Informed Consent for Intraoperative Neural Monitoring in Thyroid and Parathyroid Surgery - Consensus Statement of the International Neural Monitoring Study Group.

In the past decade, the use of intraoperative neural monitoring (IONM) in thyroid and parathyroid surgery has been widely accepted by surgeons as a useful technology for improving laryngeal nerve identification and voice outcomes, facilitating neurophysiological research, educating and training surgeons, and reducing surgical complications and malpractice litigation. Informing patients about IONM is not only good practice and helpful in promoting the efficient use of IONM resources but is indispensable for effective shared decision making between the patient and surgeon. The International Neural Monitoring Study Group (INMSG) feels complete discussion of IONM in the preoperative planning and patient consent process is important in all patients undergoing thyroid and parathyroid surgery. The purpose of this publication is to evaluate the impact of IONM on the informed consent process before thyroid and parathyroid surgery and to review the current INMSG consensus on evidence-based consent. The objective of this consensus statement, which outlines general and specific considerations as well as recommended criteria for informed consent for the use of IONM, is to assist surgeons and patients in the processes of informed consent and shared decision making before thyroid and parathyroid surgery.

Society for Vascular Surgery best practice recommendations for use of social media.

The use of social media (SoMe) in medicine has demonstrated the ability to advance networking among clinicians and other healthcare staff, disseminate research, increase access to up-to-date information, and inform and engage medical trainees and the public at-large. With increasing SoMe use by vascular surgeons and other vascular specialists, it is important to uphold core tenets of our commitment to our patients by protecting their privacy, encouraging appropriate consent and use of any patient-related imagery, and disclosing relevant conflicts of interest. Additionally, we recognize the potential for negative interactions online regarding differing opinions on optimal treatment options for patients. The Society for Vascular Surgery (SVS) is committed to supporting appropriate and effective use of SoMe content that is honest, well-informed, and accurate. The Young Surgeons Committee of the SVS convened a diverse writing group of SVS members to help guide novice as well as veteran SoMe users on best practices for advancing medical knowledge-sharing in an online environment. These recommendations are presented here with the goal of elevating patient privacy and physician transparency, while also offering support and resources for infrequent SoMe users to increase their engagement with each other in new, virtual formats.

Ethical evaluation of informed consent forms used in cardiology clinics and the importance of institutional standardized approach.

OBJECTIVE: This study aimed to evaluate the content of informed consent forms (ICFs) used during cardiology interventions by the university, research and training (R-T), and private hospitals with regard to ethical standards and compare them with the Turkish Society of Cardiology (TSC) templates and among various institutions. METHODS: A total of 185 forms from the university, R-T, and private hospitals and 19 TSC templates were selected and analyzed for 26 criteria. Compliance with TSC templates was also evaluated. Data were presented as the percentage of ICFs satisfying the criteria and compared using the Fisher exact test, and 95% confidence intervals were calculated. RESULTS: TSC templates were more compatible and included more information to comply with ethical standards than ICFs of all 3 types of healthcare institutions. The areas of improvement for these templates were prospects of treatment and alternative treatments, quality of life, explanation for third-party consent, duration of hospitalization, and time to return to normal life. Among the 3 types of hospitals, R-T-ICFs were more compatible with templates. Private hospital ICFs had the poorest compliance with TSC templates. Separate anesthesia ICFs and detailed information about exposure to radioactivity were lacking. CONCLUSION: The current ICFs for cardiology interventions have major ethical deficiencies and need urgent improvement. Professional societies such as TSC are essential institutions to develop and provide guidance and templates for ICFs to meet the ethical standards during the informed consent process and standardization of the process among various institutions.

A Normative Framework for the Reconciliation of EU Data Protection Law and Medical Research Ethics.

EU data protection law and medical research ethics overlap in scope and content in numerous instances in which personal data are processed in medical research. It is not always the case, however, that the conditions outlined by the two rule-sets precisely coincide. In the past few years, this lack of confluence has led to confusion as to how the two rule-sets should best relate to one another. This confusion has led to different approaches to the relationship being taken, on occasion leading to counter-intuitive conclusions. Unfortunately, there has hitherto been little effort to provide clarity to this confusion. In this regard, this article attempts to provide a general normative framework aimed at facilitating optimally cogent and just reconciliations of EU data protection law and medical research ethics.

Informed consent and informed intervention: SARS-CoV-2 vaccinations not just call for disclosure of newly emerging safety data but also for hypothesis generation and testing.

BACKGROUND: COVID-19 infection is a major threat to patients and health care providers around the world. One solution is the vaccination against SARS-CoV-2. METHODS: We performed a comprehensive query of the latest publications on the prevention of viral infections including the recent vaccination program and its side effects. RESULTS: The situation is evolving rapidly and there is no reasonable alternative to population-scale vaccination programs as currently enrolled. CONCLUSION: Therefore, regulatory authorities should consider supplementing their conventional mandate of post-approval pharmacovigilance, which is based on the collection, assessment, and regulatory response to emerging safety findings.

A literature review of consent declines and consent withdrawals in randomized controlled trials conducted during the COVID-19 pandemic.

