Informed Consent: A Monthly Review

June 2023 :: Issue 54

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: Center for Informed Consent Integrity – A Monthly Review_June 2023

Spotlight Articles


In a JAMA Viewpoint The Politics of Informed Consent and the Limits of the First Amendment – Sawiki explores “state-mandated messaging” in consent processes in the U.S. and the role of the courts as patient groups and others challenge such mandates in the courts. The author argues that “courts need to be educated about the ethical principles behind the practice of informed consent” to more competently adjudicate such challenges and that the medical community needs to engage such education, among other responses, to protect related first amendment rights.

Also in the area of legal rights Jowett examines access to and regulation of healthcare for trans youth in Australia, England and Wales in the new book Consent for Medical Treatment of Trans Youth [Cambridge U Press]. Jowett argues that legal barriers to clinical practice should be congruent with and reflect the current state of medical knowledge.

Writing in the Journal of Medical Ethics, Hoffman – Undermining autonomy and consent: the transformative experience of disease – offers interesting perspectives about how transformative  experiences proceeding from disease can challenge a patient’s ability to consent and thereby raise questions about concepts in medical ethics such as patient autonomy.

Finally, in the Canadian Journal of Anesthesia Pope et al. address an area that has received relatively little attention. In Consent for determination of death by neurologic criteria in Canada: an analysis of legal and ethical authorities, and consensus-based working group recommendations the authors discuss whether there should be a requirement to obtain family consent before determination of death by neurologic criteria.

The Politics of Informed Consent and the Limits of the First Amendment
Nadia N. Sawicki
JAMA, 17 April 2023; 329(19) pp 1635-1636
Physicians are accustomed to disclosing the risks and benefits of treatment as part of their ethical and legal duty to secure informed consent. Generally, physicians have the freedom to decide how to communicate this information, and to tailor their disclosures to the needs of individual patients. However, in today’s highly politicized climate, some state legislatures are eliminating this opportunity for professional discretion. Physicians are increasingly being compelled to communicate state-mandated messaging that may be at odds with their professional judgment, violating their ethical duty to secure informed consent by “present[ing] relevant information accurately and sensitively, in keeping with the patient’s preferences for receiving medical information.” Even though physicians and patient advocates have argued that these targeted disclosure laws are unconstitutional, the First Amendment sets few restrictions on the government’s ability to compel physician speech. This Viewpoint discusses the expansion of politically motivated informed consent laws and identifies opportunities for the medical profession to challenge them…

Consent for Medical Treatment of Trans Youth
Steph Jowett
October 2022 [Cambridge University Press]
Book Description
Access to medical treatment for trans youth occupies a haphazard and dynamic legal landscape. In this comprehensive scholarly analysis of the historical and current legal principles, Steph Jowett examines the medico-legal nexus of regulation of this healthcare in Australia and in England and Wales. This is informed by an in-depth discussion of the medical literature on treatment for trans youth, including clinical guidelines, the outcomes of treatment and outcomes for trans youth who are unable to be treated. With illustrative examples and clear language, Jowett argues that legal barriers to clinical practice should be congruent with and reflect the current state of medical knowledge. Not only does Jowett assess the extent to which key legal decisions have been consistent with medical knowledge in the past, but she offers a nuanced, comparative perspective that will inform reform efforts in the future.


Undermining autonomy and consent: the transformative experience of disease
Original Research
Bjørn Hofmann
Journal of Medical Ethics, 3 May 2023
Disease radically changes the life of many people and satisfies formal criteria for being a transformative experience. According to the influential philosophy of Paul, transformative experiences undermine traditional criteria for rational decision-making. Thus, the transformative experience of disease can challenge basic principles and rules in medical ethics, such as patient autonomy and informed consent. This article applies Paul’s theory of transformative experience and its expansion by Carel and Kidd to investigate the implications for medical ethics. It leads to the very uncomfortable conclusion that disease involves transformative experiences in ways that can reduce people’s rational decision-making ability and undermine the basic principle of respect for autonomy and the moral rule of informed consent. While such cases are limited, they are crucial for medical ethics and health policy and deserve more attention and further scrutiny.

Editor’s note: The Paul referred to in this Abstract is philosopher Laurie Ann Paul, and Carel and Kidd are Havi Carel and Ian James Kidd.

