Informed Consent: A Monthly Review
November 2022 :: Issue 47
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_November 2022
Physician’s Code of Medical Ethics updated
World Medical Association, 8 October 2022
The revised Code, regarded as the foundation of ethical principles for physicians worldwide, defines the professional duties of physicians towards their patients, other physicians and health professionals, themselves, and society as a whole. It was adopted today in a unanimous vote at the WMA’s annual General Assembly in Berlin by physician leaders from almost 60 national medical associations…
The Code says that physicians must respect not only the dignity and the rights of patients, but also explicitly mentions their autonomy…
…Duties to the patient
- In providing medical care, the physician must respect the dignity, autonomy, and rights of the patient. The physician must respect the patient’s right to freely accept or refuse care in keeping with the patient’s values and preferences.
- The physician must commit to the primacy of patient health and well-being and must offer care in the patient’s best interests. In doing so, the physician must strive to prevent or minimise harm for the patient and seek a positive balance between the intended benefit to the patient and any potential harm.
- The physician must respect the patient’s right to be informed in every phase of the care process. The physician must obtain the patient’s voluntary informed consent prior to any medical care provided, ensuring that the patient receives and understands the information needed to make an independent, informed decision about the proposed care. The physician must respect the patient’s decision to withhold or withdraw consent at any time and for any reason…
Patient involvement in the development, regulation and safe use of medicines
Council for International Organizations of Medical Sciences (CIOMS)
Working Group XI on Patient involvement, 2022; 236 pages
…Informed consent and informed assent
Informed consent is a fundamental patient’s right and an ethical imperative in medicine, whether for research, treatment, or sharing personal data. The patient needs to be given all relevant information and invited to ask questions about the procedure, treatment or data-sharing arrangement. To give informed consent, the patient should have the capacity to understand the implications of the consent. Also, the patient should be able to make the decision to give consent freely and without undue pressure.
When a child is too young to give informed consent, informed assent must be sought. The child should be meaningfully engaged in discussions about the research or medical procedure, according to the child’s capacity. Consent should also be obtained from the child’s parents or legal guardian. Moreover, the child’s written agreement can be obtained if the child’s literacy level allows this, taking into account emotional and psychological maturity as well as relevant individual circumstances. Informed assent is also appropriate for adults who do not have the legal capability to give consent…
Community consultation for Exception from Informed Consent (EFIC) before and during the COVID-19 pandemic
David J. Gagnon, Richard R. Riker, Frank Chessa, Christine Lord, Ashley Eldridge, Meghan Searight, Sarah Bockian, Barbara McCrum, Teresa L. May, Douglas Sawyer, David B. Seder
Resuscitation Plus, 20 October 2022
Describe community consultation and surrogate consent rates for two Exception From Informed Consent (EFIC) trials for out-of-hospital cardiac arrest (OOHCA) – before and during the COVID-19 pandemic.
The PEARL study (2016-2018) randomized OOHCA patients without ST-elevation to early cardiac catheterization or not. Community consultation included flyers, radio announcements, newspaper advertisements, mailings, and in-person surveys at basketball games and ED waiting rooms. The PROTECT trial (2021-present) randomizes OOHCA survivors to prophylactic ceftriaxone or placebo; the community consultation plan during the pandemic included city council presentations, social media posts, outpatient flyers, but no in-person encounters. Demographics for PROTECT community consultation were compared to PEARL and INTCAR registry data, with p-value <0.05 considered significant.
PEARL surveyed 1,362 adults, including 64% ≥60 years old, 96% high school graduates or beyond; research acceptance rate was 92% for the community and 76% for personal level. PROTECT initially obtained 221 surveys from electronic media – including fewer males (28% vs 72%,p<0.001) and those >60 years old (14% vs 53%;p<0.001) compared to INTCAR. These differences prompted a revised community consultation plan, targeting 79 adult in-patients with cardiac disease which better matched PEARL and INTCAR data: the majority were ≥60 years old (66%) and male (54%). Both PEARL and PROTECT enrolled more patients using surrogate consent vs EFIC (57%, 61%), including 71% as remote electronic consents during PROTECT.
Community consultation for EFIC studies changed with the COVID-19 pandemic, resulting in different demographic patterns. We describe effective adaptations to community consultation and surrogate consent during the pandemic.
