" in language understandable to the subject "--or not. Mark Hochhauser, Ph.D. Readability Consultant Golden Valley, Minnesota

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1 " in language understandable to the subject "--or not. Mark Hochhauser, Ph.D. Readability Consultant Golden Valley, Minnesota In its 1995 Information Sheets for Institutional Review Boards and Clinical Investigators, the FDA required that "the information that is given to the subject or representative shall be in language understandable to the subject or the representative," and that "technical and medical terminology should be avoided or must be explained." As an IRB member since 1994 I still see consent forms that do not meet either of those requirements, although some consent form writers have done a slightly better job of explaining some of the technical and medical terms. I've reviewed some consent forms that have come before our IRB in the last year or so and listed examples of complicated language and terms starting with the title and going through the consent form as written. These lists include only the generic language that might be found in almost any consent form, not the language or terms specific to trials in oncology, cardiology, infectious disease, etc. Table #1 includes complicated language in the Study Title and Purpose sections. Although a study's title should give prospective subjects a clear idea of what the trial is all about, most titles are completely incomprehensible. Consent form writers should not assume that everyone understands Roman numerals, let alone the meaning of Phase I, Phase II, Phase III, Phase IV, or the other terms typically found in very long titles. The study purpose often shifts back and forth between investigational drug, investigational agent, experimental drug, study drug, active study drug, etc. While researchers might see these as equivalent terms, prospective subjects may think the different terms refer to different drugs. Table #2 lists medical and technical terms in the Procedures and Risks sections. Because patients expect to get the best treatment possible from their physicians, they may have a hard time understanding or accepting the concept of random assignment. Even if it's explained to them, sometimes as "like the flip of a coin" or "like rolling dice," some patients do not want to believe that their physician would put them in the placebo group, or randomly decide what experimental therapy they're going to receive. The concept of random assignment doesn't fit well with the patient's concept of personalized quality care in which their physician wouldn't do anything that's not in their best interest. Study risks, especially if they're not explained well, can be almost meaningless. Not every patient understands < or >, or how likely they are to actually have side effects described (but not defined or quantified) as very common, common, or rare. Plus, patients may be confused by being "on study," but not being "in a study." Telling subjects that "You may experience some, none or rarely, all of these side effects and they may be mild, moderate or severe" completely overstates the study's risks: Is any subject likely to experience all 34 listed side effects? Table #3 lists ambiguous language from the Benefits and Rights sections. Consent forms are usually vague about potential benefits. Surely sponsors have some idea of what the experimental drug might accomplish reducing the size of a tumor, extending the lifespan by several weeks or months, etc. But since specific benefits usually aren't described perhaps to reduce the possibility of "therapeutic misconception"-- prospective subjects are left to ponder just what "medical benefits" they might or might not experience. Subject rights are usually described using the boilerplate language from federal regulations. While consent forms tell subjects they can refuse to be in a study, or can withdraw at any time "without penalty or loss of benefits to which you are otherwise entitled," I have yet to see a consent form describe those penalties or benefits. Subjects are told that by being in a clinical trial they "do not waive any of their legal rights," but those legal rights are never 1

2 explained. I've seen only one consent form acknowledge that "You have the right to obtain legal advice if you're injured in this study." Otherwise, subjects are told that they have legal rights they're just not told what those legal rights are. "I have read and understand this entire consent form." Language above the signature line is often "I have read and understand this entire consent form" or " I can withdraw at any time without penalty or bias" or "I have read this consent form and understand the possible risks and benefits of my participation in this study" or "I am not giving up any of my legal rights by signing this consent form." It seems impossible for anyone to understand the entire consent form; even IRB members sometimes can't understand the "entire" consent form. The FDA recommends not using that language because prospective subjects can't always know what they understand and don't understand, even though consent forms state that "I have had the opportunity to ask questions and these have been answered to my satisfaction." Given the language and terms in the tables above, subjects are unlikely to really understand the risks, benefits and legal rights involved in the study, even if the consent form tells prospective subjects to "Please ask your doctor or the study staff to explain any words or information you do not fully understand." A researcher's "satisfactory" answers may still be incomplete or ambiguous or even wrong. Some of these terms are hard enough to understand that patients are unlikely to "fully understand" some topics, even if they're willing to ask many questions. But because patients don't want to appear ignorant, they may ask very few questions. If prospective subjects really understood the consent form, you should be able to ask them to define some of the terms included in the above tables and expect correct answers--or not. 2

3 Table #1: Complicated language in consent form titles and study purposes Study Title Protocol Phase I, II, III, IV Randomized Multi-center Comparative Trial Open label Dose escalation Double-blind First-line treatment Study Purpose Investigational drug Investigational use Experimental products Agents Double blind study Treatment cycles Well-tolerated Efficacy and safety Monotherapy Study Title Protocol Phase I, II, III, IV Randomized Multi-center Comparative Trial Open label Dose escalation Double-blind First-line treatment Study Purpose Investigational drug Investigational use Experimental products Agents Double blind study Treatment cycles Well-tolerated Efficacy and safety Monotherapy 3

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5 Table 2 Medical and technical terms in Procedures and Risks sections Study Procedures Study Risks Randomly assigned Highest tolerated dose Study protocol Effects judged to be intolerable Different administration schedules Study treatment Baseline evaluations < or > Experimental therapies While on the study Eligibility criteria Potentially serious side effects Woman of childbearing potential Tolerate study drug Symptomatic treatment Treatment regimen Risks, discomforts, inconveniences Most common/common/rare side effects Study Procedures Study Risks Randomly assigned Highest tolerated dose Study protocol Effects judged to be intolerable Different administration schedules Study treatment Baseline evaluations < or > Experimental therapies While on the study Eligibility criteria Potentially serious side effects Woman of childbearing potential Tolerate study drug Symptomatic treatment Treatment regimen Risks, discomforts, inconveniences Most common/common/rare side effects 5

6 Table 3 Ambiguous language in Benefits and Rights sections Study Benefits Subject Rights direct medical benefit/no direct medical benefit without penalty or loss of benefits to which you are otherwise entitled increased survival you do not waive any of your legal rights. improvement or your disease and/or symptoms significant new findings no therapeutic or other direct health benefit does not constitute a waiver of any rights you have Table 3 Ambiguous language in Benefits and Rights sections Study Benefits direct medical benefit/no direct medical benefit increased survival improvement or your disease and/or symptoms no therapeutic or other direct health benefit Subject Rights without penalty or loss of benefits to which you are otherwise entitled you do not waive any of your legal rights. significant new findings does not constitute a waiver of any rights you have 6

Risk Overload and Risk Misdirection in the Consent Process Mark Hochhauser, Ph.D. Readability Consultant Golden Valley, Minnesota

Risk Overload and Risk Misdirection in the Consent Process Mark Hochhauser, Ph.D. Readability Consultant Golden Valley, Minnesota Understanding risks is a key part of the informed consent process for prospective