Informed consent for suspension microlaryngoscopy: what should we tell the patient? A consensus statement of the European Laryngological Society
Frederik G. Dikkers, Michel R. M. San Giorgi, Rico N. P. M. Rinkel, Marc Remacle, Antoine Giovanni, Małgorzata Wierzbicka, Riaz Seedat, Guillermo Campos, Guri S. Sandhu
European Archives of Oto-Rhino-Laryngology, 12 July 2022
Open Access
Abstract
Introduction
Informed consent for any surgical intervention is necessary, as only well-informed patients can actively participate in the decision-making process about their care, and better understand the likely or potential outcomes of their treatment. No consensus exists on informed consent for suspension microlaryngoscopy (SML).
Materials and methods
Informed consent procedures in nine countries on five continents were studied.
Results
Several risks can be discerned: risks of SML as procedure, anesthesiologic risks of SML, specific risks of phonosurgery, risks of inadequate glottic exposure or unexpected findings, risks of not treating. SML has recognized potential complications, that can be divided in temporary (minor) complications, and lasting (major) complications.
Conclusion
SML is a safe procedure with low morbidity, and virtually no mortality. Eleven recommendations are provided.
Month: July 2022
Patients’ satisfaction and associated factors towards preoperative informed consent process: A cross-sectional study
Patients’ satisfaction and associated factors towards preoperative informed consent process: A cross-sectional study
Tamiru Tilahun Ayele, Tadese Tamire Negash, Keder Essa oumer, Aderajew Mekuanint, Diriba Teshome, Efrem Fenta, Yewlsew Fentie, Aragaw Tesfaw Ashenafi Tolosa
Annals of Medicine and Surgery, 4 July 2022; 79
Abstract
Background
Informed consent is a process that needs time and effort to satisfy patients’ desires. Patient dissatisfaction on preoperative informed consent process may be caused by multiple factors of clinical practice. This study aimed to assess patients’ satisfaction and associated factors of informed consent process among elective surgical patients.
Methods
A cross-sectional study was conducted on 404 postoperative patients who signed the informed consent for elective surgery. A systematic sampling technique was applied to select the study participants. Modified Leiden perioperative patient satisfaction tool was adapted to assess patients’ satisfaction with preoperative informed consent process. Data were entered in to Epi-data version 4.20 and exported to SPSS version 20 for analysis. Bivariate and multivariable logistic regression was computed to identify independent variables associated with patient satisfaction towards preoperative informed consent process. A p-value of less than 0.05 was used to declare the statistical significance.
Results
The overall satisfaction of patients with preoperative informed consent process was 70.3%. Multivariable logistic regression analysis revealed that, being male (AOR: 4.75, 95% CI: 2.47–9.16), primary school (AOR: 8.42, 95% CI: 4.74–7.55), secondary school (AOR: 2.17, 95% CI: 5.74–8.62), rural residence (AOR: 1.8, 95% CI: 2.1–3.9) and received general anesthesia (AOR: 2.92, 95% CI: 1.62–5.26) were significantly associated with patients’ satisfaction with the informed consent process.
Conclusion
The overall patients’ satisfaction on preoperative informed consent process was relatively low. Being male, low level of education, living in rural area, and receiving general anesthesia were significantly associated with patients’ satisfaction on informed consent process. Surgeons and anesthesia professionals need to work more to improving the satisfaction of patients with preoperative informed consent process. Researchers are expected to do periodic assessment of patients’ level of satisfaction and factors affecting satisfaction.
Privacy Behaviour: A Model for Online Informed Consent
Privacy Behaviour: A Model for Online Informed Consent
Original Paper
Gary Burkhardt, Frederic Boy, Daniele Doneddu, Nick Hajli
Journal of Business Ethics, 14 July 2022
Open Access
Abstract
An online world exists in which businesses have become burdened with managerial and legal duties regarding the seeking of informed consent and the protection of privacy and personal data, while growing public cynicism regarding personal data collection threatens the healthy development of marketing and e-commerce. This research seeks to address such cynicism by assisting organisations to devise ethical consent management processes that consider an individual’s attitudes, their subjective norms and their perceived sense of control during the elicitation of consent. It does so by developing an original conceptual model for online informed consent, argued through logical reasoning, and supported by an illustrative example, which brings together the autonomous authorisation (AA) model of informed consent and the theory of planned behaviour (TPB). Accordingly, it constructs a model for online informed consent, rooted in the ethic of autonomy, which employs behavioural theory to facilitate a mode of consent elicitation that prioritises users’ interests and supports ethical information management and marketing practices. The model also introduces a novel concept, the informed attitude, which must be present for informed consent to be valid. It also reveals that, under certain tolerated conditions, it is possible for informed consent to be provided unwillingly and to remain valid: this has significant ethical, information management and marketing implications.
