Types of Off-Label Drug Use and Informed Consent Doctrine When Prescribing Them
M. Drogovoz, V. M. Khomenko, V. V. Krynychko, M. Barus, A. Kovpak, M. O. Ostapets, T. O. Artiukh
Pharmacology Online, 2021; 3
Open Access
Abstract
Today, medicine does not have a sufficient arsenal of drugs for the personalized treatment of cancer, neurological, psychiatric, pediatric patients, HIV-infected patients. An important aspect of informed consent when prescribing drugs off label is informing patients about potentially unknown risks, as well as about the existence of a rationale for such prescription of the drug. Thus, the doctrine of informed consent means, on the one hand, the doctor provides the patient with complete information about the use of an off label drug, an alternative method of treatment, the risks and potential benefits of such an alternative, and on the other hand, the patient decides whether he is ready to be treated with a drug that will be used off label, and confirms this with informed consent. In modern good medical practice, the patient’s rights take precedence over the opinion of the medical practitioner. Informed consent is an integral component of the modern relationship between doctors and their patients and a means of ensuring that the doctor’s beliefs do not override the patient’s right to self-determination and personal integrity.
Consent [BOOK CHAPTER]
Consent [BOOK CHAPTER]
Kate McCombe
Quick Hits in Obstetric Anesthesia, 1 January 2022; pp 93-96 [Springer]
Abstract
Adult patients with capacity have absolute autonomy over their bodies and so we must seek valid consent before any medical intervention. Failing to gain consent risks criminal prosecution for battery (harmful or offensive contact with another person), a civil claim in medical negligence for financial compensation, and disciplinary action from the professional regulators e.g. the General Medical Council (GMC) in the UK.
Informed Consent: A Monthly Review
___________________________
February 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_February 2022
Medical research, data sharing, and properly informed consent
Medical research, data sharing, and properly informed consent
Notebook
Sheila M. Bird
Royal Statistical Society, 25 January 2022
Abstract
When Sheila M. Bird agreed to participate in a Covid surveillance study, she did not realise her negative test result and personal details would be passed to NHS Test and Trace. Here, she calls for closer scrutiny of privacy policies by research ethics committees, and clearer communication with study participants
Informed consent during pandemics: Experimental medicine, experienced consent
Informed consent during pandemics: Experimental medicine, experienced consent
M. Botes
South African Journal of Bioethics and Law, 2021; 14(3) pp 93-96
Abstract
No known cure exists for COVID-19, and medical practitioners are exhausted and at their wits’ end trying to find treatments that prevent patients from ending up in hospital or intensive care, or even dying. A variety of treatments tried by medical practitioners include standard registered medicine, investigational or so-called experimental, unapproved or preapproved medicines, emergency or compassionate-use authorised medicine and pre-market approved medicine. However, the medicines that can be accessed via each of these categories are at different stages of efficacy testing and knowledge about adverse effects, dosages and risks. To obtain ethical and legal informed consent, medical practitioners must deal with a lot of medical uncertainty, and care must be taken to ensure that the patient understands the difference in risks they may be willing to take depending on the medicine’s stage of development. Often additional information is required to obtain ethical consent as opposed to legal consent. A purely legal approach to informed consent, especially when dealing with the medical uncertainties of health emergencies and pandemics, may lead to patients’ consent lacking in enough substance to be truly considered legal and ethical. Informed consent as respect for autonomy in this sense requires more than the patient’s explicit agreement or compliance with a certain treatment proposal. This article explains the difference in consent content attached to each different stage of a medicine’s development, especially considering the additional difficulties posed by obtaining truly informed consent during a pandemic with uncertain characteristics, treatment and solutions.
Struggling With Extensive Informed Consent Procedures for Cancer Trails – Is There Even a Benefit for the Patients?
Struggling With Extensive Informed Consent Procedures for Cancer Trails – Is There Even a Benefit for the Patients?
Tilch M, Moringlane A, Schranz M, Theobald M, Hess G
Research Square, 3 January 2022
Abstract
Purpose
Informed consent procedures in clinical trials often differ in length and complexity to those in clinical routine care. Little is known about the benefit of extensive procedures as intended in clinical trials compared to procedures in routine cancer treatment.
Methods
In two different clinical studies performed at a comprehensive cancer center, we compared patients’ comprehension and satisfaction of current informed consent procedures in routine clinical care with the level of comprehension and satisfaction of patients treated within clinical trials. Patients with a new cancer diagnosis and recent informed consent received a questionnaire about satisfaction, comprehension, time management and physician-patient relationship of the informed consent process. Patients in cohort 1 consented to cancer treatment within a clinical trial and were additionally interviewed in a structured way; patients in cohort 2 consented to “standard” chemotherapy and received a follow-up questionnaire after 6 months.
Results
In cohort 1, 82 patients completed the questionnaire and had an additional structured interview. They were treated in 41 different trials, receiving up to 40 pages of educational material. In cohort 2, 89 patients completed the first and 52 completed the follow-up questionnaire after receiving a standard informed consent form of 6 pages. Subjective understanding and satisfaction with the information provided was equally very high. However, deficits in objective understanding were observed in both cohorts.
