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Informed Consent

Informed Consent

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Informed Consent

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  1. Informed Consent Ethics Forum 2012 Duquesne University Thomas Goehring, Leah Gottlieb, Andrew Glaid, Sebastien Hebert, David George Mentor: Dr. Mike Cascio

  2. Issues Dealing with Implicit vs. Explicit Informed Consent Violations • Effectiveness of some tests demand providing a lack of information • Vaccines and placebos • If tests can have negative side effects should full and absolute information be given? • Is there a way to remove underlying fears/concerns which may influence autonomy in testing?

  3. The Milgram Experiment • Stanley Milgram: Social Psychologist from Yale University • Experiment started in 1960s after Nazi war crime trials • Lenient on rules of experimentation • Experiment of obedience • Why good people do bad things • Do they obey out of fear or to appeal to higher powers?

  4. The Test • Test subjects came from various classes and various occupations • Hired for about 4 dollars an hour • Subjects were told that they would be part of a study that would test punishment on learning ability

  5. The Test • The subject and an actor decided which was to be the teacher and the learner • Fixed coin flip • Teacher receives test shock • Teacher asks learner a series of questions • A wrong answer leads to the learner being shocked, with each at a progressively higher voltage. • Learner would complain, yell, plead, etc. at higher shocks

  6. The Test • At a certain point, teacher would hesitate to shock the learner • Experimenter would pressure teacher • If it happens four times, the experiment is halted • Only actual shock was given at test shock • Actor/Learner would give realistic screams and play tape recordings when “shocked”

  7. General Considerations • One should have a true understanding of testing, treatments, and the liability of medical professionals • One should consider the validity of the results if participants are given too much information

  8. Balancing Complexity, Length, and Information • Clear need to inform patients of risks/concerns and nature of procedures, regardless of type of procedure • Testing or vaccine trials • Many forms are lengthy and can be troublesome in countries with high illiteracy rates • Difficult to allow full autonomy of patients with complicated but necessary language • Shortening and simplification can lead to confusion or malpractice suits in the form of inadequate information

  9. Effectiveness of Treatments • If a patient is given too much or too little information, results of testing may vary • Placebo effect (or nocebo effect) may occur • If patient is informed that they are not given the drug, they may leave study and greatly skew results • Should tests and consent forms clearly deny patients knowledge of a specific nature (placebo or treatment)?

  10. HIV testing on women in a South African hospital (1998 study) • Many participants felt compelled to participate despite being reminded that the tests were voluntary • 88% of participants wanted to know their HIV status, which contrasts to other countries where participants did not want to know their status • Patients, after entering, felt compelled to remain in the study

  11. Results of Study • Many participants worried about partners vs. • Relatively few participants worried about compromised job status • Many participants entered the study voluntarily vs. • Few participants felt they would be allowed to leave the study • These results raise the question of how effective informed consent was in this study

  12. Circumstances of the Cases • Milgram: Nuremberg Trials, “only following orders” • Fully informing participants would have compromised experimental results • HIV: Differing backgrounds impact a person’s ability to understand short- and long-term implications. • Ex. What if the disease is not cured?

  13. Breach of Ethical Issues and Valuesin the Milgram Case • Deception of participants resulted in duress “In a large number of cases the degree of tension [in the participants] reached extremes that are rarely seen in sociopsychological laboratory studies. Subjects were observed to sweat, tremble, stutter, bite their lips, groan, and dig their fingernails into their flesh. These were characteristic rather than exceptional responses to the experiment.” • Results of the study: A majority of participants continued with the experiment despite their own protests

  14. Breach of Ethical Issues and Valuesin the HIV Research Case • Evaluation of the extent of informed consent • Perceived inability to abort participation “…patients relinquished autonomy to professionals in the expectation of competence.” • Perceived loss of jobs upon positive diagnosis • Pre-Counseling: 93% • Post-Counseling: 39% • Results indicate that patients must be given clear counseling to understand their participation and treatment. • A lack of participation will not compromise the health care provided to them