Malpractice Claims and Ethical Issues in Prison Health Care Related to Consent and Confidentiality
Malpractice Claims and Ethical Issues in Prison Health Care Related to Consent and Confidentiality
Review
Oana-Maria Isailă, Sorin Hostiuc
Healthcare, 12 July 2022
Open Access
Abstract
Respecting the consent and confidentiality of a patient is an underlying element in establishing the patient’s trust in the physician and, implicitly, obtaining the patient’s compliance. In particular, cases of inmate patients require increased attention in order to fulfill this goal against a background of institutional interferences, which, in certain situations, may endanger the autonomy of the physician and their respect for the inmate’s dignity. The purpose of this article is to depict the characteristics of consent and confidentiality in a prison environment, in special cases, such as hunger strikes, violent acts, HIV testing, COVID-19 measures, and drug use, bringing into focus the physician and the inmate in the context of the particular situation where the target is disciplining someone in order for them to conform to social and juridical norms. Respecting the dignity of the inmate patient requires an adequate approach of informed consent and confidentiality, depending on each case, considering the potential unspoken aspects of the inmate’s account, which can be key elements in obtaining their compliance and avoiding malpractice claims.
Ethics Considerations Regarding Donors’ and Patients’ Consent
Ethics Considerations Regarding Donors’ and Patients’ Consent
Book Chapter
Jeremy Sugarman
Brain Organoids in Research and Therapy, 10 July 2022; pp 121-130 [Springer]
Abstract
Informed consent is a crucial factor in determining whether particular uses of brain organoids for research and clinical translation are ethically acceptable. In the context of basic research, the consent of donors whose tissues are used to derive brain organoids is of primary concern, whereas in clinical translation the consent of both allogeneic donors and patients may be relevant. In this chapter, I examine key ethics considerations related to informed consent for brain organoid research and clinical translation. In order to do so, I first describe both a standard conceptual approach to informed consent that aims at meeting the ethical goal of respecting the autonomy of persons and some of the other ethically relevant functions of informed consent. This conceptual work provides a foundation for mapping ethics considerations related to informed consent in regard to the decision-making capacity and voluntariness of those being asked to consent, disclosure requirements associated with brain organoids in general and for particular proposed uses that involve morally significant aspects, threats to understanding that must be overcome, and considerations for authorization. Finally, I offer some suggestions for grappling with such informed consent challenges related to brain organoids.
The Scope of Consent
The Scope of Consent
Joseph Millum
The Philosophical Quarterly, 2 July 2022
Extract
Suppose you come to my house and I invite you in. ‘I’m just heading out’, I say, ‘but make yourself at home’. I have consented to you remaining in my house, but what else? In your home, you put your feet up on the coffee table, so may you now do that in mine? If I complain that you’ve left crumbs from eating biscuits in my bed, can you defend yourself on the grounds that I told you to make yourself at home? These questions concern the scope of my consent. How we should ascertain the scope of someone’s consent is the topic of Tom Dougherty’s book. The book is divided into three main parts, each corresponding to a view about what fixes the scope of consent: the mental account, the successful communication account, and the evidential account, which Dougherty favours…
Informed Consent: A Monthly Review
_________________
July 2022
This digest aggregates and distills key content addressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.
Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:
Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_July 2022
Informed Consent for Research with Data and Biospecimens: Points to Consider and Sample Language for Future Use and/or Sharing
Informed Consent for Research with Data and Biospecimens: Points to Consider and Sample Language for Future Use and/or Sharing
NIH – Office of Science Policy/Office of Extramural Research, May 2022; pp 1-7
Introduction
…The following resource… outlines suggested points to consider when addressing data and biospecimen storage and sharing for future use in consent language and provides supplemental sample language that could be modified as needed when developing informed consent documents. Of note, the sample language provided below is designed to be incorporated into a primary research consent document. The use of the sample language by itself does not address federal, state, local, tribal, or international requirements that may apply to the primary research. Furthermore, this resource is designed for research consent documents; it does not address the storage and sharing of data and biospecimens initially collected for clinical purposes. Use of the information provided in this resource, including sample language, is completely voluntary.
