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_December 2021
Surgery during the COVID-19 pandemic: Are we obtaining informed consent?
Emily Robinson, Joseph Ayathamattam, Holly Harris, Malcolm McFall
British Journal of Surgery, 28 October 2021; 108(Supplement 7)
It was estimated that 1 in 4 inpatients with COVID-19 acquired the virus whilst admitted in December 2020. Surgical patients that contract COVID-19 have poor outcomes, with mortality rates as high as 24% and risk of pulmonary complications as high as 50%. The Royal College of Surgeons of England published COVID-19 consenting guidelines in June 2020.
To identify the proportion of surgical patients who were informed of the risk of acquiring COVID-19 during the consenting process at two District General Hospitals.
The consent forms of 220 surgical patients who had either elective or emergency surgery during the second COVID-19 lockdown were reviewed retrospectively (1/11/2020-20/11/2020). This included General Surgery, Trauma and Orthopaedics and Urology. Patients with incomplete notes or who lacked capacity were excluded.
In total, 193 patients were included. We found that 41.5% of patients were consented for the risk of acquiring COVID-19 peri-operatively. This did not vary significantly between elective and non-elective patients.
Our study shows that current practice does not meet national recommendations. In order to provide informed consent, surgeons must engage in emerging research regarding the local prevalence of COVID-19 and the implications of infection during the peri-operative period. Only with this knowledge, will surgeons be able to balance the risks and benefits on a case by case basis, to provide the patient with necessary information for consent. We recommend that trusts adopt a COVID-19 consenting policy, as part of the pre-operative assessment.
Characterization of Informed Consent Forms Posted on ClinicalTrials.gov
Tony Tse, Sarah White, Luke Gelinas, Walker Morrell, Barbara Bierer, Deborah A. Zarin
JAMA Network Open, 18 November 2021; 4(11)
Informed consent forms (hereinafter, forms), part of a larger consent process that serves multiple bioethical functions, are intended to provide potential research volunteers with sufficient written information about a clinical trial to help them decide about participation. Despite concerns about their overall quality, broadly generalizable samples of forms have been difficult to access for quality improvement. Since July 2017, ClinicalTrials.gov has allowed voluntary posting of forms for registered studies. Subsequently (January 21, 2019), the revised Common Rule form-posting requirement (45 CFR 46.116[h]) became effective (eAppendix in the Supplement). To explore how access to forms has increased on ClinicalTrials.gov after these initiatives, we sought to characterize registered trials with available forms and posting trends. We also assessed the frequency of form posting by funder type for trials initiated since the revised Common Rule compliance date…
As of July 7, 2021, forms were publicly available on ClinicalTrials.gov for nearly 2100 US trials for a range of intervention types and conditions from across 600 mostly nonindustry sponsors. Many of these trials (1243 of 2088 [59.5%]) did not list funding by a US federal agency and, among those 1243 trials, some were initiated before the compliance date, suggesting that their forms were likely not required to be posted under the revised Common Rule. The absolute percentages of federally funded trials initiated since the Common Rule compliance date in set 2 remain relatively low, with fewer than 87 of 529 trials (16.5%) listing a key funder type of “NIH” or “other US federal agency” having posted forms. Although forms for a range of trials are now available on ClinicalTrials.gov, most appear to have been posted voluntarily. Limitations of this cross-sectional study include that retrieved trials were likely skewed toward those required by federal reporting requirements. Trials may have also been miscategorized because of errors or incomplete information in data self-reported by study sponsors. Further research is needed because it is likely too soon to assess the full impact of the revised Common Rule requirement.
Informed consent in pragmatic trials: results from a survey of trials published 2014-2019
Jennifer Zhe Zhang, Stuart G Nicholls, Kelly Carroll, Hayden Peter Nix, Cory E Goldstein, Spencer Phillips Hey, Jamie C Brehaut, Paul C McLean, Charles Weijer, Dean A Fergusson, Monica Taljaard
Journal of Medical Ethics, 15 November 2021
To describe reporting of informed consent in pragmatic trials, justifications for waivers of consent and reporting of alternative approaches to standard written consent. To identify factors associated with (1) not reporting and (2) not obtaining consent.
