Informed Consent: A Monthly Review
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 2022
Ethical Research in Fragile and Conflict Affected Contexts: Guidelines for Reviewers
UKRI Research and Innovation, 16 November 2021
Ethical considerations arise in all research. They are, however, amplified in fragile and conflict-affected contexts. The power imbalances between local and international researchers are increased and the risk of harm is augmented. The research takes place in a context where appropriate safeguards are often reduced and the probabilities of unethical research are magnified. Existing explorations of ethics and ethical review processes often focus primarily on the front end of the data cycle. Yet, we know that harm can occur at any stage in the research cycle. Ethical research in fragile and conflict-affected contexts therefore requires that researchers and funders reflect even more critically and systematically on every step of the research process – from defining the research agenda and selecting researchers through to data collection, analysis and dissemination and communication of findings. These UKRI and UNICEF reviewer guidelines provide a unique tool for reviewers to assure themselves, as reviewers and/or funders, that research projects funded will give systematic and on going consideration to the ethics of research in fragile and conflict-affected contexts. The tool provides seven criteria for consideration and a checklist for reviewers to use systematically to support their review process…
Editor’s note: UK Research and Innovation provides research and innovation funding, funded through the science budget of the Department for Business, Energy and Industrial Strategy.
A lesson from MMR: is choice of vaccine the missing link in promoting vaccine confidence through informed consent?
Ethics & Behaviour, 20 Apr 2022
A recent study suggests that vaccine hesitancy amongst key demographics – including females, younger individuals, and certain ethnic groups – could undermine the pursuit of herd immunity against COVID-19 in the United Kingdom. At the same time, the UK Joint Committee on Vaccination and Immunization (JVCI) indicated that it will not facilitate the choice between available COVID-19 vaccines. This paper reflects upon lessons from the introduction of the UK’s combined Measles, Mumps and Rubella (MMR) vaccine strategy of the 1980s when Member of Parliament Miss Julie Kirkbride argued that had parents been allowed to choose between vaccine variants, then the crisis of low herd immunity – and subsequent outbreaks – could have been avoided. This paper explores this argument, as applied to the COVID-19 vaccination strategy, by considering how three key elements of informed consent – disclosure of risk, benefit, and reasonable alternatives – may be employed to tackle vaccine hesitancy and build vaccine confidence.
Organ transplantation during the COVID-19 pandemic – impact on deceased organ donor referrals and consent rates in the Western Cape, South Africa
H Bookholane, T Du Toit, E Muller, D Thomson
South African Journal of Surgery, 11 April 2022; 60
The impact of the COVID-19 pandemic on transplantation is multifactorial. This study reports on its influence on deceased donation for transplantation in the Western Cape.
The volume of referrals and those who were consented for organ donation in the province in the pre pandemic period of May 2017 to February 2020 were compared to those of the initial pandemic period (March through December 2020).
Prior to the pandemic, there were 201 deceased donor referrals in the Western Cape province – 152 (75.6%) and 49 (24.4%) in public and private sectors, respectively. The mean referral rates ranged between 59 69 referrals per year, translating into a monthly rate of 4.8 (range 2.8–5.8). During the first 10 months of the pandemic, there were 18 referrals – 12 (66.7%) and six (33.3%) in the public and private sectors; a decrease of 63%, with a mean monthly referral rate of 1.8. The overall consent rate prior to the pandemic in the public and private sectors was 36.6% (38% and 27%, respectively) with an increase to 44.4% (37.5% and 62.5%) during the pandemic.
Despite a 10% increase in consent rate for deceased donation during the COVID-19 pandemic, there was a significant decrease in the number of potential donors referred. Strategies to improve organ donation and transplantation during and after the COVID-19 pandemic are required.
Informed Consent for Potential Recipients of Pig Kidney Xenotransplantation in the United States
Luz A. Padilla. Daniel Hurst, Kathryn Maxwell, Kennan Gawlowicz Wayne Paris, David Cleveland, David K.C. Cooper
Transplantation, 27 April 2022
Clinical trials of kidney xenotransplantation are being considered in the United States. Before this novel procedure can take place, investigators will have to obtain approval from the institutional review board. The consent form that will be used for such a trial and that will receive approval from the institutional review board will be complex. Informed consent—the process by which a research participant provides his/her permission to participate in a clinical trial—is a staple of the research process and most commonly is in the form of a physical document. In the case of a novel procedure with uncertain benefits and risks and a participant population in acute need of a transplant, the consent process is crucial. These complexities may raise several ethical considerations for the initial pig kidney xenotransplantation recipients in the United States that will require adaptations of the required elements of the informed consent process by the US Department of Human and Health Services. The ethical issues include (1) a subject’s ability to withdraw from the trial, (2) restrictions on their reproductive rights, and (3) the possibility of the need for quarantine if there is a perceived risk of xenozoonosis. This article aims to discuss ethical considerations that may challenge the general required elements of the informed consent form stipulated by the 45 Code of Federal Regulations 46 of the US Department of Health and Human Services and to suggest recommendations for deliberation.
Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop
Improving Consent and Response in Longitudinal Studies of Aging: A Workshop, 25 March 2022
National Academies of Sciences, Engineering, and Medicine; Division of Behavioral and Social Sciences and Education; Committee on National Statistics
This Proceedings of a Workshop summarizes the presentations and discussions at the Workshop on Improving Consent and Response in Longitudinal Studies of Aging, which was held virtually and live-streamed on September 27-28, 2021. The workshop was convened by the Committee on National Statistics of the National Academies of Science, Engineering, and Medicine to assist the National Institute on Aging (NIA) with its methodological research agenda and inform the different longitudinal survey programs sponsored by NIA about practices and research to improve response and consent in other survey programs. The workshop was structured to bring together scientists and researchers from multiple disciplines and countries to share their research and insights on how to improve response and consent in large, representative longitudinal studies on aging.
Experimenting with modifications to consent forms in comparative effectiveness research: understanding the impact of language about financial implications and key information
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)
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.
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.
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).
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
Lynne M. Bianchi
Research during Medical Residency, 2022 [Taylor & Francis]
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
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)
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.
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.
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.
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
Hanna Kara, Maija Jappinen, Camilla Nordberg, Anna-Leena Riitaoja
Qualitative Social Work, 2022; pp 1-16
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.