Objectives: We evaluated the extent of consent declines and consent withdrawals during the COVID-19 pandemic as seen in published randomized controlled trials (RCTs) and compared it with non-COVID-19 RCTs published at the same time and two historical controls. Methods: PubMed/Medline only was searched using key-word "COVID-19" and "RCTs" separately, and filtered for COVID-19 RCTs and non-COVID-19 RCTs respectively, published during a nine-month period (1 Feb - 1 Nov 2020). Exclusions were study protocols, observational studies, interim analysis of RCT data and RCTs with missing data. Primary outcome measures were the proportion of consent declines and consent withdrawals as percentage of total participants screened and randomized respectively in COVID-19 RCTs. We compared consent declines and consent withdrawals of COVID-19 RCTs with non-COVID-19 RCTs and two earlier studies on the same topic that served as historical controls (non-pandemic setting). Results: The search yielded a total of 111 COVID-19 RCTs and 49 non-COVID-19 RCTs. Of these, 39 (35.13%) COVID-19 RCTs and 11 (22.45%) non-COVID-19 RCTs were finally analysed. A total of 770/17759 (4.3%) consent declines and 100/7607 (1.31%) consent withdrawals were seen in 39 COVID-19 RCTs. A significant difference was observed in consent declines between COVID-19 vs non-COVID-19 RCTs [4.3% vs 11.9%, p < 0.0001] and between COVID-19 RCTs vs two historical controls [(4.3% vs 8.6%, p < 0.0001) and (4.3% vs 21.1%, p < 0.0001), respectively]. Conclusion: RCTs conducted during the COVID-19 pandemic appear to have significantly lower consent declines relative to non-COVID-19 RCTs during pandemic and RCTs conducted in non-pandemic settings.

Recent Judgement of the Italian Judiciary about medical assisted procreation (MAP): is informed consent valid after parents separation?

ABSTRACT: Law No 40/2004 regulates in Italy the matter of medically assisted procreation (MAP). Recently, the Tribunal of Capua Vetere expressed its position on the subject of informed consent in a case of MAP. In the specific case, a couple entered the preliminary stages of the PMA procedures, carrying out the fertilization of the ovum and the embryo production. Afterwards, the couple separated and the man denied consent to the continuation of the MAP. The woman, willing to proceed with the implantation, the woman made an urgent judicial appeal, obtaining the judge's permission to transfer the embryo to the uterus. This paper analyses the different bioethical positions on MAP's informed consent. In fact, on the one hand, the paper highlight what is set out in Law 219/2017 which provides for the possibility of the patient to revoke at any time the consent to the treatment given. On the other hand, it should be noted that Law 40/2004, willing to protect the embryo, establishes the irrevocability of the position of parental consent after fertilization. The judgment in question seems to favour this latter position, placing itself in the protection of the cryopreserved embryo and recall-ing the principle of entrustment following the fertilization of the egg. Nevertheless, the matter is controversial a consistent amount of legal developments are expected to arise in the next future.

Errors and omissions in deprivation of liberty authorisation forms.

Richard Griffith, Senior Lecturer in Health Law at Swansea University, considers the impact of errors and omissions in the forms required to lawfully authorise a deprivation of liberty under the Mental Health Act 2005.

Signalling Standards for Progress: Bridging the Divide Between a Valid Consent to Use Patient Data Under Data Protection Law and the Common Law Duty of Confidentiality.

In this article, we analyse the legal components of disclosing confidential patient information under the UK's common law duty of confidentiality (CLDoC) and processing personal (health) data under the UK's General Data Protection Regulation (GDPR) and Data Protection Act 2018. We describe the ostensible divide between the CLDoC and data protection law when it comes to the requirements of a valid signal of consent by a patient to use and disclose patient information, obtained by a health professional in the context of direct care, for health care and health research purposes. Ultimately, our analysis suggests that we are saddled, at least in the medium term, with two regimes operating with different standards of a valid consent-while putatively protecting similar interests. There is, however, opportunity for progress. It is possible to improve professional guidance on the interaction between the regimes and to achieve significant normative alignment without aligning the signalling standard for consent; this would promote consistent protection of reasonable expectations of patients across both regimes. Further coherence would require aligning not only the standard, but also the role played by consent under each regime. Here we argue that, in relation to direct care, any such shift should be away from consent as the normal justification. In relation to health research, on the contrary, it should be toward consent as the normal justification for use and disclosure of patient information under both the CLDoC and data protection law.

The readability of informed consent forms for research studies conducted in South Africa.

