Informed consent for stochastic effects of ionising radiation in diagnostic imaging
Commentary
Richard Mendelson
British Journal of Radiology, 24 February 2022
Abstract
The ethical and legal principles underpinning the requirement for informed consent for medical procedures are widely accepted. A recent BJR article has applied these principles to the issue of consent to ionising radiation (IR) from diagnostic imaging (DI), but the authors chose to put aside the practical problems associated with this. These problems should not be underestimated and arise from: uncertainties about the existence and magnitude of risk of stochastic effects of IR exposure in DI; the delayed manifestation of its effects; the heterogeneity of risk related to factors associated with individual sensitivity to IR, and dose variation even within examination classes and across clinical indications; and the difficulty of communication of these uncertainties and variations to patients. This article discusses these practical issues associated with consent for IR in DI.
Year: 2022
A study of adequacy of informed consent before caesarean section in a tertiary care hospital
A study of adequacy of informed consent before caesarean section in a tertiary care hospital
Nishu Bhushan, Aakriti Manhas
International Journal of Reproduction, Contraception, Obstetrics and Gynecology, February 2022; 11(2)
Abstract
Background
Informed consent is an ethical and legal requirement and is practiced before all the surgical procedures. Caesarean section is the commonest obstetric surgery so, this study was aimed to assess the adequacy of informed consent in patients who underwent caesarean section at SMGS Hospital, GMC, Jammu.
Methods
A cross-sectional study was done. A total of 230 patients were included in the study. A pre-tested and pre-validated questionnaire was used for the study. The data were expressed as percentage of proportion.
Results
230 patients participated in the study. About 96.95% patients knew the name of the procedure. 91.73% patients were informed about the indication of the surgery. 95.21% of the patients were aware about the benefits of surgery and about 93.41% of the patients were knowing risks of surgery. About 83.04% patients were informed about the procedure of the surgery. About 94.78% and 94.34% of the patients were aware about the need for the blood transfusion and future pregnancy options. Only about 4.35% of the patients were informed about the requirement and type of anaesthesia. 22.18% of the patients knew about the choice for alternate procedure and merely 2.18% of the patients were informed about the right to refuse the procedure.
Conclusions
It was found that majority of the patients were well informed about the procedure and the related consequences. Still we can improve some elements of the consent process which can be done by proper awareness and training of health care professionals.
Shared decision making and surgical informed consent in general surgery: A pilot study on differences in perspectives of physicians and patients [BOOK CHAPTER]
Shared decision making and surgical informed consent in general surgery: A pilot study on differences in perspectives of physicians and patients [BOOK CHAPTER]
Wouter K.G. Leclercq, Willem Zwaans, Loes Janssen, Johan Legemaate, Laurents P.S. Stassen, Marc R. Scheltinga
Máximazing the quality of perioperative patient counselling: Surgical informed consent and postoperative e-health in present day surgical care, 2021; Chapter 7 [Maastricht University]
Open Access
Abstract
Introduction
Shared decision making (SDM) and surgical informed consent (SIC) are increasingly recognized as important aspects of preoperative consultation in general surgery. Different perspectives of physicians and patients may result in suboptimal levels of communication, expectations and knowledge exchange. Goal of this study is to assess the quality of, and relation between, SDM and SIC in a general surgery outpatient department.
Methods
Randomly selected surgical patients completed a questionnaire concerning SDM aspects of their preoperative consultation (SDM-Q-9). Their surgeons completed the doctor’s version termed SDM-Q-Doc. SDM-Q-9 and SDM-Q-Doc scores (0-100), and SIC scores based upon the medical record (0-10) were calculated and analysed using standard statistical methods, including calculation of intraclass correlation coefficients (ICC).
Results
A total of 38 sets of both SDM-Q-9 and SDM-Q-Doc questionnaires were available for analysis. Median total SDM-Q-9 scores were higher than SDM-Q-Doc scores (90 vs. 79, P<0.05). Significant differences were found in 3 of 9 items of the patient’s and surgeon’s SDM questionnaires. SIC scores were low (4.1±1.3). Correlations between SDM-Q-9, SDM-Q-Doc and SIC scores were low (all ICCs <0.1).