Consent for determination of death by neurologic criteria in Canada: an analysis of legal and ethical authorities, and consensus-based working group recommendations
Special Article
Thaddeus M. Pope, Jennifer A. Chandler, Michael Hartwick
Canadian Journal of Anesthesia, 2 May 2023
Open Access
This article addresses the following question: should physicians obtain consent from the patient (through an advance directive) or their surrogate decision-maker to perform the assessments, evaluations, or tests necessary to determine whether death has occurred according to neurologic criteria? While legal bodies have not yet provided a definitive answer, significant legal and ethical authority holds that clinicians are not required to obtain family consent before making a death determination by neurologic criteria. There is a near consensus among available professional guidelines, statutes, and court decisions. Moreover, prevailing practice does not require consent to test for brain death. While arguments for requiring consent have some validity, proponents cannot surmount weightier considerations against imposing a consent requirement. Nevertheless, even though clinicians and hospitals may not be legally required to obtain consent, they should still notify families about their intent to determine death by neurologic criteria and offer temporary reasonable accommodations when feasible. This article was developed with the legal/ethics working group of the project, A Brain-Based Definition of Death and Criteria for its Determination After Arrest of Circulation or Neurologic Function in Canada developed in collaboration with the Canadian Critical Care Society, Canadian Blood Services, and the Canadian Medical Association. The article is meant to provide support and context for this project and is not intended to specifically advise physicians on legal risk, which in any event is likely jurisdiction dependent because of provincial or territorial variation in the laws. The article first reviews and analyzes ethical and legal authorities. It then offers consensus-based recommendations regarding consent for determination of death by neurologic criteria in Canada.

Offering Lottery Entry as an Incentive for Research Participation Compromises Informed Consent

Offering Lottery Entry as an Incentive for Research Participation Compromises Informed Consent
Simon Paul Jenkins
Ethics & Human Research, May-June 2023; 45(3) pp 18-28
This paper argues that offering entry into a lottery as an incentive to those who participate in research studies represents a challenge to the principle of informed, coercion-free consent that is considered an essential ingredient of permissible recruitment to studies. This is, first, because information about the chances of winning in this context is normally unavailable to potential participants and, without this, they cannot accurately weigh up the risks and potential benefits of participation. Second, even when this information is available, such an incentive capitalizes, I contend, on the difficulty of weighing up small probabilities, exploiting the fact that people tend to be beset by cognitive biases that make it challenging to make decisions rationally. The resulting conclusion is that we should not view lotteries as more ethical than simply paying participants, when the latter is feasible.

Regulatory compliance and readability of informed consent forms in industry-sponsored drug development clinical trials

Regulatory compliance and readability of informed consent forms in industry-sponsored drug development clinical trials
Research Article
Nahathai Dukaew, Mingkwan Na Takuathung, Wannachai Sakuludomkan, Kanyarat Chairaksa, Preeyaporn Klinjan, Nimit Morakote, Nut Koonrungsesomboon
Clinical Trials, 16 May 2023
An informed consent form is essential in drug development clinical trials. This study aimed to evaluate regulatory compliance and readability of informed consent forms currently being used in industry-sponsored drug development clinical trials.
This descriptive, cross-sectional study evaluated the informed consent forms of industry-sponsored drug development clinical trials conducted at the Faculty of Medicine, Chiang Mai University, between 2019 and 2020. The informed consent form’s compliance with the three major ethical guidelines and regulations (i.e. International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use E6(R2) Good Clinical Practice; Declaration of Helsinki; and the revised Common Rule) were analyzed. The document length and the readability scores (using Flesch Reading Ease and Flesch-Kincaid Reading Grade) were assessed.
Of 64 reviewed informed consent forms, the average page length was 22.0 ± 7.4 pages. More than half of their length was mainly devoted to three elements: trial procedures (22.9%), risks and discomforts (19.1%), and confidentiality and the limit of confidentiality (10.1%). Although most of the required elements of the informed consent form content were included in most informed consent forms, we identified four elements with often missing information in the form: aspects of research that are experimental (n = 43, 67.2%), involvement of whole-genome sequencing (n = 35, 54.7%), commercial profit sharing (n = 31, 48.4%), and posttrial provisions (n = 28, 43.8%).
The informed consent forms in industry-sponsored drug development clinical trials were long but incomplete. Our findings draw attention to ongoing challenges in industry-sponsored drug development clinical trials, where deficient informed consent form quality continues to exist.

Readability of Consent Forms: Sponsor Templates versus Locally Approved Consent Forms

