Informed Consent: A Monthly Review
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October 2023 :: Issue 58

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: Center for Informed Consent Integrity – A Monthly Review_October 2023

Upcoming Calls For Public Consultation      

We will selectively include calls for public consultation from multilateral agencies, governments, INGOs and other sources where there is a clear intersection with consent/assent. This might be obvious from the title of the draft guidance, regulations, etc., but more often, it will be a thematic area or topic – if properly addressed at all. If you would like to explore participation with our working group developing submissions for these calls, please contact us [david.r.curry@ge2p2global.org].

Public Consultation: ICH E6(R3) [GCP] Principles, Annex 1 and Annex 2
ICH – The E6(R3) EWG is working on the revision of the E6(R2) Guideline “Good Clinical Practice” (GCP) with a view to addressing the application of GCP principles to the increasingly diverse trial types and data sources being employed to support regulatory and healthcare related decision-making on drugs, and provide flexibility whenever appropriate to facilitate the use of technological innovations in clinical trials.

   Public consultation dates:
Health Canada, Canada – Deadline for comments by 20 October 2023

  Earlier consultation dates:
HSA, Singapore – Deadline for comments by 30 September 2023
EC, Europe – Deadline for comments by 26 September 2023
Swissmedic, Switzerland – Deadline for comments by 26 September 2023
MHLW/PMDA, Japan – Deadline for comments by 9 September 2023
FDA, United States – Deadline for comments by 5 September 2023
ANVISA, Brazil – Deadline for comments by 31 August 2023
MHRA, UK – Deadline for comments by 31 August 2023
NMPA, China – Deadline for comments by 31 August 2023
TFDA, Chinese Taipei – Deadline for comments by 31 August 2023

Symposia/Conferences

We will selectively include information on major symposia and conferences which address issues, evidence, analysis or debates involving consent/assent. This listing will include [1] meetings already concluded but which are posting presentations/recordings, etc.; [2] future meeting which have  posted registration/logistics information, and [3] meetings which have announced calls for abstracts/panels, etc.

8th World Conference on Research Integrity (Hybrid)
2-5 June 2024
Megaron Athens International Conference Centre (MAICC)
Athens, Greece
The biannual WCRIs cater to all disciplinary fields, all professional ranks, and all career stages, and involve all stakeholders in research integrity, including universities, research institutes, research funders, publishers, and governments. Each WCRI emphasises a specific theme, but all cater for the whole range of research integrity issues and responsible research practices. The 8th WCRI will put thematic emphasis on: Catalysing the translation of research into trustworthy policy and innovation.

Call for Abstracts now open, deadline October 17, 2023.

Spotlight Articles

In the October spotlight section we have chosen to highlight an article which was included in the March 2023 edition of the digest, and has since been debated widely in the literature. The JME article by van der PiJl et al., The ethics of consent during labour and birth: episiotomies, focuses on consent in labour. The authors argue that current practice for consenting in labour and birth must be improved upon, and suggest ways a higher standard of consent in this space ought to be achieved. Below we present the original article which sparked the debate, followed by a selection of responses. The final article is a response from the authors of the original article.

The ethics of consent during labour and birth: episiotomies
Marit van der Pijl, Corine Verhoeven, Martine Hollander, Ank de Jonge, Elselijn Kingma
Journal of Medical Ethics, 30 January 2023
Abstract
Unconsented episiotomies and other procedures during labour are commonly reported by women in several countries, and often highlighted in birth activism. Yet, forced caesarean sections aside, the ethics of consent during labour has received little attention. Focusing on episiotomies, this paper addresses whether and how consent in labour should be obtained. We briefly review the rationale for informed consent, distinguishing its intrinsic and instrumental relevance for respecting autonomy. We also emphasise two non-explicit ways of giving consent: implied and opt-out consent. We then discuss challenges and opportunities for obtaining consent in labour and birth, given its unique position in medicine. We argue that consent for procedures in labour is always necessary, but this consent does not always have to be fully informed or explicit. We recommend an individualised approach where the antenatal period is used to exchange information and explore values and preferences with respect to the relevant procedures. Explicit consent should always be sought at the point of intervening, unless women antenatally insist otherwise. We caution against implied consent. However, if a woman does not give a conclusive response during labour and the stakes are high, care providers can move to clearly communicated opt-out consent. Our discussion is focused on episiotomies, but also provides a useful starting point for addressing the ethics of consent for other procedures during labour, as well as general time-critical medical procedures. 

