Telephone consent: optimizing the recruitment of research participants
Research
Lívia Loamí Ruyz Jorge de Paula, Mateus Frederico de Paula, Levon Badiglian-Filho
Revista Bioética, April-June 2021; 29(2)
Abstract
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
Joseph Tham
Studia Universitatis Babes-Bolyai Bioethica, 2021; 65 pp 174-175
Abstract
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
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
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
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
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.

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)
Abstract
Background
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.
Objectives
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.
Methods
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.
Results
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%).
Conclusions
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
Research Article
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)
Open Access
Abstract
Background
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.
Methods
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.
Results
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.
Conclusions
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
Abstract
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
Original Contribution
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
Abstract
Background
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.
Methods
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.
Results
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.
Conclusions
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.