Informed consent must be viewed as a process
Consent should be ongoing endeavor
In the summer of 1971, Philip Zimbardo, PhD, was lead investigator on The Stanford Prison Experiment, a study designed to measure the psychological effects that imprisonment and authority would have on participants. Eighteen subjects were selected, nine were assigned the role of prisoner, the other nine the role of guard. For six days — eight shy of the planned 14 days — investigators watched as normal (according to results of psychological testing done on all potential volunteers), middle-class, young men, became subservient, depressed, withdrawn, dictatorial or even sadistic, depending on the role assigned. Two subjects were released from the study — one after suffering a near breakdown and the other after breaking out in a rash that covered his body after he was denied mock parole.
The experiment followed the guidelines of the Human Subjects Review Board, Zimbardo explained in a 1973 chapter, "Reflections on the Stanford Prison Experiment: Genesis, Transformations, Consequences."1
"There was no deception," he wrote. "All participants were told in advance that, if they became prisoners, many of their usual rights would be suspended and they would have only minimally adequate diet and health care during the study."
What they weren’t told is the possible risks and benefits and that they had the right to withdraw from the study at any time. In fact, the informed consent document offered to study volunteers specifically stated, "I will be expected to participate for the full duration of the study, that I will only be released from participation for reasons of health deemed adequate by the medical advisers to the research project or for other reasons deemed appropriate by Dr. Philip Zimbardo."
Zimbardo has written extensively about the study, from the ethics of the execution to the findings yielded during its six-day duration. "Clearly, I would not have been able to conduct such a study today," he tells IRB Advisor. "In hindsight, the situation was more powerful than anyone imagined." When asked what he would do differently, he says, "I would have someone from the IRB available at random times to check the progress of the study and have the power to terminate it."
The Stanford Prison Experiment is not only a case study in the psychology of imprisonment, but it also can serve as a case study for IRBs and the issue of informed consent.
A misstep when dealing with informed consent can result in administrative sanctions and possible civil liability, says LaDale George, JD, senior counsel, health law department/health care business counseling practicing group at Foley & Lardner in Chicago. "IRBs should consider risks and benefits, route of administration, dosage amount, disclosure of alternative treatments, etc., when evaluating an informed consent document to determine whether there is adequate information being conveyed to protect the rights of human subjects," he says.
The Office for Human Research Protections (OHRP) recently cited National Heart, Lung, and Blood Institute investigators and the IRBs that reviewed their protocols for deficiencies, which included a failure to disclose risks associated with the studies.
"If OHRP finds that the IRB has not been following statutory requirements for approving informed consent documents, they may halt the study and suspend the authority of the IRB to review trials," says George. "Similarly, the FDA [Food and Drug Administration] may refuse to accept data from trials that were approved by an IRB that is found to have approved studies with inadequate informed consent documents."
Informed consent problems also can result in civil liability. Trial subjects have filed lawsuits against IRBs and named individual members in suits, George points out, particularly when a protocol has been approved and it is determined that full disclosure of risks and benefits was lacking. "Each consent form should stand alone, and IRBs should take the time to really examine the form. Informed consent forms should be tailored to the specific trial to ensure that it meets the needs of informing the patient," he says.
"We like to see the risks described in a meaningful way — that is to have descriptors such as more likely or less likely’ or to have percentages," says Marcia Weese, MHA, IRB director at Emory University in Atlanta. "The risks section should include risks of all procedures that are related to the study. The benefits section is usually not as detailed because you don’t want to make it sound too promising."
Documents should not only disclose risks but also disclose any alternative treatments, says Margaret T. Feeney, MBA, RAC, Committee on Clinical Investigations Liaison for Quality Assurance and Audit, Beth Israel Deaconess Medical Center in Boston. "Investigators must respect the subject and recognize that if there are alternatives to a certain treatment that they are disclosed."
She points out that not only must known or potential risks be disclosed, if new risks are discovered during the course of the study, that information should be conveyed to participants.
