Article
Public, Environmental & Occupational Health
David Merola, Sebastian Schneeweiss, Deborah Schrag, Joyce Lii, Kueiyu Joshua Lin
Summary: This study aims to develop an algorithm that can identify oncology patients with high electronic health record (EHR) continuity. The results show that using this algorithm for prediction can significantly reduce variable misclassification and improve sensitivity without greatly impacting representativeness.
ANNALS OF EPIDEMIOLOGY
(2022)
Review
Health Care Sciences & Services
Edwin Cohen, Bill Byrom, Anja Becher, Magnus Jornten-Karlsson, Andrew K. Mackenzie
Summary: This systematic review evaluates the effectiveness of electronic consent (eConsent) in enhancing patient understanding, engagement, and acceptability of clinical trial information. The results show that compared to traditional paper-based consent, eConsent allows patients to better understand trial information, engage more actively, and rate the consent process as more acceptable and usable.
JOURNAL OF MEDICAL INTERNET RESEARCH
(2023)
Review
Health Care Sciences & Services
Edwin Cohen, Bill Byrom, Anja Becher, Magnus Jornten-Karlsson, Andrew K. Mackenzie
Summary: This systematic review examines the effectiveness of electronic consent (eConsent) compared to traditional paper-based consent. The findings show that patients using eConsent have a better understanding of study information, greater engagement with content, and find the consenting process more acceptable and usable. eConsent has the potential to address data quality concerns related to flawed consenting processes.
JOURNAL OF MEDICAL INTERNET RESEARCH
(2023)
Review
Ethics
Mohd Yusmiaidil Putera Mohd Yusof, Chin Hai Teo, Chirk Jenn Ng
Summary: This scoping review aims to identify the ethics related criteria that have been included in electronic informed consent processes and to synthesize and map these criteria to research ethics principles, in order to identify the gaps, if any, in current electronic informed consent processes. The study provides ethical criteria on electronic informed consent based on evidence-based data, adding significant value to the corpus of knowledge in research ethics.
BMC MEDICAL ETHICS
(2022)
Article
Remote Sensing
Vyshnave Jeyabalan, Lorie Donelle, Patrick Meier, Elysee Nouvet
Summary: Drones are being introduced in healthcare delivery worldwide, particularly in remote areas with inadequate healthcare services. However, there is limited guidance on engaging communities in decision-making about drone use. This paper focuses on obtaining consent for implementing Drones for Health projects, highlighting ethical and practical challenges.
Article
Clinical Neurology
Ally Peabody Smith, Nader Pouratian, Ashley Feinsinger
Summary: As neurologically implanted devices become more widely used in clinical applications, there are increasing opportunities for intracranial investigations in human patients. In some cases, patients participate in research during their awake brain surgery, without potential therapeutic benefits. Ethical challenges arise in such intraoperative studies, conducted during a clinical intervention, in a clinical setting, and often by the treating clinician. The need for innovative informed consent methods in intraoperative research is a pressing concern, but current practices are insufficient in addressing participant understanding and trust between patient-participants and surgeon-researchers.
Article
Medicine, General & Internal
Cristian Timmermann, Marcin Orzechowski, Oxana Kosenko, Katarzyna Woniak, Florian Steger
Summary: Through telephone interviews, it was found that clinicians in Poland and Germany generally support the normative framework but consider it complex. The biggest dilemma in the information process is whether to provide too much information or risk leaving out important facts. Clinicians are willing to exclude larger population groups from clinical studies when the information process cannot be carried out with standard procedures or when their inclusion is ethically sensitive.
FRONTIERS IN MEDICINE
(2022)
Article
Health Care Sciences & Services
Katja Voit, Tobias Skuban-Eiseler, Marcin Orzechowski, Florian Steger
Summary: Health crises like COVID-19 pose challenges to conducting clinical studies, especially regarding research ethics such as informed consent. This study examines whether proper informed consent procedures were followed in COVID-19 clinical studies at Ulm University from 2020 to 2022. A thematic analysis was conducted on the protocols of 98 COVID-19 studies, finding that informed consent was obtained through traditional written form, waived, obtained delay, or obtained by proxy.
Article
Obstetrics & Gynecology
Summary: Informed consent is a process that involves supporting patients to understand medical options and make voluntary and autonomous decisions, considering the risks, benefits, and alternatives.
FERTILITY AND STERILITY
(2023)
Article
Health Care Sciences & Services
Atsushi Kogetsu, Kazuto Kato
Summary: Online communication in medical research, including recruitment, informed consent, and data communication, provides numerous benefits, particularly for genome research and rare disease research. However, ethical challenges arising from or exacerbated by online communication must be addressed. This article presents an overview of these ethical issues and offers practical guidance for the ethical implementation of ICT in medical research.
JOURNAL OF MEDICAL INTERNET RESEARCH
(2022)
Article
Medicine, General & Internal
Evelien De Sutter, Teodora Lalova-Spinks, Pascal Borry, Peggy Valcke, Els Kindt, Anastassia Negrouk, Griet Verhenneman, Jean-Jacques Dereze, Ruth Storme, Isabelle Huys
Summary: Due to the infectious nature of COVID-19, alternative solutions such as electronic informed consent (eIC) are needed. However, stakeholders have limited experience with eIC, highlighting the need for further investment in multi-stakeholder, multi-national guidance to harmonize eIC practices.
FRONTIERS IN MEDICINE
(2022)
Article
Medicine, Research & Experimental
Tove Godskesen, Joar Bjork, Niklas Juth
Summary: This study explores the ethical challenges encountered by clinical research nurses (CRNs) in obtaining informed consent for clinical research. The findings highlight the threats to voluntariness faced by CRNs, the measures they take to safeguard voluntariness, and the questionable exclusion of certain groups. Time constraints, rushed decisions, and information overload pose challenges for CRNs, while overestimating therapeutic benefits in advanced illness stages can risk voluntariness. Proactive solutions, such as allowing ample decision-making time and supporting terminally ill patients, are outlined. Concerns are also raised about excluding individuals with language barriers or cognitive impairments. This study emphasizes the importance of refining the informed consent process, addressing participation challenges, and ensuring equitable inclusion in clinical studies.
Article
Psychology, Multidisciplinary
Edward Jacobs
Summary: As psychedelic-assisted psychotherapy (PAP) becomes more widely used, there is a need to adapt clinical ethics to accommodate its unique features. The long-term effects of psychedelic drugs and the transformative experiences they induce challenge the traditional understanding required for informed consent. This article explores the ethical implications and consequences for prospective patients.
FRONTIERS IN PSYCHOLOGY
(2023)
Article
Agricultural Economics & Policy
Anna Josephson, Melinda Smale
Summary: Ethical research requires informed consent and voluntary participation of participants, overseen by Institutional Review Boards. However, there are inconsistencies in perspectives and practices across regions. Lack of IRBs and varying principles may fail to adequately protect research participants.
APPLIED ECONOMIC PERSPECTIVES AND POLICY
(2021)
Review
Medicine, General & Internal
Edith Valdez-Martinez, Miguel Bedolla
Summary: This article discusses the waiver of informed consent and privacy notice in retrolective research, focusing on the physician's duty to patients and the contribution of retrolective research to disease control and public health improvement. Waiver of informed consent documented in medical records is crucial for retrolective research, but researchers must also consider the ethical implications of not complying with rationality and personal responsibility in society.
GACETA MEDICA DE MEXICO
(2021)