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The New England Journal of Medicine Feb 2015The author summarizes emerging standards for informed consent as the underpinning of ethical research in humans. (Review)
Review
The author summarizes emerging standards for informed consent as the underpinning of ethical research in humans.
Topics: Bioethical Issues; Delivery of Health Care; Demography; Ethics, Research; Humans; Informed Consent; Mental Competency; Population Dynamics; United States
PubMed: 25714163
DOI: 10.1056/NEJMra1411250 -
JACC. Cardiovascular Imaging Jun 2012
Topics: Cardiology; Comprehension; Consent Forms; Diagnostic Imaging; Humans; Informed Consent; Patient Selection; Practice Guidelines as Topic; Predictive Value of Tests; Risk Assessment; Risk Factors
PubMed: 22698541
DOI: 10.1016/j.jcmg.2012.05.001 -
Medical Science Monitor : International... Nov 2018Vaccinations cause controversies for numerous reasons: medical, religious, and even personal. The following paper focuses on one more, underestimated conflict between...
Vaccinations cause controversies for numerous reasons: medical, religious, and even personal. The following paper focuses on one more, underestimated conflict between individual autonomy and public health in regard to obligatory childhood vaccinations. Every medical intervention should be preceded by informed consent; however, informed consent in the case of obligatory vaccinations cannot be voluntary and valid. Moreover, asking parents to sign an informed consent form is paradoxical in a situation where not signing it will lead to legal consequences. Our paper tries to accentuate the issue of involuntariness and invalidity of informed consent in the case of obligatory vaccination and tries to propose a solution that acknowledges requirements for vaccinations and makes parents feel safer coming in and out of a vaccination visit.
Topics: Coercion; Humans; Informed Consent; Parents; Personal Autonomy; Public Health; Vaccination
PubMed: 30472718
DOI: 10.12659/MSM.910393 -
Bulletin of the World Health... Oct 2004Although a relatively recent phenomenon, the role of informed consent in human research is central to its ethical regulation and conduct. However, guidelines often... (Review)
Review
Although a relatively recent phenomenon, the role of informed consent in human research is central to its ethical regulation and conduct. However, guidelines often recommend procedures for obtaining informed consent (usually written consent) that are difficult to implement in developing countries. This paper reviews the guidelines for obtaining informed consent and also discusses prevailing views on current controversies, ambiguities and problems with these guidelines and suggests potential solutions. The emphasis in most externally sponsored research projects in developing countries is on laborious documentation of several mechanical aspects of the research process rather than on assuring true comprehension and voluntary participation. The onus for the oversight of this process is often left to overworked and ill-equipped local ethics review committees. Current guidelines and processes for obtaining informed consent should be reviewed with the specific aim of developing culturally appropriate methods of sharing information about the research project and obtaining and documenting consent that is truly informed. Further research is needed to examine the validity and user friendliness of innovations in information sharing procedures for obtaining consent in different cultural settings.
Topics: Codes of Ethics; Consent Forms; Culture; Developing Countries; Disclosure; Documentation; Ethics Committees, Research; Guidelines as Topic; Health Knowledge, Attitudes, Practice; Human Experimentation; Humans; Informed Consent; Mental Competency; Patient Selection
PubMed: 15643799
DOI: No ID Found -
The Indian Journal of Medical Research Jan 2020Comprehension and process of consent are important for persons with mental illness as they may not be impaired in considering research participation. The American...
BACKGROUND & OBJECTIVES
Comprehension and process of consent are important for persons with mental illness as they may not be impaired in considering research participation. The American Psychiatric Association developed a detailed Cultural Formulation Interview (CFI). The present study was a part of field testing of CFI, aimed to standardize cultural information affecting the patients' management in India. This paper describes the process and conclusions from the consent-seeking process of this study.
METHODS
The purpose and procedures about field trial of the CFI were introduced and the patient and caregiver were requested for participation. Consent process was carried out step by step, by reading out the consent form to the first new patient of the day in the psychiatry outpatients department of a tertiary care hospital in north India, inviting questions followed by the 'comprehension' questions. The entire process was audiotaped without any personal identifiers. The process was repeated if not comprehended.
RESULTS
A total of 67 patients consented, 11 refused and majority were educated more than secondary school. Some concerns shown by the patients and caregivers included risk of participation, loss or benefits of participation, privacy, etc. All types of mentally ill patients participated in the study.