  15. Consequences and Outcomes HIV Testing Milgram Experiment

  16. Milgram Experiment’s Consequences and Outcomes • People had to live with emotional scarring • Some even fainted or fell into fits of laughter • Believed to be do to anxiety from taking part in experiment • Milgram claimed that many enjoyed the experience • Milgram’s acceptance into the American Psychological Association was put on hold for a year

  17. Consequences and Outcomes of Milgram Case • Later found to not be in violation of ethics • Study would need to be very useful to science and/or the general public and could only work if participants were not informed of what was going on • Participants who were emotionally damaged by the study suffered greatly • Tougher restrictions on ethical guidelines • tougher restrictions on experimental types • Prevention of similar experiments and science loses the ability to come to striking conclusions. • Studies are less objective

  18. Consequences and Outcomes of the HIV Case • Permanency of HIV results on medical records • Give up autonomy for confidence in physicians’ abilities to provide treatment • Knowledge that medical practitioners know • Patients expect better care and feel protected by hospital staff • Concern with third parties finding out about medical records • Ex. insurance companies • Patients feel their jobs are at risk if they are HIV positive • By giving up autonomy and consent to HIV testing without actually wanting the treatment, patients can suffer a conflict of interest • Patients perceive that they have other options

  19. Suggestions for Milgram Experiment • Peer-review of Milgram’s experimental design and form an opinion of the risks their colleagues’ research would cause on the subjects • Weighing of results’ importance against the potential damage to the subjects themselves • Only minimal harm should have been allowed • If risks were too great, then Milgram should have been denied permission to conduct his experiment

  20. Milgram’s Legacy • Can be argued as for the greater good, or a unnecessary breach of ethical code • Helped prove the importance of ethics committees • Think about patient before thinking of the potential results • During Milgram’s time researchers often thought of ascertaining results before the welfare of the people participating in the studies • Attitude of the Nazi and Japanese scientists during WWII

  21. Why know about Milgram’s legacy? • The general public would benefit from the information • Those greatest affected by ethics violations are typically those who are most uninformed • People may wonder what they are agreeing or how much their physician didn’t tell them before a procedure • With more information, patients can feel more at ease • Doctors can feel more comfortable knowing his patient is fully aware of his or her decision • Prevents possible lawsuits

  22. HIV/AIDS Testing In Developed Nations • Negative stigma associated with AIDS • Testing should be done as discretely as possible • Results should go to the personal physician and patient only • Prevents information leaks • AIDS clinical trials: patients should be given all the information possible without complicated jargon or frightening them • Some AIDS treatments are known to have potentially serious consequences that should be addressed with each patient. • Without persuasion or coercion of any kind, patient must decide whether he or she will receive treatment • Patients can drop out of the study at any point in time without negative consequences

  23. HIV/AIDS Testing In Undeveloped Nations • Doctors may not have the time or resources to spend going over long informed consent legal documents • Illiteracy, poor understanding, and language barriers often prove to be challenging obstacles for physicians • Despite a lack of options, patients should still have the right to refuse treatment • Prior to treatment, patients must have a firm grasp of the procedure • Including its possible consequences

  24. HIV/AIDS currently • HIV/AIDS is still a incurable disease • The negative association with AIDS makes informed consent and HIPPA laws even more necessary when it comes to testing and treatment • The possible side-effects of HIV/AIDS treatments teach society that one is allowed to either refuse the doctors recommended treatment or drop out a study without negative consequences

  25. Sources Banyard, Phillip. “The Case Against Milgram.” The Open University, 2012 Billikopf , Gregorio. “Milgram’s Experiment on Obedience to Authority.” Encina University of California. 2003. Web. Herrera, C. D. (2001), Ethics, Deception, and ‘Those Milgram Experiments’. Journal of Applied Philosophy, 18: 245–256. doi: 10.1111/1468-5930.00192 Karim QA, Karim SSA, Coovadia HM, Susser M. Informed consent for HIV testing in a South African hospital: is it truly informed and truly voluntary? Am J Pub Health 1998; 88: 637–40. Veatch, Robert M. “The Basics of Bioethics.” Upper Saddle River, NJ: Pearson Education, 2012. Print.

  26. Discussion Points • What is the difference between morality and ethics? • How would you balance informed consent? • Are there cases where informed consent are absolutely necessary and results would not be influenced?