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Informed consent in clinical research: Consensus recommendations for reform identified by an expert interview panel.

ABSTRACT: Informed consent is the cornerstone for protection of human subjects in clinical trials. However, a growing body of evidence suggests that reform of the informed consent process in the United States is needed.The Clinical Trials Transformation Initiative conducted interviews with 25 experienced observers of the informed consent process to identify limitations and actionable recommendations for change.There was broad consensus that current practices often fail to meet the ethical obligation to inform potential research participants during the informed consent process. The most frequent single recommendation, which would affect all participants in federally regulated clinical research, was reform of the informed consent document. The interviews also identified the need for reform of clinical research review by institutional review boards, including transitioning to a single institutional review board for multi-site trials.The consensus recommendations from the interviewees provide a framework for meaningful change in the informed consent process. Although some proposed changes are feasible for rapid implementation, others such as substantive reform of the informed consent document may require change in federal regulations.

SUBMITTER: Lorell BH

PROVIDER: S-EPMC4657389 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

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Informed consent in clinical research: Consensus recommendations for reform identified by an expert interview panel.

Lorell Beverly H BH Mikita J Stephen JS Anderson Annick A Hallinan Zachary P ZP Forrest Annemarie A

Clinical trials (London, England) 20150715 6

<h4>Background</h4>Informed consent is the cornerstone for protection of human subjects in clinical trials. However, a growing body of evidence suggests that reform of the informed consent process in the United States is needed.<h4>Methods</h4>The Clinical Trials Transformation Initiative conducted interviews with 25 experienced observers of the informed consent process to identify limitations and actionable recommendations for change.<h4>Results</h4>There was broad consensus that current practi ...[more]

PMID: 26178662

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Project description:BackgroundMedication management for people living with dementia is a complex task as it is unclear what constitutes optimal medication management in this population due to the shifting focus of health priorities and the balance between the benefits and harms of medications.AimThis study sought expert opinion to create a consensus list to define appropriate medication management of co-morbidities for people with dementia.MethodsThis study used the Delphi technique. We invited multidisciplinary experts in geriatric therapeutics including pharmacists, doctors, nurse practitioners, a patient advocate and a psychologist to participate. Participants were asked to engage into three or more rounds of questioning. Round 1 was a questionnaire comprised of one question defining dementia and seven open-ended questions about appropriate management of co-morbidities in people with dementia. Two investigators qualitatively analysed the responses to questions from Round 1 using thematic analysis. The results of this analysis were provided to participants as statements in the Round 2 survey. The participants were asked to rate their agreement with each statement on a 5-point Likert scale. The median and interquartile range (IQR) were calculated for the responses to each statement. Consensus was pre-specified as an IQR less than or equal to 1. Statements where consensus was not achieved were presented to participants in Round 3. The Round 2 median and IQR values were provided and participants were again asked to rate their agreement with each statement on a 5-point Likert scale. The statements where participants agreed or strongly agreed were included in the Medication Appropriateness Tool for Co-morbid Health conditions in Dementia criteria.ResultsFifty-seven experts agreed to participate in the study, of whom 58% were pharmacists and 36% were medical practitioners. Fifty-five participants completed the Round 1 (95% response rate). A total of 128 statements was included in the Round 2 survey. Consensus was reached on 93 statements in Round 2 (n = 48 responders, 84% response rate) and on 18 statements in Round 3 (n = 43 responders, 75% response rate). The participants reached consensus on 111 of 128 statements. Of these statements, 67 statements were included in the Medication Appropriateness Tool for Co-morbid Health conditions in Dementia criteria. The statements were in the broad themes of preventative medication, symptom management, disease progression, psychoactive medication, treatment goals, principles of medication use, side-effects and medication reviews.DiscussionThis research provides consensus-based guidance for clinicians who manage co-morbid health conditions in people with dementia.

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Informed consent in clinical research: Consensus recommendations for reform identified by an expert interview panel.

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Informed consent in clinical research: Consensus recommendations for reform identified by an expert interview panel.

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