Ethical tensions in the informed consent process for randomized clinical trials in emergency obstetric and newborn care in low and middle-income countries
Dan K. Kaye, Gershom Chongwe, Nelson K. Sewankambo
BMC Medical Ethics, 27 April 2019; (20)27
There is unanimous agreement regarding the need to ethically conduct research for improving therapy for patients admitted to hospital with acute conditions, including in emergency obstetric care. We present a conceptual analysis of ethical tensions inherent in the informed consent process for randomized clinical trials for emergency obstetric care and suggest ways in which these could be mitigated.
A valid consenting process, leading to an informed consent, is a cornerstone of this aspect necessary for preservation and maintenance of respect for autonomy and dignity. In emergency obstetric care research, obtaining informed consent can be problematic, leading to ethical tension between different moral considerations. Potential participants may be vulnerable due to severity of disease, powerlessness or impaired decisional capacity. Time for the consent process is limited, and some interventions have a narrow therapeutic window. These factors create ethical tension in allowing potentially beneficial research while avoiding potential harms and maintaining respect for dignity, human rights, justice and autonomy of the participants.
Informed consent in emergency obstetric care in low- and middle-income countries poses numerous ethical challenges. Allowing research on vulnerable populations while maintaining respect for participant dignity and autonomy, protecting participants from potential harms and promoting justice underlie the ethical tensions in the research in emergency obstetric and newborn care. Those involved in research conduct or oversight have a duty of fair inclusion, to avoid denying participants the right to participate and to any potential research benefits.
Editor’s note: The authors mentions sub-Sharan Africa as an example of the LMICs they are referring to in this article.
Informed Consent in IBD Trials: Where We Are and Where We Need to Go
Michael Kurin, Jeffry Katz, Eric Kodish, Bret Lashner
Inflammatory Bowel Diseases, 16 April 2019
Patient enrollment is increasingly recognized as a major limiting factor to inflammatory bowel disease (IBD) clinical trial completion. Many IBD trials will fail to enroll enough patients to adequately power their study. This has led to a renewed multifaceted effort to encourage more patients to enroll in clinical trials. Although this is of clear importance, it is also important to ensure that all efforts to enroll patients in clinical trials do not compromise the quality and validity of the patient’s/study participant’s informed consent. Informed consent has 4 components: disclosure, voluntariness, understanding, and capacity. The application of informed consent to IBD clinical trials for biologic agents has not been previously studied. Yet the nature of clinical trials for biologics in IBD creates certain challenges to properly fulfilling the requirements of informed consent in the recruitment process that should be examined. In the following commentary, the components of informed consent are reviewed, challenges to their fulfillment in IBD trials are reviewed, and practical advice is offered.
Will Shorter Informed Consent Forms with Visual Aids Improve Understanding of the Document in Adult and Elderly Populations of Clinical Trials?
Bloswick, Agata, Skowron, Agnieszka
Ethics & Medicine, Spring 2019; 35(1) pp 43-44
The informed consent form (ICF) is a critical document for ensuring patients are properly informed about participation in clinical trials, yet there are no regulations that govern the length and format of the document, for the texts reach an average length of 18 pages. The aim of the present study is to conduct a readability assessment, comparing a standard version ICF of 18 pages and a modified (shortened to 11 pages and illustrated) version ICF, using the methodology for the approval of patient information leaflets for marketed medications mandated in Poland and assessing two age groups—adults aged 18-65 and elderly >65. Ten adult and 10 elderly participants were included in the study.
The long and short versions of the ICF resulted in different reading speeds in the adult group; the long version was read 75% faster than the short one on a words-per-minute basis, suggesting a less-thorough reading of the longer text. The difference in information retention, measured by a follow-up questionnaire, was over 20% better recall of risks, procedures, and benefits by the adult group readers of the short ICF.
In the elderly group of participants, the retention and understanding of the documents was significantly lower overall (50% fewer correct answers in comparison to the adult group). In contrast to the adult group, the words-per-minute reading speed for the shorter version was 50% greater than for the longer. The elderly readers appeared to have reviewed the longer document more thoroughly while skipping the tabularized elements of the shortened document that were intended to simplify key information. A detailed analysis shows that the documents with visual aids were less effective for the elderly than plain text.
Based on the information retention observed in this study, significant improvements in readability and design are needed for informed consent forms to fulfill their intended purpose.
