Informed Consent: A Monthly Review
January 2023 :: Issue 49
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_January 2023
Informed Consent: Research Staff’s Perspectives and Practical Recommendations to Improve Research Staff-Participant Communication
Delphine Eeckhout, Karolien Aelbrecht, Catherine Van Der Straeten
Journal of Empirical Research on Human Research Ethics, 23 December 2022
Informed consent (IC) is the process of communication between research staff and potential research participants. However, ensuring that participants clearly understand what research participation entails, raises significant challenges. The aim of this study is to provide insight into some communication barriers that research staff are confronted with and make practical recommendations to improve communication between research staff and participants. A qualitative research study using semi-structured interviews (n = 13) with research staff from Ghent University Hospital was conducted. Data were transcribed verbatim and coded thematically. Our results indicate that communication- and process-related factors affect the IC process. Emergent recommendations include communication training, more interactive information materials and the use of digital alternatives, increasing general knowledge about research participation and patient- and public involvement.
The Informed Consent Form Navigator: A Tool for Producing Readable and Compliant Consent Documents
Jonathan P. Bona, Joseph Utecht, Aaron S. Kemp, Jennifer M. Gan, Alison Caballero, Christopher R. Trudeau, Mathias Brochhausen, Laura James
Journal of Clinical and Translational Science, December 2022 [preprint]
Informed consent forms (ICFs) and practices vary widely across institutions. This project expands on previous work at the University of Arkansas for Medical Sciences (UAMS) Center for Health Literacy to develop a plain language ICF template. Our interdisciplinary team of researchers, comprised of biomedical informaticists, health literacy experts, and stakeholders in the Institutional Review Board (IRB) process, has developed the ICF Navigator, a novel tool to facilitate the creation of plain language ICFs that comply with all relevant regulatory requirements.
Our team first developed requirements for the ICF navigator tool. The tool was then implemented by a technical team of informaticists and software developers, in consultation with an informed consent legal expert. We developed and formalized a detailed knowledge map modeling regulatory requirements for ICFs, which drives workflows within the tool.
The ICF Navigator is a web-based tool that guides researchers through creating an ICF as they answer questions about their project. The navigator uses those responses to produce a clear and compliant ICF, displaying a real-time preview of the final form as content is added. Versioning and edits can be tracked to facilitate collaborative revisions by the research team and communication with the IRB. The navigator helps guide the creation of study-specific language, ensures compliance with regulatory requirements, and ensures that the resulting ICF is easy to read and understand.
The ICF Navigator is an innovative, customizable, open-source software tool that helps researchers produce custom readable and compliant ICFs for research studies involving human subjects.
A Review Assessing Participants’ Understanding of Informed Consent for Clinical Trials in Africa
Dorothy Maxwell Kazembe, Tigist Mesfin, Abigiya Abebe, Saba Mehari Embaye, Esther Nthenya Muthoka, Kedir Usmael, Mediha Ahmedin, Tsegahun Manyazewal
Medical Research Archives, November 2022; 10(11)
Informed consent provides detailed information to the participants to make informed voluntary and rational decision to participate in a study. It is a communication tool between investigator and the subject to ensure that high research ethical standards are followed. This review paper assessed the level of participants’ understanding of the information given to them by researchers during the clinical research.
A review approach was used to achieve the study objective.
The findings showed that the level of comprehension varied from study to study. There was a good comprehension in four domains; purpose, voluntariness, benefits and right to withdraw. Poor comprehensions were mostly in risks, side effects, and blinding. Higher level of education, repeated assessments of comprehension, time spent by the researcher explaining and clarifying the information influenced the comprehension.
The study findings point out that comprehension to informed consent is still a challenge that needs to be addressed during the field study. Once the consent is given it becomes a distant memory for most of the participants. This implies that proper tools and cut off points to determine participants’ comprehension need to be developed for standard assessment of such.
