Informed Consent Language and Parents' Willingness to Enroll Their Children in Research
Cico, Stephen John, Vogeley, Eva, Doyle, William J., IRB: Ethics & Human Research
Federal regulations governing research with humans require that specific information be provided to potential research participants in the informed consent process: 1) that the study involves research, with a description of its purpose, duration, and the procedures, including those that are experimental; 2) the study's potential risks to participants; 3) the study's potential benefits to participants or others; 4) the alternatives to participating in the study; 5) the policies for protecting the confidentiality of participant information; 6) whether compensation for research-related injuries will be provided; 7) information about whom to contact if injuries occur or questions arise; and 8) notification that participation is voluntary and that individuals can withdraw from the study at any time. (1) Yet it has become increasingly clear that securing an individual's signature on a consent document is not sufficient to satisfy the regulatory and ethical requirement for information exchange in the consent process. (2) A key concern is whether individuals comprehend the information presented to them.
Comprehension of informed consent information requires not only that potential research participants (or their legally authorized representatives) understand the words that are used in consent forms, but also that the semantic content of the words is similar, if not identical, for all parties. (3) However, in informed consent documents and in the oral consent process, different words are often used to describe the same study. (4) For instance, during our long tenure on the University of Pittsburgh's pediatric institutional review board (IRB) and the IRB at the Children's Hospital of Pittsburgh (known as the Human Rights Committee), we have seen a variety of different words used synonymously and thus interchangeably within and across protocols, irrespective of differences in the risk/benefit ratio of the studies. One concern this raises is whether descriptions about a particular study have value-laden connotations (either good or bad) that might bias parents' willingness to enroll their children in the study.5
Failure to understand essential information disclosed in the consent process could lead to the therapeutic misconception--i.e., the belief that a study will provide a therapeutic benefit to individual participants, rather than to future patients. Potential research participants who exhibit the therapeutic misconception might enroll in studies when it's not in their best interest to do so. Individuals might also enroll in a study when it is not in their best interest because the consent information does not include research-related risks. On the other hand, if consent language that is assumed to be value-free actually has negative connotations, individuals may be unwilling to enroll in a study. For example, at least one study has shown that patients and research participants rate the term "medical experiment" most negatively compared to the terms "medical research," "clinical trial," "clinical investigation," and "medical study." (6)
We report here about how the parents of children being treated in the emergency department of a pediatric hospital responded to adjective and noun descriptors about research and how those descriptors affected their willingness to enroll their child in a research study. In this pilot study, we tested the null hypothesis that parents view the terms "research project," "research study," "research experiment," "medical study," and "medical experiment"--which are commonly used in consent forms--as semantically equivalent. Implicit in this claim is that the terms are value-neutral synonyms. If that is true, then using these terms to describe research protocols should not affect the expressed willingness of parents to allow their child to participate in a research study nor influence the parents' perception of the relative risk and safety of the study. (7)
he potential study population consisted of all adult caregivers who accompanied a child that was admitted to the emergency department at the Children's Hospital of Pittsburgh and triaged to the fast-track clinic between January 28 and February 15, 2004. …