Preference and Values of Stroke Interventions, Kingdom of Saudi Arabia
Reem Alamri , Adel Alhazzani , Saeed A. Alqahtani, Hayfa Al-Alfard, ShahadMukhtar, Khadejah Alshahrany, Faisal Asiri
Neurology Research International, 1 April 2019
Acute ischemic stroke (AIS) occurs when there is a sudden occlusion of the arterial blood supply to part of the brain resulting in sudden focal neurological deficits. Recent major clinical trials of reperfusion therapy had proved the efficacy of timely stroke intervention to restore blood flow. Development of acute stroke protocols waiving the informed consent to obtain necessarily brain images or provide thrombolytic therapy is important to streamline and organize efforts to achieve the goal of early intervention and better functional outcome.
This study aims to identify the preference and values of acute stroke interventions standard of care therapy without informed consent in the absence of surrogate decision-makers.
A cross-sectional survey was conducted in the Kingdom of Saudi Arabia using an electronic questionnaire. The questionnaire addressed the patients’ preference of acute stroke protocol waiving the informed consent for hyperacute brain images and delivering thrombolytic therapy or mechanical thrombectomy in absence of surrogate. All Saudi population aging from 18 to 65 years were invited to participate.
The study included 2004 participants with ages ranging from 18 to 65 years with mean age of 30.1 years. About 66% of the participants were females and 95% were Saudi. Overall, 90.5% of the participants agreed on performing computed tomography angiography (CTA) by the medical staff for the acute strokes without consenting followed by 79% for thrombolytic therapy, 70.8% for mechanical thrombectomy, and only 49.3% for acute lifesaving surgical intervention.
Researchers found that the high percentage of participants had favorable response and positive perception toward providing acute stroke intervention and mechanical thrombectomy without informed consent. However, the study showed skeptical acceptance among participants regarding invasive surgical measures.
Informed Consent in Medical Decision Making In India
Rateesh Sareen, Akanksha Dutt
Journal of Counselling and Family Therapy, April 2019; 1(1)
Consent is one of the key elements for protection of welfare of patients or research participants. The physician has a legal and ethical responsibility to provide adequate information to the patient so that he or she is able to process the information and make appropriate decisions. The patient’s consent must be voluntary and competent. In order to meet the requirements for effective, informed decision making, a physician must disclose material facts, which are relevant to decision making, including the patient’s diagnosis, proposed treatment, risks and benefits of the treatment, alternative treatments along with their risks and benefits, and the risks of refusal. A physician must answer truthfully about the number of similar procedures or cases performed, and disclose success rates, and any financial conflict(s) of interest. The physician must advise patients of all personnel involved in their care and their respective roles, including residents, students, and equipment representatives.
Editor’s note: The vision of the Journal of Counselling and Family Therapy is to provide opportunities to bring fore new knowledge and concepts from various inter-linked subjects concerned with the study of mental health, disorders and related issues.
Consent in current psychiatric practice and research: An Indian perspective
Furkhan Ali, Gopi Gajera, Guru S Gowda, Preeti Srinivasa, Mahesh Gowda
Indian Journal of Psychiatry, 8 April 2019; 61(10) pp 667-675
Consent is a process that allows for free expression of an informed choice, by a competent individual. The consent is considered as one of the important components of health-care delivery and biomedical research today. Informed consent involves clinical, ethical, and legal dimensions and is believed to uphold an individual’s autonomy and the right to choose. It is very important in Indian mental health care as the Mental Healthcare Act (MHCA) 2017 mandates informed consent in admission, treatment, discharge planning, and research intervention/procedures. In 2017, the Indian Council of Medical Research laid down the National Ethical Guidelines for BioMedical and Health Research involving Human Participants for research protocols, which the MHCA advocates. This article gives an overview on the evaluation of consent in clinical practice and also highlights the approach and challenge in psychiatric practice in India.
The public debate on organ donation and presumed consent in Denmark: Are the right issues being addressed?
Anja M. B. Jensen, Johanne Bjørg Larsen
Scandinavian Journal of Public Health, 11 April 2019
The legal framework for organ donation in Denmark is informed consent. But due to the unsatisfactory number of organ donors, Denmark is considering changing legislation to presumed consent. This article discusses the public debate on organ donation and presumed consent in Denmark, and asks whether the right issues are being addressed in the quest towards more available organs and better donor rates? Basing our considerations on the various arguments in the debate and on scientific findings, we question the potential benefits of presumed consent and challenge some of the assumptions and rationalizations that characterize the discussions in Denmark regarding public support, public trust and the role of the family in donation decisions.
