Informed Consent: A Monthly Review

July 2021

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_May 2021

Editor’s Note:
The latest webinar in the Center’s continuing series, Closing the loop on consent: from initial decision, continued participation, through to sharing of results, was held on June 16th 2021. Dr. Katie Gillies of the University of Aberdeen spoke about her work to strengthen the informed consent by developing an understanding of what information matters most to trial participants. She then spoke about how this understanding can lead to increased participant retention and further work to be done.

Implications and advice on getting COVID-19 vaccine consent

Implications and advice on getting COVID-19 vaccine consent
Jonathan Beebee
Learning Disability Practice, 1 April 2021; 24(2) pp 10-12
How to support people with learning disabilities to get vaccinated. Vaccinations against COVID-19 are not mandatory and where people can give or refuse consent we have a responsibility to ensure consent is sought. Many people with learning disabilities will be unable to consent, but others will be able to consent if given the right support. Nurses, carers and families should begin planning as soon as possible, so they are prepared when the invitation to receive the vaccine arrives.

Randomized, Double-Blind Trial on the Impact of Word Count in Cancer Clinical Trial Consent Forms

Randomized, Double-Blind Trial on the Impact of Word Count in Cancer Clinical Trial Consent Forms
Original Contribution
Yahya Almodallal, Quyen Duong, Daniel Satele, Paul Novotny, Kathryn D. Cook , Cynthia Chauhan, Michelle K. Daiss, Jennifer Le-Rademacher, Sherry Looker, Nichole Martin, Michanda F. Smestad, Stacey J. Winham, Sumithra J. Mandrekar, Aminah Jatoi
JCO Oncology Practice, 14 June 2021
This randomized, double-blind study sought to understand whether cancer clinical trial consent form verbosity detracts from patients’ decision making on trial enrollment.
This trial tested mock consent forms of 2,000, 4,000, and 6,000 words. The first two comprised the two experimental arms and the third the control arm. Phase II was conducted to identify the promising arm, which, in phase III, was compared with the control arm. Each consent form described the same trial. Eligible adult patients reported a cancer history and English literacy. The primary end point used a patient-reported Likert scale to assess the relationship between information in the consent form and trial decision making.
In phase II, 93 patients were accrued and prompted the selection of the 2,000-word consent form for phase III. In phase III, 182 patients were recruited, resulting in 240 total evaluable patients to compare the 2,000-word versus the 6,000-word arm (control). For the primary end point, 103 (84%) and 107 (91%) patients in the 2,000- and 6,000-word arms, respectively, strongly agreed or agreed with the following: “The information in this consent form helped me make a decision about whether or not to enroll in the trial” (two-sided, P = .14). Median time to read each consent form was 8 and 12 minutes, respectively (two-sided, P < .0001). Among those assigned these consent forms, 84% and 73%, respectively (two-sided, P = .04) signed or expressed a willingness to sign.
This study’s primary end point was not met. However, secondary outcomes suggest a need to further study the efficiency and efficacy of shorter consent forms for cancer clinical trial enrollment.

Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials
Guillermo Pechero Jr., Branden Pfaff, Mayank Rao, David Pogorzelski, Paula McKay, Ella Spicer, Andrea Howe, Haley K. Demyanovich, Debra L. Sietsema, Michael F. McTague, Lolita Ramsey, Martha Holden, Joshua Rudnicki, Jeff Wells, Michelle Medeiros, Gerard P. Slobogean, Sheila Sprague
Contemporary Clinical Trials Communications, 14 June 2021; 22
Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant’s before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent.
The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have.
Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation.
Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal.

‘To say no wasn’t something we could do’; Reflexive accounts and negotiations of the ethical practice of informed consent during the research process and beyond [BOOK CHAPTER]

‘To say no wasn’t something we could do’; Reflexive accounts and negotiations of the ethical practice of informed consent during the research process and beyond [BOOK CHAPTER]
Johanna Sixtensson
The Politics and Ethics of Representation in Qualitative Research, Routledge, 2021
In this chapter, the implementation of the formal ethical principle of informed consent in the research process is discussed. By analyzing encounters and exchanges with a young research participant, both during the fieldwork and after publication, the text examines the meaning of the concept of consent and discloses complexities and ambivalences inherent in asking for and giving consent. It shows that giving consent or ‘saying no’ is a complicated practice that should not be reduced to a single act or signature on a consent form. Rather, consenting to participate in research is an open-ended, situated, ambivalent and not necessarily verbal process. It might also have an impact on participants beyond the actual research process: for instance, when faced with the researcher’s representations of personal interview accounts in research reports. The text captures the relationality that exists between researchers and those we research, especially regarding how dependent researchers are on participants’ consent, their acts and the quality of the empirical material that participants ‘generate’.

Managing Consent for Data Access in Shared Databases

Managing Consent for Data Access in Shared Databases
Osnat Drien, Antoine Amarilli, Yael Amsterdamer
IEEE Xplore, 22 June 2021
Data sharing is commonplace on the cloud, in social networks and other platforms. When a peer shares data and the platform owners (or other peers) wish to use it, they need the consent of the data contributor (as per regulations such as GDPR). The standard solution is to require this consent in advance, when the data is provided to the system. However, platforms cannot always know ahead of time how they will use the data, so they often require coarse-grained and excessively broad consent. The problem is exacerbated because the data is transformed and queried internally in the platform, which makes it harder to identify whose consent is needed to use or share the query results. Motivated by this, we propose a novel framework for actively procuring consent in shared databases, focusing on the relational model and SPJU queries. The solution includes a consent model that is reminiscent of existing Access Control models, with the important distinction that the basic building blocks – consent for individual input tuples – are unknown. This yields the following problem: how to probe peers to ask for their consent regarding input tuples, in a way that determines whether there is sufficient consent to share the query output, while making as few probes as possible in expectation. We formalize the problem and analyze it for different query classes, both theoretically and experimentally.