AI Integrated Blockchain Technology for Secure Health Care—Consent-Based Secured Federated Transfer Learning for Predicting COVID-19 on Wearable Devices
T. Ravi Shanker Reddy, B. M. Beena
International Conference on Innovative Computing and Communications, 27 September 2022; Delhi India
COVID-19 has been a major global challenge these days. The pandemic has changed human life, attitude, and behavior. This pandemic added a burden to people’s life and health. With the new variants of SARS-CoV-2, a lot of people are even scared of going to the health centers to get the COVID-19 evaluation in fear of contamination and contagious, which caused the surge in the symptoms at later stages. Data collected across various sources can play an important role in predicting and identifying of COVID-19 virus based on the models and the classifications of this data using the most sophisticated machine learning models. The concern here is accessing or transferring an individual’s data from their personal health devices which defers users’ privacy. In the recent past, there are a lot of research that has been done these days on how blockchain can help to securely track and transfer the data across trusted sources. Adding to this, federated learning also is helping on-device data usage without any critical data to be transferred to various external sources. The proposed study directs the stability of frequent health status with the help of wearable devices that capture health metrics like heart rate, blood oxygen levels, breathing rate, muscle activities, stress, emotions, movement patterns, sleep activity, precipitation, and mind/cognitive functions with the introduction of the data streams and models that can seamlessly transfer the data, with the assurance of data integrity, privacy, and control which is the scope of this paper. The usage of both the emerging technologies provides a value addition in terms of health data exchange with effective data distribution with decentralized privacy and computation. We have also introduced a consent-based personal health device registration mechanism on a blockchain consensus network with digital identity to allow and take back controls over who can access their data. We believe that this solution and the implementation would help everyone to predict the possible COVID-19 infections keeping data privacy at the most priority.
Misconduct and Consent: The Importance of Informed Consent in Medical Research
Marton Gergely, Fida K. Dankar, Saed Alrabaee
Integrity of Scientific Research, 14 October 2022; pp 81-91 [Springer]
Human subject research in the medical arena offers an indisputable contribution to society. However, all medical research needs to be conducted through maintaining strict levels of research standards and by complying with applicable regulations and guidelines. Despite this, medical research misconduct has been around for centuries, with countless examples of gross ethical oversights and morally flawed decisions made by both medical practitioners and researchers. One area of such misconduct is within that of informed consent. Despite the continually evolving rules and regulations surrounding informed consent in medical research, countless breaches are present surrounding the topic. In this paper, we discuss the origins of informed consent, the regulations and guidelines surrounding it, the common types of informed consent necessary to be gathered, and the potential pitfalls therein. We conclude with an overview of a selection of breaches in informed consent in the area of medical research and their likely reasons.
Informed consent in clinical trials
G P Kovane, V C Nikoderm, O Khondowe
South African Journal of Bioethics and Law, 12 October 2022; 15(2)
Informed consent (IC) is not only a regulatory but also an ethical requirement to participate in any clinical trial. It is essential to determine that research participants understand what they consent to. Studies that evaluate participants’ understanding of IC conclude that recall and understanding of IC is often low, and researchers recommend that interactive multimedia interventions should be implemented to optimise understanding.
To assess participants’ understanding of IC of the research trial that they agreed to participate in.
A descriptive survey design, within a quantitative research approach, was used to conduct the study at two government hospitals in the Eastern Cape Province. A semi-structured, self-administered questionnaire was used to collect information from 170 participants in research studies. Descriptive statistics were used to analyse the results.
Participants were recruited from among women who enrolled in any of the three studies that were ongoing at the two sites during the recruitment period. The study participants had a mean age of 25.9 years. Nearly one-third (30%) could not recall the purpose of the original trial that they consented to. The concept of randomisation was not understood by any of the participants.
Regardless of extensive efforts to ensure that participants understood their participation, this study unveiled poor recall of essential information on IC. It is proposed that IC should be short and only address essential components such as purpose, procedure, possible risks or benefits, alternative options if not participating and explaining the concept of voluntary participation.
Optimized Informed Consent for Psychotherapy: Protocol for a Randomized Controlled Trial
Leonie Gerke, Sönke Ladwig, Franz Pauls, Manuel Trachsel, Martin Härter, Yvonne Nestoriuc
JMIR Research Protocols, 30 September 2022; 11(9)
Informed consent is a legal and ethical prerequisite for psychotherapy. However, in clinical practice, consistent strategies to obtain informed consent are scarce. Inconsistencies exist regarding the overall validity of informed consent for psychotherapy as well as the disclosure of potential mechanisms and negative effects, the latter posing a moral dilemma between patient autonomy and nonmaleficence.
This protocol describes a randomized controlled web-based trial aiming to investigate the efficacy of a one-session optimized informed consent consultation.
