Month: September 2021

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Informed Consent: A Monthly Review
___________________________

September 2021

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:

Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_September 2021

A literature review of consent declines and consent withdrawals in randomized controlled trials conducted during the COVID-19 pandemic

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A literature review of consent declines and consent withdrawals in randomized controlled trials conducted during the COVID-19 pandemic
Original Article
NJ Gogtay, HJ Sheth, MR Maurya, MN Belhekar, UM Thatte
Journal of Postgraduate Medicine, 16 August 2021; 67(3) pp 134-138
Abstract
Objectives
We evaluated the extent of consent declines and consent withdrawals during the COVID-19 pandemic as seen in published randomized controlled trials (RCTs) and compared it with non-COVID-19 RCTs published at the same time and two historical controls.
Methods
PubMed/Medline only was searched using key-word “COVID-19” and “RCTs” separately, and filtered for COVID-19 RCTs and non-COVID-19 RCTs respectively, published during a nine-month period (1 Feb – 1 Nov 2020). Exclusions were study protocols, observational studies, interim analysis of RCT data and RCTs with missing data. Primary outcome measures were the proportion of consent declines and consent withdrawals as percentage of total participants screened and randomized respectively in COVID-19 RCTs. We compared consent declines and consent withdrawals of COVID-19 RCTs with non-COVID-19 RCTs and two earlier studies on the same topic that served as historical controls (non-pandemic setting).
Results
The search yielded a total of 111 COVID-19 RCTs and 49 non-COVID-19 RCTs. Of these, 39 (35.13%) COVID-19 RCTs and 11 (22.45%) non-COVID-19 RCTs were finally analysed. A total of 770/17759 (4.3%) consent declines and 100/7607 (1.31%) consent withdrawals were seen in 39 COVID-19 RCTs. A significant difference was observed in consent declines between COVID-19 vs non-COVID-19 RCTs [4.3% vs 11.9%, p < 0.0001] and between COVID-19 RCTs vs two historical controls [(4.3% vs 8.6%, p < 0.0001) and (4.3% vs 21.1%, p < 0.0001), respectively].
Conclusion
RCTs conducted during the COVID-19 pandemic appear to have significantly lower consent declines relative to non-COVID-19 RCTs during pandemic and RCTs conducted in non-pandemic settings.

Informed consent and informed intervention: SARS-CoV-2 vaccinations not just call for disclosure of newly emerging safety data but also for hypothesis generation and testing

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Informed consent and informed intervention: SARS-CoV-2 vaccinations not just call for disclosure of newly emerging safety data but also for hypothesis generation and testing
Letter to the Editor
Johannes C. Fischer, Albrecht G. Schmidt, Edwin Bölke, Verena Keitel, Torsten Feldt, Björn Jensen, Noemi F. Freise, Dieter Häussinger, E. Marion Schneider, Derik Hermsen, Detlef Kindgen-Milles, Wolfram Trudo Knoefel, Jan Haussmann, Balint Tamaskovics, Christian Plettenberg, Kathrin Scheckenbach, Stefanie Corradini, Jutta Rox, Vera Balz, Kitti Maas, Livia Schmidt, Olaf Grebe, Anja Erhardt, Peter Arne Gerber, Matthias Peiper, Bettina Alexandra Buhren, Artur Lichtenberg, Amir Rezazadeh, Wilfried Budach, Christiane Matuschek
European Journal of Medical Research, 6 August 2021; 26(87)
Open Access
Abstract
Background
COVID-19 infection is a major threat to patients and health care providers around the world. One solution is the vaccination against SARS-CoV-2.
Methods
We performed a comprehensive query of the latest publications on the prevention of viral infections including the recent vaccination program and its side effects.
Results
The situation is evolving rapidly and there is no reasonable alternative to population-scale vaccination programs as currently enrolled.
Conclusion
Therefore, regulatory authorities should consider supplementing their conventional mandate of post-approval pharmacovigilance, which is based on the collection, assessment, and regulatory response to emerging safety findings.

