Exploring Understanding of “Understanding”: The Paradigm Case of Biobank Consent Comprehension

Data documenting poor understanding among research participants and real-time efforts to assess comprehension in large-scale studies are focusing new attention on informed consent comprehension. Within the context of biobanking consent, we previously convened a multidisciplinary panel to reach consensus about what information must be understood for a prospective participant’s consent to be considered valid. Subsequently, we presented them with data from another study showing that many U.S. adults would fail to comprehend the information the panel had deemed essential. When asked to evaluate the importance of the information again, panelists’ opinions shifted dramatically in the direction of requiring that less information be understood. Follow-up interviews indicated significant uncertainty about defining a threshold of understanding and what should happen when prospective participants are unable to grasp key information. These findings have important implications for urgently needed discussion of whether consent comprehension is an ethical requirement or an ethical aspiration.     

Culture and social distance: a case study of methodological cautions

The authors presented, as a case study of methodological challenges in cross-cultural research, E. S. Bogardus's (1925) Social Distance Scale, which requires respondents to indicate the social distance between themselves and others. The meaningfulness of the scale depends on the assumption that respondents believe that the magnitude of social distance increases as one moves through the social categories of family member, friend, neighbor, coworker, and citizen. The authors tested this assumption for English Canadian, French Canadian, Jewish, Indian, Algerian, and Greek participants, all 1st-generation immigrants in Montreal. The participants rated their willingness to associate with members of each of the other ethnic groups in 5 social categories. The percentage of respondents in each sample whose data conformed to the prediction ranged from 63.7% to 98.0%, with English Canadian, French Canadian, and Jewish respondents providing responses most consistent with the predicted pattern. The Indian and Algerian respondents' data were the least consistent with the predicted pattern, especially when rating members of their own ethnic groups.     

Patient Expectations of Benefit from Phase I Clinical Trials: Linguistic Considerations in Diagnosing a Therapeutic Misconception

The ethical treatment of cancer patientsparticipating in clinical trials requiresthat patients are well-informed about thepotential benefits and risks associated withparticipation. When patients enrolled in phaseI clinical trials report that their chance ofbenefit is very high, this is often taken as evidence of a failure of the informed consent process. We argue, however, that some simple themes from the philosophy of language may make such a conclusion less certain. First, the patient may receive conflicting statements from multiple speakers about the expected outcome of the trial. Patients may be reporting the message they like best. Second, there is a potential problem of multivocality. Expressions of uncertainty of the frequency type(e.g., ``On average, 5 out of every 100 patientswill benefit') can be confused with expressionsof uncertainty of the belief type (e.g.,``The chance that I will benefit is about80%'). Patients may be informed using frequency-type statements and respond using belief-type statements. Third, each speech episode involving the investigator and the patient regarding outcomes may subservemultiple speech acts, some of which may beindirect. For example, a patient reporting ahigh expected benefit may be reporting a beliefabout the future, reassuring family members,and/or attempting to improve his or her outcome by apublic assertion of optimism. These sources oflinguistic confusion should be considered injudging whether the patient's reported expectation isgrounds for a bioethical concern that there hasbeen a failure in the informed consent process.