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Journal articles on the topic 'INFORMED CONSENT DOCUMENT'

Author: Grafiati

Published: 4 June 2021

Last updated: 1 February 2022

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1

Manion, F., K. Hsieh, M. Harris, and S. H. Fenton. "Informed Consent." Applied Clinical Informatics 06, no. 03 (2015): 466–77. http://dx.doi.org/10.4338/aci-2014-09-soa-0081.

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Summary Background: Despite efforts to provide standard definitions of terms such as “medical record”, “computer-based patient record”, “electronic medical record” and “electronic health record”, the terms are still used interchangeably. Initiatives like data and information governance, research biorepositories, and learning health systems require availability and reuse of data, as well as common understandings of the scope for specific purposes. Lacking widely shared definitions, utilization of the afore-mentioned terms in research informed consent documents calls to question whether all part

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Fries, Ruth, and James Ray. "A Computerized Informed Consent Document." Drug Information Journal 29, no. 4 (1995): 1259–62. http://dx.doi.org/10.1177/009286159502900426.

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Spatz, Erica S., Haikun Bao, Jeph Herrin, et al. "Quality of informed consent documents among US. hospitals: a cross-sectional study." BMJ Open 10, no. 5 (2020): e033299. http://dx.doi.org/10.1136/bmjopen-2019-033299.

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ObjectiveTo determine whether informed consent for surgical procedures performed in US hospitals meet a minimum standard of quality, we developed and tested a quality measure of informed consent documents.DesignRetrospective observational study of informed consent documents.Setting25 US hospitals, diverse in size and geographical region.CohortAmong Medicare fee-for-service patients undergoing elective procedures in participating hospitals, we assessed the informed consent documents associated with these procedures. We aimed to review 100 qualifying procedures per hospital; the selected sample

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Miller, Victoria A., and Robert M. Nelson. "Moving Beyond the Consent Document in Research on Informed Consent." Archives of Pediatrics & Adolescent Medicine 159, no. 4 (2005): 396. http://dx.doi.org/10.1001/archpedi.159.4.396.

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Desch, Karl, Jun Z. Li, Scott Kim, Naomi Laventhal, David Siemieniak, and David Ginsburg. "How Informed Is Informed Consent?" Blood 116, no. 21 (2010): 2556. http://dx.doi.org/10.1182/blood.v116.21.2556.2556.

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Abstract Abstract 2556 The informed consent process is a critical component of human subject protection in biomedical research, with the goals of informing participants of the purpose of the study, as well as the likely risks, benefits and alternatives. The signed informed consent document (ICD) is a required legal disclosure which documents that the informed consent process has taken place and provides research subjects with comprehensive information about their role in a study. Despite efforts to optimize the ICD, only limited data are available regarding the utilization of these documents b

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Hochhauser, Mark. "The Informed Consent Form: Document Development and Evaluation." Drug Information Journal 34, no. 4 (2000): 1309–17. http://dx.doi.org/10.1177/009286150003400438.

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Borello, Alessandro, Alessia Ferrarese, Roberto Passera, et al. "Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy." Open Medicine 11, no. 1 (2016): 564–73. http://dx.doi.org/10.1515/med-2016-0092.

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AbstractBackgroundSurgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion.MethodsThis prospective, randomized study involved 70 adult patients awaiting cholecystectomy for gallstones. Consent was obtained after standard verbal explanation using either a graphically formatted (study group, n=33) or a standard text document (control group, n=37). Comprehension was

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Kinkorová, Judita, Ondřej Topolčan, and Radek Kučera. "Informed Consent in the Newly Established Biobank." International Journal of Environmental Research and Public Health 16, no. 20 (2019): 3943. http://dx.doi.org/10.3390/ijerph16203943.

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Informed consent is an important document for every existing biobank or repository to obtain, store and use human biospecimens and associated data and information for current and future research. Biobanks have undergone great progress worldwide during the last three decades and have become an integral part of personalized medicine and health care systems and due to new scientific and social questions to be solved. Ethical, legal and social issues (ELSI) guarantee safe sample and data management, and informed consent is one of the key ELSI documents. The form and the consent given in biobank in

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Rodgerson, Thomas E. "Pastoral Counseling and the Informed Relationship." Journal of Pastoral Care 45, no. 4 (1991): 389–98. http://dx.doi.org/10.1177/002234099104500408.

