A comparative study of the informed consent process with or without audiovisual recording.

BACKGROUND.: The Central Standard Drugs Control Organization (CDSCO) issued an administrative order in November 201 3 mandating audiovisual (AV) recording of the informed consent process for all regulatory studies. At this point, a phase 2/3 trial ongoing at our centre had recruited 45 participants using the written, informed consent process. Another 40 participants were recruited after the order and underwent AV recording of the consent process. We assessed the difference in participants' understanding between the two consenting processes as the trial fortuitously had both forms of consent. METHODS.: A 16-item questionnaire with six domains (purpose, study procedures, risks, benefits, payment for participation, and rights and confidentiality) was designed and validated. It was administered to the participants after approval of the institutional ethics committee and written informed consent. Answers given were matched with a template of model answers. The responses were scored as fully correct (3), partially correct (2), 'don't remember' (1 ), and incorrect (0) with a total possible score of 48. Between-group analysis was done for total scores and domain-specific scores. Domain-wise analysis was done for the proportion of all categories of responses. The impact of potential confounders on participants' understanding was also factored in. RESULTS.: A total of 38 respondents-21 in the AV consent group and 1 7 in the written consent group-agreed to participate. The total mean (SD) score of the AV consent group was significantly higher (40.3 [5.9]) compared to that of the written consent group (34.8 [7.94]; p = 0.01). Between the groups the score was significant in the domains of rights and confidentiality (p = 0.01). The proportion of participants who gave fully correct answers was statistically significant in the domain of purpose (p = 0.04). The time elapsed between the original consent and this study showed a weak inverse correlation (ρ = -0.3, p = 0.01). CONCLUSION.: AV recording of the informed consent process in a clinical trial appears to improve the understanding of participants relative to the written informed consent alone.

An audit of consent refusals in clinical research at a tertiary care center in India.

BACKGROUND AND RATIONALE: Ensuring research participants' autonomy is one of the core ethical obligations of researchers. This fundamental principle confers on every participant the right to refuse to take part in clinical research, and the measure of the number of consent refusals could be an important metric to evaluate the quality of the informed consent process. This audit examined consent refusals among Indian participants in clinical studies done at our center. MATERIALS AND METHODS: The number of consent refusals and their reasons in 10 studies done at our center over a 5-year period were assessed. The studies were classified by the authors according to the type of participant (healthy vs patients), type of sponsor (investigator-initiated vs pharmaceutical industry), type of study (observational vs interventional), level of risk [based on the Indian Council of Medical Research (ICMR) "Ethical Guidelines for Biomedical Research on Human Participants"], available knowledge of the intervention being studied, and each patient's disease condition. RESULTS: The overall consent refusal rate was 21%. This rate was higher among patient participants [23.8% vs. healthy people (14.9%); P = 0.002], in interventional studies [33.6% vs observational studies (7.5%); P < 0.0001], in pharmaceutical industry-sponsored studies [34.7% vs investigator-initiated studies (7.2%); P < 0.0001], and in studies with greater risk (P < 0.0001). The most common reasons for consent refusals were multiple blood collections (28%), inability to comply with the study protocol (20%), and the risks involved (20%). CONCLUSION: Our audit suggests the adequacy and reasonable quality of the informed consent process using consent refusals as a metric.