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Assessment of the understanding of informed consent including participants' experiences, and generation of a supplemental consent decision aid for Gestational Diabetes Mellitus (GDM) research.

ABSTRACT: Background: Informed consent is a basic ethical requirement of clinical research, yet deficiencies have been documented in the comprehension of its components among trial participants. Pregnancy research is sparsely conducted. Assessment of understanding of the informed consent among pregnant women suffering from Gestational Diabetes Mellitus enrolled in a randomized controlled trial, and their experiences was planned. Methodology: A prospective observational cohort study was conducted among participants of EMERGE clinical trial at the University Hospital, Galway. Willing participants allowed observation of their consent encounters. They completed the standard QuIC questionnaire at follow up visits for assessment of objective and subjective understanding of informed consent, and reasons to participate and level of satisfaction. Data was entered and analysed using Microsoft Office Excel and Minitab version 18. Results: The most commonly asked questions asked in the twenty consent encounters observed were focused upon the safety of the study drug for the developing foetuses and women. The general attitude of the women was positive towards participation. The mean objective understanding score was 72.43 ± 7 and the subjective understanding score was 91.67 ± 8.68 (out of 100). Critical components of consent like voluntarism, randomisation, withdrawal, and benefit to others were well understood. The domains related to nonstandard nature of treatment, additional risks/discomforts and compensation were poorly understood. The women cited the desire to provide benefit to future patients as the most common reason to participate, and most were satisfied with the consent process. Conclusion: Comprehension of informed consent is good in most aspects, but the grasp of certain concepts is poor among the pregnant women. Efforts are needed to improve informed consent through engagement of investigators, research nurses and possibly, the use of a decision aid.

SUBMITTER: Atal S

PROVIDER: S-EPMC6973531 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Assessment of the understanding of informed consent including participants' experiences, and generation of a supplemental consent decision aid for Gestational Diabetes Mellitus (GDM) research.

Atal Shubham S Dunne Fidelma F

HRB open research 20180329

<b>Background:</b> Informed consent is a basic ethical requirement of clinical research, yet deficiencies have been documented in the comprehension of its components among trial participants. Pregnancy research is sparsely conducted. Assessment of understanding of the informed consent among pregnant women suffering from Gestational Diabetes Mellitus enrolled in a randomized controlled trial, and their experiences was planned. <b>Methodology:</b> A prospective observational cohort study was condu ...[more]

PMID: 32002505

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Project description:Background Informed consent is often cited as the “cornerstone” of research ethics. Its intent is that participants enter research voluntarily, with an understanding of what their participation entails. Despite agreement on the necessity to obtain informed consent in research, opinions vary on the threshold of disclosure necessary and the best method to obtain consent. We aimed to investigate Australian researchers’ views on, and their experiences with, obtaining informed consent. Methods Semi-structured interviews were conducted with 23 researchers from NSW institutions, working in various fields of research. Interviews were analysed and coded to identify themes. Results Researchers reported that consent involved information disclosure, understanding and a voluntary decision. They emphasised the variability of consent interactions, which were dependent on potential participants’ abilities and interests, study complexity and context. All researchers reported providing written information to potential participants, yet questioned the readability and utility of this information. The majority reported using signed consent forms to ‘operationalise’ consent and reported little awareness of, and lack of support in implementing more dynamic informed consent procedures, such as verbal informed consent, that was fit for the purposes of their studies. Views on Human Research Ethics Committees (HRECs) varied. Some reported inconsistent, arduous inputs on the information form and consent process. Others expressed reliance on HRECs for guidance, viewing them as institutional safeguards. Conclusions This study highlights the importance of transparent relationships, both between researchers and participants, and between researchers and HRECs. Where the relationship with study participants was reported as more robust, researchers felt that they were better able to ensure participants made better, more informed decisions. Where the relationship with HRECs was reported as more robust, researchers were more likely to view them as institutional safeguards, rather than as bureaucratic hindrances. Conscientious and mindful researchers are paramount to ensuring the procedure accommodates individual requirements. This study advocates that when designing ethical informed consent practices, researchers should be integrated as autonomous players with a positive input on the process, rather than, in the worst case, predatory recruiters to be curtailed by information forms and oversight.

Project description:Cognitive impairment is a characteristic of schizophrenia. This impairment may affect the retention of information required for ongoing knowledgeable participation in clinical trials. This study monitored retention of study-related knowledge-including assessment of therapeutic misconception-in people with stable, DSM-IV schizophrenia during participation in placebo-controlled clinical trials of adjunctive agents. Stability was defined as being on an antipsychotic with no change in medication or dose over the previous 4 weeks.This longitudinal study assessed retention of clinical trial-related consent information. Individuals enrolling in 1 of 8 clinical trials were approached for participation. Participants came from research clinics and community mental health centers. At baseline, clinical trial consent forms were reviewed and study knowledge assessed. Participants were randomized to follow-up assessments at weeks 1, 4, and 8; weeks 4 and 8; or at week 8 only. Clinical trial consent forms were not rereviewed at any follow-up visit.Fifty-nine participants were enrolled; analysis included 52 participants with at least 1 follow-up visit. Study knowledge did not decrease meaningfully in any group. Therapeutic misconception was not observed in participants during the study. The group assessed most frequently demonstrated significant improvement over baseline (t44 = 3.43, P = .001). Retention of study knowledge was not related to symptoms but had a weak correlation with cognitive capacity (R = 0.28, P = .07). Performance did not differ between participants from research clinics and those from community mental health centers.Clinically stable people with schizophrenia enrolling in a placebo-controlled adjunctive medication study, once determined to have capacity to consent to a clinical trial, retained appropriate study knowledge for at least 8 weeks. In the absence of a specific reason to suspect a loss of decisional capacity, there appears to be no need to routinely reevaluate participants during this type of clinical trial.

Dataset Information

Assessment of the understanding of informed consent including participants' experiences, and generation of a supplemental consent decision aid for Gestational Diabetes Mellitus (GDM) research.

Publications

Assessment of the understanding of informed consent including participants' experiences, and generation of a supplemental consent decision aid for Gestational Diabetes Mellitus (GDM) research.

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