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Spatz, Erica S., Lisa G. Suter, Elizabeth George, et al. "An instrument for assessing the quality of informed consent documents for elective procedures: development and testing." BMJ Open 10, no. 5 (2020): e033297. http://dx.doi.org/10.1136/bmjopen-2019-033297.

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ObjectiveTo develop a nationally applicable tool for assessing the quality of informed consent documents for elective procedures.DesignMixed qualitative-quantitative approach.SettingConvened seven meetings with stakeholders to obtain input and feedback on the tool.ParticipantsTeam of physician investigators, measure development experts, and a working group of nine patients and patient advocates (caregivers, advocates for vulnerable populations and patient safety experts) from different regions of the country.InterventionsWith stakeholder input, we identified elements of high-quality informed c

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Meade, Cathy D. "Improving understanding of the informed consent process and document." Seminars in Oncology Nursing 15, no. 2 (1999): 124–37. http://dx.doi.org/10.1016/s0749-2081(99)80070-9.

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Van Patten, Barbara A. "Using Continuous Improvement to Obtain and Document Informed Consent." Journal For Healthcare Quality 20, no. 3 (1998): 24–29. http://dx.doi.org/10.1111/j.1945-1474.1998.tb00257.x.

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Schumacher, Andrew, Carolyn Bartley, Anne Kaplan, et al. "Do patients participating in oncology clinical trials understand the informed consent form? A Brown University Oncology Research Group study." Journal of Clinical Oncology 30, no. 34_suppl (2012): 23. http://dx.doi.org/10.1200/jco.2012.30.34_suppl.23.

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23 Background: The informed consent process is used to provide research participants information that includes the purpose and procedures of the research study, risks, benefits, potential alternatives and that participation is voluntary. The goal of informed consent to is to provide this information in language that is understandable to the research participant. The aim of this study is to evaluate whether research participants in adult hematology/oncology clinical trials understand the information presented during the informed consent process. Methods: Patients receiving active treatment on a

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Hazen, Rebecca A., Dennis Drotar, and Eric Kodish. "The role of the consent document in informed consent for pediatric leukemia trials." Contemporary Clinical Trials 28, no. 4 (2007): 401–8. http://dx.doi.org/10.1016/j.cct.2006.10.011.

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Busquets, Montserrat, and Jordi Caïs. "Informed consent: A study of patients with life-threatening illnesses." Nursing Ethics 24, no. 4 (2015): 430–40. http://dx.doi.org/10.1177/0969733015614880.

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Background: The relationship between healthcare professionals and patients in the Spanish health sector has undergone dramatic change. One aspect of this is that the use of informed consent has become a key factor in the delivery of adequate healthcare. But although a certain period of time has already passed since informed consent started to be used, in Spain there is still doubt about how adequately informed consent is being used. Objectives: (a) To look at how patients understand the notion and purpose of informed consent, and (b) how the informed consent is applied – the way patients recei

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Ossemane, Ezequiel B., Troy D. Moon, Jahit Sacarlal, et al. "Assessment of Parents’/Guardians’ Initial Comprehension and 1-Day Recall of Elements of Informed Consent Within a Mozambican Study of Pediatric Bacteremia." Journal of Empirical Research on Human Research Ethics 13, no. 3 (2018): 247–57. http://dx.doi.org/10.1177/1556264618767780.

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Participants’ understanding of key elements of a research protocol is essential to their ethical enrollment in the study. Ongoing participation should be based on continued comprehension and consent, which presumes a high degree of recall. Many obstacles can prevent full understanding of information about the research protocol. This study’s aim was to evaluate the comprehension and 1-day recall of the elements of informed consent by the parents/guardians of children enrolled in a clinical study in Mozambique. We developed a 10-question test based on the study’s informed consent document. We as

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Mueller, Mary-Rose, and Susan Instone. "Beyond the informed consent procedure: continuing consent in human research." Ciência & Saúde Coletiva 13, no. 2 (2008): 381–89. http://dx.doi.org/10.1590/s1413-81232008000200013.

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An ethnographic field study about informed consent in hepatitis C clinical trials provides insight into how changes in protocol requirements and patient health status triggered the actions and decisions of researchers and human subjects during the conduct of these trials. U.S. federal guidelines recommend that informed consent should be conceptualized as more than a one-time event. Rather, a process of continuing consent should be the standard but little is understood about how exactly this process should unfold. We used a proposed typology of continuing consent to frame our analysis and were

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Malik, Laeeq, James Kuo, Desmond Yip, and Alex Mejia. "How well informed is the informed consent for cancer clinical trials?" Clinical Trials 11, no. 6 (2014): 686–88. http://dx.doi.org/10.1177/1740774514548734.

