Informed ConsentEthics Forum 2012Duquesne University

Thomas Goehring, Leah Gottlieb, Andrew Glaid, Sebastien Hebert, David George

Mentor: Dr. Mike Cascio

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?

• 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?

The Milgram Experiment

• 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

The Test

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

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”

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

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

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)?

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

Results of StudyMany 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

Circumstances of the CasesMilgram: 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?

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

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

Consequences and Outcomes

Milgram Experiment HIV Testing

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

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

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

Suggestions for Milgram ExperimentPeer-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

Milgram’s LegacyCan 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

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

HIV/AIDS Testing In Developed NationsNegative 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

HIV/AIDS Testing In Undeveloped NationsDoctors 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

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

SourcesBanyard, 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.

Discussion PointsWhat 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?