Patient consent/informed consent

1993 ◽  
Vol 20 (6) ◽  
Author(s):  
PeterJ. Ell
Keyword(s):  
Informed Consent ◽  
Patient Consent

Five years of ECT: the relationship between consent status and treatment experiences

2010 ◽  
Vol 27 (3) ◽  
pp. 117-122 ◽  
Author(s):  
Susanna Enriquez ◽  
Sheila Tighe ◽  
Noreen Fitzgibbon ◽  
Seamus Ó Flaithbheartaigh ◽  
David Meagher
Keyword(s):  
Mental Health ◽  
Cognitive Impairment ◽  
Informed Consent ◽  
Mental Health Services ◽  
Health Services ◽  
Response Rate ◽  
Electrode Placement ◽  
Severe Illness ◽  
Patient Consent ◽  
Written Informed Consent

AbstractObjectives:ECT has received limited systematic study in the Irish setting. Amendments to the Mental Health Act (2001) propose limiting the use of ECT to patients who can provide written informed consent. We report on the use of ECT in Limerick specifically addressing the issue of patient consent and how it relates to response rate.Method:Since 2003, the use of ECT within Limerick Mental Health Services has been monitored by a data gathering process that includes the documentation of mood disturbance before and after the procedure.Results:In the five years between 2003 and 2007, 153 courses of ECT were given to 126 different patients (frequency 16.7/100,000; Female:Male = 2:1). The principal indication for ECT was depressive illness (95%). Bilateral electrode application was the preferred mode comprising 83% of use. A total of 60% experienced at least a 50% reduction in MADRS score over the course of ECT with 78% experiencing a reduction of 10 points or more on the MADRS. Higher response rate was linked to use of bilateral ECT (p = 0.007; 95% CI 1.3-13.6). A total of 14% of patients were unable to provide written informed consent and these patients had more severe depression at outset (p = 0.007; 95% CI 1.8-11.1) and a trend towards greater reduction in MADRS scores during ECT (p = 0.08). The commonest adverse incident associated with ECT was cognitive impairment (33 patients). The risk of cognitive problems was not related to age, ECT dose, number of treatments, severity of depressive symptoms, treatment response, or consent status.Conclusions:Frequency of use, response and adverse effect rates for ECT in Limerick Mental Health Services are similar to other centres. Cognitive impairment was the most frequent adverse event. The choice of electrode placement for ECT requires further consideration. Restricting ECT to patients that can provide written informed consent would prevent its use in many patients with severe illness who experience significant response to treatment.

scholarly journals Ethical Considerations during the Informed Consent Process for Acute Ischemic Stroke in International Clinical Trials

2020 ◽  
Author(s):  
Tiffany R. Bellomo ◽  
Jennifer A. Fokas ◽  
Clare Anderson ◽  
Noah Tsao ◽  
Christopher Becker ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Informed Consent ◽  
Acute Ischemic Stroke ◽  
Alternative Treatment ◽  
Standard Of Care ◽  
Informed Consent Process ◽  
Consent Process ◽  
Patient Consent ◽  
Study Team ◽  
The Usa