 

Consent and the problem of epistemic injustice in obstetric care
Commentary
J Y Lee
Journal of Medical Ethics, 30 August 2023
Excerpt
An episiotomy is ‘an intrapartum procedure that involves an incision to enlarge the vaginal orifice,’1 and is primarily justified as a way to prevent higher degrees of perineal trauma or to facilitate a faster birth in cases of suspected fetal distress. Yet the effectiveness of episiotomies is controversial, and many professional bodies recommend against the routine use of episiotomies. In any case, unconsented episiotomies are alarmingly common, and some care providers in obstetric settings often fail to see consent as necessary in context. In their article, ‘The ethics of consent during labour and birth: episiotomies,’ van der Pijl et al reiterate that consent is necessary for episiotomies. They specify, further, that the antenatal period is crucial for exchanging information, establishing trust between the birthing subject and provider, and exploring the birthing subject’s—rather than the care provider’s—values and preferences regarding episiotomies. They recommend an individualised approach, which would enable birthing subjects to choose how and when they want to give consent…

Capacity assessment during labour and the role of opt-out consent
Commentary
Kelsey Mumford
Journal of Medical Ethics, 30 August 2023
Excerpt
Previous studies investigating the extent to which pregnant persons retain decision-making capacity during labour have shown poor recall, a component of capacity, about consent processes during obstetric emergency procedures in 14%–49% of cases. As the feature article acknowledges, this does not mean that pregnant persons should be assumed to lack decision-making capacity during labour. Although pain, labour intensity, exhaustion and medications can make consenting processes during labour more difficult and it is possible that these factors will result in the impaired ability of the pregnant person to make informed and voluntary decisions about treatment options, this possibility of impaired capacity should not be taken as the expected outcome nor should it be used as an excuse to skip consenting procedures. The default to treat labouring patients as able to make their own decisions still stands…

Episiotomies and the ethics of consent during labour and birth: thinking beyond the existing consent framework
Commentary
Anna Nelson, Beverley Clough
Journal of Medical Ethics, 30 August 2023
Excerpt
We agree with van der Pijl et al that the question of how to ensure consent is obtained for procedures which occur during labour and childbirth is vitally important, and worthy of greater attention. However, we argue that the modified opt-out approach to consent outlined in their paper may not do enough to protect the choice and agency of birthing people. Moreover, while their approach reflects a pragmatic attempt to facilitate legal clarity and certainty in this context, this is not necessarily responsive to the messy realities of decision-making during labour (and beyond). We outline some of our concerns with their proposals and demonstrate how these illuminate some broader, longstanding tensions around consent and medical law…

Birth, trust and consent: reasonable mistrust and trauma-informed remedies
Commentary
Elizabeth Lanphier, Leah Lomotey-Nakon
Journal of Medical Ethics, 30 August 2023
Excerpt
    In ‘The ethics of consent during labour and birth: episiotomies,’ van der Pijl et al respond to the prevalence of unconsented procedures during labour, proposing a set of necessary features for adequate consent to episiotomy. Their model emphasises information sharing, value exploration and trust between a pregnant person and their healthcare provider(s). While focused on consent to episiotomy, van der Pijl et al contend their approach may be applicable to consent for other procedures during labour and beyond pregnancy-related care.
One feature of their model for adequate informed consent is trust in the systems in which prenatal and labour and delivery care are provided. Yet, for some pregnant persons, mistrust in health systems is a reasonable sequela of experiences like racism and epistemic injustice. For a programme in which trust is central to adequate consent, it is important to identify—and counter—forms of mistrust toward pregnant persons within healthcare and acknowledge and rectify reasonable mistrust of pregnant persons toward healthcare…