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Aims: The purpose of this study was to analyze the content of informed consent forms for clinical trials in medical oncology to assess readability, determine their completeness, and identify any shortcomings. Methods: Informed consent forms for Phase I–III studies that were conducted at two tertiary care cancer centers over a 3-year period were reviewed. Information pertaining to length of the informed consent form, research regimen/methods, treatment agent, potential risks, and benefits was extracted. The reading level was assessed by Flesch–Kincaid and Gunning-Fog index readability tests. Re

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Carpenter, Joan G. "INFORMED CONSENT IN CLINICAL TRIALS FOR PERSONS WITH DEMENTIA." Innovation in Aging 3, Supplement_1 (2019): S28. http://dx.doi.org/10.1093/geroni/igz038.106.

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Abstract Informed consent is one of the most important processes during the implementation of a clinical trial; special attention must be given to meeting the needs of persons with dementia in nursing homes who have impaired decision making capacity. We overcame several challenges during enrollment and consent of potential participants in a pilot clinical trial including: (1) the consent document was designed for legally authorized representatives however some potential participants were capable of making their own decisions; (2) the written document was lengthy yet all seven pages were requir

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Yu, Michael, Baruch Fischhoff, and Tamar Krishnamurti. "Implementing a New Common Rule Requirement for Informed Consent: A Randomized Trial on Adult Asthma Patients." MDM Policy & Practice 4, no. 1 (2019): 238146831983931. http://dx.doi.org/10.1177/2381468319839315.

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Objectives. To determine how the format of a clinical trial informed consent document can affect participants’ retention of enrollment-relevant information. Background. Recent changes to the US Federal Common Rule require informed consent documents for clinical trials to be concise and start with the information most relevant for enrollment decisions. However, there is limited guidance on how to identify this information or evaluate its impact. Design. Participants with a self-reported asthma diagnosis were randomized to one of five versions of the informed consent document for a clinical tria

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Granero-Molina, José, Cayetano Fernández-Sola, and Gabriel Aguilera-Manrique. "Applying a Sociolinguistic Model to the Analysis of Informed Consent Documents." Nursing Ethics 16, no. 6 (2009): 797–812. http://dx.doi.org/10.1177/0969733009341908.

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Information on the risks and benefits related to surgical procedures is essential for patients in order to obtain their informed consent. Some disciplines, such as sociolinguistics, offer insights that are helpful for patient—professional communication in both written and oral consent. Communication difficulties become more acute when patients make decisions through an informed consent document because they may sign this with a lack of understanding and information, and consequently feel deprived of their freedom to make their choice about different treatments or surgery. This article discusse

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Patel, Madhuri, Kannan Sridharan, and Jayesh Patel. "Informed Consent Document and Process in India: Ethical and Quality Issues." Asian Bioethics Review 8, no. 1 (2016): 37–52. http://dx.doi.org/10.1353/asb.2016.0003.

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Tait, Alan R., Terri Voepel-Lewis, Shobha Malviya, and Sandra J. Philipson. "Improving the Readability and Processability of a Pediatric Informed Consent Document." Archives of Pediatrics & Adolescent Medicine 159, no. 4 (2005): 347. http://dx.doi.org/10.1001/archpedi.159.4.347.

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Kost, Rhonda G., Stephen M. Poppel, and Barry S. Coller. "Informed consent for next-generation nucleotide sequencing studies: Aiding communication between participants and investigators." Journal of Clinical and Translational Science 1, no. 2 (2017): 115–20. http://dx.doi.org/10.1017/cts.2016.21.

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IntroductionObtaining informed consent from prospective participants for research studies that include next-generation nucleotide sequencing (NGS) presents significant challenges because of the need to explain all the potential implications of participating, including the possible return of “incidental” findings, in easy-to-understand language.Methods and ResultsAfter reviewing the consent processes at other institutions, we decided to supplement the protocol-specific informed consent form with the following: (1) a short pamphlet for the prospective participant that includes a series of questi

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Kurniawati, Santi Novia Ayu. "PERLINDUNGAN HUKUM BAGI PASIEN PADA TINDAKAN OPERASI DALAM PERSETUJUAN TINDAKAN MEDIS (INFORMED CONSENT)." Jurnal Hukum dan Pembangunan Ekonomi 8, no. 2 (2021): 170. http://dx.doi.org/10.20961/hpe.v8i2.49766.