Survey of primary trial reports, published 2014-2019, identified using an electronic search filter for pragmatic trials implemented in MEDLINE, and registered in ClinicalTrials.gov.
Among 1988 trials, 132 (6.6%) did not include a statement about participant consent, 1691 (85.0%) reported consent had been obtained, 139 (7.0%) reported a waiver and 26 (1.3%) reported consent for one aspect (eg, data collection) but a waiver for another (eg, intervention). Of the 165 trials reporting a waiver, 76 (46.1%) provided a justification. Few (53, 2.9%) explicitly reported use of alternative approaches to consent. In multivariable logistic regression analyses, lower journal impact factor (p=0.001) and cluster randomisation (p<0.0001) were significantly associated with not reporting on consent, while trial recency, cluster randomisation, higher-income country settings, health services research and explicit labelling as pragmatic were significantly associated with not obtaining consent (all p<0.0001).
Not obtaining consent seems to be increasing and is associated with the use of cluster randomisation and pragmatic aims, but neither cluster randomisation nor pragmatism are currently accepted justifications for waivers of consent. Rather than considering either standard written informed consent or waivers of consent, researchers and research ethics committees could consider alternative consent approaches that may facilitate the conduct of pragmatic trials while preserving patient autonomy and the public’s trust in research.
Simplifying consent – Use of the novel integrated consent model in paediatric clinical research
Frances Yeung, Saoirse Cameron, Sepideh Taheri
Paediatrics & Child Health, 29 October 2021; 26(Supplement 1) pp e82–e84
Obtaining informed consent from patients to participate in clinical research has traditionally been a cumbersome process, often requiring lengthy documentation and the involvement of trained research staff. Moreover, this process can be a burden to the patient/family. As a result, progress in paediatric research and enabling continual improvement in care has been slow. In the last decade, research ethicists have proposed a new “integrated consent model” (ICM) for obtaining informed consent for pragmatic clinical trials that compare standard-of-care interventions, where there is clinical equipoise. In most cases of ICM, only a brief discussion with verbal consent is required, along with a handout on study purpose, risks, benefits, and procedures. This allows for a more condensed consent process, which maximizes clarity and minimizes information overload. ICM also allows the patient/family to maintain prospective autonomy and decision-making, as compared with deferred or waived consent. The ICM model allows staff in the circle of care to obtain consent, which minimizes the stress of meeting an additional person. To our knowledge, ICM has not yet been used in the paediatric population.
The objective of this abstract is to report on the utility of ICM in a non-randomized clinical trial carried out in the inpatient setting of a tertiary children’s hospital.
We compared two widely accepted standards of care for maintaining peripheral intravenous catheter patency in a cohort of children, namely continuous infusion (“to keep the vein open” or TKVO) versus saline lock (SL). The ICM process was reviewed and approved by REB. Nurses in the circle of care received a study package that included an REB approved “consent script” to be read to the patient/family, a single page information sheet, and instructions on documenting the obtained verbal consent in the patient’s chart (Graphic 1).
With ICM, 79% of participants were recruited into the trial by a nurse. Patient recruitment was completed 4 months ahead of the predicted schedule (Figure 1). Nursing, research, and medical staff were satisfied with ICM and found it easy to administer. ICM occurred smoothly and quickly for patients/families, with no interference with their medical care and practically no disruption to their daily schedule.
ICM is a practical alternative to laborious traditional consent models, is associated with higher patient recruitment rates, and is less burdensome for the patient/family. Paediatricians should be aware of the utility of this novel consent model.
Informed consent in psychotherapy: a survey on attitudes among psychotherapists in Switzerland
Klara Eberle, Martin grosse Holtforth, Marc Inderbinen, Jens Gaab, Yvonne Nestoriuc, Manuel Trachsel
BMC Medical Ethics, 12 November 2021; 22(150)
The legal and ethical guidelines of psychological professional associations stipulate that informed consent by patients is an essential prerequisite for psychotherapy. Despite this awareness of the importance of informed consent, there is little empirical evidence on what psychotherapists’ attitudes towards informed consent are and how informed consent is implemented in psychotherapeutic practice.
