Analysing and optimising Informed Consent in cooperation with ethics committees and medical researchers
Igor Matic, Gianni De Nardi, Felix Steiner
AILA Review, 9 September 2021; 34(1) pp 37–56
Medical researchers are ethically and legally required to inform participants and get written permission before enrolling them into a human research project (Informed Consent). Accordingly, information and consent represent a complex procedure, and the participant concerned “must receive comprehensible oral and written information” (Swiss legislation: Human Research Act (HRA) Art. 16). A triangle of stakeholders is involved in the procedure: ethics committees that review and approve research projects and Informed Consent (IC) documents, medical researchers who produce the documents and discuss enrolment with patients, and patients who have to be informed comprehensibly. From a linguistic point of view, the question arises as to which perceptions of comprehensibility form the basis of the IC process and how shared language can be established considering the complex relationship between these stakeholders. This contribution presents findings from two perspectives (ethics committees and researchers) while considering the needs of all three stakeholders. Firstly, the conceptualisation of comprehensibility among three ethic committees is presented, and steps toward harmonisation are outlined. Secondly, limitations of how researchers conduct oral IC information are analysed, and the measures that were implemented to improve patient information are discussed. A transdisciplinary approach is key in establishing these solutions because they do not stem from linguistic analysis alone but have been developed in close collaboration with members of ethics committees and medical researchers. Thus, the project shows how the expertise of applied linguistics in cooperation with practitioners can deliver an important impact in both academic analysis and optimisation of professional procedures.
Quantifying Withdrawal of Consent, Loss to Follow-Up, Early Drug Discontinuation, and Censoring in Oncology Trials
Brooke E. Wilson, Michelle B. Nadler, Alexandra Desnoyers, Eitan Amir
Journal of the National Comprehensive Cancer Network, 3 September 2021
Censoring due to early drug discontinuation (EDD) or withdrawal of consent or loss to follow-up (WCLFU) can result in postrandomization bias. In oncology, censoring rules vary with no defined standards. In this study, we sought to describe the planned handling and transparency of censoring data in oncology trials supporting FDA approval and to compare EDD and WCLFU in experimental and control arms.
We searched FDA archives to identify solid tumor drug approvals and their associated trials between 2015 and 2019, and extracted the planned handling and reporting of censored data. We compared the proportion of WCLFU and EDD between the experimental and control arms by using generalized estimating equations, and performed logistic regression to identify trial characteristics associated with WCLFU occurring more frequently in the control group.
Censoring rules were defined adequately in 48 (59%) of 81 included studies. Only 14 (17%) reported proportions of censored participants clearly. The proportion of WCLFU was higher in the control group than in the experimental group (mean, 3.9% vs 2.5%; β-coefficient, −2.2; 95% CI, −3.1 to −1.3; P<.001). EDD was numerically higher in the experimental arm in 61% of studies, but there was no statistically significant difference in the proportion of EDD between the experimental and control groups (mean, 21.6% vs 19.9%, respectively; β-coefficient, 0.27; 95% CI, −0.32 to 0.87; P=.37). The proportion of EDD due to adverse effects (AEs) was higher in the experimental group (mean, 13.2% vs 8.5%; β-coefficient, 1.5; 95% CI, 0.57–2.45; P=.002). WCLFU was higher in the control group in studies with an active control group (odds ratio [OR], 10.1; P<.001) and in open label studies (OR, 3.00; P=.08).
There are significant differences in WCLFU and EDD for AEs between the experimental and control arms in oncology trials. This may introduce postrandomization bias. Trials should improve the reporting and handling of censored data so that clinicians and patients are fully informed regarding the expected benefits of a treatment.
Exemption from informed consent: When it is possible in investigational product and drug trials?