Anti-Coronavirus Disease 2019 Vaccines: Need for Informed Consent.

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Anti-Coronavirus Disease 2019 Vaccines: Need for Informed Consent.
Mazraani M, Barbari A
Experimental and Clinical Transplantation, 1 August 2021; 19(8) pp 753-762
Abstract
Vaccines are among some of the most efficacious medical and public health methods ever employed to contain a pandemic, in addition to providing protective and preventive measures. Evaluation of vaccine associated adverse events through experimentation and empirical evidence is an integral part of thoroughly assessing the safety of vaccines before authorization of their widespread use. History has highlighted the importance of continuous search for possible vaccine-related adverse effects and vaccine-induced immunogenicity long after licensure, suggesting that a primary concern with new vaccines is not only efficacy but also safety, particularly over the long term. Many of the various anti-COVID-19 vaccines have used different types of technology, with some being introduced for the first time or rushed shortly into testing, bypassing animal experimentations. They have been adopted for use through emergency use authorizations, leading to a less than optimal collection of broad data on safety, immunogenicity, effectiveness, and time span of protection, as well as short follow-up of few months, despite many infectious disease experts arguing that it takes 10 years to develop a vaccine. Given the valid concerns on well-recognized short-term and long-term safety issues, such as antibody-dependent enhancement and other processes like molecular mimicry and potential genomic transformation, the experimental nature of the vaccination process, the limited short term follow-up in the main trials, and the dismissal by law of pharma companies and health care providers from any medico-legal responsibilities, the application of an informed consent should become not only a necessity but also mandatory by law in accordance with all declarations on human rights. Such information should be provided to every potential recipient in the form of an official written digital consent prior to the registration for or the receipt of the vaccine.

Editor’s note: Experimental and Clinical Transplantation is the official journal of the Middle East Society for Organ Transplantation.

How Spanish Biobanks have Adapted the Informed Consent Process During the COVID-19 Pandemic

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How Spanish Biobanks have Adapted the Informed Consent Process During the COVID-19 Pandemic
Pablo Enguer-Gosálbez, Jaime Fons-Martínez, Jacobo Martínez-Santamaría, Ana María Torres-Redondo, Cristina Villena-Portella, Aurora García-Robles, Javier Díez-Domingo
BioLaw Journal, 2021
Open Access
Abstract
Due to the situation caused by the Covid-19 pandemic, biobanks have adapted, among other processes, the obtaining of informed consents (IC). This paper details the most relevant elements of the applicable regulations, describes the adaptations done by some of the biobanks of the Spanish Biobank Network to manage the IC process, which have been approved by their Ethics Committees, and draws some conclusions from the results obtained from the survey carried out on these biobanks.

Are investigators’ access to trial data and rights to publish restricted and are potential trial participants informed about this? A comparison of trial protocols and informed consent materials

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Are investigators’ access to trial data and rights to publish restricted and are potential trial participants informed about this? A comparison of trial protocols and informed consent materials
Research Article
Asger S. Paludan-Müller, Michelle C. Ogden, Mikkel Marquardsen, Karsten J. Jørgensen, Peter C. Gøtzsche
BMC Medical Ethics, 28 August 2021; 22(115)
Open Access
Abstract
Objectives
To determine to which degree industry partners in randomised clinical trials own the data and can constrain publication rights of academic investigators.
Methods
Cohort study of trial protocols, publication agreements and other documents obtained through Freedom of Information requests, for a sample of 42 trials with industry involvement approved by ethics committees in Denmark. The main outcome measures used were: proportion of trials where data was owned by the industry partner, where the investigators right to publish were constrained and if this was mentioned in informed consent documents, and where the industry partner could review data while the trial was ongoing and stop the trial early.
Results
The industry partner owned all data in 20 trials (48%) and in 16 trials (38%) it was unclear. Publication constraints were described for 30 trials (71%) and this was not communicated to trial participants in informed consent documents in any of the trials. In eight trials (19%) the industry partner could review data during the trial, for 20 trials (48%) it was unclear. The industry partner could stop the trial early without any specific reason in 23 trials (55%).
Conclusions
Publication constraints are common, and data is often owned by industry partners. This is rarely communicated to trial participants. Such constraints might contribute to problems with selective outcome reporting. Patients should be fully informed about these aspects of trial conduct.

