Presentation on theme: "Informed Consent Ethics Forum 2012"— Presentation transcript:
1Informed Consent Ethics Forum 2012 Duquesne UniversityThomas Goehring, Leah Gottlieb, Andrew Glaid, Sebastien Hebert, David GeorgeMentor: Dr. Mike Cascio
2Issues Dealing with Implicit vs. Explicit Informed Consent Violations Effectiveness of some tests demand providing a lack of informationVaccines and placebosIf 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?
3The Milgram Experiment Stanley Milgram: Social Psychologist from Yale UniversityExperiment started in 1960s after Nazi war crime trialsLenient on rules of experimentationExperiment of obedienceWhy good people do bad thingsDo they obey out of fear or to appeal to higher powers?
4The TestTest subjects came from various classes and various occupationsHired for about 4 dollars an hourSubjects were told that they would be part of a study that would test punishment on learning ability
5The TestThe subject and an actor decided which was to be the teacher and the learnerFixed coin flipTeacher receives test shockTeacher asks learner a series of questionsA wrong answer leads to the learner being shocked, with each at a progressively higher voltage.Learner would complain, yell, plead, etc. at higher shocks
6The TestAt a certain point, teacher would hesitate to shock the learnerExperimenter would pressure teacherIf it happens four times, the experiment is haltedOnly actual shock was given at test shockActor/Learner would give realistic screams and play tape recordings when “shocked”
7General Considerations One should have a true understanding of testing, treatments, and the liability of medical professionalsOne should consider the validity of the results if participants are given too much information
8Balancing Complexity, Length, and Information Clear need to inform patients of risks/concerns and nature of procedures, regardless of type of procedureTesting or vaccine trialsMany forms are lengthy and can be troublesome in countries with high illiteracy ratesDifficult to allow full autonomy of patients with complicated but necessary languageShortening and simplification can lead to confusion or malpractice suits in the form of inadequate information
9Effectiveness of Treatments If a patient is given too much or too little information, results of testing may varyPlacebo effect (or nocebo effect) may occurIf patient is informed that they are not given the drug, they may leave study and greatly skew resultsShould tests and consent forms clearly deny patients knowledge of a specific nature (placebo or treatment)?
10HIV testing on women in a South African hospital (1998 study) Many participants felt compelled to participate despite being reminded that the tests were voluntary88% of participants wanted to know their HIV status, which contrasts to other countries where participants did not want to know their statusPatients, after entering, felt compelled to remain in the study
11Results of Study Many participants worried about partners vs. Relatively few participants worried about compromised job statusMany participants entered the study voluntarily vs.Few participants felt they would be allowed to leave the studyThese results raise the question of how effective informed consent was in this study
12Circumstances of the Cases Milgram: Nuremberg Trials, “only following orders”Fully informing participants would have compromised experimental resultsHIV: Differing backgrounds impact a person’s ability to understand short- and long-term implications.Ex. What if the disease is not cured?
13Breach of Ethical Issues and Values in 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
14Breach of Ethical Issues and Values in the HIV Research Case Evaluation of the extent of informed consentPerceived inability to abort participation“…patients relinquished autonomy to professionals in the expectation of competence.”Perceived loss of jobs upon positive diagnosisPre-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
15Consequences and Outcomes Milgram ExperimentHIV Testing
16Milgram Experiment’s Consequences and Outcomes People had to live with emotional scarringSome even fainted or fell into fits of laughterBelieved to be do to anxiety from taking part in experimentMilgram claimed that many enjoyed the experienceMilgram’s acceptance into the American Psychological Association was put on hold for a year
17Consequences and Outcomes of Milgram Case Later found to not be in violation of ethicsStudy 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 onParticipants who were emotionally damaged by the study suffered greatlyTougher restrictions on ethical guidelinestougher restrictions on experimental typesPrevention of similar experiments and science loses the ability to come to striking conclusions.Studies are less objective
18Consequences and Outcomes of the HIV Case Permanency of HIV results on medical recordsGive up autonomy for confidence in physicians’ abilities to provide treatmentKnowledge that medical practitioners knowPatients expect better care and feel protected by hospital staffConcern with third parties finding out about medical recordsEx. insurance companiesPatients feel their jobs are at risk if they are HIV positiveBy giving up autonomy and consent to HIV testing without actually wanting the treatment, patients can suffer a conflict of interestPatients perceive that they have other options
19Suggestions for Milgram Experiment Peer-review of Milgram’s experimental design and form an opinion of the risks their colleagues’ research would cause on the subjectsWeighing of results’ importance against the potential damage to the subjects themselvesOnly minimal harm should have been allowedIf risks were too great, then Milgram should have been denied permission to conduct his experiment
20Milgram’s LegacyCan be argued as for the greater good, or a unnecessary breach of ethical codeHelped prove the importance of ethics committeesThink about patient before thinking of the potential resultsDuring Milgram’s time researchers often thought of ascertaining results before the welfare of the people participating in the studiesAttitude of the Nazi and Japanese scientists during WWII
21Why know about Milgram’s legacy? The general public would benefit from the informationThose greatest affected by ethics violations are typically those who are most uninformedPeople may wonder what they are agreeing or how much their physician didn’t tell them before a procedureWith more information, patients can feel more at easeDoctors can feel more comfortable knowing his patient is fully aware of his or her decisionPrevents possible lawsuits
22HIV/AIDS Testing In Developed Nations Negative stigma associated with AIDSTesting should be done as discretely as possibleResults should go to the personal physician and patient onlyPrevents information leaksAIDS clinical trials: patients should be given all the information possible without complicated jargon or frightening themSome 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 treatmentPatients can drop out of the study at any point in time without negative consequences
23HIV/AIDS Testing In Undeveloped Nations Doctors may not have the time or resources to spend going over long informed consent legal documentsIlliteracy, poor understanding, and language barriers often prove to be challenging obstacles for physiciansDespite a lack of options, patients should still have the right to refuse treatmentPrior to treatment, patients must have a firm grasp of the procedureIncluding its possible consequences
24HIV/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 treatmentThe 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
25SourcesBanyard, Phillip. “The Case Against Milgram.” The Open University, 2012Billikopf , Gregorio. “Milgram’s Experiment on Obedience to Authority.” Encina University of California Web.Herrera, C. D. (2001), Ethics, Deception, and ‘Those Milgram Experiments’. Journal of Applied Philosophy, 18: 245–256. doi: /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, Print.
26Discussion 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?