Participants in clinical research sometimes view participation as therapy or exaggerate potential benefits, especially in phase I or phase II trials. We conducted this study to discover what methods might improve cancer patients’ understanding of early-phase clinical trials. We randomly assigned 130 cancer patients from three U.S. medical centers who were considering enrollment in a phase I or phase II cancer trial to receive either a multimedia intervention or a National Cancer Institute pamphlet explaining the trial and its purpose. Intervention (...) participants were 32 times more likely to believe that the trial’s purpose was to examine safety and 60 % less likely to believe they would experience long-term benefit or cure. There was no difference in enrollment decision. However, while patients’ understanding of the trial’s purpose improved and expectations of long-term benefit diminished, half the respondents still believed they would experience long-term benefit or cure from participation. Therefore, we conclude that multimedia interventions such as this one may help oncologists to explain the risks and benefits of early-phase cancer trials in a way that patients can more easily understand, helping them to make more informed decisions about participation. But further research into other factors that influence patients’ beliefs about the outcome of enrollment is needed, both to modify the interventions and to determine how malleable patient beliefs are. (shrink)

BackgroundStudies on different methods to supplement the traditional informed consent process have generated conflicting results. This study was designed to evaluate whether participants who received group counseling prior to administration of informed consent understood the key components of the study and the consent better than those who received individual counseling, based on the hypothesis that group counseling would foster discussion among potential participants and enhance their understanding of the informed consent.MethodsParents of children participating in a trial of nutritional supplementation were (...) randomized to receive either group counseling or individual counseling prior to administration of the informed consent. To assess the participant's comprehension, a structured questionnaire was administered approximately 48-72 hours afterwards by interviewers who were blinded to the allocation group of the respondents.ResultsA total of 128 parents were recruited and follow up was established with 118 (90.2%) for the study. All respondents were aware of their child's participation in a research study and the details of sample collection. However, their understanding of study purpose, randomization and withdrawal was poor. There was no difference in comprehension of key elements of the informed consent between the intervention and control arm.ConclusionsThe results suggest that the group counseling might not influence the overall comprehension of the informed consent process. Further research is required to devise better ways of improving participants' understanding of randomization in clinical trials.Trial RegistrationClinical Trial Registry - India (CTRI): CTRI/2009/091/000612. (shrink)

Informed consent is a central topic in contemporary biomedical ethics. Yet attempts to set defensible and feasible standards for consenting have led to persistent difficulties. In Rethinking Informed Consent in Bioethics Neil Manson and Onora O'Neill set debates about informed consent in medicine and research in a fresh light. They show why informed consent cannot be fully specific or fully explicit, and why more specific consent is not always ethically better. They argue that consent needs distinctive communicative transactions, by which (...) other obligations, prohibitions, and rights can be waived or set aside in controlled and specific ways. Their book offers a coherent, wide-ranging and practical account of the role of consent in biomedicine which will be valuable to readers working in a range of areas in bioethics, medicine and law. (shrink)

OBJECTIVES: To study whether linguistic analysis and changes in information leaflets can improve readability and understanding. DESIGN: Randomised, controlled study. Two information leaflets concerned with trials of drugs for conditions/diseases which are commonly known were modified, and the original was tested against the revised version. SETTING: Denmark. PARTICIPANTS: 235 persons in the relevant age groups. MAIN MEASURES: Readability and understanding of contents. RESULTS: Both readability and understanding of contents was improved: readability with regard to both information leaflets and understanding with (...) regard to one of the leaflets. CONCLUSION: The results show that both readability and understanding can be improved by increased attention to the linguistic features of the information. (shrink)

