satisfied by what information a reasonable, prudent patient would need to make an informed consent(American rule) The burden is now on the physician/researcher to ensure that the patient is satisfied (NOT based on what others would do) – This is generally a tougher a burden Subjective rule: Same as American rule except the information disclosed must acknowledge any material risk for the particular patient Beneficence
Beneficence It is the researchers responsibility to ensure the well
being of participants. It is YOUR responsibility to protect subjects from any harm, and ensure that they receive the possible benefits. Risk vs. benefits: The Belmont Report (1979) on the protection of human subjects indicates "maximize possible benefits and minimize possible harms." Benefits to society versus the possible risks of research? Ref: University of Minnesota, Informed consent overview
Justice Who gets to participate and who gets excluded “Are some classes or persons being selected simply because of their availability, their compromised position, or their manipulability while others are not?” Minorities and poor
Participants should not be selected due to class, socioeconomic status, or race unless justified by study objectives. Underrepresentation of women and minorities
Teacherstudent relationship The Burden
The Burden The burden of adequately informed consent is greater in research (therapeutic and nontherapeutic) than in therapeutic studies Benefit to researcher The burden is greatest for non
therapeutic research No benefit to patient Informed Consent: Key Events
Informed Consent: Key Events Nazi experiments on prisoners The Nuremberg Code, 19461949 Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical research Involving Human Subjects, Helsinki, 1964
The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, 1979
International Ethical Guidelines for Biomedical Research Involving Human Subjects, CIOMS, Switzerland, 1993 The Nuremberg Code (1947)
The Nuremberg Code (1947)
1. The voluntary consent of the human subject is absolutely essential.
2. The experiment should be such as to yield fruitful results.
3. The experiment should be so designed and based on the results of animal experimentation and knowledge of the natural history of the disease.
4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
5. No experiment...
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This note was uploaded on 03/17/2014 for the course BME 314 taught by Professor Frey during the Spring '08 term at University of Texas at Austin.
- Spring '08