Informed Consent: an Update

~ paigefitzsimmons ~ Leave a comment

Informed Consent: an Update
Biermann E
Anasthesiol Intensivmed Notfallmed Schmerzther, 25 Jul 2019; 54(7-8) pp 457-473
Abstract
An indication for a medical intervention alone is not sufficient to justify its implementation. In addition, consent has to be obtained from the patient who has been given relevant information by a doctor. If, instead of the patient, other persons are entitled to decide for him (parents for children incapable of consent, authorised representatives, carers), they must be informed. If the patient, who is aware of the significance of his decision, refuses to consent to the measure as a whole or to parts of it, the physician is bound by it – even if the patient’s refusal is based on religious, ideological or other reasons which are not comprehensible to the physician. In urgent cases, and in the case of a patient unable to give consent, the doctor can initiate treatment according to the principle of so-called presumed consent. The physician must inform the patient about all circumstances essential for the consent in a timely and comprehensible manner, i.e. also in the language of the patient in the case of patients who do not understand German. The patient must be informed about alternatives if there are other common treatment methods that are medically equally indicated, but which carry substantially different burdens, risks or chances of recovery. From a medical and forensic point of view, risk education is of the greatest importance, in particular information about the typical risks specific to interventions which are unknown to the patient and which, if they materialise, might have a lasting adverse effect on the patient’s lifestyle. The extent of risk disclosure is influenced by the urgency of the intervention; the scope of risk disclosure is in inverse proportion to its urgency. An enlightened or otherwise adequately informed patient (e.g. in the case of a series of dressing changes under general anaesthesia) does not have to be enlightened every time, provided that the risk spectrum for the patient has not changed. Consent and clarification are also verbally effective, written form is strongly recommended for reasons of preserving evidence. However, the patient’s right to self-determination also means that the patient can expressly dispense with more detailed information. Such a waiver should be carefully documented.

Editor’s note: This is a German language publication.

How Do We Really Communicate? Challenging the Assumptions behind Informed Consent Interventions

~ paigefitzsimmons ~ Leave a comment

How Do We Really Communicate? Challenging the Assumptions behind Informed Consent Interventions
Article
Stephanie Solomon Cargill
Ethics & Human Research, 23 July 2019
Abstract
It is generally accepted that ethical research requires valid informed consent and that current informed consent practice frequently fails to attain it. Interventions concerning the content and methods of communication in informed consent have met with limited success. One explanation is that they reflect an outdated and limited model of how communication functions, the transmission model of communication. This model assumes that communication is linear, is limited in time, and succeeds when the content of a message is passed from one person to another without distortion. Later communication models have challenged the limitations and inaccuracies of this model, emphasizing the continuous, contextual, and relational nature of communication. Looking beyond these assumptions behind current interventions can open multiple paths of research and intervention that have the potential to affect and improve the informed consent process in much greater ways than have been achieved previously.

Bioethical reflexivity and requirements of valid consent: conceptual tools

~ paigefitzsimmons ~ Leave a comment

Bioethical reflexivity and requirements of valid consent: conceptual tools
Debate
John Barugahare
BMC Medical Ethics, 4 July 2019; 20(44)
Open Access
Abstract
Background
Despite existing international, regional and national guidance on how to obtain valid consent to health-related research, valid consent remains both a practical and normative challenge. This challenge persists despite additional evidence-based guidance obtained through conceptual and empirical research in specific localities on the same subject. The purpose of this paper is to provide an account for why, despite this guidance, this challenge still persist and suggest conceptual resources that can help make sense of this problem and eventually mitigate it’.
Main body
This paper argues that despite the existence of detailed official guidance and prior conceptual and empirical research on how to obtain valid consent, the question of ‘how to obtain and ascertain valid consent to participation in health-related research’ cannot always be fully answered by exclusivereference to pre-determined criteria/guidance provided by the guidelines and prior research’. To make intelligible why this is so and how this challenge could be allayed, the paper proposes six concepts. The first five of these are intended to account for the persistent seeming inadequacies of existing guidelines. These are fact-skepticism; guideline insufficiency; generality; context-neutrality and presumptiveness. As an outcome of these five, the paper analyzes and recommends a sixth, called bioethical reflexivity. Bioethical reflexivity is reckoned as a handy tool, skill, and attitude by which, in addition to guidance from context-specific research, the persisting challenges can be further eased.
Conclusions
Existing ethical guidelines on how to obtain valid consent to health-related research are what they ought to be – general, presumptive and context-neutral. This explains their seeming inadequacies whenever they are being applied in concrete situations. Hence, the challenges being encountered while obtaining valid consent can be significantly eased if we appreciate the guidelines’ nature and what this means for their implementation. There is also a need to cultivate reflexive mindsets plus the relevant skills needed to judiciously close the unavoidable gaps between guidelines and their application in concrete cases. This equally applies to the gaps which cannot be filled by reference to additional guidance from prior conceptual and empirical research in specific contexts.

