Experimenting with modifications to consent forms in comparative effectiveness research: understanding the impact of language about financial implications and key information
Research
Nyiramugisha K. Niyibizi, Candace D. Speight, Gabriel Najarro, Andrea R. Mitchell, Ofer Sadan, Yi-An Ko, Neal W. Dickert
BMC Medical Ethics, 27 March 2022; 23(34)
Open Access
Abstract
Background
Informed consent forms are intended to facilitate research enrollment decisions. However, the technical language in institutional templates can be unfamiliar and confusing for decision-makers. Standardized language describing financial implications of participation, namely compensation for injury and costs of care associated with participating, can be complex and could be a deterrent for potential participants. This standardized language may also be misleading in the context of comparative effectiveness trials of standard care interventions, in which costs and risk of injury associated with participating may not differ from regular medical care. In addition, the revised U.S. Common Rule contains a new requirement to present key information upfront; the impact of how this requirement is operationalized on comprehension and likelihood of enrollment for a given study is unknown.
Methods
Two online surveys assessed the impact of (1) changes to compensation for injury language (standard vs. tailored language form) and (2) changes to the key information page (using the tailored compensation language form with standard key information vs. modified key information vs. modified key information plus financial information) on both likelihood of enrollment in and understanding of a hypothetical comparative effectiveness trial.
Results
Likelihood of enrolling was not observed to be different between the standard and tailored language forms in Study 1 (73 vs. 75%; p = 0.6); however, the tailored language group had a higher frequency of understanding the compensation for injury process specific to the trial (25 vs. 51%; p < 0.0001). Modifications to the key information sheet in Study 2 did not affect likelihood of enrolling (88 vs. 85 vs. 85%; p = 0.6); however, understanding of randomization differed by form (44 vs. 59 vs. 46%; p = 0.002).
Conclusions
These findings suggest that refining consent forms to clarify key information and tailoring compensation for injury language to the nature of the study, especially in the context of comparative effectiveness trials, may help to improve study comprehension but may not impact enrollment.
Obtaining Informed Consent for Research Studies
Obtaining Informed Consent for Research Studies
Book Chapter
Lynne M. Bianchi
Research during Medical Residency, 2022 [Taylor & Francis]
Abstract
This chapter describes how to communicate the information included in our institutional review board-approved consent form in an effective and appropriate manner to optimize comprehension and minimize undue influence and coercion. Effective communication involves more than simply reading the form to someone. Informed consent requires that potential participants are given the required information and sufficient time to decide whether they wish to join a study. The informed consent document and conversations include discussion of the voluntary nature of participation, the study purpose, methods, duration, risks, benefits, confidentiality of records, contact information for questions or concerns. Whether investigator- or participant-initiated withdrawal, if there are treatments, protocols, or follow-up appointments required to protect the well-being of the participant upon study withdrawal, those are explained in the consent form and reviewed during informed consent conversations. A parent or legally authorized representative grants the consent for the individual to participate.
Use of pre-enrollment randomization and delayed consent to maximize participation in a clinical trial of opt-in versus opt-out tobacco treatment
Use of pre-enrollment randomization and delayed consent to maximize participation in a clinical trial of opt-in versus opt-out tobacco treatment
Original Research
Babalola Faseru, Laura M. Mussulman, Niaman Nazir, Edward F. Ellerbeck, Elena Shergina, Taneisha S. Scheuermann, Byron J. Gajewski, Delwyn Catley, Kimber P. Richter
Substance Abuse, 18 April 2022; 43(1)
Abstract
Background
Enrollment in smoking cessation trials remain sub-optimal. The aim of this analysis was to determine the effectiveness of a modified Zelen’s design in engaging hospitalized patients who smoke in a pragmatic OPT-IN versus OPT-OUT tobacco treatment trial.
Methods
At bedside, clinical staff screened smokers for eligibility, randomized eligible into study arms, and delivered the appropriate treatment approach. Study staff called randomized patients at one-month post-discharge, debriefed patients on the study design, and collected consent to participate. We used frequencies and percentages for categorical variables and means and standard deviations for quantitative variables to describe the characteristics of those who consented and were enrolled versus those who did not enroll. We also compared the characteristics of participants who consented and those who were reached and explicitly refused consent at one-month follow-up. We used the Cohen’s d measure of effect size to evaluate differences.
Results
Of the 1,000 randomized, 741 (74.1%) consented to continue in the study at one-month follow-up. One hundred and twenty-seven (12.7%) refused consent and 132 (13.2%) were unreachable. Cohen’s d effect size differences between those who consented/enrolled (n = 741) and those who were not enrolled (n = 259) were negligible (<0.2) for age, gender, race/ethnicity, and most forms of insurance. The effect size was small for Medicaid (0.36), and other public insurance (0.48). After excluding those unreached at 1 month (12.7%), there were medium Cohen’s d effect size differences between those who consented to participate (n = 741) and those who explicitly refused (n = 127) with respect to age (0.55) and self-pay or no insurance (0.51). There were small to negligible effect size differences with respect to sex, race/ethnicity, and other forms of health insurance.