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<p>Abstract<br />This research aims to determine the agreement for surgery based on informed consent and legal protection for patients in surgery in an informed consent. This research uses empirical legal research. The results of this study were that before the operation was performed, the hospital provided a medical action agreement document based on the informed consent which had to be signed by the patient and / or family as the person in charge and 2 witnesses, namely from the family and the hospital. The agreement document based on informed consent consists of 2 parts, namely

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Rifenburg, J. Michael, and Emily Pridgen. "Negotiating informed consent: A students-as-partners perspective." International Journal for Students as Partners 4, no. 2 (2020): 132–37. http://dx.doi.org/10.15173/ijsap.v4i2.4240.

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Building on our 2019 ISSOTL poster presentation, we (Michael: a tenured English Department faculty member; and Emily: an undergraduate English major) are developing a reflective essay about our in-progress SaP project designed to assess the effectiveness of recent university system mandated curricular changes to multiple sections of an introductory college-level writing course at our home institution, the University of North Georgia, USA. Even though we received the necessary institutional and federal government permissions to conduct this research, and even though the research participants si

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Taylor, Helen, and James Brogan. "Exploring the concept of ‘informed consent’ within the context of paramedic practice." Journal of Paramedic Practice 12, no. 7 (2020): 1–6. http://dx.doi.org/10.12968/jpar.2020.12.7.cpd1.

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The phrase ‘informed consent’ is used widely in healthcare. Practitioners ask their patients for their consent to a treatment or a diagnostic or monitoring procedure and, if consent is given, will document this. There is a general understanding that consent is a prerequisite for care and signifies the patient’s permission for the paramedic to proceed with assessments and other therapeutic interventions. Obtaining the patient’s informed consent is fundamental to contemporary healthcare: what is informed consent and why is it so important? This article explores the meaning of consent in practice

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Humphrey Beebe, Lora, and Kathlene Smith. "Informed consent to research in persons with schizophrenia spectrum disorders." Nursing Ethics 17, no. 4 (2010): 425–34. http://dx.doi.org/10.1177/0969733010364581.

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This manuscript describes the responses and correlates of outpatients with schizophrenia spectrum disorders to a tool designed to measure comprehension before obtaining informed consent for research participation. We used the Evaluation to Sign Consent form to document comprehension in 100 outpatients as part of their consent to participate in an ongoing study of an exercise intervention. The findings suggest that using this form is a feasible and acceptable approach to documenting comprehension of research procedures prior to obtaining informed consent. Age 49 years and older and the receipt

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Desch, Karl, Jun Li, Scott Kim, et al. "Analysis of Informed Consent Document Utilization in a Minimal-Risk Genetic Study." Annals of Internal Medicine 155, no. 5 (2011): 316. http://dx.doi.org/10.7326/0003-4819-155-5-201109060-00009.

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Paris, Adeline, Christian Brandt, Catherine Cornu, Patrick Maison, Claire Thalamas, and Jean-Luc Cracowski. "Informed consent document improvement does not increase patients' comprehension in biomedical research." British Journal of Clinical Pharmacology 69, no. 3 (2010): 231–37. http://dx.doi.org/10.1111/j.1365-2125.2009.03565.x.

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Wall, Louisa K., and Rebecca D. Pentz. "Another look at the informed consent process: The document and the conversation." Cancer 122, no. 3 (2015): 352–54. http://dx.doi.org/10.1002/cncr.29760.

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Ruhana, Ati Rusyda, Vivi Yosafianti Pohan, and Tri Hartiti. "Monitoring Analysis of Filling The Informed Consent of Blood Transfusion." South East Asia Nursing Research 3, no. 1 (2021): 40. http://dx.doi.org/10.26714/seanr.3.1.2021.40-44.

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Informed consent is evidence of the accountability of health service providers in the hospital. it is carried out in every carrying out the procedure of actions that have the risk of causing disability or death. Incomplete documentation of patient informed consent can reduce the quality of hospital services. the implementation of informed consent documentation in hospitals often faces obstacles. this is due to the lack of human resources and the high workload available. This case study aims to determine the filling of informed consent documentation in the patient's blood transfusion. This stud

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Chung, Christine S., and Lisa Soleymani Lehmann. "Informed Consent and the Process of Cadaver Donation." Archives of Pathology & Laboratory Medicine 126, no. 8 (2002): 964–68. http://dx.doi.org/10.5858/2002-126-0964-icatpo.