Attitudes Regarding Enrollment in a Genetic Research Project: An Informed Consent Simulation Study Comparing Views of People With Depression, Diabetes, and Neither Condition

~ paigefitzsimmons ~ Leave a comment

Attitudes Regarding Enrollment in a Genetic Research Project: An Informed Consent Simulation Study Comparing Views of People With Depression, Diabetes, and Neither Condition
Research Article 
Jane Paik Kim, Katie Ryan, Laura Weiss Roberts
Journal of Emirical Research on Human Research Ethics, 22 July 2019 
Abstract
In this study, participants with a self-reported history of depression, diabetes, or no illness underwent a simulated informed consent process for a hypothetical genetic study related to depression or diabetes. Participants completed a survey assessing their perceived understanding of the research process, perceptions of its risks and benefits, their satisfaction with the informed consent process, and their readiness to make a hypothetical enrollment decision. All participants indicated strong readiness to make an enrollment decision regarding the research characterized in the simulation. Participants reported understanding the consent process relatively well and being generally satisfied with it. Greater concerns were expressed regarding psychosocial risks than biological risks for genetic studies on mental disorders. Our study documented positive attitudes toward volunteering for research that involved the collection of genetic data.

How to Strengthen Patients’ Meaning Response by an Ethical Informed Consent in Psychotherapy

~ paigefitzsimmons ~ Leave a comment

How to Strengthen Patients’ Meaning Response by an Ethical Informed Consent in Psychotherapy
Conceptual Analysis Article
Manuel Trachsel, Martin grosse Holtforth
Frontiers in Psychology, 31 July 2019
Open Access
Abstract
Healthcare professionals including psychotherapists are legally and ethically obliged to ensure informed consent for the provided treatments comprising type and duration or potential benefits and possible risks (e.g., side effects) among others. In the present contribution, we argue that as potential benefit, informed consent can foster the patient’s meaning response. Moerman’s notion of the meaning response as the physiological or psychological effects of meaning in the course and treatment of an illness is a useful concept in explaining the effects of communicating a treatment rationale as part of the informed consent procedure. The more compelling the rational explanation of the targeted treatment effects including an explanatory model and a model of unique and common change mechanisms, the stronger the meaning response is expected to be resulting in increased hope and positive expectations with regard to the treatment.

Privacy, Sensitive Questions, and Informed Consent: Their Impacts on Total Survey Error, and the Future of Survey Research

~ paigefitzsimmons ~ Leave a comment

Privacy, Sensitive Questions, and Informed Consent: Their Impacts on Total Survey Error, and the Future of Survey Research
Eric Plutzer
Public Opinion Quarterly, 28 June 2019; 83(1) pp 169-184
Abstract
Survey science is driven to maximize data quality and reduce Total Survey Error (TSE). At the same time, survey methodologists have ethical and professional obligations to protect the privacy of respondents and ensure their capacity to provide informed consent for their participation, for data linkage, passive data collection, and the archiving of replication data. We have learned, however, that both sensitive topics and the consent process can contribute to errors of representation and errors of measurement. These compound threats to data quality that arise due to broader concerns about privacy, the intrusiveness of surveys, and the increasing number of participation requests directed to the same respondents. This article critically assesses the extant literature on these topics—including six original articles in this issue—by viewing these challenges through the lens of the TSE framework. This helps unify several distinct research programs and provides the foundation for new research and for practical innovations that will improve data quality.

