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_March 2021
Clinical Trial Ethics in the Era of COVID-19 Pandemic
Muhammet Arslan, Nuket Ornek Buken
Journal of Clinical & Experimental Investigations, March 2021; 12(1) pp 1-7
The world has been suffering from the deadly effects of coronavirus and seemingly will continue to suffer for quite more time. Humanity has witnessed many kinds of outbreaks that have affected the population endemically or epidemically. Urgent need for treatment of COVID-19 is necessary and essential. In this article the cornerstones of clinical trial ethics, current publications and statements are analyzed to overcome the difficulties of pandemics with an additional focus on Turkey. The researching physician, volunteering patients, industry, institutions, and national/international ethico-legal bodies are playing important role in clinical research. As stated in the Hippocratic Oath, it is a physician’s duty to “first do no harm”. Many international documents also state the fact that preserving the dignity of people and basic rights is the most essential attitude. Clinical trials follow a certain set of principles regulated by legislative bodies. Medical ethics try to establish a common base for all research to fulfill the need for an internationally acceptable standard. Rather than serving the benefit of qualifications, ethical standards preserve qualitative values. It can be said that medical ethics is an appropriate discipline to serve the improvement of both science and morals.
Rethinking Consent for Stroke Trials in Time-Sensitive Situations Insights From the COVID-19 Pandemic
Mayank Goyal, Johanna Maria Ospel, Aravind Ganesh, Martha Marko, Marc Fisher
Stroke, 16 February 2021
Informed consent is a key concept to ensure patient autonomy in clinical trials and routine care. The coronavirus disease 2019 (COVID-19) pandemic has complicated informed consent processes, due to physical distancing precautions and increased physician workload. As such, obtaining timely and adequate patient consent has become a bottleneck for many clinical trials. However, this challenging situation might also present an opportunity to rethink and reappraise our approach to consent in clinical trials. This viewpoint discusses the challenges related to informed consent during the COVID-19 pandemic, whether it could be acceptable to alter current consent processes under these circumstances, and outlines a possible framework with predefined criteria and a system of checks and balances that could allow for alterations of existing consent processes to maximize patient benefit under exceptional circumstances such as the COVID-19 pandemic without undermining patient autonomy.
An international core outcome set for evaluating interventions to improve informed consent to clinical trials: the ELICIT Study
Katie Gillies, Paula R Williamson, Vikki A Entwistle, Heidi Gardner, Shaun Treweek, Marion K Campbell
Journal of Clinical Epidemiology, 26 February 2021
To develop a core outcome set for the evaluation of interventions that aim to improve how people make decisions about whether to participate in RCTs (of healthcare interventions), the ELICIT Study.
International mixed-method study involving a systematic review of existing outcomes, semi-structured interviews, an online Delphi survey, and a face-to-face consensus meeting.
The literature review and stakeholder interviews (n=25) initially identified 1045 reported outcomes that were grouped into 40 individually distinct outcomes. These 40 outcomes were scored for importance in two rounds of an online Delphi survey (n=79), with 18 people attending the consensus meeting. Consensus was reached on 12 core outcomes: therapeutic misconception; comfort with decision; authenticity of decision; communication about the trial; empowerment; sense of altruism; equipoise; knowledge; salience of questions; understanding, how helpful the process was for decision making; and trial attrition.
The ELICIT core outcome set is the first internationally agreed minimum set of outcomes deemed essential to be measured in all future studies evaluating interventions to improve decisions about participating in an RCT. Use of the ELICIT core set will ensure that results from these trials are comparable and relevant to all stakeholders.
Adding dynamic consent to a longitudinal cohort study: A qualitative study of EXCEED participant perspectives
Susan E. Wallace & José Miola
BMC Medical Ethics, 9 February 2021; 22(12)
Dynamic consent has been proposed as a process through which participants and patients can gain more control over how their data and samples, donated for biomedical research, are used, resulting in greater trust in researchers. It is also a way to respond to evolving data protection frameworks and new legislation. Others argue that the broad consent currently used in biobank research is ethically robust. Little empirical research with cohort study participants has been published. This research investigated the participants’ opinions of adding a dynamic consent interface to their existing study.