Consent Codes: Maintaining Consent in an Ever-expanding Open Science Ecosystem
Stephanie O. M. Dyke, Kathleen Connor, Victoria Nembaware, Nchangwi S. Munung, Kathy Reinold, Giselle Kerry, Mamana Mbiyavanga, Lyndon Zass, Mauricio Moldes, Samir Das, John M. Davis, Jordi Rambla De Argila, J. Dylan Spalding, Alan C. Evans, Nicola Mulder, Jason Karamchandani
Neuroinformatics, 15 December 2022
We previously proposed a structure for recording consent-based data use ‘categories’ and ‘requirements’ – Consent Codes – with a view to supporting maximum use and integration of genomic research datasets, and reducing uncertainty about permissible re-use of shared data. Here we discuss clarifications and subsequent updates to the Consent Codes (v4) based on new areas of application (e.g., the neurosciences, biobanking, H3Africa), policy developments (e.g., return of research results), and further practical considerations, including developments in automated approaches to consent management.
Attitudes of the Public Toward Consent for Biobank Research in Japan
Masanori Oikawa, Yoshiyuki Takimoto, Akira Akabayashi
Biopreservation & Biobanking, 19 December 2022
Parallel to the rapid advancement of biological and information technologies, the role and forms of biobank research have been constantly changing. The ethical, legal, and social implications of consent in biobank research are in a state of flux. This study aimed to clarify current Japanese public preferences regarding the consent model and explore how public attitudes are determined.
We conducted an online, population-based quantitative survey among Japanese residents aged between 20 and 69 years. Statistical analyses consisted of univariate and multivariate logistic regression.
Of the 1580 respondents, 60.9% preferred autonomy-based consent (specific or dynamic consent) and 23.9% preferred broad-type consent (opt-out or broad consent). Marital status, gender, and privacy concerns were significantly associated with the preference for a consent model.
Our results demonstrated the public’s current preference for autonomy-based consent, including dynamic consent. However, our findings also revealed that approximately half of the respondents considered broad consent as somewhat preferable.
Evaluating visual imagery for participant understanding of research concepts in genomics research
Erin Rothwell, Naomi O. Riches, Erin Johnson, Kimberly A. Kaphingst, Kelsey Kehoe, Sabrina Malone Jenkins, Rachel Palmquist, Carrie Torr, Caren J. Frost, Bob Wong, Joshua L. Bonkowsky
Journal of Community Genetics, 19 December 2022
Informed consent is crucial for participant understanding, engagement, and partnering for research. However, current written informed consents have significant limitations, particularly for complex topics such as genomics and biobanking. Our goal was to identify how participants visually conceptualize terminology used in genomics and biobanking research studies, which might provide a novel approach for informed consent. An online convenience sample was used from May to July 2020 to collect data. Participants were asked to draw 10 randomly chosen words out of 32 possible words commonly used in consent forms for genomics and biobanking research. An electronic application captured drawings that were downloaded into a qualitative software program for analysis. A total of 739 drawings by 269 participants were captured. Participants were mostly female (61.3%), eight different race/ethnicities were represented (15.6% Black, 13.8% Hispanic), and most had some college education (68.8%). Some words had consistent visual themes such as different types of risky activities for risk or consistent specific images such as a double helix for DNA. Several words were frequently misunderstood (e.g., ascend for assent), while others returned few submissions (e.g., phenotype or whole genome sequencing). We found that although some words used in genomics and biobanking research were visually conceptualized in a common fashion, but misunderstood or less well-known words had no, few, or mistaken drawings. Future research can explore the incorporation of visual images to improve participant comprehension during consent processes, and how to utilize visual imagery to address more challenging concepts.
Rapid Genome Sequencing: Consent for New Technologies in the Neonatal Intensive Care Context
Fiona Lynch, Trisha Prentice, Lynn Gillam, Zornitza Stark, Christopher Gyngell
Pediatrics, 29 November 2022; 150(6)
The clinical utility of rapid genome sequencing (rGS) in critically unwell infants has been consistently demonstrated, and there are calls for rGS to be implemented as a first-line test in the NICU. A diagnosis from rGS can enable rapid initiation of precision treatment, making it potentially lifesaving. However, in many patients rGS leads to the diagnosis of severe and life-limiting conditions, prompting discussion with families about withdrawal of life-sustaining treatment.
