Incentivization and the moral problem of involuntary consent in medical research

Incentivization and the moral problem of involuntary consent in medical research
Review
Victor Chidi Wolemonwu
History and Philosophy of Medicine, 18 January 2023
Open Access
Abstract
The legal and moral permissibility of clinical research entails that researchers must secure the voluntary, informed consent of prospective research participants before enrolling them in studies. In seeking the consent of potential participants, researchers are also allowed to incentivise the recruitment process because many studies would fail to meet enrollment goals without a financial incentive for participation. Some philosophers and bioethicists contend that the use of incentives to secure consent from research subjects is problematic because it constitutes undue inducement and a coercive offer. Some proponents of this view are Ruth Macklin (1981, 1989) and Joan McGregor (2005). Macklin claims that it is ethically inappropriate to pay research subjects. The payment is likely to coerce the research subject, thereby violating the ethical requirement on the voluntariness of research participation. Also, such offers can prompt subjects to lie, deceive or conceal information that, if known, would disqualify them as participants. For McGregor, incentives could be undue and coercive because they make offerees better off relative to their baseline as well as constrain them to accept the offer of incentives as the only eligible choice or option. I argue that coercive offers are distinct from undue inducement. Coercive offers are essentially morally objectionable because by making people accept an offer through threats for the sake of some interests or ends, the offeror vitiates the offeree’s capacity to make informed, voluntary, and rational decisions and choices. I further claim that the quantity of an incentive does not render an inducement undue. I contend that the only condition under which incentives are regarded as an undue inducement and as such vitiates an agent’s voluntary consent is if they are offered through deceptive or manipulative means.

Using the consolidated framework for implementation research to guide a pilot of implementing an institution level patient informed consent process for clinical research at an outpatient setting

Using the consolidated framework for implementation research to guide a pilot of implementing an institution level patient informed consent process for clinical research at an outpatient setting
Research
Xuling Lin, Joanne Yong Ern Yuen, Wei Quan Jeremy Chan, Tushar Gosavi Divakar, Nicole Chwee Har Keong, Lester Chee How Lee, Sumeet Kumar, Chew Seah Tan, Kim Chin Pauline Soon, Yee Pheng Amy Chew, Heriati Mohd Yazid, Farah Julieanna Mohd Saleh, Fenglong Cai, Fui Chih Chai, Nur Fakhirah Mohamed Azwan, Nurhidayah Mohamad Faizal, Siew Choo Lou, Siew Sin Priscilla Tan, Cut Marini Jarimin, Gowri Michael Stanley, Khadijah Hussien, Nurhazah Sanmwan, Nur Hidayah Amran, Nurliana Ramli, Shermyn Xiu Min Neo, Louis Chew Seng Tan, Eng King Tan, Elaine Lum
Pilot and Feasibility Studies, 12 January 2023; 9(6)
Open Access
Abstract
Background
In Singapore, research teams seek informed patient consent on an ad hoc basis for specific clinical studies and there is typically a role separation between operational and research staff. With the enactment of the Human Biomedical Research Act, there is increased emphasis on compliance with consent-taking processes and research documentation. To optimize resource use and facilitate long-term research sustainability at our institution, this study aimed to design and pilot an institution level informed consent workflow (the “intervention”) that is integrated with clinic operations.
Methods
We used the Consolidated Framework for Implementation Research (CFIR) as the underpinning theoretical framework and conducted the study in three stages: Stage 1, CFIR constructs were used to systematically identify barriers and facilitators of intervention implementation, and a simple time-and-motion study of the patient journey was used to inform the design of the intervention; Stage 2, implementation strategies were selected and mapped to the Expert Recommendations for Implementing Change (ERIC) taxonomy; Stage 3, we piloted and adapted the implementation process at two outpatient clinics and evaluated implementation effectiveness through patient participation rates.
Results
We identified 15 relevant CFIR constructs. Implementation strategies selected to address these constructs were targeted at three groups of stakeholders: institution leadership (develop relationships, involve executive boards, identify and prepare champions), clinic management team (develop relationships, identify and prepare champions, obtain support and commitment, educate stakeholders), and clinic operations staff (develop relationships, assess readiness, conduct training, cyclical tests of change, model and simulate change, capture and share local knowledge, obtain and use feedback). Time-and-motion study in clinics identified the pre-consultation timepoint as the most appropriate for the intervention. The implementation process was adapted according to clinic operations staff and service needs. At the conclusion of the pilot, 78.3% of eligible patients provided institution level informed consent via the integrated workflow implemented.
Conclusions
Our findings support the feasibility of implementing an institution level informed consent workflow that integrates with service operations at the outpatient setting to optimize healthcare resources for research. The CFIR provided a useful framework to identify barriers and facilitators in the design of the intervention and its implementation process.