Adult participants in the Extended Cohort for E-health, Environment and DNA (EXCEED) longitudinal cohort study who are members of the EXCEED Public and Participant Engagement Group were recruited. Four focus groups were conducted and analysed for thematic content. Discussion topics were derived from a review of the current literature on dynamic consent.
Participants were in favour of many aspects of a dynamic consent interface, such as being able to update their information, add additional data to their records and choose withdrawal options. They were supportive provided it was simple to use and not intrusive. Participants expressed a markedly high level of trust in the study and its investigators and were unanimously happy with their current participation. No strong support was found for adding a dynamic consent interface to EXCEED.
Trust in the study researchers was the strongest theme found. Openness and good data security were needed to retain their trust. While happy to discuss dynamic consent, participants were satisfied with the current study arrangements. There were indications that changing the study might unnecessarily disturb their trust. This raised the question of whether there are contexts where dynamic consent is more appropriate than others. This study was limited by the small number of participants who were committed to the study and biased towards it. More research is needed to fully understand the potential impact of adding a dynamic consent interface to an existing cohort study.
Patient accrual and understanding of informed consent in a two-stage consent design
Andrew J Vickers, Emily A Vertosick, Sigrid V Carlsson, Behfar Ehdaie, Scott Y H Kim
Clinical Trials, 2 February 2021
We previously introduced the concept of “two-stage” (or “just-in-time”) informed consent for randomized trials with usual care control. We argued that conducting consent in two stages—splitting information about research procedures from information about the experimental intervention—would reduce the decisional anxiety, confusion, and information overload commonly associated with informed consent. We implemented two-stage consent in a low-stakes randomized trial of a mindfulness meditation intervention for procedural distress in patients undergoing prostate biopsy. Here, we report accrual rates and patient understanding of the consent process.
Patients approached for consent for the biopsy trial were asked to complete the standard “Quality of Informed Consent” questionnaire to assess their knowledge and understanding of the trial.
Accrual was excellent with 108 of 110 (98%) patients approached for consent signing first-stage consent. All 51 patients randomized to the experimental arm and who later presented for biopsy signed second-stage consent and received the mindfulness intervention. Quality of Informed Consent data were available for 48 patients assigned to the mindfulness treatment arm and 44 controls. The mean Quality of Informed Consent score was similar in the meditation and control arms with and overall mean of 75 (95% confidence interval = 74–76) for the knowledge section and 86 (95% confidence interval = 81–90) for understanding, comparable to the normative scores of 80 and 88. On further analysis and patient interview, two of the Quality of Informed Consent questions were found to be misleading in the context of a two-stage consent study for a mindfulness intervention. Excluding these questions increased knowledge scores to 88 (95% confidence interval = 87–90).
We found promising data that two-stage consent facilitated accrual without compromising patient understanding of randomized trials or compliance with allocated treatment. Further research is needed incorporating randomized comparison of two-stage consent to standard consent approaches, measuring patient anxiety and distress as an outcome, using suitable modifications to the Quality of Informed Consent questionnaire and trials with higher stakes.
Details of risk–benefit communication in informed consent documents for phase I/II trials
Hannes Kahrass, Sabine Bossert, Christopher Schürmann, Daniel Strech
Clinical Trials, 24 November 2020
Informed consent documents for clinical studies should disclose all reasonably foreseeable risks and benefits. Little guidance exists on how to navigate the complexities of risk–benefit communication, especially in early clinical research. Practice-oriented development of such guidance should be informed by evidence on what and how details of risks and benefits are currently communicated.
We surveyed the responsible parties of phase I/II trials registered in ClinicalTrials.gov that started 2007 or later and completed between 2012 and 2016 to sample informed consent documents from a broad spectrum of early phase clinical trials. Based on an assessment matrix, we qualitatively and quantitatively assessed the informed consent documents for details of risk–benefit communication.
The risk–benefit communication in the 172 informed consent documents differed substantially in several regards. The outcome, extent, and likelihood of health risks, for example, were described in 83%, 32%, and 63% of the informed consent documents. Only 45% of informed consent documents specified the outcome of mentioned health benefits, and the extent and likelihood of health benefits were never specified. From those informed consent documents reporting risk likelihoods, only 57% added frequency numbers to words such as “common” or “rare,” and even in these cases, we found strong variations for presented frequency ranges. Substantial heterogeneity also exists for how informed consent documents communicate other risk and benefit types and related safeguards.
