Preserving consent-for-consent with feasibility-assessment and recruitment in clinical studies: FARSITE architecture.
ABSTRACT Best practice guidance for clinical studies asks investigators to employ the highest possible standards in privacy and consent. When considering the feasibility of a clinical study, issues of privacy extend not only to actual but also to potential study participants. The consent required to access records to determine whether or not an individual might be eligible to participate in a study is sometimes referred to as consent-for-consent. Some initiatives to enhance the efficiency of study-recruitment could compromise consent-for-consent, for example by inviting a patient to take part in a study without the knowledge of their attending clinician. Through iterative working with experts and examination of protocols we explored a range of scenarios for assessing the feasibility of clinical trials and observational studies, and recruiting participants. The main requirement we identified was to speed up feasibility-assessment and recruitment while preserving the patient-clinician trust relationship that is central to consent-for-consent. We present an appropriate information system architecture, FARSITE (Feasibility Assessment and Recruitment System for Improving Trial Efficiency), and show in principle that faster recruitment into clinical studies need not compromise best practice in privacy or consent. We show that FARSITE is a specific instance of an 'e-Lab' architecture for assembling data, methods and expertise around study protocols and defined populations.
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ABSTRACT: The identification of suitable patients is a common problem in clinical trials that is especially evident in tertiary care hospitals. We developed and analysed a workflow, which uses routine data captured during patient care in a hospital information system (HIS), to identify potential trial subjects. Study nurses or physicians are notified automatically by email and verify eligibility. As a case study we implemented the system for acute myeloid leukemia (AML) trials in Münster. During a test period of 50 days 41 patients were identified by the system. 13 could be included as new trial patients, 7 were already included during earlier visits. According to review of paper records no AML trial patient was missed by the system. In addition, the hospital information system further allowed to preselect patients for specific trials based on their disease status and individual characteristics. Routine HIS data can be used to support patient recruitment for clinical trials by means of an automated notification workflow.Trials 02/2008; 9:2. · 2.21 Impact Factor
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ABSTRACT: The World Medical Association's Declaration of Helsinki was first adopted in 1964. In its 40-year lifetime the Declaration has been revised five times and has risen to a position of prominence as a guiding statement of ethical principles for doctors involved in medical research. The most recent revision, however, has resulted in considerable controversy, particularly in the area of the ethical requirements surrounding placebo-controlled trials and the question of responsibilities to research participants at the end of a study. This review considers the past versions of the Declaration of Helsinki and asks the question: How exactly has the text of the Declaration changed throughout its lifetime? Regarding the present form of the Declaration of Helsinki we ask: What are the major changes in the most recent revision and what are the controversies surrounding them? Finally, building on the detailed review of the past and present versions of the Declaration of Helsinki, we give consideration to some of the possible future trajectories for the Declaration in the light of its history and standing in the world of the ethics of medical research.British Journal of Clinical Pharmacology 07/2004; 57(6):695-713. · 3.58 Impact Factor
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ABSTRACT: The electronic Primary Care Research Network (ePCRN) is an electronic infrastructure that facilitates the conduct of randomized controlled trials (RCTs) in primary care and promotes the translation of research findings into practice. It provides a highly secure, Internet-based electronic infrastructure that will enable primary care practices anywhere in the United States to link with researchers in academic centers or the National Institutes of Health (NIH) to facilitate recruitment, entry, and follow-up of participants in multidisciplinary RCTs. The ePCRN also establishes a standardized clinic-based registry using distributed database technology to promote the translation of research findings into practice and to facilitate the process of clinical trials recruitment. The overall goals of the ePCRN are to provide the ability to perform large national collaborative studies throughout the United States, improve efficiency and reduce costs for individual trials, provide easier access for data retrieval and analysis, and involve primary care practices in the discovery and the translation of research findings into practice.The Journal of the American Board of Family Medicine 19(1):93-7. · 1.76 Impact Factor