Month: June 2024

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Informed Consent: A Monthly Review
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July 2024 :: Issue 67

In preparing this digest, we monitor a broad range of academic journals and utilize Google Scholar to search articles referencing  informed consent or assent. After careful consideration, a selection of these results appear in the digest. We also monitor other research, analysis, guidance and commentary beyond the academic literature globally, including calls for public consultation and symposia/conferences which address consent/assent in whole or in part. We recognize that some of the arguments presented in this edition may be controversial and may warrant closer scrutiny. We have elected to be generous in our inclusion with the goal of presentating of a wholistic landscape of informed consent literature as it is being published. 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_July 2024

Spotlight

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This month we have chosen to highlight the posting of informed consent forms (ICFs) on clinicaltrials.gov by industry funded trials. In the American Association of Pharmaceutical Scientists Journal article ‘Principal Features of Industry-Funded Trials that Posted Informed Consent Forms on ClinicalTrials.gov: a Cross-Sectional Analysis’ Dal-Ré and Mahillo-Fernández advocate for a new regulatory standard requiring the posting of ICFs. The authors found that of 116,281 industry funded trials only 741, or 0.6%, posted their ICFs on clinicaltrials.gov. We note from other ongoing work undertaken by the Center for Informed Consent Integrity that there are currently over 9,000 ICFs posted, making the 741 available from industry funded trials even more striking.

The article finds that when industry sponsors do make their ICFs available, they are highly compliant with transparency standards, seemingly having found a resolution to the general objection from commercial organizations that the posting of ICFs would reveal trade secrets and/or ongoing research programs. These findings raise questions about how to increase the availability of ICFs and enhance shared learning across the field of informed consent.

Principal Features of Industry-Funded Trials that Posted Informed Consent Forms on ClinicalTrials.gov: a Cross-Sectional Analysis
Rafael Dal-Ré, Ignacio Mahillo-Fernández
American Association of Pharmaceutical Scientists Journal, 18 June 2024; 26(4)
Abstract
We aim to characterize industry-funded trials that have posted the informed consent forms (ICFs), and to assess whether the role played by industry as ‘sponsor’ or ‘collaborator’ could impact several relevant variables. A cross-sectional study was conducted on ClinicalTrials.gov on all industry-funded trials registered on or before 25 February 2023. We registered types of intervention, current recruitment status, design, enrollment, and countries involved. For trials with special interest to potential participants and investigators and/or clinicians an analysis of the role played by industry as ‘sponsor’ or ‘collaborator’ was performed. Of 116,281 industry-funded trials registered, 741 (0.6%) had posted ICFs. Most of these trials were categorized as ‘completed’ (n = 408) or ‘terminated’ (n = 107). The review of a sample of 359 trials showed that most were on drugs and/or biologics (59%), were randomized (51%), conducted exclusively in the USA (72%), and had posted results (79%), protocols (92%), and statistical analysis plans (SAPs) (89%). Trials in which industry participated as ‘collaborator’ were significantly more likely to post ICFs when trials were in the ‘active, not recruiting’ phase (OR 4.70, 99.71% CI 1.59-13.9, p < 0.001) than industry-sponsored trials. This was also the case when assessing drugs/biologics (OR 2.64, 99.71% CI 1.25-5.58, p < 0.001). Conversely, companies acting as ‘sponsors’ were significantly more likely to post ICFs with trials assessing devices, radiation interventions and/or diagnostic tests (OR 0.37, 99.71% CI 0.17-0.79, p < 0.001) than when participating as ‘collaborators’. While industry-funded trials rarely post ICFs, when they do, they are highly compliant with transparency requirements. Regulations and ethics codes should consider requiring posting of protocols, SAPs, and ICFs for all clinical trials, regardless the type of sponsor.