Our study points to several shortcomings and heterogeneities in how informed consent documents communicate risks and benefits to potential research participants. Health risks, for example, should be specified with frequency numbers, and health benefits should be specified at least by mentioning their outcomes. Further demand for research and policy development is needed to harmonize risk–benefit communication and to clarify ways to specify the likelihood of health benefits.
A Qualitative Analysis of Ethical Perspectives on Recruitment and Consent for Human Intracranial Electrophysiology Studies
Joncarmen V. Mergenthaler, Winston Chiong, Daniel Dohan, Josh Feler, Cailin R. Lechner, Philip A. Starr, Jalayne J. Arias
AJOB Neuroscience, 2 February 2021; pp 57-67
Intracranial electrophysiological research methods, including those applying electrodes on the cortical surface or in deep structures, have become increasingly important in human neuroscience. They also pose novel ethical concerns, as human studies require the participation of neurological patients undergoing surgery for conditions such as epilepsy and Parkinson’s disease. Research participants in this setting may be vulnerable to conflicts of interest, therapeutic misconception, and other threats to valid recruitment and consent. We conducted semi-structured interviews with investigators from NIH-funded studies involving recording or stimulation inside the human skull. We elicited perspectives on study recruitment and consent procedures, and analyzed transcripts using a modified grounded theory approach. We interviewed 26 investigators from 19 separate intracranial electrophysiology studies, who described two study types: opportunity studies (n = 15) and experimental trials (n = 4). Respondents described significant heterogeneity in recruitment and consent procedures, even among studies employing similar techniques. In some studies, clinician-investigators were specifically barred from obtaining consent, while in other studies clinician-investigators were specifically required to obtain consent; regulatory guidance was inconsistent. Respondents also described various models for subject selection, the timing of consent, and continuing consent for temporally extended studies. Respondents expressed ethical concerns about participants’ vulnerability and the communication of research-related risks. We found a lack of consensus among investigators regarding recruitment and consent methods in human intracranial electrophysiology. This likely reflects the novelty and complexity of such studies and indicates a need for further discussion and development of best practices in this research domain.
DynamiChain: Development of Medical Blockchain Ecosystem Based on Dynamic Consent System
Tong Min Kim, Seo-Joon Lee, Dong-Jin Chang, Jawook Koo, Taenam Kim, Kun-Ho Yoon, In-Young Choi
Applied Science, 10 February 2021; 11(1612)
Although blockchain is acknowledged as one of the most important technologies to lead the fourth industrial revolution, major technical challenges regarding security breach and privacy issues remain. This issue is particularly sensitive in applied medical fields where personal health information is handled within the network. In addition, contemporary blockchain-converged solutions do not consider restricted medical data regulations that are still obstacles in many countries worldwide. This implies a crucial need for a system or solution that is suitable for the healthcare sector. Therefore, this article proposes the development of a dynamic consent medical blockchain system called DynamiChain, based on a ruleset management algorithm for handling health examination data. Moreover, medical blockchain-related studies were systematically reviewed to prove the novelty of DynamiChain. The proposed system was implemented in a scenario where the exercise management healthcare company provided health management services based on data obtained from the data provider’s hospital. The proposed research is envisioned to provide a widely compatible blockchain medical system that could be applied in future healthcare fields.
A Systematic Review of Blockchain for Consent Management
Prasanth Varma Kakarlapudi, Qusay H. Mahmoud
Healthcare, 1 February 2021
Blockchain technology was introduced through Bitcoin in a 2008 whitepaper by the mysterious Satoshi Nakamoto. Since its inception, it has gathered great attention because of its unique properties—immutability and decentralized authority. This technology is now being implemented in various fields such as healthcare, IoT, data management, etc., apart from cryptocurrencies. As it is a newly emerging technology, researchers and organizations face many challenges in integrating this technology into other fields. Consent management is one of the essential processes in an organization because of the ever-evolving privacy laws, which are introduced to provide more control to users over their data. This paper is a systematic review of Blockchain’s application in the field of consent and privacy data management. The review discusses the adaptation of Blockchain in healthcare, IoT, identity management, and data storage. This analysis is formed on the principles of the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) and a process of systematic mapping review. We provide analysis of the development, challenges, and limitations of blockchain technology for consent management.