Readability of Consent Forms: Sponsor Templates versus Locally Approved Consent Forms
Joyce D. Brown
Rush University ProQuest Dissertations Publishing, 2023
Respect for person is a basic ethical principle of the Belmont Report and includes the need to treat research participants as autonomous individuals during the consenting process. Federal guidance has recommended consents be written at a 6th to 8th grade reading level. However, it is not clear that these reading recommendations actually occur in reality. The overall goal of this project explores whether the results of sponsor provided, and Institutional Review Board (IRB) approved consents at a local site achieve the desired reading levels.
This quality improvement project identified research studies in the Pulmonary and Critical Care Division of Rush University Medical Center from 2014-2023, where a sponsor consent and a Rush IRB consent were both available. Readability software calculated consent comparison scores. Data resulted from use of the Flesch Reading Ease (FRE), Flesch- Kincaid Grade Level (FKRL), and Simple Measure of Gobbledygook Index (SMOG) scores.
After reviewing the research study records, 18 studies met inclusion criteria for the project and consents selected for the medical intensive care unit recruitment (39%) and (61%) for outpatient pulmonary disorders research. The eighth-grade level for each metric was 60 for FRE, 8 for FKGL and 8 for the Smog Index score. Using a t-test, the mean readability metrics for the sponsor consents was greater than the 8th grade (FRE: 53.75 (SE=1.56), t-test = -3.98; p = < 0.001; FKGL: 9.74 (SE=0.29), t-test = 5.83; p = < 0.000; Smog Index: 12.15 (SE=0.23), t-test = 17.62; p = < 0.000). Similarly, the mean readability metrics for Rush IRB consents was greater X than the 8th grade (FRE: 53.51(SE=0.90), t-test = -7.17; p = < 0.000; FKRL: 9.90 (SE=0.17), ttest =  10.61; p = < 0.000; Smog Index: 12.20 (SE=0.14), t-test = -29.13; p = < 0.000). Paired ttest results conducted on the sponsor and IRB consents show no difference on any of the readability metric and therefore show no statistically significant difference (sponsor vs. Rush IRB for FRE 53.75 vs. 53.51, t-test = -2.32, p = 0.81); for FKGL 9.74 vs 9.90; t-test = 0.83, p = 0.41, and for SMOG 12.15 vs 12.20, t-test = .33, p = 0.73.
Readability scored both the sponsor and IRB consent templates above the 8th grade reading level. Additional research is warranted to advance the properties of readability in the sponsor and IRB templates.

A Narrative Review of the Rationale for Conducting Neonatal Emergency Studies with a Waived or Deferred Consent Approach

A Narrative Review of the Rationale for Conducting Neonatal Emergency Studies with a Waived or Deferred Consent Approach
Review Articles
Anup Katheria, Georg M. Schmölzer, Annie Janvier, Vishal Kapadia, Ola D. Saugstad, Maximo Vento, Alla Kushnir, Mark Tracy, Wade Rich, Ju Lee Oei
Neonatology, 9 May 2023
Emergency research studies are high-stakes studies that are usually performed on the sickest patients, where many patients or guardians have no opportunity to provide full informed consent prior to participation. Many emergency studies self-select healthier patients who can be informed ahead of time about the study process. Unfortunately, results from such participants may not be informative for the future care of sicker patients. This inevitably creates waste and perpetuates uninformed care and continued harm to future patients. The waiver or deferred consent process is an alternative model that may be used to enroll sick patients who are unable to give prospective consent to participate in a study. However, this process generates vastly different stakeholder views which have the potential to create irreversible impediments to research and knowledge. In studies involving newborn infants, consent must be sought from a parent or guardian, and this adds another layer of complexity to already fraught situations if the infant is very sick. In this manuscript, we discuss reasons why consent waiver or deferred consent processes are vital for some types of neonatal research, especially those occurring at and around the time of birth. We provide a framework for conducting neonatal emergency research under consent waiver that will ensure the patient’s best interests without compromising ethical, beneficial, and informative knowledge acquisition to improve the future care of sick newborn infants.

Informed Consent and Debriefing When Deceiving Participants: A Systematic Review of Research Ethics Guidelines

Informed Consent and Debriefing When Deceiving Participants: A Systematic Review of Research Ethics Guidelines
Review Article
Kamiel Verbeke, Tomasz Krawczyk, Dieter Baeyens, Jan Piasecki, Pascal Borry
Journal of Empirical Research on Human Research Ethics, 15 May 2023
Informed consent and debriefing of research participants in studies that use deception are ethical safeguards for which existing scholarly work on their implementation remains variable and insufficiently clear. A systematic review of research ethics guidelines was conducted to sketch a picture of whether, why and how informed consent and debriefing are recommended when using deception. Documents roughly agreed on several general principles, but varied significantly in the specifics of why and whether these safeguards are necessary, in which conditions and how they should be implemented. Various aspects that appear in the literature could not be found in the guidelines. In our review, guidance was integrated and showed a variation of implementation strategies that could help in contextualizing these safeguards.