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Abstract Context.—Informed consent entails more than signing a document. Ideally, it should involve a process in which individuals are given sufficient information to make a voluntary decision. Little is known about the process of informed consent for cadaver donation. Objective.—To assess existing consent procedures for cadaver donation in a sample of US medical schools. Design.—Cross-sectional survey and content analysis of informational brochures and consent forms given to potential cadaver donors. Setting and Participants.—The 22 largest medical schools in the United States, as ranked by t

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Harap, Inensa Khoirul. "Informed Consent Position in Doctor and Patient Relationship." Journal La Sociale 2, no. 1 (2021): 31–39. http://dx.doi.org/10.37899/journal-la-sociale.v2i1.304.

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Awareness of risks may be interpreted as a patient's approval in the context of submitting the doctor's schedule with the necessary details for making an appointment or an informed refuse. Prior to signing the consent document, the agreement, the prospective student already confirmed that she understood the terms and conditions. to let the patient understand anything before doing it, and when making the judgment, the patient should make the most of any of an exhaustive information (informed decision). The kinds of studies found in this paper are what lawyers refer to as "normative" studies. Th

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Pieczkiewicz, David, Andrea Mahnke, Catherine McCarty, Justin Starren, Bonnie Westra, and Joseph Plasek. "The Role of Nonverbal and Verbal Communication in a Multimedia Informed Consent Process." Applied Clinical Informatics 02, no. 02 (2011): 240–49. http://dx.doi.org/10.4338/aci-2011-02-ra-0016.

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SummaryObjective: Nonverbal and verbal communication elements enhance and reinforce the consent form in the informed consent process and need to be transferred appropriately to multimedia formats using interaction design when re-designing the process.Methods: Observational, question asking behavior, and content analyses were used to analyze nonverbal and verbal elements of an informed consent process.Results: A variety of gestures, interruptions, and communication styles were observed. Conclusion: In converting a verbal conversation about a textual document to multimedia formats, all aspects o

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Perry, Courtney, and Terrence Barrett. "3412 Informed Consent: Refining the Process." Journal of Clinical and Translational Science 3, s1 (2019): 123. http://dx.doi.org/10.1017/cts.2019.280.

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OBJECTIVES/SPECIFIC AIMS: -This study aims to evaluate our retention rate into our prospective clinical trial. We will be comparing the rate of withdrawal both before and after our revamped informed consent process. -We aim to assess patient satisfaction with our study and u METHODS/STUDY POPULATION: -The informed consent process for an observational prospective study at our institution has been modified to lengthen the recruitment and consenting process. -In brief, the research protocol for this observational prospective aims to evaluate the role of steroids on ulcer healing in patients with

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Blackwood, R. Alexander, Ronald F. Maio, Adam J. Mrdjenovich, et al. "Analysis of the Nature of IRB Contingencies Required for Informed Consent Document Approval." Accountability in Research 22, no. 4 (2015): 237–45. http://dx.doi.org/10.1080/08989621.2014.956866.

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Coyne, Cathy A., Ronghui Xu, Peter Raich, et al. "Randomized, Controlled Trial of an Easy-to-Read Informed Consent Statement for Clinical Trial Participation: A Study of the Eastern Cooperative Oncology Group." Journal of Clinical Oncology 21, no. 5 (2003): 836–42. http://dx.doi.org/10.1200/jco.2003.07.022.

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Purpose: Studies have documented that the majority of consent documents for medical diagnosis and treatment are written at a reading level above that of the majority of the U.S. population. This study hypothesized that use of an easy-to-read consent statement, when compared with a standard consent statement, will result in higher patient comprehension of the clinical treatment protocol, lower patient anxiety, higher patient satisfaction, and higher patient accrual. Methods: A randomized controlled trial was conducted in 44 institutions that were members or affiliates of three cooperative oncol

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Nagpal, R., and E. M. D. Warrier. "Informed Consent: Pitfalls in a Patriarchal & Poorly Literate Society." European Psychiatry 41, S1 (2017): S612—S613. http://dx.doi.org/10.1016/j.eurpsy.2017.01.974.