Dematerialisation of patient’s informed consent in radiology: insights on current status and radiologists’ opinion from an Italian online survey
Francesca Coppola, Lorenzo Faggioni, Roberto Grassi, Corrado Bibbolino, Agatina Rizzo, Nicoletta Gandolfo, Antonella Calvisi, Carlo Alberto Cametti, Giorgio Benea, Andrea Giovagnoni, Carmelo Privitera, Daniele Regge
La radiologia medica, 2 April 2019; pp 1–8
To assess the current status of patient’s informed consent (PIC) management at radiological centres and the overall opinion of radiologist active members of the Italian Society of Medical Radiology (SIRM) about PIC dematerialisation through an online survey.
Methods and materials
All members were invited to join the survey as an initiative by the Imaging Informatics Chapter of SIRM. The survey consisted of 11 multiple-choice questions about participants’ demographics, current local modalities of PIC acquisition and storage, perceived advantages and disadvantages of PIC dematerialisation over conventional paper-based PIC, and overall opinion about PIC dematerialisation.
A total of 1791 radiologists (amounting to 17.4% of active SIRM members for the year 2016) joined the survey. Perceived advantages of PIC dematerialisation were easier and faster PIC recovery (96.5%), safer storage and conservation (94.5%), and reduced costs (90.7%). Conversely, the need to create dedicated areas for PIC acquisition inside each radiological unit (64.0%) and to gain preliminary approval for the use of advanced digital signature tools from patients (51.8%) were seen as potential disadvantages. Overall, 94.5% of respondents had a positive opinion about PIC dematerialisation.
Radiologists were mostly favourable to PIC dematerialisation. However, concerns were raised that its practical implementation might face hurdles due to its complexity in current real life working conditions.
Determine the Influence of Social Demography and Access to Information on Giving Consent of Medical Action Toward an Understanding of Informed Consent in Public Hospital With Class C at Pekanbaru [Indonesia]
Tri Purnama sari, Doni Jepisah
Journal of Economic Info, 18 February 2019; 6(1)
Informed consent is approval of medical action which is given by the patient or his immediate family after obtaining a complete explanation about medical or dentist action that will be performed on that patient. This study aims to determine the influence of social demography and access to information on giving consent of medical action toward an understanding of informed consent in Public hospital with class C at Pekanbaru. This study employs quantitative method with cross sectional analytic design. The population in this study were all Patient or Families of patient who had received medical treatments in inpatient room for three days before the return of patient as much 267 respondent where the total sample of this research are 194 respondents. The sampling technique is Proportional Random Sampling. Data analysis was carried out in three stages: univariate, bivariate, and multivariate analysis. Based on the result of study found that there was a significant relationship between Education variable (p value 0.007 POR 2,368), work variable (p value 0.042 POR 1,937), age (p value 0.017 POR 2,158), Completeness Information (p value 0.001 POR 2,857), Language Delivery (p value 0.002 POR 2,871) with an understanding of the approval of medical action. Based on the results of multivariate test, it was found that education, completeness of information and language of delivery were the most influential factors. The submission of information must be adjusted to the characteristics of consent provider, especially those related to education, completeness of information and language delivery, so that, if things happen that are not desirable after surgery, the patient or family is expected to receive it because before the surgery is done, the doctor has given an explanation to the patient.
Legal review of the civil, criminal, and administrative consequences of informed consent violation in medical practice
Vallejo-Jiménez, Geovana A.a; Nanclares-Márquez, Julianab
Colombian Journal of Anesthesiology, April-June 2019; 47(2) pp 107–112
The informed consent (IC) ensures respect of the patient’s rights to information, freedom, and autonomy. However, when the physician neglects the obligation to inform, legal consequences may follow, including the award of damages or even imprisonment.
To analyze the legal implications for a medical practitioner who fails to obtain the patient’s IC.
Based on the relevant jurisprudence and legal decisions. With regards to the former, the decisions and legal precedents of the Colombian High Courts with regards to IC and medical practice were studied, emphasizing the rulings of the State Council and the Supreme Court of Justice (civil and penal chambers). With regards to the legal decisions, the analysis enabled the review, systematization and interpretation of the discussions generated around the topic of interest, pursuant to the doctrine or research on civil administrative, and criminal law.
There is consensus in the Colombian jurisprudence about the liability of the healthcare professional and of the state when the IC or any of its component parts is missing in the doctor–patient relationship. Nevertheless, there are different standpoints, particularly in the criminal arena, where a lack of unanimity exists with regards to this issue.
Any violation of the IC or the lack of an IC, could give rise to the practitioner’s civil liability and disciplinary actions, in addition to the administrative liability of the State, but there should be no criminal liability for the physician.