Discussion
This pilot studying both shared decision making (SDM) and informed consent (SIC) in a surgical outpatient department indicates an imbalance in expectations between surgical patients, their surgeons and consent recordings. Future initiatives should be aimed at reducing this imbalance to optimize the physician-patient relationship with respect to legal standards.
Informed Consent, Error and Suspending Ignorance: Providing Knowledge or Preventing Error?
Informed Consent, Error and Suspending Ignorance: Providing Knowledge or Preventing Error?
Arnon Keren, Ori Lev
Ethical Theory and Moral Practice, 26 February 2022
Abstract
The standard account of informed consent has recently met serious criticism, focused on the mismatch between its implications and widespread intuitions about the permissibility of conducting research and providing treatment under conditions of partial knowledge. Unlike other critics of the standard account, we suggest an account of the relations between autonomy, ignorance, and valid consent that avoids these implausible implications while maintaining the standard core idea, namely, that the primary purpose of the disclosure requirement of informed consent is to prevent autonomy-undermining ignorance. The problem with the standard account, we argue, is that it fails to distinguish between different forms of ignorance–in particular, error and suspending ignorance–that have very different effects on individuals’ ability to provide valid consent. While error often undermines our ability to provide valid consent, suspending ignorance, we argue, does not. Once the moral weight of this distinction is appreciated, it becomes apparent that valid informed consent requires far less knowledge than suggested by the standard account.
Lack of Informed Consent Form Reading in Online Studies
Lack of Informed Consent Form Reading in Online Studies
Case Study
Michael M. Knepp
SAGE Research Methods: Doing Research Online, 2022
Abstract
This case study will discuss the design and, unlike most methods cases, findings of an experiment in order to highlight issues around collecting informed consent and help the reader decide how to best obtain informed consent for their project. My interest in this field of research began when a colleague of mine conducted a study where multiple subjects withdrew during the second hour of his study when requested to do an awkward stress task. That situation inspired a study exploring the rates at which subjects read informed consent forms before signing them. This investigation emphasized how one could improve a severe lack of reading consent forms in an online setting where there is no additional researcher oversight. Four hundred fifty-eight students participated in a study advertised as an adult temperament study. The study actually examined whether answering five questions about the informed consent form improved the likelihood of noticing a manipulation placed in the form’s method section in the laboratory and online settings. The additional questions did improve reading the full form in both laboratory and online settings; yet, overall reading rates were still low. The study concluded that there are serious online research consent issues given subject reading rates in the online setting as only 13% of students in the online-no questions read enough of the form to notice the manipulation.
Ethics and consent in more-than-human research: Some considerations from/with/as Gumbaynggirr Country, Australia
Ethics and consent in more-than-human research: Some considerations from/with/as Gumbaynggirr Country, Australia
Aunty Shaa Smith, Uncle Bud Marshall, Neeyan Smith, Sarah Wright, Lara Daley, Paul Hodge
Transactions of the Institute of British Geographers, 21 November 2021
Open Access
Abstract
A considerable body of recent work within the social sciences has attempted to engage more deeply with place, place-based knowledge, and more-than-human agency. Yet what this might look like in relation to ethical research practice, especially in the case of research proceeding on unceded Indigenous lands, is unclear. Taking more-than-human agency seriously means ethical research practice must be extended beyond a human-centric approach. As a Gumbaynggirr and non Gumbaynggirr research collective researching on, with, and as Gumbaynggirr Country in so-called Australia, we offer a contribution to discussions of research ethics and protocols that centres the consent of Country: the lands, waters, and skies of Aboriginal and Torres Strait Islander homelands, and the human and more-than-human beings that co-become there. In this paper, we share some of our learnings and discuss how we have tried not just to listen to Country but also to honour its agencies, knowledges, and sovereignties. As part of this honouring, we prioritise in particular the deeply placed Gumbaynggirr knowledges of Aunty Shaa Smith and Uncle Bud Marshall to explore what being guided by Gumbaynggirr Law/Lore and sovereignty means in practice and the challenges and possibilities of gaining consent of Country in ways underpinned by Indigenous Law/Lore. We propose a more expansive understanding of consent that includes attention to more- than- human sovereignties and draw on our collective’s learning to reframe the need for limits on research as openings rather than closures. In sharing our Gumbaynggirr-led and Country-led perspectives, we aim to deepen decolonising research praxis within human geography and the social sciences more broadly.