155 psychotherapists in Switzerland completed an online survey assessing their attitudes regarding informed consent.
Among the surveyed psychotherapists, there was a high consensus on important information that should be communicated to patients in the context of informed consent. Almost all psychotherapists rated confidentiality and its exemptions (95%) and self-determined decision-making (97%) as important. The importance to disclose information regarding fees and the empirical effectiveness of the provided treatment, were both seen as important by more than 80% of participants. The disclosure of personal information about the therapist was rated as important by 60%. Other aspects, which are not direct components of informed consent but rather overarching goals, were also evaluated rather homogeneously: self-determined decision making of the patient was rated as important by almost all of the surveyed psychotherapists (97%). The following components were also judged as important by a majority of the participants: promotion of hope (80%) and discussion of treatment goals (93%). Most psychotherapists described the implementation of informed consent as an ongoing process, rather than a one-time event during the first session of therapy. Therapists’ age, postgraduate training, treated patient group, and setting influenced attitudes towards informed consent.
The present study shows that informed consent is perceived by psychotherapists as both a challenge and a resource. The implementation of informed consent in psychotherapy requires further research from a clinical and ethical perspective.
From Shadow Profiles to Contact Tracing: Qualitative Research into Consent and Privacy
Sacha Molitorisz, James Meese, Jennifer Hagedorn
Law, Technology and Humans, 8 November 2021; 3(2)
For many privacy scholars, consent is on life support, if not dead. In July 2020, we held six focus groups in Australia to test this claim by gauging attitudes to consent and privacy, with a spotlight on smartphones. These focus groups included discussion of four case studies: ‘shadow profiles’, eavesdropping by companies on smartphone users, non-consensual government surveillance of its citizens and contact tracing apps developed to combat COVID-19. Our participants expressed concerns about these practices and said they valued individual consent and saw it as a key element of privacy protection. However, they saw the limits of individual consent, saying that the law and the design of digital services also have key roles to play. Building on these findings, we argue for a blend of good law, good design and an appreciation that individual consent is still valued and must be fixed rather than discarded – ideally in ways that are also collective. In other words, consent is dead; long live consent.
“A Question of Trust” and “a Leap of Faith”—Study Participants’ Perspectives on Consent, Privacy, and Trust in Smart Home Research: Qualitative Study
Mari-Rose Kennedy, Richard Huxtable, Giles Birchley, Jonathan Ives, Ian Craddock
JMIR Mhealth Uhealth, November 2021; 9(11)
Ubiquitous, smart technology has the potential to assist humans in numerous ways, including with health and social care. COVID-19 has notably hastened the move to remotely delivering many health services. A variety of stakeholders are involved in the process of developing technology. Where stakeholders are research participants, this poses practical and ethical challenges, particularly if the research is conducted in people’s homes. Researchers must observe prima facie ethical obligations linked to participants’ interests in having their autonomy and privacy respected.
This study aims to explore the ethical considerations around consent, privacy, anonymization, and data sharing with participants involved in SPHERE (Sensor Platform for Healthcare in a Residential Environment), a project for developing smart technology for monitoring health behaviors at home. Participants’ unique insights from being part of this unusual experiment offer valuable perspectives on how to properly approach informed consent for similar smart home research in the future.
Semistructured qualitative interviews were conducted with 7 households (16 individual participants) recruited from SPHERE. Purposive sampling was used to invite participants from a range of household types and ages. Interviews were conducted in participants’ homes or on-site at the University of Bristol. Interviews were digitally recorded, transcribed verbatim, and analyzed using an inductive thematic approach.
Four themes were identified—motivation for participating; transparency, understanding, and consent; privacy, anonymity, and data use; and trust in research. Motivations to participate in SPHERE stemmed from an altruistic desire to support research directed toward the public good. Participants were satisfied with the consent process despite reporting some difficulties—recalling and understanding the information received, the timing and amount of information provision, and sometimes finding the information to be abstract. Participants were satisfied that privacy was assured and judged that the goals of the research compensated for threats to privacy. Participants trusted SPHERE. The factors that were relevant to developing and maintaining this trust were the trustworthiness of the research team, the provision of necessary information, participants’ control over their participation, and positive prior experiences of research involvement.
