Informed Consent: A Monthly Review

December 2022 :: Issue 48

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 2022

Informed Consent for Risk of COVID-19 in Preoperative Trauma Patients

Informed Consent for Risk of COVID-19 in Preoperative Trauma Patients
Harvey, A. Sheokand, R. Rambani
Orthopaedic Proceedings, 14 November 2022; 104
Open Access
The risk of Covid-19 community and hospital acquired infection (HAI) on patient outcomes in trauma is still relevant. Patient’s should be routinely consented for this risk to ensure informed consent for perioperative contraction.
A prospective audit was completed from December-March 2022 examining a consecutive series of patient admissions with capacity to consent. The standards for compliance was RCOS Toolkit 5#3 stating the importance of enhanced consent for risk of contraction, in operating and changes to care pathways. The target was 95% compliance. 2/2 contingency tables were generated to determine odds ratio for compliance versus Covid+ rate.
This audit generated 80 consecutive patients from which 28 were excluded as non-operative or lacking capacity. It was found that 25% (13/52) had been specifically consented for risks of Covid-19. The rate of PCR-positive results was 15% (8/52) with a mortality of 25%. Approximately 2% of patients in this series were informed of the risk and had a positive Covid-PCR. An odds ratio of 0.38 indicates that being informed of the risk is not associated with rate of infection e.g by adopting enhanced personal protective measures.
The pandemic recovery has not removed this substantial community and nosocomial risk. Our results demonstrate poor compliance with RCS guidance despite ongoing relevance to care. Consent includes the counselling of a patient to specific Covid-related risks including thrombosis & death. Dissemination of these results will be followed by completion of the audit cycle to look for improvements in compliance.


Informed Consent in Mass Vaccination against COVID-19 in Romania: Implications of Bad Management

Informed Consent in Mass Vaccination against COVID-19 in Romania: Implications of Bad Management
Sînziana-Elena Bîrsanu, Maria Cristina Plaiasu, Codrut Andrei Nanu
Vaccines, 5 November 2022; 10(11)
Informing patients and obtaining valid informed consent were significant challenges for the COVID-19 immunization program. In Romania, the authorities issued a strategy for activities regarding vaccination against COVID-19, including the informed consent procedure. The lack of legal preparedness was evident when the medical personnel at the vaccination centers were provided with informed consent forms that did not respect the existing legal requirements. In addition, the protocol for persons seeking vaccination stated that the patient was supposed to receive the informed consent form from the receptionist in order to read and sign it. We analyzed the legal implications and the malpractice litigation risk associated with this practice. Due to essential deficiencies and in the absence of an official enactment of new regulations, we conclude that the vaccination consent process did not comply with the legal requirements. Implications include medical personnel’s legal liability, loss of malpractice insurance coverage, and public mistrust that may have contributed to a low vaccination rate. Given the potential of future pandemics or other health crises, this may be a valuable lesson for developing better legal strategies.

The approach to informed consent in acute care research

The approach to informed consent in acute care research
Rafael Dal-Ré, Arthur L Caplan
Lancet Respiratory Medicine, 3 November 2022
Open Access
In their discussion of the contrasting responses of the UK and the USA to the unprecedented situation posed by the COVID-19 pandemic—and the urgent need for randomised controlled trials to guide clinical practice—Jonathan D Casey and colleagues state that the Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial was approved “with an alteration of informed consent” to facilitate enrolment. We are concerned that this statement could confuse clinical investigators and research ethics committee members…

Editor’s note: The article referenced in this correspondence is Casey JD Beskow LM Brown J et al. Use of pragmatic and explanatory trial designs in acute care research: lessons from COVID-19. Lancet Respir Med. 2022; 10: 700-714.

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
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.
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.
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.
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
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
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.
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.
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.
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.

Overcoming barriers to informed consent in neurological research: Perspectives from a national survey

Overcoming barriers to informed consent in neurological research: Perspectives from a national survey
Research Article
Lauren R Sankary, Megan E Zelinsky, Paul J Ford, Eric C Blackstone, Robert J Fox
Research Ethics, 30 October 2022
Open Access
The ethical recruitment of participants with neurological disorders in clinical research requires obtaining initial and ongoing informed consent. The purpose of this study is to characterize barriers faced by research personnel in obtaining informed consent from research participants with neurological disorders and to identify strategies applied by researchers to overcome those barriers. This study was designed as a web-based survey of US researchers with an optional follow-up interview. A subset of participants who completed the survey were selected using a stratified purposeful sampling strategy and invited to participate in an in-depth qualitative interview by phone or video conference. Data were analyzed using a mixed methods approach, including content analysis of survey responses and thematic analysis of interview responses. Over 1 year, 113 survey responses were received from US research personnel directly involved in obtaining informed consent from participants in neurological research. Frequently identified barriers to informed consent included: cognitive and communication impairments (e.g. aphasia), unrealistic expectations of research participants, mistrust of medical research, time constraints, literacy barriers, lack of available social support, and practical or resource-related constraints. Strategies to enhance informed consent included: involving close others to support participant understanding of study-related information, collaborating with more experienced research personnel to facilitate training in obtaining informed consent, encouraging participants to review consent forms in advance of consent discussions, and using printed materials and visual references. Beyond conveying study-related information, researchers included in this study endorsed ethical responsibilities to support deliberation necessary to informed consent in the context of misconceptions about research, unrealistic expectations, limited understanding, mistrust, and/or pressure from close others. Findings highlight the importance of training researchers involved in obtaining informed consent in neurological research to address disease-specific challenges and to support the decision-making processes of potential research participants and their close others.