ABSTRACTIntroductionObtaining informed consent from acute ischemic stroke patients poses many challenges, especially in the context of a research setting. Specifically, consenting for alternative acute ischemic stroke treatments to the standard of care, Tissue Plasminogen Activator (tPA), can cause delays leading to increased time to reperfusion and worse outcomes.ObjectivesWe sought to investigate the experiences of researchers in existing active-control trials in acute ischemic stroke comparing investigational therapy to tPA in order to identify the approaches and challenges in obtaining informed consent in this unique patient population.MethodsOut of 401 articles evaluated, 14 trials met inclusion criteria of patients receiving IV tPA vs alternative treatment within 4.5 hours of onset of symptoms for acute ischemic stroke. Trial representatives were emailed by the study team with a request for a copy of their patient consent form, other documents related to informed consent, and to complete a survey concerning aspects of the consent process.ResultsOf the 6 trials conducted across 6 continents that completed the survey in its entirety, 2 were ongoing, 4 were published between 2009 and 2016, and the median NIHSS for each published trial was at least an 8. All published trials in the sample stated that informed consent was obtained, but only half reported involvement of a research ethics committee. Although 3 trials performed in Europe or Asia reported directly consenting 75-100% of enrolled patients, the median NIHSS for these trials represented a moderate stroke. Trials with 75-100% of patients directly consented had shorter door to treatment (DTT) times than trials that directly consented less than 50% of enrolled patients. 5 trials allowed consent by proxy, but only 2 of those trials also required patient assent. 4 trials had translators available and translated consent documents, and these trials had longer DTT times. All trials relied on experienced providers or dedicated research coordinators to obtain informed consent; however, only 2 of 6 trials mentioned specific training with regards to informed consent skills.ConclusionsThe current informed consent process is not transparent and poses challenges to investigators in the USA directly comparing tPA to an alternative treatment. International differences in the standards of informed consent, such as deferred consent, may have allowed more patients with moderate strokes to provide direct consent after treatment administration without delaying DTT time. While targeted and innovative approaches for informed consent are needed to improve patient outcomes, we must balance protecting the autonomy of individuals whose willing involvement enables such pivotal discoveries. The stroke community must aim for efficiency, transparency, and inclusion of patients of diverse backgrounds in the informed consent process so that therapeutic advances are possible.

scholarly journals An audit of consent for allograft use in elective orthopaedic surgery

2016 ◽  
Vol 98 (04) ◽  
pp. 254-257 ◽  
Author(s):  
CJ Mullan ◽  
R Pagoti ◽  
H Davison ◽  
MG McAlinden
Keyword(s):  
Informed Consent ◽  
Disease Transmission ◽  
Orthopaedic Surgery ◽  
High Volume ◽  
General Medical Council ◽  
Adverse Outcomes ◽  
Audit And Feedback ◽  
Medical Council ◽  
Patient Consent ◽  
Arthroplasty Surgery

Introduction Patients receiving musculoskeletal allografts may be at risk of postoperative infection. The General Medical Council guidelines on consent highlight the importance of providing patients with the information they want or need on any proposed investigation or treatment, including any potential adverse outcomes. With the increased cost of defending medicolegal claims, it is paramount that adequate, clear informed patient consent be documented. Methods We retrospectively examined the patterns of informed consent for allograft bone use during elective orthopaedic procedures in a large unit with an onsite bone bank. The initial audit included patients operated over the course of 1 year. Following a feedback session, a re-audit was performed to identify improvements in practice. Results The case mix of both studies was very similar. Revision hip arthroplasty surgery constituted the major subgroup requiring allograft (48%), followed by foot and ankle surgery (16.3%) and revision knee arthroplasty surgery (11.4%) .On the initial audit, 17/45 cases (38%) had either adequate preoperative documentation of the outpatient discussion or an appropriately completed consent form on the planned use of allograft. On the re-audit, 44/78 cases (56%) had adequate pre-operative documentation. There was little correlation between how frequently a surgeon used allograft and the adequacy of consent (Correlation coefficient -0.12). Conclusions Although the risk of disease transmission with allograft may be variable, informed consent for allograft should be a routine part of preoperative discussions in elective orthopaedic surgery. Regular audit and feedback sessions may further improve consent documentation, alongside the targeting of high volume/low compliance surgeons.

Informed consent in orthopaedics

2018 ◽  
Vol 100-B (9) ◽  
pp. 1253-1259 ◽  
Author(s):  
S. Seewoonarain ◽  
A. A. Johnson ◽  
M. Barrett
Keyword(s):  
United Kingdom ◽  
Informed Consent ◽  
Reading Ability ◽  
General Medical Council ◽  
Medical Council ◽  
Written Information ◽  
The United Kingdom ◽  
Patient Consent ◽  
Improve Compliance ◽  
The Mean

