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:

Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
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
Sheila M. Bird
Royal Statistical Society, 25 January 2022
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
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
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.
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.
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.
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
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
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
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
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.

Informed Consent in Digital Data Management [BOOK CHAPTER]

Informed Consent in Digital Data Management [BOOK CHAPTER]
Elisabeth Hildt, Kelly Laas
Codes of Ethics and Ethical Guidelines, 1 January 2022; pp 55-81 [Springer]
This article discusses the role of informed consent, a well-known concept and standard established in the field of medicine, in ethics codes relating to digital data management. It analyzes the significance allotted to informed consent and informed consent-related principles in ethics codes, policies, and guidelines by presenting the results of a study focused on 31 ethics codes, policies, and guidelines held as part of the Ethics Codes Collection. The analysis reveals that up to now, there is a limited number of codes of ethics, policies, and guidelines on digital data management. Informed consent often is a central component in these codes and guidelines. While there undoubtedly are significant similarities between informed consent in medicine and digital data management, in ethics codes and guidelines, informed consent-related standards in some fields such as marketing are weaker and less strict. The article concludes that informed consent is an essential standard in digital data management that can help effectively shape future practices in the field. However, a more detailed reflection on the specific content and role of informed consent and informed consent-related standards in the various areas of digital data management is needed to avoid the weakening and dilution of standards in contexts where there are no clear legal regulations.

An enhanced participant information leaflet and multimedia intervention to improve the quality of informed consent to a randomised clinical trial enrolling people living with HIV and obesity: a protocol for a Study Within A Trial (SWAT)

An enhanced participant information leaflet and multimedia intervention to improve the quality of informed consent to a randomised clinical trial enrolling people living with HIV and obesity: a protocol for a Study Within A Trial (SWAT)
Study Protocol
Lydia O’Sullivan, Stefano Savinelli, Stephen O’Hare, Sinéad Holden, Ciara McHugh, Patrick Mallon, Peter Doran
Trials, 17 January 2022; 23(50)
Open Access
It is the investigator’s responsibility to communicate the relevant information about a clinical trial to participants before they provide informed consent to take part. Systematic reviews indicate that participants often have a poor understanding of the concepts which are key to ensuring valid informed consent, such as randomisation and risks/discomforts. Paper-based participant information leaflets and informed consent forms (PIL/ICFs) are becoming longer and are often too complex for many participants. Multimedia interventions and enhanced PIL/ICFs have been trialled in an attempt to improve participants’ understanding of various aspects of research studies. However, there is insufficient empirical evidence to determine how effective such interventions are. This protocol describes a study to evaluate whether an enhanced PIL/ICF and website help research participants to understand important information about a human immunodeficiency virus (HIV) randomised clinical trial.
This Study Within A Trial (SWAT) is a prospective, multi-centre, randomised, controlled, parallel-group study embedded in a host clinical trial. The host trial (the SWIFT trial; EudraCT: 2019-002314-39) is a prospective, multi-centre, randomised, open-label, controlled trial investigating if semaglutide along with dietary advice assists individuals with HIV and obesity to lose weight, compared to dietary advice alone. For the SWAT, participants will be randomised in a 1:1 ratio to either the control (standard PIL/ICF) or the intervention (an enhanced PIL/ICF and a website which includes animations). The enhanced PIL/ICF and website were developed in line with the guidance from organisations which promote plain English and accessible public-facing materials in conjunction with HIV Ireland, a HIV advocacy organisation, and our previous work on consent documents. The primary outcome of the SWAT is the quality of informed consent, assessed by a validated comprehension test—the modified Deaconess Informed Consent Comprehension Test (DICCT). The DICCT will be administered within 48 h of consent to the host trial. The secondary is recall, measured by the modified DICCT questionnaire scores 2 weeks post-consent to the host trial.
The results of this SWAT will add to the methodological evidence base on the use of multimedia to improve the quality of informed consent to randomised clinical trials.