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1.
《Human brain mapping》2021,42(7):1945
Having the means to share research data openly is essential to modern science. For human research, a key aspect in this endeavor is obtaining consent from participants, not just to take part in a study, which is a basic ethical principle, but also to share their data with the scientific community. To ensure that the participants'' privacy is respected, national and/or supranational regulations and laws are in place. It is, however, not always clear to researchers what the implications of those are, nor how to comply with them. The Open Brain Consent (https://open-brain-consent.readthedocs.io) is an international initiative that aims to provide researchers in the brain imaging community with information about data sharing options and tools. We present here a short history of this project and its latest developments, and share pointers to consent forms, including a template consent form that is compliant with the EU general data protection regulation. We also share pointers to an associated data user agreement that is not only useful in the EU context, but also for any researchers dealing with personal (clinical) data elsewhere. 相似文献
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Neil Ryan Johanna Wall Emma J Crosbie Mark Arends Tjalling Bosse Saimah Arif Asma Faruqi Ian Frayling Raji Ganesan Ye L Hock Raymond McMahon Ranjit Manchanda W Glenn McCluggage Pinias Mukonoweshuro Gerhard van Schalkwyk Lucy Side John H Smith Bruce Tanchel D Gareth Evans C Blake Gilks Naveena Singh 《Histopathology》2019,75(6):813-824
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《International journal of oral and maxillofacial surgery》2020,49(6):822-826
The aim of this study was to determine whether the use of a professionally prepared educational video on third molar extraction enhances comprehension and retention of general and informed consent information. A prospective cohort study of adult patients undergoing consultation followed by extraction of third molars in the Oral and Maxillofacial Surgery Clinic, University of Illinois at Chicago was completed. At the initial consultation, the subjects viewed an educational video and received specific verbal individual information about their case. A written examination (group 1) was then completed; a subgroup of the subjects (group 2) was selected randomly to complete the same examination at the next visit prior to the procedure. The primary predictor variable was utilization of the video. The primary outcome variable was comprehension of information regarding third molars, assessed by examination scores. The secondary outcome variable was retention of the information, assessed by repeat examination scores. One hundred adults (34 male, 66 female; group 1) completed the examination at least once; 54 (19 male, 35 female) completed both examinations (group 2). Correct responses ranged from 64% to 100% in group 1 and from 37% to 100% in group 2. In group 2, all questions answered incorrectly at the first visit were answered correctly at the second visit, without any additional information being provided. Patient comprehension and retention of pertinent pre-surgical information is poor, despite use of an educational video to supplement the usual verbal consultation. These results confirm those of prior studies and may have medico-legal implications regarding the informed consent process for third molar surgery. 相似文献
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《Educación Médica》2020,21(2):106-111
IntroductionTraining through medical simulation allows for continuous learning under controlled conditions. Simulation-based training activities can be used simultaneously with other educational strategies to strengthen the attitudinal skills needed to develop an informed consent process in the context of health research.ObjectiveTo facilitate learning in undergraduate medicine students, and to evaluate their competences to carry out an informed consent process in a scenario that resembles reality.Materials and methodsIn this semi-longitudinal study, a simulation-based activity was conducted with 136 medical students of the fourth (Group A) and fifth year (Group B) of the Marist University of Mérida, in southern Mexico.ResultsThe mean score for both groups was 72.48 ± 1.05 (95% CI = 70.4–74.5); 86.2 ± 0.96 (95% CI = 84.2–88.0); and 77.7 ± 0.72 (95% CI = 76.3–79.1), in the pre-test, the simulation and the post-test, respectively. The students of group A self-evaluated their performance with 3.93/5.00, and those of Group B, 4.04/5.00.DiscussionThis study showed that Group A students did not score lower on simulation-based activity when compared to students in Group B, suggesting that before the fifth year of undergraduate medical education, students could properly develop an informed consent-process for health research if they receive early education about medical ethics and research bioethics. Issues related to bioethics in human health research can be included as soon as medical students initiate research methodology courses. 相似文献
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《Journal of pain and symptom management》2020,59(1):49-57
ContextSignature informed consent (SIC) is a part of a Veterans Health Administration ethics initiative for patient education and shared decision making with long-term opioid therapy (LTOT). Historically, patients with cancer-related pain receiving LTOT are exempt from this process.ObjectivesOur objective is to understand patients' and providers' perspectives on using SIC for LTOT in patients with cancer-related pain.MethodsSemistructured interviews with 20 opioid prescribers and 20 patients who were prescribed opioids at two large academically affiliated Veterans Health Administration Medical Centers. We used a combination of deductive and inductive approaches in content analysis to produce emergent themes.ResultsPotential advantages of SIC are that it can clarify and help patients comprehend LTOT risks and benefits, provide clear upfront boundaries and expectations, and involve the patient in shared decision making. Potential disadvantages of SIC include time delay to treatment, discouragement from recommended opioid use, and impaired trust in the patient-provider relationship. Providers and patients have misconceptions about the definition of SIC. Providers and patients question if SIC for LTOT is really informed consent. Providers and patients advocate for strategies to improve comprehension of SIC content. Providers had divergent perspectives on exemptions from SIC. Oncologists want SIC for LTOT to be tailored for patients with cancer.ConclusionProvider and patient interviews highlight various aspects about the advantages and disadvantages of requiring SIC for LTOT in cancer-related pain. Tailoring SIC for LTOT to be specific to cancer-related concerns and to have an appropriate literacy level are important considerations. 相似文献
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Ciléin Kearns Nethmi Kearns Anna M. Paisley 《Journal of visual communication in medicine》2020,43(2):76-83
AbstractSupporting patients in making informed healthcare decisions is a cornerstone of ethical medical practice. Surgeons frequently draw for and show images to patients when consenting them for operations but the value of this practice in informed decision-making is unclear. An audit was conducted in a General Surgery Department. 244 patients completed questionnaires on the value of visual materials when giving consent for surgery. The complexity of the operations was classified into “simple”, “moderate” or “complex”. 100% of patients felt they had given informed consent to surgery. 62% of patients received at least one form of visual material during the consenting process. All patients who received a drawing, and 99% of those provided with other images, valued these resources. Visual materials were considered more useful to patients when giving consent for moderate or complex operations than simple ones. Approximately one third of patients who did not receive visual materials would have appreciated these when making an informed decision. This research highlights the value of surgeons drawing for, and providing other visual resources to, their patients as part of the consent process. There is a role for further research and training materials in drawing skills for surgeons. 相似文献