Electronic consent in a COVID-19 vaccine implementation trial in South Africa: Participant perspectives
Electronic consent in a COVID-19 vaccine implementation trial in South Africa: Participant perspectives
Gonasagrie Nair, Siti M. Kabanda, Meagan M.M. Jacobs-Alfred, Adetayo E.A. Obasa, Michael G. McCaul, Keymanthri Moodley
South African Journal of Science, 31 May 2022; 5
Open Access
Abstract
The COVID-19 pandemic has warranted modifications to clinical research implementation to ensure adherence to public health and safety measures. Often, this modification has necessitated a deviation from the traditional face-to-face approach to an electronic or hybrid consent process. We assessed the acceptability and preference for electronic consent and explored understanding of the electronic consent information – an outcome which is vital in providing reassurance that consent is provided with full appreciation of the risks and benefits of study participation. In this descriptive study, healthcare professionals (HCPs) were invited, through a database of HCP contacts, snowball sampling and advertisement, to participate in an online survey between 14 July 2021 and 17 September 2021, to explore their experiences of providing electronic consent for enrolment into the largest implementation trial of a COVID vaccine in South Africa (SISONKE Trial). Descriptive analysis was used to characterise respondents and categorical data were expressed as frequencies. The prevalence of recurring responses to open-ended questions allowed for the identification of themes. A total of 1025 HCPs completed the online survey. Access to a COVID-19 vaccine was the strongest motivating factor for enrolment (82.3%) into the SISONKE Trial. Over a third of participants (38.6%) were not able to discuss the study with research staff. While the majority of participants (85.2%) indicated that online consent was acceptable, it was recognised that acceptability was context specific. Although 64% indicated awareness that reporting both a positive COVID test and adverse events were requirements, a significant percentage (32%) did not recall that the reporting period was 2 years. The electronic consent process was easily navigated by educated HCPs with access to electronic devices and data. Vaccine access was the most important motivation for participation, thus raising questions about how voluntary the consent process was and the role of desperation in deciding to participate.
Improving first-in-human and window-of-opportunity informed consent forms through participant feedback
Improving first-in-human and window-of-opportunity informed consent forms through participant feedback
Anna Avinger, Hannah Claire Sibold, Gavin Paul Campbell, Eli Rowe Abernethy, John Bourgeois, Tekiah McClary, Shannon M. Blee, Margie D. Dixon, R. Donald Harvey, Rebecca D. Pentz
Journal of Clinical Oncology, 1 June 2022 [2022 ASCO Annual Meeting]
Open Access
Abstract
Background
Although patient advocates have created templates for standard consent forms, assessing patient preferences for First in Human (FIH) and Window of Opportunity (WO) trials consents is important given their unique risks. FIH trials are the first time a drug is tested in humans. In WO trials, treatment naïve patients receive a therapeutic agent in the window of time between diagnosis and standard of care (SOC) surgery. Our goal was to determine patient-preferred presentation of important information in FIH and WO consent forms.
Methods
The study consisted of two phases: (1) analysis of consents for FIH and WO oncology trials open at a cancer center between 2019 and 2022; (2) interview patients who had reviewed consents for FIH or WO trials during the consent process. FIH consents were analyzed for the location(s) of information stating that the study drug has not been tested in humans (FIH info). The WO consents were analyzed for the location(s) of information stating the risk that trial may delay SOC surgery (WO info). Participants were asked about their preferred placement of the information in their own trial’s consent form and whether the consent was clear. Interviews were audio-recorded and double coded. Consent form analysis was compared to patients’ preferences.
Results
25 consents [20 FIH; 5 WO] were analyzed. 19/20 FIH consent forms included FIH info, and 4/5 WO consent forms included WO info. 42 patients were approached [19 FIH; 23 WO]; 34 [17 FIH; 17 WO] participated. 12/17 (71%) WO participants thought that the trial explanation in the consent form was clear. Conversely, only 9/17 (53%) FIH participants found it clear.
Conclusions
Patients preferred that the important FIH and WO information be placed early in the consent, though exactly where varied. 82% of FIH participants wanted FIH information in the purpose, while only 19% of WO participants clearly preferred that WO information be in the purpose, and 41% preferred WO information to remain in the risks section. Using consent templates that reflect patient preferences accurately is essential for ethical informed consent; however, a one-size fits all approach may not accurately capture patient preferences, so multiple templates may be necessary.
Center for Informed Consent Integrity 