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The judiciary enquiring suomotu into deaths following an oncology trial in central India opened a can of worms. Searching investigation suggested that informed consent was only a cosmetic exercise and the victim was usually illiterate, poor and for a monetary reward and without being informed of the consequences of the intervention, subjected to a drug trial. Further, the process of informed consent was dispensed with and “patient” was asked to sign at the bottom of the document, no questions asked. The ‘patient’ in these trials usually is from the urban poor or deeply patriarchal, poorly lite

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Willis, Roxana. "Observations online: Finding the ethical boundaries of Facebook research." Research Ethics 15, no. 1 (2017): 1–17. http://dx.doi.org/10.1177/1747016117740176.

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Informed consent may be unobtainable in online contexts. This article examines the difficulties of obtaining informed consent online through a Facebook case study. It is proposed that there are at least two ways informed consent could be waived in research: first, if the data are public, and second, if the data are textual. Accordingly, the publicness of the Facebook News Feed is considered. Taking account of the wide availability of Facebook users’ data, and reflecting on how public those users perceive their information to be, this paper argues that some Facebook data are properly viewed as

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Simon, Christian M., Helen A. Schartz, Gary E. Rosenthal, Eric L. Eisenstein, and David W. Klein. "Perspectives on Electronic Informed Consent From Patients Underrepresented in Research in the United States: A Focus Group Study." Journal of Empirical Research on Human Research Ethics 13, no. 4 (2018): 338–48. http://dx.doi.org/10.1177/1556264618773883.

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Digital informed consent may better inform individuals about health research and increase participation. In the United States and elsewhere, minorities and rural populations are underrepresented in health research and may benefit from well-designed electronic informed consent (eIC). Seven focus groups were conducted with 50 Caucasian, African American, and rural patients in the United States. Participants were asked their preferences for a paper versus electronic informed consent document. Participants found the e-version easier to use, more interesting, and better for understanding. Minority

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Ranjan, Rajesh, Nidhi B. Agarwal, Prem Kapur, Amit Marwah, and Rizwana Parveen. "Study of Awareness and Practice of Informed Consent Process Among Clinical Trial Participants and Their Motives Behind Participation." Asia Pacific Journal of Public Health 31, no. 8 (2019): 710–18. http://dx.doi.org/10.1177/1010539519883135.

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Process to obtain informed consent is an essential component in research involving human subjects. However, much is not known about the level of awareness participants have about optimal consenting process and the motives that drive their participation in the trials. A cross-sectional study was conducted among volunteers who had been participating in clinical trials in contract research organizations of Delhi. Validated questionnaires were used to assess their knowledge, attitude, and practice of informed consent process. Most of the volunteers, 226 (56.5%), had participated in 1 to 3 clinical

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Purvis, Rachel S., Leah R. Eisenberg, Christopher R. Trudeau, Christopher R. Long, and Pearl A. McElfish. "Facilitators, barriers, and recommendations related to the informed consent of Marshallese in a randomized control trial." Clinical Ethics 15, no. 2 (2020): 75–83. http://dx.doi.org/10.1177/1477750920903458.

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Background The Pacific Islander population is the second fasting growing population in the United States and Arkansas is home to the largest Marshallese population in the continental US. The Marshallese community have significant health disparities with high prevalence of diabetes, heart disease, and obesity compared to the general US population. Using a community-based participatory research approach, researchers and Marshallese community stakeholders identified diabetes as the top health issue for research. Methods From 2014 to 2018, a randomized control trial was conducted comparing standar

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Fresa, Riccardo. "Informed consent of the critically ill patient and drug therapy: legal aspects." Reviews in Health Care 4, no. 2S (2013): 21–30. http://dx.doi.org/10.7175/rhc.v4i2s.874.

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Legal issues concerning the doctor-patient relationship are numerous, and belong to the wider field of professional liability in health care. This article will be dealt with the issues related to informed consent in patients temporarily unable to express consent, or patients who are in a state of temporary incapacity. If the patients are temporarily incapable, and therefore are not able to receive the information nor to express consent to treatment, the physicians’ duty to provide medical treatment and the patients’ self-determination should be considered: the patients can consent or refuse tr

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Alvarez, Mary, Emily Hotton, Sam Harding, Joanna F. Crofts, and Julia Wade. "Investigation of informed consent procedures initiated in the intrapartum period." British Journal of Midwifery 28, no. 4 (2020): 251–58. http://dx.doi.org/10.12968/bjom.2020.28.4.251.