Extending the ethics of episiotomy to vaginal examination: no place for opt-out consent
Commentary
Rebecca Brione
Journal of Medical Ethics, 30 August 2023
Excerpt
   van der Pijl et al argue that if ‘stakes are high’ and there is ‘clear conviction by the care provider’ that it is ‘necessary’, episiotomy may be given after ‘opt-out consent’. Here I caution against the applicability of their approach to vaginal examination (VE): another routine intervention in birth to which they suggest their discussion may apply. I highlight three concerns: first, the subjective and unjustified nature of assessments of ‘necessity’; second, the inadequacy of current consent practices in relation to VE; and third, the significant risk of perpetuating under-recognised harms associated with unwanted or unconsented VE. I argue that opt-out consent cannot be ethically justified for VE. Its use would result in further weakening of consent practices, circumvention of individuals’ autonomy, and greater harm for women and birthing people.
At the outset, it is important to recognise that the authors do not claim that their approach should be applied to VE, merely that their discussion may have relevance to consent for other interventions beyond episiotomy ‘where consent is also frequently lacking, and which are under-researched’, including VE.1 Nonetheless, it is easy to assume that episiotomy and VE are sufficiently similar that their analysis might be transferred wholesale. I disagree…

Safeguards for procedural consent in obstetric care
Commentary
David I Shalowitz, Steven J Ralston
Journal of Medical Ethics, 30 August 2023
Excerpt
Van der Pijl et al outline data suggesting an alarmingly high incidence of violation of the bodily integrity of patients in labour, including episiotomies performed without patients’ consent, or over their explicit objection.1 Similar data have been reported from the USA and Canada. The authors appropriately conclude that explicit consent is required at the time of all invasive obstetrical procedures, including episiotomy. Commonsense adjustments to the duration and detail of consent under conditions of clinical urgency are appropriate and should be familiar to any clinician involved in perinatal care, as well as non-obstetric proceduralists caring for acutely ill patients. However, complete omission of consent for any of these procedures is both disrespectful to patients’ autonomy and strongly associated with morbidity from birth-related psychosocial trauma…

Informed decision-making in labour: action required
Commentary
Gordon M Stirrat
Journal of Medical Ethics, 30 August 2023
Excerpt
    The timely feature article by van der Pijl et al 1 highlights not only the widespread frequency with which unconsented episiotomies and other procedures during labour are reported by women but also that there is hardly any discussion in the literature on the ethics of consent for procedures in labour. Those national and international bodies with responsibility for midwifery and obstetric practice need not only to recognise but also act to remedy this unacceptable situation.
The studies quoted used the recollection of women in reporting consent or lack of it and, although this is an entirely appropriate measure, it gives no insight into what, if any, informed decision-making the care providers carried out. Such information would be useful to determine how better practice might be achieved. A study into the practice of episiotomies by Dutch midwives and obstetricians is referred to and is not reassuring.2 They frequently expressed surprise that consent should be necessary and women were minimally involved in the decision for performing episiotomy. This and other examples quoted of lack of valid consent have a corrosive effect on the fundamental but fragile trust and necessary trustworthiness of the relationship between the person being cared for…

Setting a human rights and legal framework around ‘the ethics of consent during labour and birth: episiotomies’
Commentary
Bashi Kumar-Hazard, Hannah Grace Dahlen
Journal of Medical Ethics, 30 August 2023
Excerpt
    We commend the authors for their comprehensive discussion on consent and episiotomies. They correctly observe that informed consent for all proposed interventions in maternity care is always necessary. The claim that consent for maternity health services does not always have to be fully informed or explicit, however, is erroneous. We are especially concerned with, and surprised by, the endorsement of ‘opt-out consent’. ‘Opt-out consent’ (a.k.a. substitute decision making) is already standard practice in maternity healthcare, with obstetric violence a normalised response to conclusive refusals or requests for explanations.
Informed consent is based on the fundamental human rights to bodily autonomy and integrity, which healthcare providers are obliged to respect. Healthcare structured around human rights violations is not care. It is cruel and inhumane treatment—a violation of yet another fundamental human right—and a reflection of poor-quality care. To be valid, consent must always be informed, specific, timely, freely given and reversible. The provider must provide information specific to each and every proposed intervention in a timely manner. The consumer has the right to consider, freely accept or refuse before providers can act. They can also change their mind at any time…

Consent and episiotomies: do not let the perfect be the enemy of the good
Commentary
Elselijn Kingma, Marit van der Pijl, Corine Verhoeven, Martine Hollander, Ank de Jonge
Journal of Medical Ethics, 30 August 2023
Excerpt
… Neither informed consent alone, nor our proposal, can solve every problem in maternity care. Commenting authors noted several limitations and further challenges. But nearly all agree our proposal is a very significant and realistic step in the right direction, which can significantly improve the situation for vast numbers of women and healthcare providers. We particularly emphasise the importance of multilevel institutional support and ongoing education in its implementation and want to draw attention to our original discussion of the intrinsic value of asking consent: this retains significant value even among many other shortcomings and (perhaps especially) power differences. Our practising healthcare providers, finally, emphasise that within the reality of a busy maternity ward there are very many challenges. We should not let the perfect be the enemy of what nearly all commentators agree is a very significant improvement, which has potential for (well researched and suitably modified) application to other interventions in labour.