The Effects of Expectation Setting and Bundle Consent on Acute Caregiver Stress in the PICU: A Randomized Controlled Trial

The Effects of Expectation Setting and Bundle Consent on Acute Caregiver Stress in the PICU: A Randomized Controlled Trial
Goldstein G, Karam O, Miller Ferguson N
Pediatric Critical Care Medicine: a Journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies, 1 May 2023
Having a child admitted to the PICU is a stressful experience for parents and can have long-term negative mental health consequences. The objective was to determine if formalized expectation setting and bundled consent for invasive procedures upon admission impacts the acute stress burden on parents.
Prospective cluster randomized controlled trial.
Single-center, tertiary PICU.
Parents/guardians of patients, 0-18 years old, admitted to PICU.
During experimental weeks, all patients admitted to PICU were bundled-consented for common procedures and given a novel unit introductory letter and “Common Procedures Explained” document. During control weeks, all patients were consented for invasive procedures with separate consents for each procedure. Parents then completed a demographic survey and Stress Overload Scale-Short (SOS-S) 48-72 hours after their child’s admission. For each participant, the SOS-S generates a Personal Vulnerability (PV) score and an Event Load (EL) score. Parents’ perception of the life-threatening nature of their child’s condition was also evaluated.
Measurements and main results
Over 73 weeks, 1,882 patients were screened and 261 consented to the SOS-S. Median PV score was 10.4 in the control group and 9.1 in the experimental group (p = 0.15). Median EL score was 11.3 for the control group and 10.5 in the experimental group (p = 0.42). Adjusting for demographic variables and severity of illness, there was no independent association between either PV or EL and bundled consent. However, a parent’s perception of threat-to-life was significantly related to the allocated group (p = 0.036), which resulted in a decreased percentage of parents who rated their child’s illness as “Extremely” life-threatening (experimental group, 17% vs control group, 26%).
This study did not demonstrate a decrease in stress when bundled consent was obtained. However, this intervention decreased the parents’ perceived severity of illness. Further multicenter studies are needed to evaluate the effects of bundled consent on parents.

A cross‑sectional audit of informed consent of online survey: Characteristics and adherence to prevalent guidelines

A crosssectional audit of informed consent of online survey: Characteristics and adherence to prevalent guidelines
Himel Mondal, Shaikat Mondal, Sachin Soni
Perspectives in Clinical Research, 17 April 2023
Research on human participants requires formal approval from a competent ethics committee. During the recruitment of the research participants, obtaining informed consent is a prerequisite. The online survey method is used by many researchers as it can collect the data from a diverse population in a short time.
This study aimed to observe the characteristics and adherence to prevalent guidelines (set by the Indian Council of Medical Research [ICMR]) of informed consent coupled with online surveys.
We collected the informed consent text from online survey links obtained from a network of colleagues who got a request to participate in a survey. Data were collected from July 2020 to June 2022. The text was anonymized for further analysis. The word count, sentences, and Flesch reading ease score were calculated. The adherence to ICMR guidelines where checked by two authors individually and a consensus was reached to prepare the final result.
A total of 44 online surveys in English were audited and among them, 10 did not have informed consent. The informed consent in 34 surveys had a median of 6 sentences and 84 words. The median reading ease score was 45.7 (college level). The majority of the consent states the purpose of the research (91.18%), the voluntary nature of the participation (85.29%), and mentioned that it is research (64.71%). However, the rest of the components are ignored by the majority of the survey consent form.
Informed consent form with online surveys lacks adherence to the components suggested by ICMR. Hence, the forms should be made carefully by the researchers so that the vigor of informed consent is maintained in the online surveys.

Adaptive, platform trials assessing therapies for hospitalized COVID-19 patients: Informed consent forms omitted a few important elements of information

Adaptive, platform trials assessing therapies for hospitalized COVID-19 patients: Informed consent forms omitted a few important elements of information
Rafael Dal-Ré, Teck Chuan Voo, Søren Holm
Journal of Global Health, 12 May 2023
The information provided to participants of adaptive platform trials assessing therapies for COVID-19 inpatients is unknown. We aim to evaluate it by reviewing participant information sheets/informed consent forms (PIS/ICFs).
We searched the Cochrane COVID-19 Study Register and (28 March 2022) to identify non-industry-sponsored adaptive platform phase 2+ trials with publicly available protocols and PIS/ICFs, selecting versions closest to the initial one. We assessed the elements of information included in the Good Clinical Practice guidelines and the Declaration of Helsinki as present, absent, or deficient (incompletely described).
We included PIS/ICFs of 11 trials (ACCORD-2, ACTIV-1IM, Bari-SolidAct, CATALYST, Discovery, HEAL-COVID, ITAC, RECOVERY, REMAP-COVID, Solidarity and TACTIC-R), which were 4-32 pages long (median (md) = 11). Between two and 11 (md = 6) of the 25 different elements of information assessed were omitted or deficiently described in the PIS/ICFs of the 11 trials. Information about providing trial results, investigators’ conflicts of interest, post-study provisions, payment to and anticipated expenses for participants, number of participants, and on whether participants will receive new information that could impact their decision on staying in the trial, were omitted or deficiently described in at least five PIS/ICFs.
Investigators failed to include a few important elements of information in the trial’s PIS/ICF deemed relevant by international standards. In protocols of future trials, investigators should explain why elements of information specified in the Good Clinical Practice guidelines and/or by the Declaration of Helsinki were omitted from the PIS/ICFs.