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_August 2021
Informed Consent in the Council for International Organizations of Medical Sciences (CIOMS) guidance on Clinical research in resource-limited settings, held on July 21st 2021, was the latest webinar in the Center’s continuing series. David Curry opened the call with a high-level overview of the guidance. Paige Fitzsimmons followed with a brief summary of how informed consent is treated in the guidance. Getnet Yimer then provided observations and reflections on this guidance and associated challenges with implementation from a field research and ethics review board perspective. Dónal O’Mathúna closed the discussion by examining how community engagement is treated in the new guidance.
COVID-19 Vaccination of Minors Without Parental Consent; Respecting Emerging Autonomy and Advancing Public Health
Larissa Morgan, Jason L. Schwartz, Dominic A. Sisti
JAMA Pediatrics, 12 July 2021
In May 2021, the Pfizer-BioNTech COVID-19 vaccine received emergency use authorization from the US Food and Drug Administration in adolescents aged 12 to 15 years, with authorization for younger children expected later this year.1 Despite reported clinical trial data indicating that the vaccine is safe and 100% efficacious for this age range, some parents and guardians may remain hesitant or outright opposed to vaccinating their children, particularly in politically and culturally conservative communities… Children and adolescents have the capacity to understand and reason about low-risk and high-benefit health care interventions. State laws should therefore authorize minors to consent to COVID-19 vaccination without parental permission…
Implications and advice on getting COVID-19 vaccine consent: How to support people with learning disabilities to get vaccinated
Learning Disability Practice, 2021; 10-12
Vaccinations against COVID-19 are not mandatory and where people can give or refuse consent we have a responsibility to ensure consent is sought. Many people with learning disabilities will be unable to consent, but others will be able to consent if given the right support. Nurses, carers and families should begin planning as soon as possible, so they are prepared when the invitation to receive the vaccine arrives.
Implementation of documented and written informed consent for clinical trials of communicable diseases: Lessons learned, barriers, solutions, future directions identified during the conduct of a COVID-19 clinical trial
Patricia Woods, Maura Flynn, Paul Monach, Karen Visnaw, Sara Schiller, Erika Holmberg, Sarah Leatherman, Ryan Ferguson, Westyn Branch-Elliman
Contemporary Clinical Trials Communications, September 2021, 23
Background and objective
The communicable nature of many infectious diseases, including SARS-CoV-2, creates challenges for implementing and obtaining regulatory-compliant written informed consent. The goal of this project was to identify and evaluate processes that address these barriers while maintaining clinical and research staff safety.
We reviewed Federal Drug Administration (FDA), World Health Organization (WHO), and VA Office of Research and Development (ORD) guidance about informed consent during the COVID-19 pandemic, and identified and pilot-tested several mechanisms for obtaining regulatory-compliant consent during our COVID-19 therapeutics clinical trial.
Several processes were identified. These included a standard face-to-face consent with a plan for maintaining a paper copy of the signed consent form, a phone or video chat consent process that included taking a picture of the signed consent form or a screen shot of the signed document during a video chat, integration of the consent forms into software embedded within the electronic health record, and secure software programs with electronic signature. These processes are FDA-compliant but time-intensive, often requiring four or more hours of coordination between the clinical team, research staff, patients, and legally authorized representatives.
Future studies could evaluate how to improve efficiency, and whether some elements of the consenting process, such as the requirement for documented written signed consent, rather than a witnessed oral consent, is an acceptable standard for research participants with communicable diseases.
Ethical and legal requirements for biomedical research involving health data in the context of the Covid-19 pandemic: is informed consent still playing the leading role?
Federico de Montalvo Jääskeläinen
BioLaw Journal, February 2021
The current pandemic could have accelerated a change of the traditional paradigm about the secondary use of health data. The traditional one has been based on the faculty of the individuals about accepting or not that use of their health data through the main role of informed consent. The new paradigm considers the current value of that secondary use for the improvement of the health of community and its individuals, through the possibilities offered by Big Data and AI. Therefore, the need of a balance between individual rights and the common good is indispensable. Pseudonymization could be the way to find this balance.
Editor’s note: This article notes that pseudonymization is understood as the processing of personal data in such a way that they can no longer be attributed to an interested party without using additional information.