Optimizing Informed Consent in Cancer Clinical Trials

Optimizing Informed Consent in Cancer Clinical Trials
Subha Perni, Rachel Jimenez, Reshma Jagsi
Seminars in Radiation Oncology, October 2023; 33(4) pp 349-357
Abstract
The concept of informed consent has evolved considerably over the course of the 20th century, leading to its establishment as a foundational ethical principle for the conduct of biomedical research in the United States. Even though it is now a highly regulated part of cancer research, the process of obtaining informed consent is often impeded by systemic, clinician, and patient factors that require both small- and large-scale intervention. New challenges and considerations continue to emerge due to innovations in clinical trial design, increases in utilization of genomic sequencing, and advances in genomic editing and artificial intelligence. We present a review of the history, policy, pragmatic challenges, and evolving role of the central ethical tenet of informed consent in clinical trials.

Simplified consent in cluster randomised trials: the new EU Clinical Trials Regulation does not provide sufficient guidance

Simplified consent in cluster randomised trials: the new EU Clinical Trials Regulation does not provide sufficient guidance
Analysis
Cory E Goldstein
BMJ, 13 September 2023
Excerpt
    The new European Union (EU) Clinical Trials Regulation 536/2014 is designed to streamline and harmonise the submission and review process for clinical trials conducted in EU member states and countries in the European Economic Area. Since 31 January 2023, clinical trial applications in the EU must be submitted through the Clinical Trials Information System and must abide by the regulation.

This includes applications to conduct cluster randomised trials (CRTs), which are commonly used for the evaluation of public health, health policy, and health system interventions. In contrast to individually randomised trials in which people are randomly allocated to receive study interventions, in CRTs intact groups (such as geographical areas or clinics) are randomly assigned to receive the study interventions. Study interventions can be delivered to the entire cluster as a unit (such as a mass media smoking cessation campaign on the radio) or to professionals in each cluster (such as educational workshops for health providers to improve hand hygiene), but only CRTs that evaluate medicinal products delivered to patients in each cluster fall under the purview of the EU Clinical…

How do journals publishing palliative and end-of-life care research report ethical approval and informed consent?

How do journals publishing palliative and end-of-life care research report ethical approval and informed consent?
Original Article
Tove Godskesen, Knut Jørgen Vie, William Bülow, Bodil Holmberg, Gert Helgesson, Stefan Eriksson
Learned Publishing, 8 September 2023
Open Access
Abstract
This study explores how papers published in international journals in palliative and end-of-life care report ethical approval and informed consent. A literature search following PRISMA guidelines was conducted in PubMed, the Web of Science Core Collection, Scopus, the ProQuest Social Science Premium Collection, PsycINFO, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL). A total of 169 empirical studies from 101 journals were deductively coded and analysed. The results showed that 5% of publications provided no information on ethical approval, 12% reported minimal information, 56% reported rudimentary information, and 27% reported comprehensive details. We also found that 13% did not report any information on informed consent, 17% reported minimal information, 50% reported rudimentary information, and 19% reported comprehensive details. The prevalence of missing and incomplete ethical statements and inadequate reporting of informed consent processes in recent publications raises concerns and highlights the need for improvement. We suggest that journals advocate high reporting standards and potentially reject papers that do not meet ethical requirements, as this is the quickest path to improvement.