Is the informed consent form only a symbolic document in clinical trials?

Is the informed consent form only a symbolic document in clinical trials?
Mini Review
Buket Gungor
Archives of Pharmacy and Pharmaceutical Sciences, 19 December 2022
Open Access
Excerpt
Being one of the basic principles of clinical research, informed consent is definitely a legal responsibility and ethical duty for health professionals. The purpose of obtaining informed consent is to enable the subjects to make an autonomous decision by providing them with accurate and clear information about the research at the stage of participation. Due to medical advancements and the increasing complexity of diagnostic and experimental methods in clinical research, the prepared Informed Consent Forms (ICFs) have become difficult to understand. Viewing ICFs as just a necessary legal and symbolic document of participation in research often results in an insufficiently informed consent process for subjects. Research shows that the rate of understanding the basic information in the consent forms prepared for the subjects participating in the clinical trials ranged from 52.1% to 75.8%…

Informed Consent for Routine Genetic Screening: Realistic or Idealistic?

Informed Consent for Routine Genetic Screening: Realistic or Idealistic?
Blair Stevens, Chelsea Wagner, Meagan Choates, Jacqueline Harkenrider, Samantha Montgomery, Shannon Mulligan, Aarti Ramdaney, Lea Jenna
American Journal of Obstetrics & Gynecology, 1 January 2023
Abstract
Objective
Aneuploidy and carrier screening should be offered to in the context of pretest education about the benefits and limitations of screening. We aimed to assess informed decision making regarding non-invasive prenatal testing (NIPT) and carrier screening (CS) using a validated Multi-Dimensional Measure of Informed Choice tool, which includes a knowledge scale, attitude scale and test behavior.
Study Design
Knowledge and satisfaction were assessed in a low risk cohort of patients who received pretest education for routine prenatal genetic screening through two different service models. Participants underwent either a consult with a genetic counselor (GC) (n=100) or utilized an interactive online module created by a team of GCs (n=115). Results from each cohort were compared to assess for differences in self reported informed decision making and knowledge.
Results
Overall scores regarding knowledge of NIPT and CS were higher in the GC-cohort (Mdn=84%, range=41-96%) compared to participants who utilized the online module (Mdn= 70%, range= 24-79%), demonstrating a significant difference in knowledge between these two groups (p=0.02). The majority of both groups expressed satisfaction with their pretest education regardless if it was through a GC (Mdn=97%, range=94-99%) or online education module (Mdn= 93%, range= 89-99%). There was no significant difference between the cohorts and their reported satisfaction (p=0.06). The majority of both cohorts believed they made informed decisions regarding their genetic screening.
Conclusion
Significantly lower knowledge scores do not appear to affect participant perception of informed decision making or satisfaction in a low risk patient population. We argue that knowledge based questions skew the standard of achieving informed consent to information seeking or highly educated patient populations. Our study supports that accessible information and autonomous decision making were sufficient for patients to feel satisfied and informed about their decision. Informed consent measures should be reconsidered with a diverse patient population in mind.

Fragmented understanding: exploring the practice and meaning of informed consent in clinical trials in Ho Chi Minh City, Vietnam

Fragmented understanding: exploring the practice and meaning of informed consent in clinical trials in Ho Chi Minh City, Vietnam
Jennifer Ilo Van Nuil, Evelyne Kestelyn, Susan Bull, Phu Hoan Nguyen, Phuong Thanh Le, Ngoc Bao Hong Lam, Thuan Trong Dang, Yen Hong Thi Nguyen
BMC Medical Ethics, 16 January 2023; 24(3)
Open Access
Abstract
Background
The informed consent process in clinical trials has been extensively studied to inform the development processes which protect research participants and encourage their autonomy. However, ensuring a meaningful informed consent process is still of great concern in many research settings due to its complexity in practice and intertwined socio-cultural factors.
Objectives
This study explored the practices and meaning of the informed consent process in two clinical trials conducted by Oxford University Clinical Research Unit in collaboration with the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam.
Methods
We used multiple data collection methods including direct observations, in-depth interviews with study physicians and trial participants, review of informed consent documents from 2009 to 2018, and participant observation with patients’ family members. We recruited seven physicians and twenty-five trial participants into the study, of whom five physicians and thirteen trial participants completed in-depth interviews, and we held twenty-two direct observation sessions.
Results
We use the concept “fragmented understanding” to describe the nuances of understanding about the consent process and unpack underlying reasons for differing understandings.
Conclusions
Our findings show how practices of informed consent and different understanding of the trial information are shaped by trial participants’ characteristics and the socio-cultural context in which the trials take place.

