Community consultation for Exception from Informed Consent (EFIC) before and during the COVID-19 pandemic
Short paper
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
Abstract
Aim
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.
Methods
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.
Results
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.
Conclusions
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.
Year: 2022
AI Integrated Blockchain Technology for Secure Health Care—Consent-Based Secured Federated Transfer Learning for Predicting COVID-19 on Wearable Devices
AI Integrated Blockchain Technology for Secure Health Care—Consent-Based Secured Federated Transfer Learning for Predicting COVID-19 on Wearable Devices
Conference paper
T. Ravi Shanker Reddy, B. M. Beena
International Conference on Innovative Computing and Communications, 27 September 2022; Delhi India
Abstract
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
Misconduct and Consent: The Importance of Informed Consent in Medical Research
Book Chapter
Marton Gergely, Fida K. Dankar, Saed Alrabaee
Integrity of Scientific Research, 14 October 2022; pp 81-91 [Springer]
Abstract
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
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)
Abstract
Background
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.
Objectives
To assess participants’ understanding of IC of the research trial that they agreed to participate in.
Methods
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.
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.
Conclusion
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
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)
Abstract
Background
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.
Objective
This protocol describes a randomized controlled web-based trial aiming to investigate the efficacy of a one-session optimized informed consent consultation.
Methods
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.
Results
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.
Conclusions
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
Informed consent in clinical trials: Implementing methods to improve patient understanding in cancer research—A quality improvement initiative in a sarcoma trials unit
Meeting Abstract
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
Abstract
Background
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.
Methods
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.
Results
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.
Conclusions
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
Ethical Relativism and Circumstances of Social and Cultural Contingencies on Informed Consent in the Conduct of Research: Clinical Trials in Nigeria
Original Paper
Sola Aluko-Arowolo, Saheed Akinmayọwa Lawal, Isaac A. Adedeji, Stephen Nwaobilor
Asian Bioethics Review, 13 October 2022
Abstract
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.
Computable Consent – From Regulatory, Legislative, and Organizational Policies to Security Policies
Computable Consent – From Regulatory, Legislative, and Organizational Policies to Security Policies
Conference paper
Zoran Milosevic, Frank Pyefinch
International Conference on Enterprise Design, Operations, and Computing, 28 September 2022; Italy
Abstract
Consumer-facing health applications are increasingly requiring flexible approaches for expressing consumer consent preferences for the use of their health data across multiple providers, and across cloud and on-premises systems. This and the recognition of the need for clear governance and legislative rules that specify enforceable policies over how consumer data is used by the nominated and other providers, including AI vendors, increasingly require machine readable, i.e. computable consent expressions. These expressions can be regarded as additional constraints over security policies, applicable to all stakeholders, while accommodating rules from regulatory and legislative policies. Support for both kind of policies contribute to improving consumer trust in the use of their data. This is applicable to both care delivery processes but also research projects, such as clinical trials. This paper proposes a computable consent framework and positions it in the context of the new developments within Health Level Seven (HL7®) Fast Health Interoperability Resources (FHIR®) standard. The proposal is based on the use of precise policy concepts from the ISO/ITU-T RM-ODP (Reference Model for Open Distributed Processing) standard. The aim is to provide general standards-based policy semantics guidance to interoperability/solution architects and implementers involved in digital health applications. The framework is driven by consent requirements, while leveraging broader policy input from medico-legal community.
Consent form, the highest ethical standard in creating DNA databases for criminal investigation
Consent form, the highest ethical standard in creating DNA databases for criminal investigation
Renata Jankova, Pavlinka Donevska-Stefanov, Natasha Bitoljanu, Goran Pavlovski, Robert Janevski, Aleksandar Stankov
Forensic Science International: Genetics Supplement Series, 25 October 2022
Abstract
Preparation of DNA databases for the purpose of criminal investigation opens discussions about ethical-legal issues concerning violation of human rights. The practice shows that one of the human rights that can be misused while creating such a database is the right to freedom, the freedom to make a decision. When preparing DNA databases, the right to freedom refers to free decision of the person to be sampled for carrying out the test. The right to freedom and respect to self-determination of the person implies the necessity of prior consent of the subject when preparing a database on general population level. This is not a case when databases are created from persons under investigation for committing a crime, who are compulsory subjected for obtaining samples for DNA analysis. Legal regulations approve the duty of the police and its authorization in collecting samples for personal or criminalistic identification, analyzing, keeping and eliminating collected personal information when criminal prosecution is concerned. In these cases, consent form from the subject is not necessary. However, we should be aware that the process of taking and collecting of personal information by the national institutions can have direct impact of privacy of the subject, no matter if this information is going to be used or not. In purpose of fair balance between public and private interest, consent form can be redefined and the person from whom the biological material is provided will be unequivocally made aware of the purposes for which his genetic data will be used, how long his DNA will undergo further automated processing, and about the procedure and under what conditions his DNA profile can be removed from the national DNA databases.
Safeguarding Personal Data: Meta Consent as a Remedy to Section 28(2)(c) of Kenya’s Data Protection Act
Safeguarding Personal Data: Meta Consent as a Remedy to Section 28(2)(c) of Kenya’s Data Protection Act
Wanditi Gathumbi
Strathmore Law Review, 2022; 7(1) pp 127-159
Abstract
Biometric identity systems have been adopted in the Global South, following the Global North’s lead. The greatest discrepancy, however, is the existence of legal frameworks that govern the use, storage and processing of the data collected. The Kenyan government’s roll-out of the Huduma Namba registration exercise in April 2019 with no existing data protection law in Kenya exemplifies this. Thereafter, Parliament passed the Data Protection Act. Unfortunately, parts of this law are not keen enough to protect personal data. Deviating from the requirement for personal data to be directly collected from the data subject, section 28(2)(c) of the referenced Act permits indirect collection of personal data from a source other than the data subject themselves. Relying on desk-based research and using the Huduma Namba exercise as a case study, this paper examines this permission and the imminent danger it poses to privacy of the personal data of Kenyans. Finding that section 28(2)(c) exposes personal data to the privacy violations of secondary use and exclusion threatens the right to privacy, this research suggests that the meta consent model as embraced by the healthcare sector emerges as a feasible solution. This model allows data subjects to determine their consent preferences i.e., how and when they wish their consent to be sought for further collection and use, at the point of primary collection of personal data. Additionally, this paper recommends that the model should be embraced by the judiciary in its adjudication of matters and finally, that an amendment incorporating the solution should be made.
Center for Informed Consent Integrity 