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
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
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
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
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
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”
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.
A Pilot Evaluation of an Educational Video to Support Consent to a Pediatric Malignancy Biobank
A Pilot Evaluation of an Educational Video to Support Consent to a Pediatric Malignancy Biobank
Research Article
Biopreservation and Biobanking, 27 May 2024
Abstract
Introduction
The collection of biological specimens is necessary to support basic and translational research. However, the complexity of biobanking introduces numerous ethical issues, particularly regarding informed consent.
Objective
To evaluate the acceptability and perceived benefits of an educational video facilitating the consent process for the Children’s Cancer Centre Biobank.
Methods
We invited individuals who had previously consented to be (or their child to be) part of the Biobank, and health professionals who were involved in obtaining consent. Participants watched the video and completed a purpose-designed online survey.
Results
A total of 16 health professionals (invited = 30) and 15 patients/caregivers (invited = 127) participated. Most patients/caregivers felt informed about the Biobank at consent, however, noted how overwhelmed they were at the time and that they did not engage with the written information. Overall, both patients/caregivers and health professionals rated the video favorably regarding the information provided and format. Participants valued that it was simple and clear, with several health professionals noting the need for linguistic translations to better support the families they work with. Most patients/caregivers agreed that the video provided enough information to begin considering participation. This aligned with the health professionals’ feedback that the video was most effective when used as a conversation starter to help formalize the written consent.
Conclusion
Our findings suggest that our video is an acceptable and beneficial tool to assist in the Biobank consenting process, from both the perspective of decision-makers and health professionals obtaining consent. It appears particularly valuable as a precursor to an interactive, formal consent discussion. Further work is required to determine whether our video has a significant impact on outcomes such as decision-making satisfaction and knowledge, and to determine the value to adolescents.
Whole genome sequencing in (recurrent) glioblastoma: challenges related to informed consent procedures and data sharing
Whole genome sequencing in (recurrent) glioblastoma: challenges related to informed consent procedures and data sharing
Mira C Hasner, Mark P van Opijnen, Filip Y F de Vos, Edwin Cuppen, Marike L D Broekman
Acta neurochirurgica, 14 June 2024; 166(1)
Abstract
Increased use of whole genome sequencing (WGS) in neuro-oncology for diagnostics and research purposes necessitates a renewed conversation about informed consent procedures and governance structures for sharing personal health data. There is currently no consensus on how to obtain informed consent for WGS in this population. In this narrative review, we analyze the formats and contents of frameworks suggested in literature for WGS in oncology and assess their benefits and limitations. We discuss applicability, specific challenges, and legal context for patients with (recurrent) glioblastoma. This population is characterized by the rarity of the disease, extremely limited prognosis, and the correlation of the stage of the disease with cognitive abilities. Since this has implications for the informed consent procedure for WGS, we suggest that the content of informed consent should be tailor-made for (recurrent) glioblastoma patients.
A contextual integrity approach to genomic information: what bioethics can learn from big data ethics
A contextual integrity approach to genomic information: what bioethics can learn from big data ethics
Scientific Contribution
Medicine, Health Care and Philosophy, 12 June 2024
Nina F. de Groot
Open Access
Abstract
Genomic data is generated, processed and analysed at an increasingly rapid pace. This data is not limited to the medical context, but plays an important role in other contexts in society, such as commercial DNA testing, the forensic setting, archaeological research, and genetic surveillance. Genomic information also crosses the borders of these domains, e.g. forensic use of medical genetic information, insurance use of medical genomic information, or research use of commercial genomic data. This paper (1) argues that an informed consent approach for genomic information has limitations in many societal contexts, and (2) seeks to broaden the bioethical debate on genomic information by suggesting an approach that is applicable across multiple societal contexts. I argue that the contextual integrity framework, a theory rooted in information technology and big data ethics, is an effective tool to explore ethical challenges that arise from genomic information within a variety of different contexts. Rather than focusing on individual control over information, the contextual integrity approach holds that information should be shared and protected according to the norms that govern certain distinct social contexts. Several advantages of this contextual integrity approach will be discussed. The paper concludes that the contextual integrity framework helps to articulate and address a broad spectrum of ethical, social, and political factors in a variety of different societal contexts, while giving consideration to the interests of individuals, groups, and society at large.
Center for Informed Consent Integrity 