Informed Consent: Research Staff’s Perspectives and Practical Recommendations to Improve Research Staff-Participant Communication

Informed Consent: Research Staff’s Perspectives and Practical Recommendations to Improve Research Staff-Participant Communication
Delphine Eeckhout, Karolien Aelbrecht, Catherine Van Der Straeten
Journal of Empirical Research on Human Research Ethics, 23 December 2022
Abstract
Informed consent (IC) is the process of communication between research staff and potential research participants. However, ensuring that participants clearly understand what research participation entails, raises significant challenges. The aim of this study is to provide insight into some communication barriers that research staff are confronted with and make practical recommendations to improve communication between research staff and participants. A qualitative research study using semi-structured interviews (n = 13) with research staff from Ghent University Hospital was conducted. Data were transcribed verbatim and coded thematically. Our results indicate that communication- and process-related factors affect the IC process. Emergent recommendations include communication training, more interactive information materials and the use of digital alternatives, increasing general knowledge about research participation and patient- and public involvement.

The Informed Consent Form Navigator: A Tool for Producing Readable and Compliant Consent Documents

The Informed Consent Form Navigator: A Tool for Producing Readable and Compliant Consent Documents
Jonathan P. Bona, Joseph Utecht, Aaron S. Kemp, Jennifer M. Gan, Alison Caballero, Christopher R. Trudeau, Mathias Brochhausen, Laura James
Journal of Clinical and Translational Science, December 2022 [preprint]
Open Access
Abstract
Background/Objective
Informed consent forms (ICFs) and practices vary widely across institutions. This project expands on previous work at the University of Arkansas for Medical Sciences (UAMS) Center for Health Literacy to develop a plain language ICF template. Our interdisciplinary team of researchers, comprised of biomedical informaticists, health literacy experts, and stakeholders in the Institutional Review Board (IRB) process, has developed the ICF Navigator, a novel tool to facilitate the creation of plain language ICFs that comply with all relevant regulatory requirements.
Methods
Our team first developed requirements for the ICF navigator tool. The tool was then implemented by a technical team of informaticists and software developers, in consultation with an informed consent legal expert. We developed and formalized a detailed knowledge map modeling regulatory requirements for ICFs, which drives workflows within the tool.
Results
The ICF Navigator is a web-based tool that guides researchers through creating an ICF as they answer questions about their project. The navigator uses those responses to produce a clear and compliant ICF, displaying a real-time preview of the final form as content is added. Versioning and edits can be tracked to facilitate collaborative revisions by the research team and communication with the IRB. The navigator helps guide the creation of study-specific language, ensures compliance with regulatory requirements, and ensures that the resulting ICF is easy to read and understand.
Conclusion
The ICF Navigator is an innovative, customizable, open-source software tool that helps researchers produce custom readable and compliant ICFs for research studies involving human subjects.

A Review Assessing Participants’ Understanding of Informed Consent for Clinical Trials in Africa

A Review Assessing Participants’ Understanding of Informed Consent for Clinical Trials in Africa
Dorothy Maxwell Kazembe, Tigist Mesfin, Abigiya Abebe, Saba Mehari Embaye, Esther Nthenya Muthoka, Kedir Usmael, Mediha Ahmedin, Tsegahun Manyazewal
Medical Research Archives, November 2022; 10(11)
Abstract
Background
Informed consent provides detailed information to the participants to make informed voluntary and rational decision to participate in a study. It is a communication tool between investigator and the subject to ensure that high research ethical standards are followed. This review paper assessed the level of participants’ understanding of the information given to them by researchers during the clinical research.
Methods
A review approach was used to achieve the study objective.
Results
The findings showed that the level of comprehension varied from study to study. There was a good comprehension in four domains; purpose, voluntariness, benefits and right to withdraw. Poor comprehensions were mostly in risks, side effects, and blinding. Higher level of education, repeated assessments of comprehension, time spent by the researcher explaining and clarifying the information influenced the comprehension.
Conclusion
The study findings point out that comprehension to informed consent is still a challenge that needs to be addressed during the field study. Once the consent is given it becomes a distant memory for most of the participants. This implies that proper tools and cut off points to determine participants’ comprehension need to be developed for standard assessment of such.