Informed Consent Writing: Facing the Patient Is in the Interest of the Sponsor

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Informed Consent Writing: Facing the Patient Is in the Interest of the Sponsor
Tatiana Zhiganova, Olga Golubeva, Maxim Belotserkovskiy
American Medical Writers Association Journal, 13 June 2024
Abstract
This article analyzes the most common findings of the European Medicines Agency (EMA) and regulatory agencies regarding the quality of essential documents that led to delays in study approvals and major observations by EMA inspectors. The authors analyzed the content and length of informed consent forms used within clinical trials within the last 10 years and revealed a tendency toward increased length and complexity of the documents. Criteria for developing patient informed consent forms are suggested to implement in medical writing practice to make informed consent forms short and simple to read and understand by a layperson.

Simplifying informed consent as a universal precaution

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Simplifying informed consent as a universal precaution
Iris Z. Feinberg, Ajeet Gajra, Lori Hetherington, Kathryn S. McCarthy
Scientific Reports, 8 June 2024
Abstract
One barrier to participating in clinical research is that patients with low literacy skills (1 in 5 US adults) may struggle to understand the informed consent document (ICD). Writing consents using health literacy and plain language guidelines including simplified syntax and semantics can increase understandability and facilitate inclusivity of research populations with literacy challenges. Our study aim was to evaluate a simplified ICD for understandability while considering factors known to relate to comprehension (reading skills and working memory). We performed an on-line survey of 192 adults ages 18–77 in Georgia. Participants performed significantly better on the simplified ICD test. We built an additional model with all version x measure interactions (i.e., age, sex, race, urbanicity, GMVT, WM). This model did not significantly improve model fit, F < 1.00, suggesting that individual differences did not moderate the effect of simplification. Our findings suggest that using plain language and simplified syntax and semantics in ICD as a universal precaution may reduce cognitive reading burden for adults regardless of differences in reading skill or working memory. Increasing understandability in ICD may help improve targets for clinical trial enrollment.

Enhancing diverse representation in clinical studies: Recommendations from external subject matter experts (SMEs) and patients to optimize protocols, informed consent and study designs

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Enhancing diverse representation in clinical studies: Recommendations from external subject matter experts (SMEs) and patients to optimize protocols, informed consent and study designs
Meeting Abstract: 2024 ASCO Annual Meeting I
Gregory A. Vidal, Haiying Cheng, Andrea Curry, Oana Cristina Danciu, Balazs Halmos, Jennifer Hopton-Jones, Stephen Huddleston, Kapil Kapoor, Maya Khalil, Ryan Huu-Tuan Nguyen, Jason Porter, Brieyona Reaves, Meredith Russell, Suyasha Gupta, Lauren Henderson, Meghan Mckenzie, Diana Ndunda, Noah Rosenberg, Ruma Bhagat
Journal of Clinical Oncology, June 2024
Open Access
Abstract
Background
Well-characterized disparities in clinical research have disproportionately affected patients of color, particularly in underserved communities. To tackle these barriers, the Roche-Genentech U.S. Advancing Inclusive Research Site Alliance solicited feedback from external SMEs about recommendations for strategies and tactics to increase Black, Hispanic/Latinx and older adult patient clinical research participation.
Methods
Feedback was received virtually and via 1:1 interviews from 13 external SMEs defined as investigators, study coordinators or other clinical research roles that engage directly with patients regarding a Phase III small-cell lung cancer protocol as a use case. Two patients provided recommendations for future clinical study protocols and designs. Additionally, multiple healthcare providers from International Society of Geriatric Oncology provided recommendations for the inclusion of older adults in study protocols. A cross-functional, pan-Roche-Genentech team reviewed the feedback and finalized all materials.
Results
Six key themes emerged: (a) use lay terms and humanizing language in patient materials; (b) integrate patient lifestyle realities by allowing flexibility in protocol inclusion/exclusion criteria; (c) improve the ease of patient participation and seek only what is clinically necessary for study assessment; (d) incorporate options for sites to enable them to make the right, and fastest, decision(s) for patients without sacrificing safety or data quality; (e) show commitment to diversity in words and actions such as including target enrollment goals in protocols and incorporating patient input on protocols before protocol finalization; (f) include older patients > 70 years. Patient feedback reinforced the SME themes, except for inclusion of older patients. Patients suggested efficiency, clarity and local community realities be factored into future study designs. Some examples are fewer clinic visits, remote visit options, providing patient transportation and food support in connection with protocol-required visits. Patients also highlighted the importance of explaining the probability of side-effects, clinics being present in the community and the need for greater education and awareness regarding barriers to clinical trial enrollment. One patient relayed the importance of early trial education through general physician offices before a trial is actually needed for a given patient.
Conclusion
These SME recommendations provide actionable insights to inform protocol design and patient recruitment strategy and tactics to enhance future protocols from an inclusivity-specific lens. Study teams can use these recommendations to address barriers that make enrollment/retention by underrepresented patient populations difficult.