The Impact of a Digital Vaccine Consent Form in a Large Community Pharmacy Chain
Aylin Unal, Amy Sparkman, Pramit Nadpara, Jean-Venable R. Goode
Innovations in Pharmacy, 26 July 2021; 12(3)
A large community pharmacy chain implemented a new digital platform to eliminate the need for patients to fill out a traditional vaccine consent form in the pharmacy. The new digital vaccine consent form allowed patients to complete the form online, where it was transmitted directly to the pharmacy’s network.
To identify the characteristics of patients who used an online digital vaccine consent form to receive vaccinations and to evaluate patient satisfaction and confidence in utilizing the digital vaccine consent form to receive pharmacy services.
This three-month prospective study was conducted in the Mid-Atlantic division of a large community pharmacy chain. A 16-question survey was developed using information from the literature to collect demographic information and patient confidence and satisfaction with the digital vaccine consent form. An email was sent to pharmacy staff containing instructions on the procedure for posting a recruitment flyer, distributing the survey post-vaccination, and how to return completed surveys. Univariate and bi-variate analysis were conducted.
Thirty-six participants responded to the survey, majority of participants were female (56%). Two patients used the digital vaccine consent form; both used because it was more convenient and were likely to use the form again. For those who did not use the digital vaccine consent form, 32% feel somewhat unconfident in using digital technologies for pharmacy services. A majority of patients prefer to be notified about new online services by email (39%) or advertisements in the pharmacy (31%). When asked the likelihood of using the digital vaccine consent form in the future, majority stated unlikely (34%) or neutral (25%).
Most participants did not utilize the new digital vaccine form. This provides an opportunity to further engage patients on the availability and use of the digital vaccine consent form in order to advance digital technologies for pharmacy services.
The CORBEL matrix on informed consent in clinical studies: a multidisciplinary approach of Research Infrastructures Building Enduring Life-science Services
Cinzia Colombo, Michaela Th. Mayrhofer, Christine Kubiak, Serena Battaglia, Mihaela Matei, Marialuisa Lavitrano, Sara Casati, Victoria Chico, Irene Schluender, Tamara Carapina, Paola Mosconi
BMC Medical Ethics, 17 July 2021; 22(95)
Informed consent forms for clinical research are several and variable at international, national and local levels. According to the literature, they are often unclear and poorly understood by participants. Within the H2020 project CORBEL—Coordinated Research Infrastructures Building Enduring Life-science Services—clinical researchers, researchers in ethical, social, and legal issues, experts in planning and management of clinical studies, clinicians, researchers in citizen involvement and public engagement worked together to provide a minimum set of requirements for informed consent in clinical studies.
The template was based on a literature review including systematic reviews and guidelines searched on PubMed, Embase, Cochrane Library, NICE, SIGN, GIN, and Clearinghouse databases, and on comparison of templates gathered through an extensive search on the websites of research institutes, national and international agencies, and international initiatives. We discussed the draft versions step-by-step and then we referred to it as the “matrix” to underline its modular character and indicate that it allows adaptation to the context in which it will be used. The matrix was revised by representatives of two international patient groups.
The matrix covers the process of ensuring that the appropriate information, context and setting are provided so that the participant can give truly informed consent. It addresses the key topics and proposes wording on how to clarify the meaning of placebo and of non-inferiority studies, the importance of individual participants’ data sharing, and the impossibility of knowing in advance how the data might be used in future studies. Finally, it presents general suggestions on wording, format, and length of the information sheet.
The matrix underlines the importance of improving the process of communication, its proper conditions (space, time, setting), and addresses the participants’ lack of knowledge on how clinical research is conducted. It can be easily applied to a specific setting and could be a useful tool to identify the appropriate informed consent format for any study. The matrix is mainly intended to support multicentre interventional randomized clinical studies, but several suggestions also apply to non-interventional research.
Informed consent in biomedical research: Scopes and challenges
Reflections on Research
Kingshuk Chatterjee, Nilay K Das
Inidian Dermatology Online Journal, 14 July 2021; 12(4) 529-535
Medical science is evolving constantly and this evolution cannot happen without biomedical research involving human participant. Owing to a tumultuous history, importance of ethical research cannot be over emphasized in today’s world and the concept of informed consent becomes the guardian of ethics, not only to improve the bonding between the participant and researcher aiding a wholehearted involvement but also ensuring safety for the participants from research related injury/loss. Subject information sheet (SIF) and Informed consent form (ICF) are the fundamental elements of informed consent document. Process of obtaining them from illiterate and vulnerable populations involves the legally authorized representative (LAR) and impartial witness. Audiovisual recording becomes important in case of clinical trials. Process of obtaining informed consent becomes challenging for vulnerable populations as well as during pandemic situations. A comprehensive informed consent is essential for a credible and ethical research.