Saudi Journal of Anesthesia, 2 September 2021; 15(4) pp 428-430
One of the most important ethical step in conducting investigational product trials or drug trials is obtaining informed consent from the participants. Although consent from the participants regarding participation is of prime importance but is not always practical or feasible. There may be several instances where it is practically impossible to obtain informed consent, whereas in some cases, obtaining informed consent from the trial participants adversely affects the quality and validity of the study data. Obtaining informed consent is a highly complex and technical process if the participants are not literate or suffering from a terminal illness, Also in some instances obtaining informed consent regarding the washout of prior prescribed medicine which may affect the trial outcomes. Although many guidelines exist for obtaining proper informed consent while very scarce literature exists on the instances where it can be waived off. Therefore, this brief narrative review aims to provide insight into currently available knowledge about when to obtain informed consent during testing of investigational product trials and drug trials and other possible scenarios where it can be waived off considering the effects of the washout period.
Telephone consent: optimizing the recruitment of research participants
Lívia Loamí Ruyz Jorge de Paula, Mateus Frederico de Paula, Levon Badiglian-Filho
Revista Bioética, April-June 2021; 29(2)
Informed consent aims to protect the autonomy of potential research participants, providing the information necessary to make the right decision. This study reports the experience of collecting the informed consent via telephone from individuals. Telephone contact was successfully achieved for more than 90% of the participants; 1.16% understood the survey, but did not accept to participate; and 0.70% refused to provide telephone consent and required a consent form by mail. Women from all regions of Brazil participated and most had some procedure in the hospital at least 62 days after the date of the call. The results show that telephone consent can be an alternative method of recruiting patients given the high rate of acceptance of the participants and time gains in data collection.
The Challenges of Multiculturalism on Informed Consent in Clinical Research
Studia Universitatis Babes-Bolyai Bioethica, 2021; 65 pp 174-175
The UNESCO Chair in Bioethics and Human Rights held its 6th international workshop to discuss the issues of Informed Consent and Clinical Research. Being part of the i-Consent consortium, a project funded by the European Union’s Horizon 2020 research and innovation program, the workshop focused on the multicultural and interdisciplinary dimension of ethical requirements of informed consent applied to translational/clinical research. Bioethical experts from Buddhism, Confucianism, Christianity, Hinduism, Islam and Judaism discussed the key challenges and the requirements of informed consent in clinical research. Some of the ethical gaps, barriers and challenges present in obtaining informed consent from patients/subjects in different, challenging cultural contexts were identified, as they represent minority groups and vulnerable populations. One of the findings is that many religious traditions do not accept the Western idealization of the autonomous self and prefer a more relational or communitarian understanding of doctorpatient/researcher-subject relationship. Western medicine and its current gold standard of informed consent that is practiced globally may not adequately address the theoretical skepticism towards the underlying principle of autonomy by different religions and cultures. This tension is becoming more pronounced with migrant and minority groups when they are asked to participate in clinical research as well as doing research in different parts of the world. A shift from individual to relational autonomy may offer a more nuanced improvement of the readability, design and obtaining process of consent forms. This shift will take into consideration the conscious and unconscious cultural biases of the investigators; multicultural and religious variables of the subjects’ understanding; cross-cultural vision of vulnerability, knowledge, communication and empathy; the need for individualized approaches to promote health protective behaviors; and framing questions for a multi-layered informed consent which includes East/West – North/South perspectives.
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
Asger S. Paludan-Müller, Michelle C. Ogden, Mikkel Marquardsen, Karsten J. Jørgensen, Peter C. Gøtzsche
BMC Medical Ethics, 28 August 2021; 22(115)
To determine to which degree industry partners in randomised clinical trials own the data and can constrain publication rights of academic investigators.
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.
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%).
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
Lydia O’ Sullivan, Laura Feeney, Rachel K. Crowley, Prasanth Sukumar, Eilish McAuliffe, Peter Doran
Trials, 18 August 2021; 22(544)
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.
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.
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.
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
Sylvestre, N. Orr Gaucher, T. Perez, O. Drouin
Ethics, Medicine and Public Health, December 2021; 19
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.
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.
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.
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
Evelien De Sutter, Pascal Borry, David Geerts, Isabelle Huys
BMC Medical Ethics, 31 July 2021; 22(108)
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.
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.
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.
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.
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.