Informed consent to midwifery practices and interventions during the second stage of labor—An observational study within the Oneplus trial

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Informed consent to midwifery practices and interventions during the second stage of labor—An observational study within the Oneplus trial
Research Article
Cecilia Häggsgård, Christine Rubertsson, Pia Teleman, Malin Edqvist
PLOS One, 12 June 2024
Open Access
Abstract
Objectives
To study informed consent to midwifery practices and interventions during the second stage of labor and to investigate the association between informed consent and experiences of these practices and interventions and women’s experiences of the second stage of labor.
Methods
This study uses an observational design with data from a follow-up questionnaire sent to women one month after giving birth spontaneously in the Oneplus trial, a study aimed at evaluating collegial midwifery assistance to reduce severe perineal trauma. The trial was conducted between 2018–2020 at five Swedish maternity wards and trial registered at clinicaltrials.gov, no NCT03770962. The follow-up questionnaire contained questions about experiences of the second stage of labor, practices and interventions used and whether the women had provided informed consent. Evaluated practices and interventions were the use of warm compresses held at the perineum, manual perineal protection, vaginal examinations, perineal massage, levator pressure, intermittent catheterization of the bladder, fundal pressure, and episiotomy. Associations between informed consent and women’s experiences were assessed by univariate and multivariable logistic regression.
Findings
Of the 3049 women participating in the trial, 2849 consented to receive the questionnaire. Informed consent was reported by less than one in five women and was associated with feelings of being safe, strong, and in control. Informed consent was further associated with more positive experiences of clinical practices and interventions, and with less discomfort and pain from interventions involving physical penetration of the genital area.
Conclusion
The findings indicate that informed consent during the second stage is associated with feelings of safety and of being in control. With less than one in five women reporting informed consent to all practices and interventions performed by midwives, the results emphasize the need for further action to enhance midwives’ knowledge and motivation in obtaining informed consent prior to performance of interventions.

Co-creating Consent for Data Use — AI-Powered Ethics for Biomedical AI

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Co-creating Consent for Data Use — AI-Powered Ethics for Biomedical AI
Barbara J. Evans, Azra Bihorac
New England Journal of Medicine, 14 June 2024
Abstract
As nations design regulatory frameworks for medical AI, research and pilot projects are urgently needed to harness AI as a tool to enhance today’s regulatory and ethical oversight processes. Under pressure to regulate AI, policy makers may think it expedient to repurpose existing regulatory institutions to tackle the novel challenges AI presents. However, the profusion of new AI applications in biomedicine — combined with the scope, scale, complexity, and pace of innovation — threatens to overwhelm human regulators, diminishing public trust and inviting backlash. This article explores the challenge of protecting privacy while ensuring access to large, inclusive data resources to fuel safe, effective, and equitable medical AI. Informed consent for data use, as conceived in the 1970s, seems dead, and it cannot ensure strong privacy protection in today’s large-scale data environments. Informed consent has an ongoing role but must evolve to nurture privacy, equity, and trust. It is crucial to develop and test alternative solutions, including those using AI itself, to help human regulators oversee safe, ethical use of biomedical AI and give people a voice in co-creating privacy standards that might make them comfortable contributing their data. Biomedical AI demands AI-powered oversight processes that let ethicists and regulators hear directly and at scale from the public they are trying to protect. Nations are not yet investing in AI tools to enhance human oversight of AI. Without such investments, there is a rush toward a future in which AI assists everyone except regulators and bioethicists, leaving them behind.