The optimized informed consent consultation was developed to provide information on the setting, efficacy, mechanisms, and negative effects via expectation management and shared decision-making techniques. A total of 122 participants with an indication for psychotherapy will be recruited. Participants will take part in a baseline assessment, including a structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders-fifth edition (DSM-5) disorders. Eligible participants will be randomly assigned either to a control group receiving an information brochure about psychotherapy as treatment as usual (n=61) or to an intervention group receiving treatment as usual and the optimized informed consent consultation (n=61). Potential treatment effects will be measured after the treatment via interview and patient self-report and at 2 weeks and 3 months follow-up via web-based questionnaires. Treatment expectation is the primary outcome. Secondary outcomes include the capacity to consent, decisional conflict, autonomous treatment motivation, adherence intention, and side-effect expectations.
This trial received a positive ethics vote by the local ethics committee of the Center for Psychosocial Medicine, University-Medical Center Hamburg-Eppendorf, Hamburg, Germany on April 1, 2021, and was prospectively registered on June 17, 2021. The first participant was enrolled in the study on August 5, 2021. We expect to complete data collection in December 2022. After data analysis within the first quarter of 2023, the results will be submitted for publication in peer-reviewed journals in summer 2023.
If effective, the optimized informed consent consultation might not only constitute an innovative clinical tool to meet the ethical and legal obligations of informed consent but also strengthen the contributing factors of psychotherapy outcome, while minimizing nocebo effects and fostering shared decision-making.
Informed consent in clinical trials: Implementing methods to improve patient understanding in cancer research—A quality improvement initiative in a sarcoma trials unit
Caitriona Goggin, Bader Al-Badri, Anna Stansfeld, Elizabeth Barquin, Benjamin Durand, Thuy-Giang Nguyen, Preethika Mahalingam, Eniola Ayeni, Andrea Napolitano, Shane Zaidi, Aisha Miah, Robin Lewis Jones, Charlotte Benson
American Society of Clinical Oncology Journal, Quality Care Symposium, 2022
Clinical trials are considered the cornerstone of improving outcomes for cancer patients. The understanding of an individual patient of the trial on which they are enrolled can vary significantly, with some studies demonstrating poor patient understanding of their involvement in trials. This exploratory study aimed to improve patient understanding of clinical trials and patient experience of the informed consent process by implementing measures to present complex trial information in alternative formats.
The project was undertaken in a sarcoma trials unit in a specialist cancer treatment centre. Baseline knowledge was assessed using an adapted version of the Quality of Informed Consent (QuIC) questionnaire. A decision-aid was created following focus group discussions with stakeholders, focusing on key trial questions for patients, such as consent, the research description, risks, benefits, and alternatives to the trial. A patient education video was produced by the research team, explaining general aspects of clinical trials in patient-friendly language. The decision-aids and videos were distributed during the informed consent process of trial recruitment over a 12-week period. The patient group was assessed with post-intervention questionnaires. Statistical analysis was descriptive due to the small numbers.
Thirty sarcoma patients participated in the project, including baseline assessment of 15 patients previously enrolled on study, and 15 patients considering participation in a trial who underwent the intervention. 100% (n = 15) of the interventional group found the video and decision-aid useful. 60% (n = 18) of patients had a university level education, indicating a well-educated population. A pre- and post-intervention comparison demonstrated an improved understanding of 10 key elements of clinical trial information as shown in Table.
Our exploratory study has shown that patient education tools including decision-aids and patient videos can be successfully implemented to help improve patient understanding of clinical trial information and may be of benefit in other trials units. Further larger studies are required to confirm these findings.
Ethical Relativism and Circumstances of Social and Cultural Contingencies on Informed Consent in the Conduct of Research: Clinical Trials in Nigeria
Sola Aluko-Arowolo, Saheed Akinmayọwa Lawal, Isaac A. Adedeji, Stephen Nwaobilor
Asian Bioethics Review, 13 October 2022
There have been debates across the globe for a social and culturally sensitive ethics to meditate a catalyst of template for informed consent (IC) in the conduct of social researches and clinical trial. The study adopted ethical relativism theory to explore social and cultural contingencies on IC with descriptive research design and snowball sampling techniques with a pool of 23 participants randomly and purposively selected amongst the stakeholders including researchers. Seven lecturers and 5 medical practitioners from selected universities, 5 clergy members of different genders and denominations with 2 Imams, 1 chief and 2 traditional health practitioners completing the pool. The data were compiled separately with pseudonym to maintain the anonymity of the participants and content analysed thematically to probe awareness, understanding, patriarchy and religious dimensions on IC. The paper argued that ethics and law regulations must be strengthened to leverage on different individual values, norms and social indices. The paper concluded and suggested that researchers can avoid and resolve ethical dilemmas and maintain research regularity when ethical obligations are well understood and strictly adhered to, and to develop the Informed Consent Evaluation Feedback Tool (ICEFbT) with oversight function from Institution Review Board (IRB) in the universities and research institutes before the commencement of research and/or medical procedures.