Aims Informed patient consent is a legal prerequisite endorsed by multiple regulatory institutions including the Royal College of Surgeons and the General Medical Council. It is also recommended that the provision of written information is available and may take the form of a Patient Information Leaflet (PIL) with multiple PILs available from leading orthopaedic institutions. PILs may empower the patient, improve compliance, and improve the patient experience. The national reading age in the United Kingdom is less than 12 years and therefore PILs should be written at a readability level not exceeding 12 years old. We aim to assess the readability of PILs currently provided by United Kingdom orthopaedic institutions. Patients and Methods The readability of PILs on 58 common conditions provided by seven leading orthopaedic associations in January 2017, including the British Orthopaedic Association, British Hip Society, and the British Association of Spinal Surgeons, was assessed. All text in each PIL was analyzed using readability scores including the Flesch–Kincaid Grade Level (FKGL) and the Simple Measure of Gobbledygook (SMOG) test. Results The mean FKGL was 10.4 (6.7 to 17.0), indicating a mean reading age of 15 years. The mean SMOG score was 12.8 (9.7 to 17.9) indicating a mean reading age of 17 years. Conclusion Orthopaedic-related PILs do not comply with the recommended reading age, with some requiring graduate-level reading ability. Patients do not have access to appropriate orthopaedic-related PILs. Current publicly available PILs require further review to promote patient education and informed consent. Cite this article: Bone Joint J 2018;100-B:1253–9.

Consenting and Assenting to Psychoanalytic Work

2020 ◽  
Vol 68 (4) ◽  
pp. 583-613
Author(s):  
Allannah Furlong
Keyword(s):  
Informed Consent ◽  
Analytic Work ◽  
Working Through ◽  
Psychoanalytic Treatment ◽  
Patient Consent ◽  
Consent To Treatment ◽  
The Moment ◽  
Over Time

The moment is opportune for a renewed look at what we understand about patient consent to treatment. Until recently, little reference to informed consent could be found in the literature, as though it has never been a preoccupation for psychoanalytic practitioners. Yet several post-Freudian authors offer reasons to suppose the risk of misunderstandings about consent. In fact, the very discovery of transference, replete with unrequited infantile wishes, implies that at some level, at some moment, in every psychoanalytic treatment there will be moments when “consent” will to some extent vacillate. A distinction, justifiable on etymological and intersubjective grounds, is made between patients’ consent as a cognitive, somewhat passive, acceptance and patients’ assent as an arduous, conflicted, partial disagreement with the symbolically limiting details of analytic work. It is in the discovery and working through of unexpected unconscious responses to aspects of the analytic setting and to the analyst that patients become “informed” of the unique risks to their psychic equilibrium the process poses, as well as its benefits. Instead of a static and unitary contractual event, informed consent in psychoanalysis is more properly conceived as a multilayered, repetitively posed, and necessarily ambivalent process of good-enough assenting over time.

scholarly journals Informed Voluntary Consent of the Patient

2021 ◽  
Vol 2 (42) ◽  
pp. 69-75
Author(s):  
Muratbek Sainov ◽  
◽  
Aigul Kulniyazova ◽  
Ainur Sisenbaeva ◽  
◽  
...  
Keyword(s):  
Informed Consent ◽  
Law Enforcement ◽  
Medical Intervention ◽  
Medical Professional ◽  
Alternative Methods ◽  
Sufficient Information ◽  
Voluntary Consent ◽  
Patient Consent ◽  
Intervention Patient ◽  
Rule Making

Informed consent is a patient's voluntary consent to a medical intervention, which is based on obtaining sufficient information from a medical professional in an understandable form about the options for this medical intervention, the proposed and alternative methods of diagnosis and treatment, and their health consequences. The principle of informed voluntary consent of the patient to medical intervention is one of the fundamental principles in the field of rule-making and law enforcement in the field of health protection. Keywords: informed consent, voluntary patient consent, medical intervention, patient rights, patient refusa

scholarly journals INFORMED CONSENT STATUS IN OBSERVATIONAL STUDIES WITH RETROSPECTIVE DESIGN: A POOR SHOW

2017 ◽  
Vol 10 (3) ◽  
pp. 480
Author(s):  
Parveen Bansal ◽  
Supreet Kaur Gill ◽  
Vikas Gupta
Keyword(s):  
Informed Consent ◽  
Observational Studies ◽  
Retrospective Studies ◽  
Current Status ◽  
Ethical Review ◽  
Retrospective Design ◽  
Ich Guidelines ◽  
Patient Consent ◽  
Vital Component ◽  
Ethical Clearance