How to deal with the consent of adults with cognitive impairment involved in European geriatric living labs?

How to deal with the consent of adults with cognitive impairment involved in European geriatric living labs?
Guillaume Sacco, Frédéric Noublanche, Frédéric Blazek, Catherine Hue, Loïc Carballido, Marine Asfar, Philippe Allain, Cédric Annweiler
Philosophy, Ethics, and Humanities in Medicine, 16 June 2021; 16(3)
Open Access
Living labs are realistic environments designed to create links between technology developers and end-users (i.e. mostly older adults). Research in LLH (Living labs in health) covers a wide range of studies from non-interventional studies to CT (clinical trials) and should involve patients with neurocognitive disorders. However, the ethical issues raised by the design, development, and implementation of research and development projects in LLH have been the subject of only little interest thus far.
Our aim was to determine a pragmatic, ethical and regulatory correct approach to seek the informed consent of patients with neurocognitive disorders according to the different types of studies carried out in European LLH, with a focus on the French context.
A narrative review of regulatory texts and clinical articles was conducted, and a pragmatic procedure to determine the decision-making capacity of older adults in LLH was proposed.
Individuals must be adequately informed and freely agree to participate in CT. The capacity to consent should be assessed in CT including cognitively impaired older adults. We propose the following steps: first to assess for delirium using the 4 ‘A’s Test (4AT) or the 3-min Diagnostic interview for Confusion Assessment Method (3D-CAM), second to search for medical history of major neurocognitive disorder, and third to assess the decision capacity using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC).
Including individuals with neurocognitive disorders in research implies using an efficient and pragmatic strategy to inform participants and obtain their consent. The tool we offer here may be useful in the routine operation of LLH but can also be extended to all CT with this population.

Facilitators and barriers for parental consent to pediatric emergency research

Facilitators and barriers for parental consent to pediatric emergency research
Clinical Research Article
Reagan L. Miller, R. Dawn Comstock, Lauren Pierpoint, Jan Leonard, Lalit Bajaj, Rakesh D. Mistry
Pediatric Research, 4 June 2021
Obtaining informed consent for clinical research in the pediatric emergency department (ED) is challenging. Our objective was to understand the factors that influence parental consent for ED studies.
This was a cross-sectional survey assessing parents’ willingness to enroll their children into an ED research study. Parents reporting a willingness to enroll in ED studies were presented with two hypothetical scenarios, a low-risk and a high-risk study, and then asked about decision influencers affecting consent. Parents expressing a lack of willingness to enroll were asked which decision influencers impacted their consent decision.
Among 118 parents, 90 (76%) stated they would be willing to enroll their child into an ED study; of these, 86 (96%) would consent for a low-risk study and 54 (60%) would consent for a high-risk study. Caucasian parents, and those with previous research exposure, were more likely to report willingness to participate. Those who would consent to the high-risk study cited “benefits that research would provide to future children” most strongly influenced their decision to agree.
ED investigators should highlight the benefits for future children and inquire about parents’ previous exposure to research to enhance ED research enrollment. Barriers to consent in non-Caucasian families should be further investigated.

Late adolescents’ own and assumed parental preferences towards health-care related confidentiality and consent in Belgium

Late adolescents’ own and assumed parental preferences towards health-care related confidentiality and consent in Belgium
David De Coninck, Koen Matthijs, Peter de Winter, Jaan Toelen
PLoS One, 2 June 2021
Health care professionals regularly struggle with issues relating to confidentiality and consent for physical and/or mental health issues among adolescents. We investigate late adolescents’ own and assumed parental preferences towards health-care related confidentiality and consent.
We analyzed online survey data of four vignettes from 463 first-year university students at KU Leuven (Flanders, Belgium). We used paired samples t-tests to assess the (in)consistency between attitudes of late adolescents and their assumed parental attitudes, independent samples t-tests to estimate gender differences, and binomial logistic regressions to analyze the association of assumed parental preferences with late adolescents’ own preferences.
Attitudinal inconsistencies were present in all vignettes. Late adolescents were significantly more in favor of confidentiality and adolescent consent than what they believed their parents were. Gender differences were limited. Binomial logistic regressions indicated that assumed parental preferences were strongly associated with late adolescents’ own preferences.
Findings suggest a clear difference between late adolescents’ preferences and assumed parental preferences: they believe that their parents are less inclined to favor confidentiality and adolescent consent. We also find that this difference depends on the case, indicating that there is no such thing as general ‘confidentiality preferences’. Rather, a decision- and/or context-specific perspective should be adopted.

Soliciting parental consent among adolescent minor mothers: A barrier in adolescent HIV research?

Soliciting parental consent among adolescent minor mothers: A barrier in adolescent HIV research?
L T Gebrekristos
South African Medical Journal, May 2021; 111(6) pp 526-527
Open Access
Adolescents fare worse on the HIV prevention and treatment cascade than adults. This disparity may be particularly acute for adolescent minors (i.e. <18 years of age). Current trends show that adolescents, and especially adolescent minors, are a particularly vulnerable population. The under-representation of adolescent minors (especially unemancipated induviduals) in HIV research negatively affects the development and evaluation of interventions to improve their health. Despite growing consensus regarding the value of conducting HIV research with adolescent minors, concerns about perceived barriers to enrolling them persists. Specifically, researchers and adolescnets minors in studies have voices concerns that requiring parental consent might affect adolescent minors’ autonomy and/or confidentiality…