An e-consent framework for tiered informed consent for human genomic research in the global south, implemented as a REDCap template

An e-consent framework for tiered informed consent for human genomic research in the global south, implemented as a REDCap template
Tsaone Tamuhla, Nicki Tiffin, Taryn Allie
BMC Medical Ethics, 24 November 2022; 23(119)
Open Access
Research involving human participants requires their consent, and it is common practice to capture consent information on paper and store those hard copies, presenting issues such as long-term storage requirements, inefficient retrieval of consent forms for reference or future use, and the potential for transcription errors when transcribing captured informed consent. There have been calls to move to electronic capture of the consent provided by research participants (e-consent) as a way of addressing these issues. A tiered framework for e-consent was designed using the freely available features in the inbuilt REDCap e-consent module. We implemented ‘branching logic’, ‘wet signature’ and ‘auto-archiver’ features to the main informed consent and withdrawal of consent documents. The branching logic feature streamlines the consent process by making follow-up information available depending on participant response, the ‘wet signature’ feature enables a timestamped electronic signature to be appended to the e-consent documents and the ‘auto-archiver’ allows for PDF copies of the e-consent documents to be stored in the database. When designing the content layout, we provided example participant information text which can be modified as required. Emphasis was placed on the flow of information to optimise participant understanding and this was achieved by merging the consent and participant information into one document where the consent questions were asked immediately after the corresponding participant information. In addition, we have provided example text for a generic human genomic research study, which can be easily edited and modified according to specific requirements. Building informed consent protocols and forms without prior experience can be daunting, so we have provided researchers with a REDCap template that can be directly incorporated into REDCap databases. It prompts researchers about the types of consent they can request for genomics studies and assists them with suggestions for the language they might use for participant information and consent questions. The use of this tiered e-consent module can ensure the accurate and efficient electronic capture and storage of the consents given by participants in a format that can be easily queried and can thus facilitate ethical and effective onward sharing of data and samples whilst upholding individual participant preferences.

Toward Dynamic Consent for Privacy-Aware Pervasive Health and Well-being: A Scoping Review and Research Directions

Toward Dynamic Consent for Privacy-Aware Pervasive Health and Well-being: A Scoping Review and Research Directions
Hyunsoo Lee, Uichin Lee
IEEE Pervasive Computing, 2022; pp 1-8
Recent advances in sensor-enabled services have facilitated the use of mobile, wearable, and IoT devices; for example, an extensive range of sensor data are used to automatically track symptoms and diagnose health and well-being status of an individual (e.g., depression). As personal data are being continuously and unobtrusively sensed and collected at large scale, this raises privacy concerns in certain contexts (e.g., GPS data collection at privacy-sensitive places). Current one-off informed consent in such pervasive sensing scenarios does not offer context-awareness support that enables selective data disclosure based on a user’s needs or preferences (e.g., disabling GPS data collection when visiting hospitals). A lack of context-awareness support in informed consent would be a critical barrier to user acceptance of data-intensive pervasive computing for health and well-being. As an alternative method, we introduce the concept of “dynamic consent,” a type of informed consent that enables granular data consent and management, initially introduced in biomedical research for patient data management. We explore how this consent practice within biomedical research might inform usable privacy designs in pervasive computing by conducting a scoping review of dynamic consent literature and discussing future research directions.

A Preliminary Study to Explore the Informed Consent Approach and the Ethical Challenges in the Malaysian Biobanking for Research

A Preliminary Study to Explore the Informed Consent Approach and the Ethical Challenges in the Malaysian Biobanking for Research
Amnah Azahar, Aimi Nadia Mohd Yusof, Zahir Izuan Azhar
Asian Bioethics Review, 8 November 2022
Open Access
Since 2005, Malaysia has established several biobanks to keep in line with the advancement of biomedical research and development of biobanks in other countries such as the UK and the USA. Despite the establishment of several biobanks in Malaysia, little is known about the informed consent approach in biobanking research and its ethical challenges. This study aims to identify the approach in obtaining informed consent in the Malaysian biobanking for research and explore its ethical challenges. Using non-probability purposive sampling, an in-depth interview with the key informants was conducted in Klang Valley. Based on the interviews, broad consent is the main approach used in obtaining informed consent in biobanking for research in Malaysia and five major ethical challenges were identified. These challenges include the informants’ opinion on the current informed consent approach, understanding participants’ rights, the role of the research ethics committee, biobanking governance in Malaysia, and informants’ knowledge and awareness. In summary, there is a lack of understanding among those involved in biobanking on the ethical, legal, and social aspects of biobanking for research in Malaysia.