ABSTRACTObjective: Informed consent is very important to protect the rights of patients and is obtained as a vital component of any clinical study. Requirementof patient consent in retrospective research continues to stir controversy even today. Some of directions of regulatory authorities even waive off theconsent for retrospective studies, whereas few recommend that at least clearance from the Ethical Review Board may be taken or information topatient may be given or oral consent must be given by patient for usage of the data in any retrospective study. The aim of this study was to analyze thecurrent status of informed consent procedures in observational studies with retrospective design.Methods: This review was intended to find out the current status of procedures involved in informed consent in India and abroad. A total of 100retrospective studies were searched for this objective from the internet and other literature sources.Results: Data show that in 65% of studies neither informed consent/oral consent nor ethical clearance was taken. Only 1% of studies have beenconducted with informed consent as well as ethical clearance. Only 14% of studies were conducted with informed consent and 21% with ethicalapproval.Conclusion: The study reflects very poor status of informed consent in retrospective studies and noncompliance of ICH guidelines for clinical researchin relation to informed consent.Keywords: Clinical research, Informed consent, Retrospective studies.

scholarly journals Informed Consent: Is it Sacrosanct?

2005 ◽  
Vol 1 (3) ◽  
pp. 77-83 ◽  
Author(s):  
Alison Assiter
Keyword(s):  
Informed Consent ◽  
Medical Ethics ◽  
Research Ethics ◽  
Ethical Issues ◽  
Personal Data ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Patient Consent ◽  
Human Participants ◽  
Alder Hey

Following Alder Hey and the earlier and much more extreme practices at Nuremberg, legislation has been developed governing the practice of medical ethics and research involving human participants more generally. In the medical context, relevant legislation includes GMC guidance, which states that disclosure of identifiable patient information without consent, for research purposes, is not acceptable unless it is justified in the public interest. There is a presumption, in other words, in favour of the view that patient consent ought to be obtained before any piece of research is conducted. The Data Protection Act, furthermore, requires informed consent to be given before any use of identifiable personal data is made for any purpose. Moreover, ensuring that the informed consent of participants is gained is common practice on most research ethics committees. I argue, in this paper, that applying the principle of ‘informed consent’ too mechanistically in the research ethics context risks undermining the very principle it is designed to support – the principle of autonomy. This issue has been much discussed in medical ethics but not so much, so far, in the research ethics context. It will be argued that a more discerning and a less rigid and mechanistic approach, applied by research ethics committees, may help ensure that ethical issues are properly considered.

scholarly journals Rethinking Consent for Stroke Trials in Time-Sensitive Situations

Stroke ◽  
2021 ◽  
Author(s):  
Mayank Goyal ◽  
Johanna Maria Ospel ◽  
Aravind Ganesh ◽  
Martha Marko ◽  
Marc Fisher
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Patient Autonomy ◽  
Routine Care ◽  
Patient Benefit ◽  
Checks And Balances ◽  
Patient Consent ◽  
Challenging Situation ◽  
Physician Workload

Informed consent is a key concept to ensure patient autonomy in clinical trials and routine care. The coronavirus disease 2019 (COVID-19) pandemic has complicated informed consent processes, due to physical distancing precautions and increased physician workload. As such, obtaining timely and adequate patient consent has become a bottleneck for many clinical trials. However, this challenging situation might also present an opportunity to rethink and reappraise our approach to consent in clinical trials. This viewpoint discusses the challenges related to informed consent during the COVID-19 pandemic, whether it could be acceptable to alter current consent processes under these circumstances, and outlines a possible framework with predefined criteria and a system of checks and balances that could allow for alterations of existing consent processes to maximize patient benefit under exceptional circumstances such as the COVID-19 pandemic without undermining patient autonomy.

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