This study offers valuable insights into the perspectives of participants in smart home research on important ethical considerations around consent and privacy. The findings may have practical implications for future research regarding the types of information researchers should convey, the extent to which anonymity can be assured, and the long-term duty of care owed to the participants who place trust in researchers not only on the basis of this information but also because of their institutional affiliation. This study highlights important ethical implications. Although autonomy matters, trust appears to matter the most. Therefore, researchers should be alert to the need to foster and maintain trust, particularly as failing to do so might have deleterious effects on future research.
A Blockchain-Based Dynamic Consent Architecture to Support Clinical Genomic Data Sharing (ConsentChain): Proof-of-Concept Study
Faisal Albalwy, Andrew Brass, Angela Davies
JMIR Medical Informatics, 3 November 2021; 9(11)
In clinical genomics, sharing of rare genetic disease information between genetic databases and laboratories is essential to determine the pathogenic significance of variants to enable the diagnosis of rare genetic diseases. Significant concerns regarding data governance and security have reduced this sharing in practice. Blockchain could provide a secure method for sharing genomic data between involved parties and thus help overcome some of these issues.
This study aims to contribute to the growing knowledge of the potential role of blockchain technology in supporting the sharing of clinical genomic data by describing blockchain-based dynamic consent architecture to support clinical genomic data sharing and provide a proof-of-concept implementation, called ConsentChain, for the architecture to explore its performance.
The ConsentChain requirements were captured from a patient forum to identify security and consent concerns. The ConsentChain was developed on the Ethereum platform, in which smart contracts were used to model the actions of patients, who may provide or withdraw consent to share their data; the data creator, who collects and stores patient data; and the data requester, who needs to query and access the patient data. A detailed analysis was undertaken of the ConsentChain performance as a function of the number of transactions processed by the system.
We describe ConsentChain, a blockchain-based system that provides a web portal interface to support clinical genomic sharing. ConsentChain allows patients to grant or withdraw data requester access and allows data requesters to query and submit access to data stored in a secure off-chain database. We also developed an ontology model to represent patient consent elements into machine-readable codes to automate the consent and data access processes.
Blockchains and smart contracts can provide an efficient and scalable mechanism to support dynamic consent functionality and address some of the barriers that inhibit genomic data sharing. However, they are not a complete answer, and a number of issues still need to be addressed before such systems can be deployed in practice, particularly in relation to verifying user credentials.
Improving patient informed consent for haemophilia gene therapy: the case for change
Laurence Woollard, Richard Gorman, Dakota J. Rosenfelt
Therapeutic Advances in Rare Disease, 26 September 2021
Adeno-associated virus-based gene therapy points to a coming transformation in the treatment of people living with haemophilia, promising sustained bleed control and potential improvement in quality of life. Nevertheless, the consequences of introducing new genetic material are not trivial. The perceived benefits should not minimise the challenges facing patients in understanding the long-term risks and providing a valid and meaningful informed consent, whether in a research or clinical setting. Informed consent is a fundamentally important doctrine in both medical ethics and health law, upholding an individual’s right to define their personal goals and make their own autonomous choices. Patients should be enabled to recognise their clinical situation, understand the implications of treatment and integrate every facet of their life into their decision. This review describes informed consent processes for haemophilia gene therapy clinical trials, factors affecting patients’ decision making and the availability of patient-centred decision support interventions, to ensure that patients’ interests are being protected. Regulatory guidance has been published for physicians and manufacturers in haemophilia on informed consent, including for gene therapy, while best-practice recommendations for patient–physician discussions are available. In all settings, however, communicating and presenting highly technical and complex therapeutic information is challenging, especially where multiple barriers to scientific knowledge and health literacy exist. We propose several evidence-informed strategies to enhance the consent procedure, such as utilising validated literacy and knowledge assessment tools as well as participatory learning environments over an extended period, to ensure that patients are fully cognisant of the consent they give or deny. Further research is needed to define new, creative approaches for patient education and the upholding of ethical values in the informed consent process for gene therapy. The lessons learnt and approaches developed within haemophilia could set the gold standard for good practice in ensuring ethical preparedness amidst advances in genetic therapies.