Informed Consent: A Monthly Review
This digest aggregates and distills key content adressing 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_November 2020
Surgical consent during the COVID-19 pandemic
Rotimi, K. Beatson, A. Aderombi, W. Lam, O. Bajomo, N. Kukreja
Annals of Medicine and Surgery, 9 October 2020; 59 pp 229-233
Background and aims
During the COVID-19 pandemic, surgical practice may deviate with operative and non-operative management considered. Appropriate discussion of options with patients is paramount to quality surgical care. Intercollegiate and EAES guidelines recommend discussing and documenting risk of COVID-19 exposure in the consent process for patients undergoing surgery.
Materials and methods
Closed-loop audit of consent forms for patients undergoing emergency and elective surgical procedures. Interventions implemented included education of wider surgical teams. Data was collected during a one-week period for each cycle and analysed using Chi-squared test.
In cycle 1, 6/17 (35.3%) case notes documented discussion of COVID-19 risk. Following intervention, compliance improved to 23/29 (79.3%) cases in cycle 2 and 33/45 (73.3%) cases in cycle 3.
Pre-intervention, our consenting practice was non-compliant. Our interventions led to significant and sustained improvements in practice. We recommend provision of wider surgical team education to facilitate good consenting practice.
Consent concerns in clinical trials of investigational therapies for COVID-19: Vulnerability versus voluntariness
Perspectives in Clinical Research, 6 October 2020
Obtaining informed consent from vulnerable patients participating in clinical trials of investigational therapies for COVID-19 is a major ethical challenge. Ethical and operational considerations – voluntariness, waiver, timing, time, documentation, and responsibilities of the sponsor, the investigator, and the ethics committee – are discussed briefly.
Nocebo effects by providing informed consent in shared decision making? Not necessarily: a randomized pilot-trial using an open-label placebo approach
Fabian Holzhüter, Johannes Hamann
BMC Medical Ethics, 14 October 2020; 21(97)
Thorough information of the patient is an integral part of the process of shared decision making. We aimed to investigate if detailed information about medication may induce nocebo (or placebo) effects.
We conducted a randomized, single-blind, pilot-study including n = 51 psychiatric in-patients aged between 18 and 80 years with a depressive disorder and accompanying sleeping disorders. In the intervention group we provided thorough information about adverse effects, while the control group received only a simple consent procedure. In both groups, patients received an open-label placebo pill instead of their sleeping medication.
No statistically significant differences between the intervention group and the control group were found regarding the main outcome parameter (a visual analogue scale indicating impairment by the new pill).
In this study, we were not able detect an effect of informed consent vs. simple consent on the emergence of placebo or nocebo effects. This finding is contrary to most assumptions and publications about this topic.
Neuropsychological validation of a brief quiz to examine comprehension of consent information in observational studies of substance users
Aldebarán Toledo-Fernández, Ricardo Sánchez-Domínguez, Luis Villalobos-Gallegos, Alejandro Pérez-López, Alan Macías-Flores, Rodrigo Marín-Navarrete
Ethics & Behaviour, 12 October 2020
The objective of this study was to determine the accuracy of a brief informed consent quiz (ICQ) to detect consent comprehension in individuals with cognitive impairment (as a proxy of incomprehension) and to explore the degree to which cognitive domains and recent substance use, independently, predict comprehension. We performed a secondary analysis of two cross-sectional studies in individuals with substance use disorders. The ICQ total score was used as the index test and the Montreal Cognitive Assessment (MoCA) as reference standard in receiver operating characteristic curves. Two independent multiple binary logistic regression models were performed using cognitive domains and days of recent substance use as predictors of ICQ outcome. We analyzed data from 215 and 251 participants, respectively. The ICQ showed moderate accuracy for major cognitive impairment (MoCA ≤ 21) (area under the curve ~ 77) and lower accuracy for mild impairment (MoCA ≤ 24) (area under the curve ~ 65). Optimal cutoff score was set at 10 points or less for detecting comprehension difficulty. Lower scores in Short-Term Memory, Attention, Language, and Orientation increased the probability of failing the ICQ. A procedure including both the ICQ and cognitive screening measure could improve the accuracy of consent comprehension assessments.