An evaluation of the process of informed consent: views from research participants and staff

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An evaluation of the process of informed consent: views from research participants and staff
Research
Lydia O’ Sullivan, Laura Feeney, Rachel K. Crowley, Prasanth Sukumar, Eilish McAuliffe, Peter Doran
Trials, 18 August 2021; 22(544)
Open Access
Abstract
Background
The process of informed consent for enrolment to a clinical research study can be complex for both participants and research staff. Challenges include respecting the potential participant’s autonomy and information needs while simultaneously providing adequate information to enable an informed decision. Qualitative research with small sample sizes has added to our understanding of these challenges. However, there is value in garnering the perspectives of research participants and staff across larger samples to explore the impact of contextual factors (time spent, the timing of the discussion and the setting), on the informed consent process.
Methods
Research staff and research participants from Ireland and the UK were invited to complete an anonymous survey by post or online (research participants) and online (research staff). The surveys aimed to quantify the perceptions of research participants and staff regarding some contextual factors about the process of informed consent. The survey, which contained 14 and 16 multiple choice questions for research participants and staff respectively, was analysed using descriptive statistics. Both surveys included one optional, open-ended question, which were analysed thematically.
Results
Research participants (169) and research staff (115) completed the survey. Research participants were predominantly positive about the informed consent process but highlighted the importance of having sufficient time and the value of providing follow-up once the study concludes, e.g. providing results to participants. Most staff (74.4%) staff reported that they felt very confident or confident facilitating informed consent discussions, but 63% felt information leaflets were too long and/or complicated, 56% were concerned about whether participants had understood complex information and 40% felt that time constraints were a barrier. A dominant theme from the open-ended responses to the staff survey was the importance of adequate time and resources.
Conclusions
Research participants in this study were overwhelmingly positive about their experience of the informed consent process. However, research staff expressed concern about how much participants have understood and studies of patient comprehension of research study information would seem to confirm these fears. This study highlights the importance of allocating adequate time to informed consent discussions, and research staff could consider using Teach Back techniques.

Rethinking informed consent in the age of behavioural sciences and relational autonomy

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Rethinking informed consent in the age of behavioural sciences and relational autonomy
Original Article
Sylvestre, N. Orr Gaucher, T. Perez, O. Drouin
Ethics, Medicine and Public Health, December 2021; 19
Summary
Background and objectives
Informed consent is one of the cornerstones of modern medicine, clinical ethics, and biomedical research. However, emerging evidence in behavioural sciences and relational accounts of autonomy in clinical ethics have highlighted biases and constructs that may challenge informed consent. In this paper, we examine these findings and explore ways forward to ensure the integrity of informed medical decision making.
Method
Cognitive biases affecting patients and clinicians were reviewed in relation to their influence on the cognitive abilities traditionally considered fundamental to informed decision making required for consent: understanding, appreciation and reasoning. The way these findings resonate with criticisms advanced by proponents of relational autonomy was explored.
Results
For patients and clinicians alike, perceiving risks, interpreting probabilities and projecting oneself into the future are influenced by many biases, including loss aversion, underweighting of small probabilities and optimistic bias. These biases directly impact informed decision making by affecting the cognitive processes of understanding, appreciation, and reasoning. In clinical ethics, growing interest in relational accounts of autonomy have highlighted how people are socially embedded, and how patients’ identities and preferences are forged through important social and relational influences. In all, evidence from the behavioural sciences offers support for relational accounts of autonomy and ways forward to improve current practices of informed consent.
Conclusion
Integrating the empirical evidence from behavioural sciences and theoretical elements of relational autonomy compels us to adapt current practices of informed consent. To ensure the integrity of informed medical decision making, the process must further consider the inherent contextual and relational elements that shape how persons consider risks and make decisions.