Association of Preoperative Disclosure of Resident Roles With Informed Consent for Cataract Surgery in a Teaching Program

~ paigefitzsimmons ~ Leave a comment

Association of Preoperative Disclosure of Resident Roles With Informed Consent for Cataract Surgery in a Teaching Program
Original Investigation
Alicia M. Corwin, Jonathan N. Rajkumar, Bruce J. Markovitz, Avrey Thau, Douglas M. Wisner, John M. Spandorfer, Benjamin E. Leiby, Robert Bailey, George L. Spaeth, Alex V. Levin
JAMA Ophthalmology, 25 July 2019
Abstract
Importance  
Cataract surgery is the most commonly performed intraocular surgery. Academic centers have mandates to train the next surgeon generation, but resident roles are often hidden in the consent process.
Objective  
To investigate associations of full preoperative disclosure of the resident role with patient consent rates and subjective experience of the consent process.
Design, Setting, and Participants  
Full scripted disclosure of residents’ roles in cataract surgery was delivered by the attending surgeon. Qualitative analysis was conducted from recorded interviews of patients postoperatively regarding consent process experience and choice of whether to allow resident participation. Associations were sought regarding demographic characteristics and consent rates. Patients were recruited though a private community office. Surgery was performed at a single hospital where resident training was routinely conducted. The study included systemically well patients older than 18 years with surgical cataract. They had no previous eye surgery, English fluency, and ability to engage in informed consent decision-making and postsurgery interview. Patients were ineligible if they had monocular cataracts, required additional simultaneous procedures, had history of ocular trauma, or had cataracts that were surgically technically challenging beyond the usual resident skill level.
Interventions  
Eligible patients received an informed consent conversation by the attending physician in accordance with a script describing projected resident involvement in their cataract surgery. Postoperatively, patients were interviewed and responses were analyzed with a quantitative and thematic qualitative approach.
Main Outcomes and Measures  
Consent rates to resident participation and qualitative experience of full disclosure process.
Results  
Ninety-six patients participated. Participants were between ages 50 and 88 years, 53 were men (55.2%), and 75 were white (85.2%). A total of 54 of 96 participants (56.3%; 95% CI, 45.7%-66.4%) agreed to resident involvement. There were no associations between baseline characteristics and consent to resident involvement identified with any confidence, including race/ethnicity (60% [45 of 75] in white patients vs 30.8% [4 of 13] in nonwhite patients; difference, 29.2%; 95% CI, −0.7% to 57.3%; Fisher exact P = .07). Thematically, those who agreed to resident involvement listed trust in the attending surgeon, contributing to education, and supervision as contributing factors. Patients who declined stated fear and perceived risk as reasons.
Conclusions and Relevance  
Our results suggest 45.7% to 66.4% of community private practice patients would consent to resident surgery. Consent rates were not associated with demographic factors. Because residents are less often offered the opportunity to do surgery on private practice patients vs academic center patients, this may represent a resource for resident education.

Training surgeons and the informed consent discussion in paediatric patients: a qualitative study examining trainee participation disclosure

~ paigefitzsimmons ~ Leave a comment

Training surgeons and the informed consent discussion in paediatric patients: a qualitative study examining trainee participation disclosure
Original Article
Kunal Bhanot, Justin Chang, Samuel Grant, Annie Fecteau, Mark Camp
BMJ, 19 July 2019
Open Access
Abstract
Background 
The process of obtaining informed consent is an important and complex pursuit, especially within a paediatric setting. Medical governing bodies have stated that the role of the trainee surgeon must be explained to patients and their families during the consent process. Despite this, attitudes and practices of surgeons and their trainees regarding disclosure of the trainee’s participation during the consent process has not been reported in the paediatric setting.
Methods 
Nineteen face-to-face interviews were conducted with surgical trainees and staff surgeons at a tertiary-level paediatric hospital in Toronto, Canada. These were transcribed and subsequently thematically coded by three reviewers.
Results 
Five main themes were identified from the interviews. (1) Surgeons do not consistently disclose the role of surgical trainees to parents. (2) Surgical trainees are purposefully vague in disclosing their role during the consent discussion without being misleading. (3) Surgeons and surgical trainees believe parents do not fully understand the specific role of surgical trainees. (4) Graduated responsibility is an important aspect of training surgeons. (5) Surgeons feel a responsibility towards both their patients and their trainees. Surgeons do not explicitly inform patients about trainees, believing there is a lack of understanding of the training process. Trainees believe families likely underestimate their role and keep information purposely vague to reduce anxiety.
Conclusion 
The majority of surgeons and surgical trainees do not voluntarily disclose the degree of trainee participation in surgery during the informed consent discussion with parents. An open and honest discussion should occur, allowing for parents to make an informed decision regarding their child’s care. Further patient education regarding trainees’ roles would help develop a more thorough and patient-centred informed consent process.