Researchers’ views on, and experiences with, the requirement to obtain informed consent in research involving human participants: a qualitative study
Antonia Xu, Melissa Therese Baysari, Sophie Lena Stocker, Liang Joo Leow, Richard Osborne Day & Jane Ellen Carland
BMC Medical Ethics, 2 October 2020; 21(93)
Informed consent is often cited as the “cornerstone” of research ethics. Its intent is that participants enter research voluntarily, with an understanding of what their participation entails. Despite agreement on the necessity to obtain informed consent in research, opinions vary on the threshold of disclosure necessary and the best method to obtain consent. We aimed to investigate Australian researchers’ views on, and their experiences with, obtaining informed consent.
Semi-structured interviews were conducted with 23 researchers from NSW institutions, working in various fields of research. Interviews were analysed and coded to identify themes.
Researchers reported that consent involved information disclosure, understanding and a voluntary decision. They emphasised the variability of consent interactions, which were dependent on potential participants’ abilities and interests, study complexity and context. All researchers reported providing written information to potential participants, yet questioned the readability and utility of this information. The majority reported using signed consent forms to ‘operationalise’ consent and reported little awareness of, and lack of support in implementing more dynamic informed consent procedures, such as verbal informed consent, that was fit for the purposes of their studies. Views on Human Research Ethics Committees (HRECs) varied. Some reported inconsistent, arduous inputs on the information form and consent process. Others expressed reliance on HRECs for guidance, viewing them as institutional safeguards.
This study highlights the importance of transparent relationships, both between researchers and participants, and between researchers and HRECs. Where the relationship with study participants was reported as more robust, researchers felt that they were better able to ensure participants made better, more informed decisions. Where the relationship with HRECs was reported as more robust, researchers were more likely to view them as institutional safeguards, rather than as bureaucratic hindrances. Conscientious and mindful researchers are paramount to ensuring the procedure accommodates individual requirements. This study advocates that when designing ethical informed consent practices, researchers should be integrated as autonomous players with a positive input on the process, rather than, in the worst case, predatory recruiters to be curtailed by information forms and oversight.
High-impact RCTs without prospective informed consent: a systematic review
Roma Dhamanaskar, Jon F Merz
Journal of Investigative Medicine, 1 October 2020
The prevalence of randomized controlled trials (RCTs) performed without fully informed prospective consent from subjects is unknown. We performed this study to estimate the prevalence of high-impact RCTs performed without informed consent from all subjects and examine whether such trials are becoming more prevalent. We performed a systematic review of English-language RCTs published from 2014 through 2018 identified in Scopus and sorted to identify the top 100 most highly cited RCTs each year. Text search of title and abstract included terms randomized controlled or clinical trial and spelling variants thereof, and excluded metaanalyses and systematic reviews. We independently identified the most highly cited RCTs based on predefined criteria and negotiated to agreement, then independently performed keyword searches, read, abstracted and coded information regarding informed consent from each paper and again negotiated to agreement. No quality indicators were assessed. We planned descriptive qualitative analysis and appropriate quantitative analysis to examine the prevalence and characteristics of trials enrolling subjects with other than fully informed prospective consent. We find that 44 (8.8%, binomial exact 95% CI 6.5% to 11.6%) of 500 high-impact RCTs did not secure informed consent from at least some subjects. The prevalence of such trials did not change over the 5 years (OR=1.09, z=0.78, p=0.44). A majority (66%) of the trials involved emergency situations, and 40 of 44 (90.9%) of the trials involved emergency interventions, pragmatic designs, were cluster randomized, or a combination of these factors. A qualitative analysis explores the methods of and justifications for waiving informed consent in our sample of RCTs.
Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review
Evelien De Sutter, Drieda Zaçe, Stefania Boccia, Maria Luisa Di Pietro, David Geerts, Pascal Borry, Isabelle Huys
Journal of Medical Research, October 2020; 22(10)
Informed consent is one of the key elements in biomedical research. The introduction of electronic informed consent can be a way to overcome many challenges related to paper-based informed consent; however, its novel opportunities remain largely unfulfilled due to several barriers.
We aimed to provide an overview of the ethical, legal, regulatory, and user interface perspectives of multiple stakeholder groups in order to assist responsible implementation of electronic informed consent in biomedical research.