Personalized and long-term electronic informed consent in clinical research: stakeholder views

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Personalized and long-term electronic informed consent in clinical research: stakeholder views
Research
Evelien De Sutter, Pascal Borry, David Geerts, Isabelle Huys
BMC Medical Ethics, 31 July 2021; 22(108)
Open Access
Abstract
Background
The landscape of clinical research has evolved over the past decade. With technological advances, the practice of using electronic informed consent (eIC) has emerged. However, a number of challenges hinder the successful and widespread deployment of eIC in clinical research. Therefore, we aimed to investigate the views of various stakeholders on the potential advantages and challenges of eIC.
Methods
Semi-structured interviews were conducted with 39 participants from 5 stakeholder groups from across 11 European countries. The stakeholder groups included physicians, patient organization representatives, regulator representatives, ethics committee members, and pharmaceutical industry representatives, and all were involved in clinical research. Interviews were analyzed using the framework method.
Results
Interviewees identified that a powerful feature of eIC is its personalized approach as it may increase participant empowerment. However, they identified several ethical and practical challenges, such as ensuring research participants are not overloaded with information and offering the same options to research participants who would prefer a paper-based informed consent rather than eIC. According to the interviewees, eIC has the potential to establish efficient long-term interactions between the research participants and the research team in order to keep the participants informed during and after the study. Interviewees emphasized that a personal interaction with the research team is of utmost importance and this cannot be replaced by an electronic platform. In addition, interviewees across the stakeholder groups supported the idea of having a harmonized eIC approach across the European Member States.
Conclusions
Interviewees reported a range of design and implementation challenges which needs to be overcome to foster innovation in informing research participants and obtaining their consent electronically. It was considered important that the implementation of eIC runs alongside the face-to-face contact between research participants and the research team. Moreover, interviewees expect that eIC could offer the opportunity to enable a personalized approach and to strengthen continuous communication over time. If successfully implemented, eIC may facilitate the engagement of research participants in clinical research.

Integration of Social Media With Targeted Emails And In-Person Outreach For Exception From Informed Consent Community Consultation

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Integration of Social Media With Targeted Emails And In-Person Outreach For Exception From Informed Consent Community Consultation
Cindy H. Hsu, Jennifer Fowler, James A. Cranford, Michael P. Thomas, Robert W. Neumar
Academic Emergency Medicine, 20 August 2021
Abstract
Background
Exception from informed consent (EFIC) enables the enrollment of research subjects with emergent conditions to clinical trials without prior consent. EFIC study approval requires community consultation and public disclosure. We hypothesized that the integration of social media with targeted emails and in-person outreach is an effective community consultation strategy.
Methods
We utilized social media with targeted emails and in-person outreach for the community consultation of the ACCESS cardiac arrest trial. Study advertisements were disseminated using Facebook and Instagram, and targeted emails were sent to emergency medicine, prehospital and cardiology providers. We also interviewed at-risk individuals with cardiac conditions, their caretakers, and patient advocacy groups. Participants were asked to complete a survey about their opinions about the study.
Results
We collected 559 surveys over an 8-week period, and 70.5% of the surveys were obtained using social media. The mean age of survey respondents was 45 years; 89.9% were white and 60.1% were women. 91.3% believed ACCESS was an important study. Compared to the in-person group, more from social media (81.8% vs 63.3%, p < 0.05) and targeted email (77.4% vs 63.3%, p < 0.05) groups said they would include their loved ones in the study. More from the in-person group believed that their opinion would be considered seriously compared to the social media (75.9% vs 62.6%, p < 0.05) and targeted email (75.9% vs 54.5%, p < 0.05) groups. The incorporation of social media and targeted emails for community consultation reduced the cost per survey by 4-fold compared to an in-person only strategy.
Conclusions
The integration of social media with targeted emails and in-person outreach was a feasible and cost-saving approach for EFIC community consultation. Future work is necessary to determine the perception and best utilization of social media for community consultation.