Conclusions
The modified Zelen’s design resulted in successful enrollment of most participants who were initially randomized into the trial, including those not motivated to quit.
The ethical performance of access and consent in ethnographic research on social work encounters with migrant-background service users
The ethical performance of access and consent in ethnographic research on social work encounters with migrant-background service users
Hanna Kara, Maija Jappinen, Camilla Nordberg, Anna-Leena Riitaoja
Qualitative Social Work, 2022; pp 1-16
Open Access
Abstract
In this article, we contribute to an emerging body of literature concerning the often overlooked topics of access and consent in research. We posit our understanding of access and consent as continuous ethical reflection and negotiation, conceptualised here as ethical performance, which is particularly valuable in research in institutional contexts defined by numerous power asymmetries. We draw empirically from research on street level institutional encounters between social work practitioners and migrant-background service users in the Helsinki capital region. Access in this research was a multi-stage process including various stage-related negotiations, and the previous stages always influenced the stages that followed. Nevertheless, access and consent were always erratic and subject to revision. We describe how the need for ethical reflexivity arises in various concrete, often unpredictable, situations, and argue for the importance of paying explicit analytical attention to negotiations regarding access and consent.
Moving from ‘fully’ to ‘appropriately’ informed consent in genomics: The PROMICE framework
Moving from ‘fully’ to ‘appropriately’ informed consent in genomics: The PROMICE framework
Julian J Koplin, Christopher Gyngell, Julian Savulescu, Danya F Vears
Bioethics, 7 April 2022
Abstract
Genomic sequencing technologies (GS) pose novel challenges not seen in older genetic technologies, making traditional standards for fully informed consent difficult or impossible to meet. This is due to factors including the complexity of the test and the broad range of results it may identify. Meaningful informed consent is even more challenging to secure in contexts involving significant time constraints and emotional distress, such as when rapid genomic testing (RGS) is performed in neonatal intensive care units. In this article, we propose that informed consent matters not for its own sake, but because obtaining it furthers a range of morally important goals, such as promoting autonomy, well-being, and trust in medicine. These goals form the basis of a new framework [PROmoting Morally Important Consent Ends (PROMICE)] for assessing the ethical appropriateness of various informed consent models. We illustrate this framework with two examples: (a) a tiered and layered consent model for obtaining consent for GS, and (b) consent for RGS in critically ill newborns. We conclude that appropriately-rather than fully-informed consent provides the correct standard for genomic medicine and research.
Machine learning applications in healthcare and the role of informed consent: Ethical and practical considerations
Machine learning applications in healthcare and the role of informed consent: Ethical and practical considerations
Research Article
Giorgia Lorenzini, David Martin Shaw, Laura Arbelaez Ossa, Bernice Simone Elger
Clinical Ethics, 24 April 2022
Abstract
Informed consent is at the core of the clinical relationship. With the introduction of machine learning (ML) in healthcare, the role of informed consent is challenged. This paper addresses the issue of whether patients must be informed about medical ML applications and asked for consent. It aims to expose the discrepancy between ethical and practical considerations, while arguing that this polarization is a false dichotomy: in reality, ethics is applied to specific contexts and situations. Bridging this gap and considering the whole picture is essential for advancing the debate. In the light of the possible future developments of the situation and the technologies, as well as the benefits that informed consent for ML can bring to shared decision-making, the present analysis concludes that it is necessary to prepare the ground for a possible future requirement of informed consent for medical ML.
Public opinion on sharing data from health services for clinical and research purposes without explicit consent: an anonymous online survey in the UK
Public opinion on sharing data from health services for clinical and research purposes without explicit consent: an anonymous online survey in the UK
BMJ Open, 7 April 2022
Abstract
Objectives
UK National Health Service (NHS/HSC) data is variably shared between healthcare organizations for direct care, and increasingly de-identified for research. Few large-scale studies have examined public opinion on sharing, including of mental health (MH) versus physical health (PH) data. We measured data sharing preferences.
Design/Setting/Interventions/Outcomes
Pre-registered anonymous online survey, measuring expressed preferences, recruiting Feb–Sep 2020. Participants were randomized to one of three framing statements regarding MH versus PH data.
Participants
Open to all UK residents. Participants numbered 29275; 40% had experienced a MH condition.
Results
Most (76%) supported identifiable data sharing for direct clinical care without explicit consent, but 20% opposed this. Preference for clinical/identifiable sharing decreased with geographical distance and was slightly less for MH than PH data, with small framing effects. Preference for research/de-identified data sharing without explicit consent showed the same small PH/MH and framing effects, plus greater preference for sharing structured data than de-identified free text. There was net support for research sharing to the NHS, academic institutions, and national research charities, net ambivalence about sharing to profit-making companies researching treatments, and net opposition to sharing to other companies (similar to sharing publicly). De-identified linkage to non-health data was generally supported, except to data held by private companies. We report demographic influences on preference. A majority (89%) supported a single NHS mechanism to choose uses of their data. Support for data sharing increased during COVID-19.