INTERPRETATION & CONCLUSIONS
Translations of consent forms used simple words, consonant with understanding of the potential participants. Patients' belief that participating in this long process would improve their care, and serve humanity, influenced their decision to participate. Except for intoxication and severe psychosis, patients could understand and comprehend issues around consent. Main issues were confidentiality and culture. Our experience in the psychiatry OPD refutes the commonly held belief that mentally ill persons lack comprehension and ability to consent.
Topics: Comprehension; Female; Humans; India; Informed Consent; Interview, Psychological; Male; Mental Disorders
PubMed: 32134012
DOI: 10.4103/ijmr.IJMR_1036_18 -
Medicina Oral, Patologia Oral Y Cirugia... May 2022The healthcare practice of dentistry, as well as medicine, is framed within a legal environment. Patients have the right to know all the information related to any...
BACKGROUND
The healthcare practice of dentistry, as well as medicine, is framed within a legal environment. Patients have the right to know all the information related to any action performed on them and dental or medical doctors are obliged to obtain their patient's prior written informed consent (IC) before undertaking any healthcare procedures.
MATERIAL AND METHODS
Here we reviewed the legality and jurisprudence in Spain regarding IC. We also used INFLESZ text readability analysis software to analyse a sample of official Spanish informed consent documents (ICDs) from different surgical and interventional procedures related to dentistry and oral cavity interventions.
RESULTS
It is a mistake to confound IC with ICDs. This error prevents physicians from considering the former as a care process in which the patient's authorisation signature is the last link in a chain formed, almost in its entirety, by the informative process and deliberation alongside the patient. Multiple factors can influence communication between practitioners and their patients. Importantly, treatment adherence is greater when patients feel involved and autonomous in shared decision-making and when the circumstances of their lives are adequately considered. We concluded that although the ICDs we analysed conformed to the requirements set out in international law, they were somewhat difficult to read according to the reading habits of the general Spanish population.
CONCLUSIONS
Knowledge about the legality of IC helps professionals to understand the problems that may arise from their non-compliance. This is because the omission or defective fulfilment of IC obligations is the origin of legal responsibility for medical practitioners. In this sense, to date, there have been more convictions for defective ICs than for malpractice. The information provided in ICs should include the risks, benefits, and treatment alternatives and must be tailored to the needs and capabilities of the patient to enable autonomous decision-making.
Topics: Comprehension; Consent Forms; Dentistry; Humans; Informed Consent; Spain
PubMed: 35368004
DOI: 10.4317/medoral.25265 -
British Dental Journal Jan 2022Introduction Informed consent is the 'permission or agreement' given by the patient for a proposed action. This paper explores the clinician's role in obtaining informed...
Introduction Informed consent is the 'permission or agreement' given by the patient for a proposed action. This paper explores the clinician's role in obtaining informed consent, provides an overview of consent and parental responsibility in the UK, and presents practical adjuncts to aid dental professionals in ascertaining who has parental responsibility to delineate persons capable of providing assent on behalf of an underage patient.Consent and parental responsibility While the principles of consent have largely stayed constant with time, subtleties in parental responsibility legislation exist in different regions of the UK. An audit exploring consent and parental responsibility knowledge among clinicians within the orthodontic department at the UCLH Eastman Dental Hospital demonstrated that none of the respondents met the gold standard (100%). The results ranged from 59-89% with a mean score of 74%. The majority of questions answered incorrectly related to knowledge of parental responsibility.Conclusion It is the responsibility of clinicians providing any care within the UK to stay up to date with legislation and regulations regarding consent and parental responsibility. Knowledge-based questionnaires can highlight areas of knowledge deficit which can be addressed through continuous professional development. This paper provides a flowchart summarising parental responsibility and a prefilled parental responsibility questionnaire as adjuncts to simplify the process of dental professionals ascertaining parental responsibility.