Co-creation of information materials within the assent process: From theory to practice

Co-creation of information materials within the assent process: From theory to practice
Jaime Fons-Martinez, Cristina Ferrer-Albero, Javier Diez-Domingo
Health expectations : an international journal of public participation in health care and health policy, 23 November 2022
Open Access
Abstract
Introduction
The informed consent process is key to safeguarding the autonomy of the participant in medical research. For this process to be valid, the information presented to the potential participant should meet their needs and be understood by them. The i-CONSENT project has developed ‘Guidelines for adapting the informed consent process in clinical trials’ which aim to improve informed consent so that they are easier to understand and better adapted to the needs and preferences of the target population. The best way to tailor information to the characteristics and preferences of the target population is to involve the community itself.
Methods
Following guidelines developed by i-CONSENT, assent materials were co-created for a mock clinical trial of the human papillomavirus vaccine in adolescents. During the process, two design thinking sessions were conducted involving a total of 10 children and 5 parents. The objectives of the sessions were to find out the children’s opinion of the informed consent (assent in their case) process in clinical trials, identify the parts that were most difficult to understand and alternatives for their presentation and wording, identify the preferred formats for receiving the information and the main characteristics of these formats, design a video explaining the clinical trial and evaluate a tool for assessing comprehension.
Results
Assent materials were co-created in three formats: a web-based material following a layered approach; a video in story format; a pdf document with an innovative way of presenting information compared to traditional assent documents. In addition, the Comprehension of Assent Questionnaire was co-designed, based on the Quality of Informed Consent questionnaire.
Conclusion
The design thinking methodology has proven to be an easy and useful tool for involving children in designing information tailored to their needs and preferences.
Patient or public contribution
A sample of the target population participated in the design and piloting of the materials created using design thinking methodology. In addition, patient representatives participated in the design and evaluation of the guidelines developed by the i-CONSENT project that were followed for the development of the materials in this study.

Using provocative design to foster electronic informed consent innovation

Using provocative design to foster electronic informed consent innovation
Research
Evelien De Sutter, Stef Verreydt, Koen Yskout, David Geerts, Pascal Borry, An Outtier, Marc Ferrante, Corinne Vandermeulen, Nele Vanmechelen, Bart Van der Schueren, Isabelle Huys
BMC Medical Informatics and Decision Making, 17 November 2022; 22(296)
Open Access
Abstract
Background
The development of technological applications in clinical research, such as electronic informed consent (eIC), is on the rise. The involvement of end users throughout the design process of eIC is of utmost importance to improve the current informed consent process.
Methods
Using a provocative design, we conducted interviews with 30 clinical research participants. Provotypes were used as a starting base to discuss various aspects relevant to eIC. By providing a medium to encourage divergent thinking, participants’ views and concerns were solicited. Thematic analysis was undertaken using NVivo.
Results
The majority of participants placed trust in the principal investigator or the hospital to perform the role of eIC hosting party. Differing opinions were reported on the amount of information required related to stakeholders’ access to an eIC system, and thus, to participants’ personal data, to enable trust in an eIC system. Nevertheless, this study indicates a general willingness of participants to share personal data with physicians and pharmaceutical companies on an international level, and to receive requests for new research studies via an eIC system. Participants suggested to tailor an eIC system based upon their preferences, for example, regarding whom they want to share their personal data with. Moreover, they expressed a desire to choose how they can contact the research team, and to indicate which study-related information they would like to receive electronically. In addition, positive opinions were voiced on the integration of a test to assess participants’ understanding before providing their eIC.
Conclusions
Following a research through design approach, insights have been generated which inform the design of eIC. Provotypes were designed to help participants think beyond what is familiar to them. Study findings revealed that not all situations were perceived as provocative, because of participants’ motivation to advance scientific research and the trust they place in the research team. Nevertheless, the use of provocative design resulted in additional insights, generated by clinical research participants, which could be considered in the further design of eIC.