Conclusions
Support for healthcare data sharing for direct care without explicit consent is broad but not universal. There is net support for the sharing of de-identified data for research to the NHS, academia, and the charitable sector, but not the commercial sector. A single national NHS-hosted system for patients to control the use of their NHS data for clinical purposes and for research would have broad support.
Foundations for Meaningful Consent in Canada’s Digital Health Ecosystem: Retrospective Study
Foundations for Meaningful Consent in Canada’s Digital Health Ecosystem: Retrospective Study
Nelson Shen, Iman Kassam, Haoyu Zhao, Sheng Chen, Wei Wang, Sarah Wickham, Gillian Strudwick, Abigail Carter Langford
JMIR Medical Informatics, 31 March 2022; 10(3)
Abstract
Background
Canadians are increasingly gaining web-based access to digital health services, and they expect to access their data from these services through a central patient access channel. Implementing data sharing between these services will require patient trust that is fostered through meaningful consent and consent management. Understanding user consent requirements and information needs is necessary for developing a trustworthy and transparent consent management system.
Objective
The objective of this study is to explore consent management preferences and information needs to support meaningful consent.
Methods
A secondary analysis of a national survey was conducted using a retrospective descriptive study design. The 2019 cross-sectional survey used a series of vignettes and consent scenarios to explore Canadians’ privacy perspectives and preferences regarding consent management. Nonparametric tests and logistic regression analyses were conducted to identify the differences and associations between various factors.
Results
Of the 1017 total responses, 716 (70.4%) participants self-identified as potential users. Of the potential users, almost all (672/716, 93.8%) felt that the ability to control their data was important, whereas some (385/716, 53.8%) believed that an all or none control at the data source level was adequate. Most potential users preferred new data sources to be accessible by health care providers (546/716, 76.3%) and delegated parties (389/716, 54.3%) by default. Prior digital health use was associated with greater odds of granting default access when compared with no prior use, with the greatest odds of granting default access to digital health service providers (odds ratio 2.17, 95% CI 1.36-3.46). From a list of 9 information elements found in consent forms, potential users selected an average of 5.64 (SD 2.68) and 5.54 (SD 2.85) items to feel informed in consenting to data access by care partners and commercial digital health service providers, respectively. There was no significant difference in the number of items selected between the 2 scenarios (P>.05); however, there were significant differences (P<.05) in information types that were selected between the scenarios.
Conclusions
A majority of survey participants reported that they would register and use a patient access channel and believed that the ability to control data access was important, especially as it pertains to access by those outside their care. These findings suggest that a broad all or none approach based on data source may be accepted; however, approximately one-fifth of potential users were unable to decide. Although vignettes were used to introduce the questions, this study showed that more context is required for potential users to make informed consent decisions. Understanding their information needs will be critical, as these needs vary with the use case, highlighting the importance of prioritizing and tailoring information to enable meaningful consent.
A Big Data Framework for Consent
A Big Data Framework for Consent
Book Chapter
Wei Yap, Muhammad Rizwan Asghar
Trust, Security and Privacy for Big Data, 2022 [Taylor&Francis]
Abstract
Privacy is a vast and vital area of law with possibly diverse interpretations, legislation and standards worldwide with the aim to protect data. Consent plays a vital role in preserving privacy as it ensures that all involved parties understand the reason for the use and collection of data. Many organisations still have lengthy guidelines that cause legibility and usability issues. This makes it difficult for a data subject to understand what they are consenting to and creates a restrictive environment for consent. Unfortunately, existing works do not provide any solution for implementing a dynamic privacy consent framework. In this book chapter, we aim at presenting a dynamic consent framework for big data to ensure that each privacy consent policy is legible, understandable, usable, and customisable. We propose a new method to communicate, analyse, and request consent from a data subject in a way that is simple and understandable. We also aim to ensure that this framework does not increase the burden on data subjects to provide consent while implementing an ability to simplify and audit the consent process.
Research Ethics and Intellectual Disability
Research Ethics and Intellectual Disability
Book Chapter
Kevin Mintz, David Wasserman
The Disability Bioethics Reader, 2022 [Routledge]
Abstract
This chapter focuses on the exclusion of people with cognitive disabilities from research that is not related to their disabilities. Wasserman and Mintz argue that despite real limitations with regard to consent (most people with cognitive disabilities will only be able to assent), denying people with cognitive disabilities the ability to participate in research is largely unjustifiable. Moreover, it has effects that ought to be avoided namely, moral harm of persons with cognitive disabilities and increased vulnerability to abuses and violations when they do participate in research. Wasserman and Mintz argue that there is no good reason to exclude people with cognitive disabilities on the basis of their limitations, especially because people of similar cognitive ages are able to participate in research.
Center for Informed Consent Integrity 