Topics: Humans; Informed Consent; Parental Consent; Parents; Surveys and Questionnaires
PubMed: 35091615
DOI: 10.1038/s41415-022-3877-7 -
Acta Clinica Croatica Sep 2019This paper deliberates on the place and role of informed consent in everyday clinical laboratory practice. Taking into account international ethical guidelines such as... (Review)
Review
This paper deliberates on the place and role of informed consent in everyday clinical laboratory practice. Taking into account international ethical guidelines such as the UNESCO Universal Declaration on Bioethics and Human Rights, the Declaration of Helsinki of the World Medical Association, and Croatian national laws and codes such as the Act on the Protection of Patients' Rights, the Act on Medical Biochemistry, the Code of Ethics of Medical Biochemists and Medical Deontology, the Act on Healthcare Services, and the Code of Ethics of the Croatian Chamber of Healthcare Workers, an overview is given on the actual implementation of the aforementioned recommendations and regulations. A distinction between consent to a medical procedure and consent to enrolment in a research protocol is strongly stressed out. Special emphasis is placed on the role of specialists in laboratory medicine and masters of medical biochemistry in the process of obtaining informed consent. The design of an 'informed consent interview' is to be taken into consideration. Additional deliberation is needed on the option of 'broad consent'. It is concluded that informed consent should represent an important and routine activity within Croatian clinical laboratories.
Topics: Adult; Aged; Aged, 80 and over; Bioethics; Clinical Laboratory Services; Croatia; Female; Forecasting; Humans; Informed Consent; Male; Middle Aged; Practice Guidelines as Topic
PubMed: 31969763
DOI: 10.20471/acc.2019.58.03.14 -
Annals of the Royal College of Surgeons... Nov 2017Introduction The aim of this study was to objectively ascertain the level of readability of standardised consent forms for orthopaedic procedures. Methods Standardised...
Introduction The aim of this study was to objectively ascertain the level of readability of standardised consent forms for orthopaedic procedures. Methods Standardised consent forms (both in summary and detailed formats) endorsed by the British Orthopaedic Association (BOA) were retrieved from orthoconsent.com and assessed for readability. This involved using an online tool to calculate the validated Flesch reading ease score (FRES). This was compared with the FRES for the National Health Service (NHS) Consent Form 1. Data were analysed and interpreted according to the FRES grading table. Results The FRES for Consent Form 1 was 55.6, relating to the literacy expected of an A level student. The mean FRES for the BOA summary consent forms (n=27) was 63.6 (95% confidence interval [CI]: 61.2-66.0) while for the detailed consent forms (n=32), it was 68.9 (95% CI: 67.7-70.0). All BOA detailed forms scored >60, correlating to the literacy expected of a 13-15-year-old. The detailed forms had a higher FRES than the summary forms (p<0.001). Conclusions This study demonstrates that the BOA endorsed standardised consent forms are much easier to read and understand than the NHS Consent Form 1, with the detailed BOA forms being the easiest to read. Despite this, owing to varying literacy levels, a significant proportion of patients may struggle to give informed consent based on the written information provided to them.
Topics: Comprehension; Consent Forms; Humans; Informed Consent; Literacy; Orthopedic Procedures
PubMed: 29046092
DOI: 10.1308/rcsann.2017.0188 -
Journal of the American Dental... Apr 2017Ethics in health care and research is based on the fundamental principle of informed consent. However, informed consent in geriatric dentistry is not well documented.... (Review)
Review
BACKGROUND
Ethics in health care and research is based on the fundamental principle of informed consent. However, informed consent in geriatric dentistry is not well documented. Poor health, cognitive decline, and the passive nature of many geriatric patients complicate this issue.
METHODS
The authors completed this systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The authors searched the PubMed (MEDLINE), Web of Science, PsycINFO, and Cochrane Library databases. The authors included studies if they involved participants 65 years or older and discussed topics related to informed consent beyond obtaining consent for health care. The authors explored informed consent issues in dentistry and other biomedical care and research.
RESULTS
The authors included 80 full-text articles on the basis of the inclusion criteria. Of these studies, 33 were conducted in the United States, 29 addressed consent issues in patients with cognitive impairment, 29 were conducted in patients with medical conditions, and only 3 involved consent related to dental care or research.
CONCLUSIONS
Informed consent is a neglected topic in geriatric dental care and research. Substantial knowledge gaps exist between the understanding and implementation of consent procedures. Additional research in this area could help address contemporary consent issues typically encountered by dental practitioners and to increase active participation from the geriatric population in dental care and research.
PRACTICAL IMPLICATIONS
This review is the first attempt, to the authors' knowledge, to identify informed consent issues comprehensively in geriatric dentistry. There is limited information in the informed consent literature covering key concepts applicable to geriatric dentistry. Addressing these gaps could assist dental health care professionals in managing complex ethical issues associated with geriatric dental patients.
Topics: Aged; Dental Care for Aged; Dental Research; Humans; Informed Consent; Mental Competency
PubMed: 28065430
DOI: 10.1016/j.adaj.2016.11.019