Editor’s note: We note that the article references the knowledges of Aunty Shaa Smith and Uncle Bud Marshall while also being lead authors on the paper.
Informed Consent: A Monthly Review
___________________________
March 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_March 2022
Informed Consent and Protection of Personal Data in Genetic Research on COVID-19
Informed Consent and Protection of Personal Data in Genetic Research on COVID-19
Piergiorgio Fedeli, Roberto Scendoni, Mariano Cingolani, Marcelo Corrales Compagnucci, Roberto Cirocchi, Nunzia Cannovo
Healthcare, 11 February 2022; 10(349)
Open Access
Abstract
The particular characteristics of COVID-19 demand the careful biomedical study of samples from patients who have shown different symptomatology, in order to understand the genetic foundations of its phenotypic expression. Research on genetic material from COVID-19 patients is indispensable for understanding the biological bases for its varied clinical manifestations. The issue of “informed consent” constitutes the crux of the problem in regulating research biobanks, because it concerns the relationship between the person and the parts separated from the body. There are several consensus models that can be adopted, varying from quite restricted models of specific informed consent to forms that allow very broad authorization (open consent). Our current understanding of COVID-19 is incomplete. Thus, we cannot plan, with precision, the research to be conducted on biological samples that have been, or will be, collected from patients infected by the novel coronavirus. Therefore, we suggest utilizing the “participation pact” between researchers and donors, based on a new form of participation in research, which offers a choice based on the principles of solidarity and reciprocity, which represent the communication of “values”. In the last part of this paper, the general data protection regulation concerning the matter is discussed. The treatment of personal data must be performed with explicit goals, and donors must be provided with a clear, transparent explanation of the methods, goals and time of storage. The data must not be provided to unauthorized subjects. In conclusion, open informed consent forms will be necessary for research on individual patients and on populations.
Ethical Aspects of the Informed Consent During COVID-19 Vaccination
Ethical Aspects of the Informed Consent During COVID-19 Vaccination
Original Research
Zorin KV , Gurevich KG
Medical Ethics, 31 March 2021
Open Access
Abstract
The main tactics used for COVID-19 prevention should be both quarantine measures and the large scale vaccination of the population. This does raise many ethical issues related to obtaining informed consent in biomedical research and clinical practice. The full and adequate ethical review of vaccination against the novel coronavirus infection can be provided only subject to ethical aspects of voluntary informed consent. Without that, it would be impossible to control the quality, efficiency and safety of the vaccine, and, consequently, the patients’ vaccination and its results.
Transparency informed consent related to patient dishonesty amid COVID-19 pandemic in Indonesia: In law perspective
Transparency informed consent related to patient dishonesty amid COVID-19 pandemic in Indonesia: In law perspective
Indonesian Research
Tiwuk Herawati, Fifik Wiryani, M. Nasser, Mokhammad Najih
Diponegoro Law Review, 2021; 6(2) pp 279-288
Abstract
To break the chain of transmission of COVID-19 outbreak, the public is expected to be honest in explaining chronological physical contact when treating to health facilities, especially if the patient experiences symptoms of COVID-19. Honesty of patients indicated by COVID-19 is very important so that the chain of transmission of COVID-19 does not expand and facilitate health workers in data collection. Denial, lies, even like the refusal of COVID-19 corpses if it continues to be left, does not mean the countermeasures of COVID-19 are increasingly stretched. This article tries to review the transparency of informed consent in relation to patient dishonesty, where transparent communication is expected by the patient to be honest and not to cover the perceived symptoms or various things related to COVID-19. This research is normative juridical research. In normative legal research, library material is the basic data that in research science is classified as secondary data.
Editor’s note: Diponegoro Law Review is published by the Faculty of Law, Diponegoro University, Indonesia.