Enrollment with and without Exception from Informed Consent in a Pilot Trial of Tranexamic Acid in Children with Hemorrhagic Injuries
Seth W. Linakis, Nathan Kuppermann, Rachel M. Stanley, Hilary Hewes, Sage Myers, John M. VanBuren, T. Charles Casper, Matthew Bobinski, Simona Ghetti, Walton O. Schalick III, Daniel K. Nishijima
Academic Emergency Medicine, 12 July 2021
Federal exception from informed consent (EFIC) procedures allow studies to enroll patients with time-sensitive, life-threatening conditions when written consent is not feasible. Our objective was to compare enrollment rates with and without EFIC in a trial of tranexamic acid (TXA) for children with hemorrhagic injuries.
We conducted a four-center randomized controlled pilot and feasibility trial evaluating TXA in children with severe hemorrhagic brain and/or torso injuries. We initiated the trial enrolling patients without EFIC. After 3 months of enrollment, we met our a priori futility threshold and paused the trial to incorporate EFIC procedures and obtain regulatory approval. We then restarted the trial allowing EFIC if the guardian was unable to provide timely written consent. We used descriptive statistics to compare characteristics of eligible patients approached with and without EFIC procedures. We also calculated the time delay to restart the trial using EFIC.
We enrolled 1 of 15 (6.7%) eligible patients (0.17 per site per month) prior to using EFIC procedures. Of the 14 missed eligible patients, 7 (50%) were not enrolled because guardians were not present or were injured and unable to provide written consent. After obtaining approval for EFIC, we enrolled 30 of 48 (62.5%) eligible patients (1.34 per site per month). Of these 30 patients, 22 (73.3%) were enrolled with EFIC. Of the 22, no guardians refused written consent after randomization. There were no significant differences in the eligibility rate and patient characteristics enrolled with and without EFIC procedures. Across all sites, the mean delay to restart the trial using EFIC procedures was 12 months.
In a multicenter trial of severely injured children, the use of EFIC procedures greatly increased the enrollment rate and was well accepted by guardians. Initiating the trial without EFIC procedures led to a significant delay in enrollment.
Ethical Issues in Intraoperative Neuroscience Research: Assessing Subjects’ Recall of Informed Consent and Motivations for Participation
Anna Wexler, Rebekah J. Choi, Ashwin G. Ramayya, Nikhil Sharma, Brendan J. McShane, Love Y. Buch, Melanie P. Donley-Fletcher, Joshua I. Gold, Gordon H. Baltuch, Sara Goering, Eran Klein
AJOB Empirical Bioethics, 6 July 2021
An increasing number of studies utilize intracranial electrophysiology in human subjects to advance basic neuroscience knowledge. However, the use of neurosurgical patients as human research subjects raises important ethical considerations, particularly regarding informed consent and undue influence, as well as subjects’ motivations for participation. Yet a thorough empirical examination of these issues in a participant population has been lacking. The present study therefore aimed to empirically investigate ethical concerns regarding informed consent and voluntariness in Parkinson’s disease patients undergoing deep brain stimulator (DBS) placement who participated in an intraoperative neuroscience study.
Two semi-structured 30-minute interviews were conducted preoperatively and postoperatively via telephone. Interviews assessed participants’ motivations for participation in the parent intraoperative study, recall of information presented during the informed consent process, and participants’ postoperative reflections on the research study.
Twenty-two participants (mean age = 60.9) completed preoperative interviews at a mean of 7.8 days following informed consent and a mean of 5.2 days prior to DBS surgery. Twenty participants completed postoperative interviews at a mean of 5 weeks following surgery. All participants cited altruism or advancing medical science as “very important” or “important” in their decision to participate in the study. Only 22.7% (n = 5) correctly recalled one of the two risks of the study. Correct recall of other aspects of the informed consent was poor (36.4% for study purpose; 50.0% for study protocol; 36.4% for study benefits). All correctly understood that the study would not confer a direct therapeutic benefit to them.
Even though research coordinators were properly trained and the informed consent was administered according to protocol, participants demonstrated poor retention of study information. While intraoperative studies that aim to advance neuroscience knowledge represent a unique opportunity to gain fundamental scientific knowledge, improved standards for the informed consent process can help facilitate their ethical implementation.