Analysis of ethical review issues of informed consent form for clinical trials of registered anti-tumor drugs in our hospital

Analysis of ethical review issues of informed consent form for clinical trials of registered anti-tumor drugs in our hospital
Xiaohua Tang, Yi Bi, Xia Chen, Jun Li, Haiwei Zhang
China Pharmacy, 2023; 12 pp 648-652
Abstract
Objective
To promote the standardization and integrity of the informed consent form for clinical trials of registered anti-tumor drugs, and to protect the legitimate rights and interests of the subjects.
Methods
The ethical review resolutions of clinical trial projects of registered anti-tumor drugs that were initially reviewed by the Ethics Committee of our hospital from July 1st, 2020 to July 1st, 2022 were summarized to statistically analyze the problematic items according to the “Quality Analysis Form of Informed Consent” prepared by our hospital.
Results
Of the 316 clinical trials of registered anti-tumor drugs that were initially reviewed, 257 (81.3%) had problems with the contents of informed consent form, mainly domestic multi-center trials and phase three trials. The main problems included the vague notification of the test fee bearer (68.5%), the incomplete notification of the test content (59.1%), the insufficient notification of rights and interests and risks (58.4%), the insufficient notification of personal information protection (56.0%), and the nonstandard expression of the informed consent form (52.5%).
Conclusions
There is still a gap between the informed consent form of the clinical trials of registered anti-tumor drugs in our hospital and the requirements of the new version of Good Clinical Practice for Drugs (GCP). The parties involved in the test can take a number of measures to improve the standardization and integrity of the informed consent form, and the research team should design the informed consent form in strict accordance with the requirements of the new GCP and pay attention to the comprehensive notification about the test. The Ethics Committee can provide the sponsor and researcher with the template of informed consent form and the key points of writing, continue to strengthen the examination ability, improve the examination quality, and effectively protect the safety and interests of the subjects.

Evaluation of CTRL: a web application for dynamic consent and engagement with individuals involved in a cardiovascular genetic disorders cohort

Evaluation of CTRL: a web application for dynamic consent and engagement with individuals involved in a cardiovascular genetic disorders cohort
Matilda A. Haas, Evanthia O. Madelli, Rosie Brown, Megan Prictor, Tiffany Boughtwood
European Journal of Human Genetics, 14 September 2023
Open Access
Abstract
There has been keen interest in whether dynamic consent should be used in health research but few real-world studies have evaluated its use. Australian Genomics piloted and evaluated CTRL (‘control’), a digital consent tool incorporating granular, dynamic decision-making and communication for genomic research. Individuals from a Cardiovascular Genetic Disorders Flagship were invited in person (prospective cohort) or by email (retrospective cohort) to register for CTRL after initial study recruitment. Demographics, consent choices, experience surveys and website analytics were analysed using descriptive statistics. Ninety-one individuals registered to CTRL (15.5% of the prospective cohort and 11.8% of the retrospective cohort). Significantly more males than females registered when invited retrospectively, but there was no difference in age, gender, or education level between those who did and did not use CTRL. Variation in individual consent choices about secondary data use and return of results supports the desirability of providing granular consent options. Robust conclusions were not drawn from satisfaction, trust, decision regret and knowledge outcome measures: differences between CTRL and non-CTRL cohorts did not emerge. Analytics indicate CTRL is acceptable, although underutilised. This is one of the first studies evaluating uptake and decision-making using online consent tools and will inform refinement of future designs.

The reuse of genetic information in research and informed consent

The reuse of genetic information in research and informed consent
David Lorenzo, Montse Esquerda, Margarita Bofarull, Victoria Cusi, Helena Roig, Joan Bertran, Joan Carrera, Francesc Torralba, Francisco José Cambra, Martí Vila, Martina Garriga & Francesc Palau
European Journal of Human Genetics, 13 September 2023
Abstract
Important advances in genetics research have been made in recent years. Such advances have facilitated the availability of huge amounts of genetic information that could potentially be reused beyond the original purpose for which such information was obtained. Any such reuse must meet certain ethical criteria to ensure that the dignity, integrity, and autonomy of the individual from whom that information was obtained are protected. The aim of this paper is to reflect on these criteria through a critical analysis of the literature. To guarantee these values, ethical criteria need to be established in several respects. For instance, the question must be posed whether the information requires special attention and protection (so-called genetic exceptionalism). Another aspect to bear in mind is the most appropriate type of consent to be given by the person involved, on the one hand favouring research and the reuse of genetic information while on the other protecting the autonomy of that person. Finally, there is a need to determine what protection such reuse should have in order to avoid detrimental consequences and protect the rights of the individual. The main conclusions are that genetic information requires special care and protection (genetic exceptionalism) and that broad consent is the most practical and trustworthy type of consent for the reuse of genetic information.