Ethical challenges of obtaining informed consent from surgical patients

~ paigefitzsimmons ~ Leave a comment

Ethical challenges of obtaining informed consent from surgical patients
Research Article 
Sanaz Moeini, Mohsen Shahriari, Mahdi Shamali
Nursing Ethics, 11 July 2019 
Abstract
Background
Informed consent can be obtained by various methods, by various people, and with use of various types of consent forms. Persistent effort is necessary to reveal the practical realities of informed consent to improve ethical and legal standards.
Objective
To determine the ethical challenges of obtaining informed consent from surgical patients.
Methods
The present study was a descriptive cross-sectional study using two researcher-made questionnaires and a checklist for data collection. Data were collected from nursing personnel (n = 95) and surgical patients (n = 203) on the surgical wards of three university hospitals in Isfahan, Iran. Data were analyzed using descriptive statistics, Spearman’s rank correlation, Pearson’s correlation coefficient, and the t-test.
Ethical considerations
The study was approved by the Ethics Committee of Isfahan University of Medical Sciences (No: 396478).
Results
The mean scores (maximum 100) of awareness, competency, and authority were 36.3, 67.7, and 57.6, respectively. The overall quality of the informed consent was poor (score 53.9 of 100). The higher educational level in patients was correlated with lower awareness of and less authority to give informed consent. Only 12.6% of the nurses stated that patients were given sufficient information to assure informed consent. In 89.2% of the consent forms, the risks of the treatment were mentioned. However, alternative methods and risks and advantages of rejecting the treatment were not mentioned in any of the forms.
Conclusion                              
Ethical challenges to obtaining informed consent include patients’ poor awareness of their rights, a failure to provide adequate information to patients, absence of consideration of patients’ educational level, an unclear definition of who is responsible for obtaining informed consent from the patients, time constraints, and use of unclear language and medical jargon. Constructing an ethical framework may guide nursing staff in dealing with the ethical challenges involved in obtaining informed consent.

Implementation of a Bundled Consent Process in the ICU; A Single-Center Experience

~ paigefitzsimmons ~ Leave a comment

Implementation of a Bundled Consent Process in the ICU; A Single-Center Experience
Asha M. Anandaiah, Jennifer P. Stevens, Amy M. Sullivan
Critical Care Medicine, 11 July 2019
Abstract
Objectives 
A bundled consent process, where patients or surrogates provide consent for all commonly performed procedures on a single form at the time of ICU admission, has been advocated as a method for improving both rates of documented consent and patient/family satisfaction, but there has been little published literature about the use of bundled consent. We sought to determine how residents in an academic medical center with a required bundled consent process actually obtain consent and how they perceive the overall value, efficacy, and effects on families of this approach.
Design
Single-center survey study.
Setting
Medical ICUs in an urban academic medical center.
Subjects 
Internal medicine residents.
Interventions
We administered an online survey about bundled consent use to all residents. Quantitative and qualitative data were analyzed.
Measurements and Main Results
One-hundred two of 164 internal medicine residents (62%) completed the survey. A majority of residents (55%) reported grouping procedures and discussing general risks and benefits; 11% reported conducting a complete informed consent discussion for each procedure. Respondents were divided in their perception of the value of bundled consent, but most (78%) felt it scared or stressed families. A minority (26%) felt confident that they obtained valid informed consent for critical care procedures with the use of bundled consent. An additional theme that emerged from qualitative data was concern regarding the validity of anticipatory consent.
Conclusions
Resident physicians experienced with the use of bundled consent in the ICU held variable perceptions of its value but raised concerns about the effect on families and the validity of consent obtained with this strategy. Further studies are necessary to further explore what constitutes best practice for informed consent in critical care.