Conclusion
Extensive informed consent procedures for clinical cancer trials have not been associated with a higher level of satisfaction or measurable objective understanding, therefore the benefit seems to be limited.
“Informed Consent in the Refugees and Immigrants Mental Health Researches – A Qualitative Systematic Review and Recommendations”
“Informed Consent in the Refugees and Immigrants Mental Health Researches – A Qualitative Systematic Review and Recommendations”
Fatemah Samir Alghamdi
Arab Journal for Scientific Publishing, January 2022
Open Access
Abstract
The refugee and migration crisis is at its most critical consideration in history. Millions of people fled their countries to save their lives from armed conflicts or natural disasters that impacted their mental and physical health. This article aimed to map out the body of published articles in the refugees’ and immigrants’ researches to highlight the method of informed consent process that is crucial for the Institutional Review Boards. This research systematically reviewed published literature between 2010 and 2020 on acquiring informed consent among refugees and immigrants. This systematic review was conducted in the Association of Computing Machinery (ACM), PschInfo, EBSCO, and PubMed using Preferred Reporting Items of Systematic Review and Meta-Analyses (PRISMA) framework to identify the process of informed consent in researches that addressed mental health and related issues among refugees and immigrants. A total of 32 qualitative and quantitative research genres were reviewed to highlight the informed consent procedure in refugees and immigrants researches between 2010 to 2020. The current research found out three themes: a third party involvement, participants’ educational level, and ethical violation in the informed consent process. Also, this research suggested the multifaceted informed consent to maximize their search outcomes and elude ethical violations.
Consent for rapid genomic sequencing for critically ill children: legal and ethical issues
Consent for rapid genomic sequencing for critically ill children: legal and ethical issues
Original Article
Christopher Gyngell, Fiona Lynch, Zornitza Stark, Danya Vears
Monash Bioethics Review, 31 December 2021; 39 pp 117–129
Abstract
Although rapid genomic sequencing (RGS) is improving care for critically ill children with rare disease, it also raises important ethical questions that need to be explored as its use becomes more widespread. Two such questions relate to the degree of consent that should be required for RGS to proceed and whether it might ever be appropriate to override parents’ decisions not to allow RGS to be performed in their critically ill child. To explore these questions, we first examine the legal frameworks on securing consent for genomic sequencing and how they apply to the specific context of RGS for critically ill children. We then use a tool from clinical ethics, the Zone of Parental Discretion, to explore two case studies and identify under which circumstances it might be appropriate for parental refusal of RGS to be overridden. We argue that RGS may be a context where, in addition to assessing the complexity of the test offered, it is ethically appropriate to consider an effect on patient outcomes when deciding the degree of consent required. We also suggest that there are some contexts where it may be ethically justified to perform RGS, even when it is actively against the wishes of the parents. More work is needed to examine exactly how ‘time-sensitive’ exceptions to current guidance on consent for genomic sequencing could be formulated and operationalised for RGS for critically ill-children.
Health data: when children reach the age of consent
Health data: when children reach the age of consen
World View
Jillian Hastings Ward
Nature Medicine, 6 January 2022
Open Access
Excerpt
Parents give consent for their children’s health data to be used in research, but what happens when the children reach adulthood, and how can researchers keep families involved in the meantime? COVID-19 vaccinations for teenagers have been in the news, which raises questions about parental influence over the decision of children to get vaccinated — or not. In some countries, including the UK, children under the age of 16 can give consent for medical treatment once they are deemed able to fully appreciate what is involved (sometimes known as ‘Gillick competence’). This is of growing importance for children whose parents have signed them up for genetic research and other studies that use their health data. When and how do children get a say in what happens to their health data?..
CrowdMed-II: a blockchain-based framework for efficient consent management in health data sharing
CrowdMed-II: a blockchain-based framework for efficient consent management in health data sharing
Chaochen Hu, Chao Li, Guigang Zhang, Zhiwei Lei, Mira Shah, Yong Zhang, Chunxiao Xing, Jinpeng Jiang, Renyi Bao
World Wide Web, 1 January 2022
Open Access
Abstract
The healthcare industry faces serious problems with health data. Firstly, health data is fragmented and its quality needs to be improved. Data fragmentation means that it is difficult to integrate the patient data stored by multiple health service providers. The quality of these heterogeneous data also needs to be improved for better utilization. Secondly, data sharing among patients, healthcare service providers and medical researchers is inadequate. Thirdly, while sharing health data, patients’ right to privacy must be protected, and patients should have authority over who can access their data. In traditional health data sharing system, because of centralized management, data can easily be stolen, manipulated. These systems also ignore patient’s authority and privacy. Researchers have proposed some blockchain-based health data sharing solutions where blockchain is used for consensus management. Blockchain enables multiple parties who do not fully trust each other to exchange their data. However, the practice of smart contracts supporting these solutions has not been studied in detail. We propose CrowdMed-II, a health data management framework based on blockchain, which could address the above-mentioned problems of health data. We study the design of major smart contracts in our framework and propose two smart contract structures. We also introduce a novel search contract for searching patients in the framework. We evaluate their efficiency based on the execution costs on Ethereum. Our design improves on those previously proposed, lowering the computational costs of the framework. This allows the framework to operate at scale and is more feasible for widespread adoption.
Center for Informed Consent Integrity 