BACKGROUND: Informed consent forms (ICFs) are used to obtain consent from participants. However the complexity and comprehensiveness of these forms may not be appropriate. Readability can be quantified by formulas in Microsoft (MS) Word, such as the Flesch Reading Ease test. The South African (SA) ethics guidelines suggest that the MS Word Flesch-Kincaid Reading Grade score should be used to assess the complexity of ICFs and should be the equivalent of grade 8 level, or lower. OBJECTIVES: To use readability formulas to determine whether current SA ICFs are appropriate for the general population. METHODS: This was a descriptive study of a sample of English ICFs (solicited from our studies, as well as from local researchers) which received approval from local ethical review boards during the past 5 years, for prospective (≥6 months) drug studies that explored treatment and prevention of HIV, tuberculosis, diabetes or cardiovascular disease. ICFs were evaluated in MS Word for Flesch Reading Ease and Flesch-Kincaid Reading Grade, with the Simple Measure of Gobbledygook (SMOG) index calculated using www.readabilityformulas.com. Recommended targets for easy readability are above 60 for the Flesch Reading Ease score, and less than or equal to a grade 8 reading level for the Flesch-Kincaid Reading Grade and SMOG. RESULTS:   A total of 75 consent forms from 35 individual research studies conducted in SA over the last 5 years were included. The consent forms had been approved by six ethics committees across seven of the SA provinces. The median (interquartile range (IQR)) Flesch Reading Ease score was 55.8 (48.7 - 59.7) and 18 (25.0%) of the ICFs had easy or standard readability, while the median (IQR) Flesch-Kincaid Grade was 10.2 (8.8 - 11.4), with 23 (30.6%) at least a grade 8 level or lower. The median (IQR) SMOG index was 9.8 (9.0 - 11.1) and 4 (5.3%) scored below grade 8 level. CONCLUSIONS: Two-thirds of the ICFs from this study fail to meet the SA readability standard, a result matched by using alternative readability formulas. Readability can be improved with simple techniques and by actively monitoring readability metrics.

Deferral of Consent: Recent Lessons From Canadian Acute Stroke Trials.

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Thinking about the idea of consent in data science genomics: How 'informed' is it?

In this paper we argue that 'informed' consent in Big Data genomic biobanking is frequently less than optimally informative. This is due to the particular features of genomic biobanking research which render it ethically problematic. We discuss these features together with details of consent models aimed to address them. Using insights from consent theory, we provide a detailed analysis of the essential components of informed consent which includes recommendations to improve consent performance. In addition, and using insights from philosophy of mind and language and psycholinguistics we support our analyses by identifying the nature and function of concepts (ideas) operational in human cognition and language together with an implicit coding/decoding model of human communication. We identify this model as the source of patients/participants poor understanding. We suggest an alternative, explicit model of human communication, namely, that of relevance-theoretic inference which obviates the limitations of the code model. We suggest practical strategies to assist health service professionals to ensure that the specific information they provide concerning the proposed treatment or research is used to inform participants' decision to consent. We do not prescribe a standard, formal approach to decision-making where boxes are ticked; rather, we aim to focus attention towards the sorts of considerations and questions that might usefully be borne in mind in any consent situation. We hope that our theorising will be of real practical benefit to nurses and midwives working on the clinical and research front-line of genomic science.

Assessment of capacity to give informed consent for medical assistance in dying: a qualitative study of clinicians' experience.

BACKGROUND: Under the Canadian Criminal Code, medical assistance in dying (MAiD) requires that patients give informed consent and that their ability to consent is assessed by 2 clinicians. In this study, we intended to understand how Canadian clinicians assessed capacity in people requesting MAiD. METHODS: This qualitative study used interviews conducted between August 2019 and February 2020, by phone, video and email, to explore how clinicians assessed capacity in people requesting MAiD, what challenges they had encountered and what tools they used. The participants were recruited from provider mailing listserves of the Canadian Association of MAiD Assessors and Providers and Aide médicale à mourir. Interviews were audio-recorded and transcribed verbatim. The research team met to review transcripts and explore themes as they emerged in an iterative manner. We used abductive reasoning for thematic analysis and coding, and continued to discuss until we reached consensus. RESULTS: The 20 participants worked in 5 of 10 provinces across Canada, represented different specialties and had experience assessing a total of 2410 patients requesting MAiD. The main theme was that, for most assessments, the participants used the conversation about how the patient had come to choose MAiD to get the information they needed. When the participants used formal capacity assessment tools, this was mostly for meticulous documentation, and they rarely asked for psychiatric consults. The participants described how they approached assessing cases of nonverbal patients and other challenging cases, using techniques such as ensuring a quiet environment and adequate hearing aids, and using questions requiring only "yes" or "no" as an answer. INTERPRETATION: The participants were comfortable doing MAiD assessments and used their clinical judgment and experience to assess capacity in ways similar to other clinical practices. The findings of this study suggest that experienced MAiD assessors do not routinely require formal capacity assessments or tools to assess capacity in patients requesting MAiD.

Views on genomic research result delivery methods and informed consent: a review.

There has been little discussion of the way genomic research results should be returned and how to obtain informed consent for this. We systematically searched the empirical literature, identifying 63 articles exploring stakeholder perspectives on processes for obtaining informed consent about return of results and/or result delivery. Participants, patients and members of the public generally felt they should choose which results are returned to them and how, ranging from direct (face-to-face, telephone) to indirect (letters, emails, web-based delivery) communication. Professionals identified inadequacies in result delivery processes in the research context. Our findings have important implications for ensuring participants are supported in deciding which results they wish to receive or, if no choice is offered, preparing them for potential research outcomes.