Informed consent

Summary

Informed consent is a principle in medical ethics and medical law and media studies, that a patient must have sufficient information and understanding before making decisions about their medical care. Pertinent information may include risks and benefits of treatments, alternative treatments, the patient's role in treatment, and their right to refuse treatment. In most systems, healthcare providers have a legal and ethical responsibility to ensure that a patient's consent is informed. This principle applies more broadly than healthcare intervention, for example to conduct research and to disclose a person's medical information. Within the US, definitions of informed consent vary, and the standard required is generally determined by the state. Informed consent requires a clear appreciation and understanding of the facts, implications, and consequences of an action. To give informed consent, the individual concerned must have adequate reasoning faculties and possess all relevant facts.

Official source

https://en.wikipedia.org/wiki/Informed_consent

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Pesticides have been proved to potentially cause multiple adverse health effects. The present study is part of a global project focusing on pesticides impacts on the environment and human health in gardening in Burkina Faso. In absence of existing monitoring, the present study aims at proposing a comprehensive indicator of occupational exposure to 48 pesticides identified during field campaigns. As a noninvasive and safe indicator of long term exposure, increasing interest is being observed in hair analysis for biomonitoring of human exposure to pesticides. In order to dissociate occupational and environmental exposure in the study area, two study populations have been randomly selected: fifty gardeners (operators) and fifty non users (reference population). The Ethics Committee of the Burkina Faso approved this study and written informed consent was obtained from all donors. Multiresidue extraction procedure using a modified QuEChERS extraction method has been developed and applied to the collected samples. Briefly, hairs were cut on the posterior of the head, subsequently cut in small pieces and spiked with appropriate 13C- or deuterated surrogates. After overnight incubation, they were extracted in acetonitrile, cleaned-up by Dispersive SPE (dSPE), concentrated and separated prior analysis on GC-MS and LC-MS/MS. Each sample was accompanied by a questionnaire on hair care practices. Different incubation, extraction methods and dSPE sorbents have been tested (temperature, type, volume, etc.). The best method was found to be a modified AOAC 2007.01 QuEChERS procedure, including 12h incubation at 37°C followed by dSPE clean-up with Supelco Z-sep/C18® sorbent. The substances detected in collected samples include pesticides commonly used in the study area such as acetamiprid, imidacloprid, cypermethrin, profenofos but also dieldrin a banned persistent organochlorine. These pesticides were detected in hairs of the gardeners but also in the samples of the reference population indicating the occurrence of passive contamination. This study presents a comprehensive assessment of sample preparation, extraction and clean-up procedure for multi-class pesticide residues analysis in human hairs. The modified QuEChERS extraction procedure proposed offers a simple and robust tool suitable to developing countries for monitoring human exposure and evaluation of compliance with policies. The study design, including comparison between reference and operators populations allowed to dissociate the influence of environmental exposure and direct occupational exposure. Results indicate that potential carcinogen, endocrine disruptor, neurotoxic and persistent pesticides have been detected in collected hairs.

2016

MP2RAGE and Susceptibility-Weighted Imaging in Lesional Epilepsy at 7T

Maxime Olivier Baud, João Pedro Forjaco Jorge, Giannina Rita Iannotti, François Lazeyras, Lijing Xin

BACKGROUND AND PURPOSE: Surgery is the first choice therapeutic approach in case of drug-resistant epilepsy. Unfortunately, up to 43% of patients referred for presurgical assessment do not have a lesion detectable by routine 3T magnetic resonance imaging (MRI) (MRI-negative), although most of them likely have an underlying epileptogenic lesion. Thus, new MRI modalities with increased sensibility for epileptogenic lesions are required. This paper describes the magnetization-prepared two rapid acquisition gradient echoes (MP2RAGE) and susceptibility-weighted imaging (SWI) findings at 7T in a series of patients with drug-resistant epilepsy of different etiologies. METHODS: Prospective pilot study of 7 patients with drug-resistant lesional epilepsy and absence of contraindications for MRI underwent a research 7T head-only scanner. Qualitative analysis of the high-resolution MP2RAGE and SWI sequences is given for each case. This study was approved by the local ethics committee. Written informed consent was obtained from each participant. RESULTS: This study shows that such sequences at ultra-high field are new and valuable approaches to unravel and characterize epileptogenic lesions. Particularly, MP2RAGE shows a better delineation of lesions due to high gray-white matter contrast and structural resolution, and SWI reveals new imaging signs related to improved magnitude and phase contrast imaging. CONCLUSION: MRI at ultra-high field is very promising for the detection of inconspicuous epileptogenic lesions and may facilitate epilepsy surgery of a great number of to-date MRI-negative patients.

2018

Privacy-Preserving Processing of Raw Genomic Data

Erman Ayday, Urs Beda Hengartner, Jean-Pierre Hubaux, Adam Molyneaux, Jean Louis Raisaro

Geneticists prefer to store patients' aligned, raw genomic data, in addition to their variant calls (compact and summarized form of the raw data), mainly because of the immaturity of bioinformatic algorithms and sequencing platforms. Thus, we propose a privacy-preserving system to protect the privacy of aligned, raw genomic data. The raw genomic data of a patient includes millions of short reads, each comprised of between 100 and 400 nucleotides (genomic letters). We propose storing these short reads at a biobank in encrypted form. The proposed scheme enables a medical unit (e.g., a pharmaceutical company or a hospital) to privately retrieve a subset of the short reads of the patients (which include a definite range of nucleotides depending on the type of the genetic test) without revealing the nature of the genetic test to the biobank. Furthermore, the proposed scheme lets the biobank mask particular parts of the retrieved short reads if (i) some parts of the provided short reads are out of the requested range, or (ii) the patient does not give consent to some parts of the provided short reads (e.g., parts revealing sensitive diseases). We evaluate the proposed scheme to show the amount of unauthorized genomic data leakage it prevents. Finally, we implement the proposed scheme and assess its practicality.

2013

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2016