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Background When research involves procedures initiated in the intrapartum period, there is considerable variation in information provision. If midwives are to optimise the process of information provision and facilitate good understanding of the research, we need to understand how information is currently being provided. Aim To investigate the feasibility and acceptability of an approach to investigating information provision for informed consent to research involving interventions initiated during the intrapartum period. Methods Audio recordings of seven study recruitment consultations and si

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WANG, Deyan. "知情同意與語境". International Journal of Chinese & Comparative Philosophy of Medicine 4, № 2 (2002): 24–37. http://dx.doi.org/10.24112/ijccpm.41428.

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LANGUAGE NOTE | Document text in Chinese; abstract also in English.理解是實現知情同意的基礎，而理解與知情同意的語境學問題有密切關係。醫生常常抱怨病人聽不懂，病人也認為醫生的解釋過科術語化。問題就在於醫患雙方語境的差異。20世紀80年代對知情同意的研究已經開始從告訴病人什麼資訊轉向了怎樣告訴病人的研究。因此醫生除了關心病人敘述的意義之外，還需要關注以各㮔語言為中介與事實之間所建立的聯繫，注意語句的規範性以及正確地把握雙方的語言意圖和目的。本文試圖對知情同意進行語義學、語形學和語用學的分析，以便從這三者統一上來透視和闡述知情同意的各種語境的規定性，以提高知情同意的可理解性。Understanding, being closely associated with the context, is the basis of realization of informed consent. Physician often complains that patients cannot well comprehend medical information, while patients are often unsatisfied with the explanatory statements and technical term

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O'Sullivan, Jane, Cathleen McCarrick, Paul Tierney, Donal B. O'Connor, Jack Collins, and Robert Franklin. "Identification of Informed Consent in Patient Videos on Social Media: Prospective Study." JMIR Medical Education 6, no. 2 (2020): e14081. http://dx.doi.org/10.2196/14081.

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Background The American Medical Association Code of Medical Ethics states that any clinical image taken for public education forms part of the patient’s records. Hence, a patient’s informed consent is required to collect, share, and distribute their image. Patients must be informed of the intended use of the clinical image and the intended audience as part of the informed consent. Objective This paper aimed to determine whether a random selection of instructional videos containing footage of central venous catheter insertion on real patients on YouTube (Google LLC) would mention the presence o

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KAWAKAMI, Takahiro, Katsuhiko NAGASE, Yuko YOKOI, Yoshimichi SAI, and Toshinori MURAYAMA. "Improvement of Informed Consent Document Management in Clinical Trials Using an Electronic Medical Record System." Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics 50, no. 3 (2019): 81–86. http://dx.doi.org/10.3999/jscpt.50.81.

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Ghimire, Namita, Pawan Kumar Hamal, Asmita Panthee, et al. "Ethical Characteristics of Research Proposals Related of COVID-19 Pandemic in Nepal: A Retrospective Review." Journal of Nepal Health Research Council 19, no. 1 (2021): 148–53. http://dx.doi.org/10.33314/jnhrc.v19i1.3373.

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Background: Public health emergency is vulnerable time where maintaining ethical principles is obligatory while doing research, on the other hand, it is the same time when breach in ethics is much likely whenever a researcher is unaware, unprepared or hastens to do research. The aim of this study was to assess ethical issues of the coronavirus disease 2019 (COVID-19) related research proposals submitted during the early stages of pandemic in Nepal.Methods: Retrospective analysis of COVID-19 related research proposals and their informed consent document submitted to the ethical review board at

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Moturu, Anoosha, Jessica Howe, and Grace Tran. "Qualitative Review of Wrong-Site Surgeries: What Side Will My Surgery Take Place?" Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care 7, no. 1 (2018): 267–73. http://dx.doi.org/10.1177/2327857918071063.

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Wrong site surgeries (WSS) are classified as “never events” and signify adverse events that are preventable. The prevalence of procedures in the wrong location is up to 50 WSS per week in the United States. Informed consent (IC) related contributing factors include communication breakdowns between staff and across units, lack of cross-checking documents, equipment-related issues, and lack of automation in document coordination. As part of a patient safety initiative, a qualitative review of IC and WSS-related factors was conducted using patient safety event (PSE) data within a large healthcare

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