Feasibility and cost of obtaining informed consent for essential review of medical records in large-scale health services research.
ABSTRACT To evaluate the effectiveness and cost of obtaining consent for review of medical records within the passively observed non-intervention arm of a cluster randomized controlled trial, 'Comparison Arm for ProtecT'.
Two hundred and thirty men, who had been notified to the trial by cancer registries as having prostate cancer, were sent a consent form from their general practitioner or secondary care clinician. The consent rate of participants to the review of their medical records and the estimated costs of the process were evaluated.
One hundred and seventy-nine men (84%: 95% CI = 78%, 89%) consented to have their medical notes reviewed at an estimated cost of pound123 (euro172, $248) per person.
A high consent rate for review of medical notes is achievable but at a cost. There needs to be renewed debate about the automatic need for consent to review medical records where the chance of personal harm is negligible and the purpose of the review is to provide robust evidence to save lives, prevent needless suffering, and improve the effectiveness and efficiency of health care delivery.
- European Journal of Epidemiology 06/2013; · 5.12 Impact Factor
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ABSTRACT: BACKGROUND: Opt-in consent is usually required for research, but is known to introduce selection bias. This is a particular problem for large scale epidemiological studies using only pre-collected health data. Most previous studies have shown that members of the public value opt-in consent and can perceive research without consent as an invasion of privacy. Past research has suggested that people are generally unaware of research processes and existing safeguards, and that education may increase the acceptability of research without prior informed consent, but this recommendation has not been formally evaluated. Our objectives were to determine the range of public opinion about the use of existing medical data for research and to explore views about consent to a secondary review of medical records for research. We also investigated the effect of the provision of detailed information about the potential effect of selection bias on public acceptability of the use of data for research. METHODS: We carried out a systematic review of existing literature on public attitudes to secondary use of existing health records identified by searching PubMed (1966-present), Embase (1974-present) and reference lists of identified studies to provide a general overview, followed by a qualitative focus group study with 19 older men recruited from rural and suburban primary care practices in the UK to explore key issues in detail. RESULTS: The systematic review identified twenty-seven relevant papers and the findings suggested that males and older people were more likely to consent to a review of their medical data. Many studies noted participants' lack of knowledge about research processes and existing safeguards and this was reflected in the focus groups. Focus group participants became more accepting of the use of pre-collected medical data without consent after being given information about selection bias and research processes. All participants were keen to contribute to NHS-related research but some were concerned about data-sharing for commercial gain and the potential misuse of information. CONCLUSIONS: Increasing public education about research and specific targeted information provision could promote trust in research processes and safeguards, which in turn could increase the acceptability of research without specific consent where the need for consent would lead to biased findings and impede research necessary to improve public health.BMC Medical Research Methodology 06/2013; 13(1):72. · 2.21 Impact Factor
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ABSTRACT: High quality human biospecimens, such as tissue, blood, cell derivatives, and associated patient clinical information, are key elements of a scientific infrastructure that supports discovery and identification of molecular biomarkers and diagnostic agents. The goal of most biorepositories is to collect, process, store, and distribute human biospecimen for use in basic, translational and clinical research. A biorepository serving as the central hub provides investigators with an invaluable resource with appropriately examined and characterized biospecimens with associated patient clinical information. Expertise in standardization, quality control, information technology, and awareness of cutting edge research developments are generally required for biorepository development and management. The availability of low cost whole genome profiles of individual tumors has opened up new possibilities for personalized medicine to deliver the most appropriate treatments to individual patient with minimal toxicity. A biorepository in support of personalized medicine thus requires the highest standards of operation and adequate funding, training and certification. This review provides an overview of the development of an institutional cancer biorepository for clinical research and personalized medicine advancement.Clinical biochemistry 12/2013; · 2.02 Impact Factor