Unleashing the power of clinical trial data: a proposal for enhancing informed consent and data sharing

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Unleashing the power of clinical trial data: a proposal for enhancing informed consent and data sharing
Commentary
Lorenzo Trippa, Sean Khozin
The Oncologist, 10 June 2024
Excerpt
Clinical trials play a crucial role in establishing the safety and efficacy of new treatments. Despite the uncertainties surrounding potential benefits and risks, patients willingly participate in these studies and their contributions deserve not only recognition but also optimal utilization. Creating new mechanisms for sharing data from clinical trials can honor such contributions by advancing scientific research and aligning with patients’ altruistic motivations…

Is pay-or-consent for privacy justifiable? Evidence from different users’ privacy attitudes toward behavioral data collection in South Korea

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Is pay-or-consent for privacy justifiable? Evidence from different users’ privacy attitudes toward behavioral data collection in South Korea
Sangjun Nam, Youngsun Kwon
Telecommunications Policy, 30 May 2024
Open Access
Abstract
As regulators began prohibiting online platforms from collecting personal data based on the “take-it-or-leave-it” basis, platform firms must adopt more refined user consent rules such as the pay-or-consent approach. Ensuring sufficient user options could increase the welfare of privacy-sensitive users but reduce the efficiency of data-driven business models. To balance the benefits and costs of enhanced privacy protection, regulators should understand the diversity in users’ attitudes toward behavioral data collection in free online platforms. Tradeoffs among privacy, conveniences, and free services based on users’ heterogeneous preferences are considered to investigate the user’s different privacy attitudes in free online platforms. Three distinct user groups were found: the first one reluctantly accepts the “take-it-or-leave-it” condition because of the lack of alternatives, the second one accepts it for free services, and the third one accepts it because it does not matter. These three user segments constituted 32.9%, 47.0%, and 20.1% of all the respondents, respectively. The pay-or-consent approach can be justifiable in terms of balancing the benefits and costs of the privacy regulations if it properly reflects privacy-sensitive users’ willingness to pay for privacy.

How to Elucidate Consent-Free Research Use of Medical Data: A Case for “Health Data Literacy”

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How to Elucidate Consent-Free Research Use of Medical Data: A Case for “Health Data Literacy”
Gesine Richter,  Michael Krawczak
JMIR Medical Informatics, 2024
Abstract
The extensive utilization of personal health data is one of the key success factors of modern medical research. Obtaining consent to the use of such data during clinical care, however, bears the risk of low and unequal approval rates and risk of consequent methodological problems in the scientific use of the data. In view of these shortcomings, and of the proven willingness of people to contribute to medical research by sharing personal health data, the paradigm of informed consent needs to be reconsidered. The European General Data Protection Regulation gives the European member states considerable leeway with regard to permitting the research use of health data without consent. Following this approach would however require alternative offers of information that compensate for the lack of direct communication with experts during medical care. We therefore introduce the concept of “health data literacy,” defined as the capacity to find, understand, and evaluate information about the risks and benefits of the research use of personal health data and to act accordingly. Specifically, health data literacy includes basic knowledge about the goals and methods of data-rich medical research and about the possibilities and limits of data protection. Although the responsibility for developing the necessary resources lies primarily with those directly involved in data-rich medical research, improving health data literacy should ultimately be of concern to everyone interested in the success of this type of research.