We conducted a systematic literature search using Web of Science (Core collection), PubMed, EMBASE, ACM Digital Library, and PsycARTICLES. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were used for reporting this work. We included empirical full-text studies focusing on the concept of electronic informed consent in biomedical research covering the ethical, legal, regulatory, and user interface domains. Studies written in English and published from January 2010 onward were selected. We explored perspectives of different stakeholder groups, in particular researchers, research participants, health authorities, and ethics committees. We critically appraised literature included in the systematic review using the Newcastle-Ottawa scale for cohort and cross-sectional studies, Critical Appraisal Skills Programme for qualitative studies, Mixed Methods Appraisal Tool for mixed methods studies, and Jadad tool for randomized controlled trials.
A total of 40 studies met our inclusion criteria. Overall, the studies were heterogeneous in the type of study design, population, intervention, research context, and the tools used. Most of the studies’ populations were research participants (ie, patients and healthy volunteers). The majority of studies addressed barriers to achieving adequate understanding when using electronic informed consent. Concerns shared by multiple stakeholder groups were related to the security and legal validity of an electronic informed consent platform and usability for specific groups of research participants.
Electronic informed consent has the potential to improve the informed consent process in biomedical research compared to the current paper-based consent. The ethical, legal, regulatory, and user interface perspectives outlined in this review might serve to enhance the future implementation of electronic informed consent.
Exception From Informed Consent: How IRB Reviewers Assess Community Consultation and Public Disclosure
Makini Chisolm-Straker, Denise Nassisi, Mohamud R. Daya, Jennifer N.B. Cook, Ilene F. Wilets, Cindy Clesca, Lynne D. Richardson
AJOB Empirical Bioethics, 29 September 2020
Exception from Informed Consent (EFIC) regulations detail specific circumstances in which Institutional Review Boards (IRB) can approve studies where obtaining informed consent is not possible prior to subject enrollment.
To better understand how IRB members evaluate community consultation (CC) and public disclosure (PD) processes and results, semi-structured interviews of EFIC-experienced IRB members were conducted and analyzed using thematic analysis.
Interviews with 11 IRB members revealed similar approaches to reviewing EFIC studies. Most use summaries of CC activities to determine community members’ attitudes; none reported using specific criteria nor recalled any CC reviews that resulted in modifications to or denials of EFIC studies. Most interviewees thought metrics based on Community VOICES’s domains (feasibility, participant selection, quality of communication, community perceptions, investigator/IRB perceptions) would be helpful.
IRB members had similar experiences and concerns about reviewing EFIC studies. Development of metrics to assess CC processes may be useful to IRBs reviewing EFIC studies.
The Meaning of Informed Consent: Genome Editing Clinical Trials for Sickle Cell Disease
Stacy Desine, Brittany M. Hollister, Khadijah E. Abdallah, Anitra Persaud, Sara Chandros Hull, Vence L. Bonham
AJOB Empirical Bioethics, 12 October 2020; 11(4) pp 195-207
A first therapeutic target of somatic genome editing (SGE) is sickle cell disease (SCD), the most commonly inherited blood disorders, affecting more than 100,000 individuals in the United States. Advancement of SGE is contingent on patient participation in first in human clinical trials. However, seriously ill patients may be vulnerable to overestimating the benefits of early phase studies while underestimating the risks. Therefore, ensuring potential clinical trial participants are fully informed prior to participating in a SGE clinical trial is critical.
We conducted a mixed-methods study of adults with SCD as well as parents and physicians of individuals with SCD. Participants were asked to complete a genetic literacy survey, watch an educational video about genome editing, complete a twopart survey, and take part in focus group discussions. Focus groups addressed topics on clinical trials, ethics of gene editing, and what is not understood regarding gene editing. All focus groups were audio-recorded, transcribed, and analyzed using conventional content analysis techniques to identify major themes.
Our study examined the views of SCD stakeholders regarding what they want and need to know about genome editing to make an informed decision to participate in a SGE clinical trial. Prominent themes included stakeholders’ desire to understand treatment side effects, mechanism of action of SGE, trial qualification criteria, and the impact of SGE on quality of life. In addition, some physicians expressed concerns about the extent to which their patients would understand concepts related to SGE; however, individuals with SCD demonstrated higher levels of genetic literacy than estimated by physicians.
Designing ethically robust genome editing clinical trials for the SCD population will require, at a minimum, addressing the expressed information needs of the community through culturally sensitive engagement, so that they can make informed decisions to consider participation in clinical trials.