The complexity of information about rGS, together with the heightened emotions of parents in the NICU, poses significant challenges for informed decision making in this context. We present a case where both parents are unable to provide informed consent, and the treating team must decide whether to proceed with rGS. Our discussion highlights the important differences between genome sequencing and other types of genetic testing, and the crucial role played by pre-test counseling in facilitating informed consent and preparing parents for a range of possible outcomes. We then discuss the consent paradigms at play in NICUs; whereas admission generally comes with an understanding that the treating team will perform interventions thought to be in the best interest of the child, rGS is substantially different because of its long-term implications for patients and family members. Finally, we look at the ethical interplay between parental consent and the interests of the child. We conclude by showing how cases like this are resolved at our tertiary center and how they may be resolved differently in future.
Patient informed consent for a clinical trial of gene-edited pig kidney transplantation: A representative consent form
David K. C. Cooper
Xenotransplantation, 26 November 2022
When clinical trials of gene-edited pig organ transplantation are initiated, the consent form that the patient is requested to sign will be an important document. Consent to receive a pig xenograft will have significant differences when compared with the requirements of most experimental clinical procedures. We here suggest a consent form for pig kidney transplantation that addresses the major points that will be required and hope it will provide a basis for discussion and future modification, if necessary. There is purposely some repetition in the document, but we believe this is necessary to ensure that the patient has a clear understanding of what he/she is consenting to.
Assessment of cognitive function among adults aged ≥ 60 years using the Revised Hasegawa Dementia Scale: cross-sectional study, Lao People’s Democratic Republic
Sengchanh Kounnavong, Manithong Vonglokham, Somphou Sayasone, Vanthanom Savathdy, Emiko Masaki, Ryoma Kayano, Bounfeng Phoummalaysith, Boungnong Boupha, Nobuyuki Hamajima
Health Research Policy and Systems, 29 November 2022; 20(121)
Rapid population ageing remains an important concern for health, social and economics systems; thus, a broader assessment of cognitive decline among adults aged ≥ 60 years is essential. It is important to regularly collect reliable data through validated and affordable methods from people living in different areas and in different circumstances to better understand the significance of this health problem. This study aimed to identify the prevalence of cognitive impairment and the related risk factors by reassessing the scoring of the Revised Hasegawa Dementia Scale among older adults in the Lao People’s Democratic Republic.
A community-based cross-sectional investigation was conducted in rural and urban settings in six districts of three provinces in the country from January to July 2020. In total, 2206 individuals aged 60–98 years (1110 men and 1096 women) were interviewed in person using a pretested Lao version of the Revised Hasegawa Dementia Scale and the WHO STEPwise approach to noncommunicable disease (NCD) risk factor surveillance (the STEPS survey tool). The adjusted odds ratios (AORs) and 95% confidence intervals (95% CIs) were estimated using a logistic model.
The study found that 49.3% (1088/2206) of respondents (39.7% [441/1110] of men and 59.0% [647/1096] of women) had scores associated with some level of cognitive impairment. In addition to age, the following factors were significantly associated with cognitive impairment: having no formal education (AOR = 9.5; 95% CI: 5.4 to 16.8, relative to those with a university education), living in the northern region of the country (AOR = 1.4; 95% CI: 1.1 to 1.9, relative to living in the central region), living in a rural area (AOR = 1.5; 95% CI: 1.2 to 1.8), needing assistance with self-care (AOR = 1.8; 95% CI: 1.2 to 2.7) and being underweight (AOR = 1.5; 95% CI: 1.1 to 2.2). Factors associated with no cognitive impairment among older adults include engaging in moderate-intensity physical activity lasting for 10 minutes and up to 1 hour (AOR = 0.6; 95% CI: 0.5 to 0.8) and for > 1 hour (AOR = 0.6; 95% CI: 0.4 to 0.8).
Using the Lao version of the Revised Hasegawa Dementia Scale, this study found that more than half of adults aged ≥ 60 years had cognitive impairment, and this impairment was associated with several risk factors. The limitations of this study may include possible overdetection due to the cutoff point for the assessment of cognitive decline used in the Revised Hasegawa Dementia Scale, given that the participants were not familiar with the instrument. However, the study results can be used to help inform health policy in the Lao People’s Democratic Republic regarding the urgent need for a routine data collection system and for providing an environment that addresses and reduces the identified risk factors for cognitive decline to mitigate their impact.