Comprehension and recall of informed consent was assessed after the study closure in the parents/guardians of a birth cohort of children participating in an intensive three-year diarrhoeal surveillance. A structured questionnaire was administered by field workers who had not participated in the study's follow-up protocol. Of 368 respondents, 329 (89.4 per cent) stated that the study was adequately explained during enrolment, but only 159 (43.2 per cent) could recall that it was on diarrhoea. Nearly half (45.9 per cent) of the (...) respondents stated that they would not have participated if free medical treatment was not provided, although the free medical clinic was not offered at enrolment. Spousal approval (82.9 per cent) was the most important factor in the decision to participate. In the multivariate analysis, maternal education was associated with increased awareness about the disease under study: mothers without any formal education had the lowest awareness (OR = 3.47, 95 per cent CI = 1.60–7.51). Despite a high compliance with the study protocol, retention of understanding about the research study was low over a long period of time. Although the local government provides free healthcare in the study area, respondents cited free healthcare as an important reason for participation, highlighting the need for true health equity before meaningful informed consent can be obtained. (shrink)

Researchers at the New Mexico Veterans’ Affairs Health Care System and the University of New Mexico Hospital developed a clinical trials information handbook for patients and conducted a study to gauge its effectiveness. Participants from outpatient clinics were randomized to a control group and an intervention group. Members of the control group were given a questionnaire to complete to assess their knowledge of clinical trials. Members of the intervention group read the handbook prior to completing the questionnaire. The study showed (...) that a clinical trials information handbook used during the informed consent process improved individuals’ knowledge about the process and decreased perceived risk from trial participation. This, in turn, could affect trial enrollment. (shrink)

PURPOSE: To evaluate the effects of social support on comprehension and recall of consent form information in a study of Parkinson disease patients and their caregivers.DESIGN and METHODS: Comparison of comprehension and recall outcomes among participants who read and signed the consent form accompanied by a family member/friend versus those of participants who read and signed the consent form unaccompanied. Comprehension and recall of consent form information were measured at one week and one month respectively, using Part A of the (...) Quality of Informed Consent Questionnaire .RESULTS: The mean age of the sample of 143 participants was 71 years . Analysis of covariance was used to compare QuIC scores between the intervention group and control group . In the 1-week model, no statistically significant intervention effect was found . However, the intervention status by patient status interaction was statistically significant . In the 1-month model, no statistically significant intervention effect was found . Again, however, the intervention status by patient status interaction was statistically significant . At both time periods, intervention group patients scored higher on the QuIC than did intervention group caregivers, and control group patients scored lower on the QuIC than did control group caregivers.IMPLICATIONS: Social support played a significant role in enhancing comprehension and recall of consent form information among patients. (shrink)

Comprehension and recall of informed consent was assessed after the study closure in the parents/guardians of a birth cohort of children participating in an intensive three-year diarrhoeal surveillance. A structured questionnaire was administered by field workers who had not participated in the study's follow-up protocol. Of 368 respondents, 329 stated that the study was adequately explained during enrolment, but only 159 could recall that it was on diarrhoea. Nearly half of the respondents stated that they would not have participated if (...) free medical treatment was not provided, although the free medical clinic was not offered at enrolment. Spousal approval was the most important factor in the decision to participate. In the multivariate analysis, maternal education was associated with increased awareness about the disease under study: mothers without any formal education had the lowest awareness. Despite a high compliance with the study protocol, retention of understanding about the research study was low over a long period of time. Although the local government provides free healthcare in the study area, respondents cited free healthcare as an important reason for participation, highlighting the need for true health equity before meaningful informed consent can be obtained. (shrink)

The objective of this study—a substudy to a phase I bioequivalence study—was to compare the effect of standard and concise consent forms on research volunteers’ comprehension of and satisfaction with consent forms, as well as to assess the effect of select volunteer characteristics, such as financial motivations to participate in research, on their comprehension. A 36-item questionnaire measured volunteers’ comprehension, satisfaction, and motivations for participation. Volunteers were randomized to the standard Pfizer consent form or a concise, easier-to-read form. We approached (...) 139 volunteers to participate, and 138 completed the questionnaire . The cohorts did not differ in sociodemographic characteristics. We found that the average comprehension scores for the standard consent form cohort and the concise consent cohort were about the same, and that satisfaction with the consent form was high in both cohorts. Surprisingly, volunteers with a financial motivation had significantly greater comprehension of the study. (shrink)