"Principal investigators should first inform the IRB and then provide the research subject with any information that may affect their willingness to continue to participate," Feeney says.
More than just a signature
"There are two goals involved in obtaining informed consent for research: complying with government regulations and meeting the ethical mandate to ensure that people provide authorization to participate," says Jeremy Sugarman, MD, MPH, MA, Director of the Center for the study of Medical Ethics and Humanities, Duke University Medical Center in Durham, NC. "The regulations tend to emphasize what needs to be included in informed consent documents, but in order to meet the ethical goal of informed consent, you have to first make sure that the potential research participant has adequate decision making capacity and that they are able to make a voluntary choice."
"Our committee looks at how subjects’ understanding is assessed and what happens if the subject is unable to give informed consent — whether they are excluded from a study or whether consent is obtained from a legally authorized representative," says Weese. "The committee also looks at when and where consent will be discussed and documentation obtained to ensure that potential subjects have had time to consider their participation."
In other words, it’s not enough to hand subjects a form and ask them to sign. "The act of obtaining informed consent is an ongoing process," says Feeney, involving not only communicating the particulars of the study but also ensuring that participants understand their rights.
The process begins with communicating to participants the following:
• Participating is voluntary.
• The study may or may not benefit the participant, though knowledge gained through the study may benefit others.
• Participants may withdraw from the study at any time.
• Participation or withdrawal will not affect care.
The rest of the form contains information regarding the specifics of the study, and responsibility and rights of participants.
"We want the subject to be able to make a rational choice, and this can only be done if information is provided in a clear, understandable manner," explains Feeney.
What’s clear and understandable?
Clear and understandable seems to be a challenge when it comes to how medical information is communicated. Readability expert Mark Hochhauser, PhD, completed an analysis of more than 30 Health Insurance Portability and Accountability Act privacy notices and found that most were written at first- or second-year college level. Complexity is not just a problem with privacy notices, it’s a problem that Weese sees when evaluating consent documents submitted to her IRB. "The most common problem encountered is that the consent is written at too high a level," she says.
Hochhauser recommends that you keep it simple by employing the following:
• Sentence length — 15 to 20 words
• Word choice — use everyday words
• Sentence complexity — short with short words, short with a few long words, or medium with a few long words.
"We’re looking for an eighth-grade reading level. Some principal investigators write a consent document that would be challenging for a nonmedical person to understand," says Feeney.
"Our committee makes sure that all procedures described in the protocol are reflected in the consent and that it is written in language that is non-scientific and nontechnical. It’s not just a matter of going down a checklist — each consent has to be evaluated," says Weese.
1. Blass T, ed. Obedience to Authority: Current Perspectives on the Milgram Paradigm. Mahwah, NJ: Lawrence Erlbaum Associates; 2000.
Informed Consent Form Contents
• Introduction/Purpose: An explanation of the purpose of the research, why the subject is being asked to participate, and how long the subject may be involved in the study.
• Procedure: A detailed description of what procedures will be performed on the subject and a detailed description of what the subject is expected to do during the study.
• Risks: A description of any foreseeable risks to or discomforts that may be experienced by the subject.
• Benefits: A description of possible benefits, including disclosure that the subject my not experience any benefits during the study.
• Alternatives: A listing of alternative procedures or courses of treatment that are available.
• Confidentiality: A description of how records will be maintained to ensure that subjects’ privacy is protected.
• Compensation/Costs: A description of how much or what kind of compensation, if any, subjects will receive for participating in the study, as well as a description of costs that may be incurred by participants.
• Voluntary Participation/Withdrawal: An explanation that participation is voluntary and that subjects may withdraw at any time. Also include an explanation of medical consequences of withdrawal, if any; circumstances under which investigator may discontinue participation of a subject; and procedures for possible data collection or follow up once a participant has withdrawn.
• Contact persons: Names and addresses and/or telephone numbers of persons who can be contacted with questions.
• New findings: How and if results of the study will be communicated.
Source: Emory University IRB, Atlanta.