Informed Consent Ethics Forum 2012 - PowerPoint Presentation

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Informed Consent

Ethics Forum 2012Duquesne UniversityThomas Goehring, Leah Gottlieb, Andrew Glaid, Sebastien Hebert, David GeorgeMentor: Dr. Mike Cascio

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Issues Dealing with Implicit vs

. Explicit Informed Consent ViolationsEffectiveness 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?

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Stanley Milgram

: Social Psychologist from Yale UniversityExperiment started in 1960s after Nazi war crime trialsLenient on rules of experimentation

Experiment of obedience

Why

good people do bad

thingsDo they obey out of fear or to appeal to higher powers?

The Milgram Experiment

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Test subjects came from various classes and various occupations

Hired for about 4 dollars an hourSubjects were told that they would be part of a study that would test punishment on learning ability

The Test

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The Test

The subject and an actor decided which was to be the teacher and the learnerFixed coin flipTeacher 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

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The Test

At a certain point, teacher would hesitate to shock the learnerExperimenter would pressure teacherIf 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”

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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

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Balancing 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 language

Shortening and simplification can lead to confusion or malpractice suits in the form of inadequate information

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Effectiveness 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)?

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HIV 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

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Results 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

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Circumstances 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?

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Breach of Ethical Issues and Values

in the Milgram CaseDeception 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

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Breach of Ethical Issues and Values

in the HIV Research CaseEvaluation 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 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

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Consequences and Outcomes

Milgram Experiment

HIV Testing

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Milgram 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 experience

Milgram’s acceptance into the American Psychological Association was put on hold for a year

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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

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Consequences and Outcomes of the HIV Case

Permanency of HIV results on medical recordsGive up autonomy for confidence in physicians’ abilities to provide treatment

Knowledge that medical practitioners know

Patients expect

better

care and feel protected by hospital staffConcern with third parties finding out about medical records

Ex. i

nsurance 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

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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 subjectsWeighing of results’ importance against the potential damage to the subjects themselvesOnly minimal harm should have been allowed

If risks were too great, then

Milgram should have been denied permission to conduct his

experiment

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Milgram’s Legacy

Can 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 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

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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

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HIV/AIDS Testing In Developed Nations

Negative stigma associated with AIDS Testing should be done as discretely as possibleResults should

go

to the personal physician and patient

only

Prevents information leaksAIDS 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

.

W

ithout

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

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HIV/AIDS Testing

In Undeveloped NationsDoctors 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 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

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HIV/AIDS currently

HIV/AIDS is still a incurable diseaseThe 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

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Sources

Banyard, Phillip. “The Case Against Milgram.” The Open University, 2012Billikopf , 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.

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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?