Researchers experience and views on participants’ comprehension of informed consent in clinical trials in Malawi: a descriptive qualitative study
Research
Dorothy Maxwell Kazembe, Yimtubezinash Woldeamanuel, Solomon Mequanente Abay
BMC Medical Ethics, 27 September 2024
Open access
Abstract
Background
Informed consent is the cornerstone of research ethics. One of its goals is that participants enter research with an understanding of what their participation entails. This paper is a study on how researchers understand the informed consent process. Previous studies have looked at this topic from a research participant perspective. However, few studies focus on the perspectives of the researchers. Therefore, this is an important paper that highlights an important issue (informed consent) from the perspective of those who administer it during research.
Methods
In-depth interviews were conducted with 18 researchers from 3 different research centers in Malawi working in clinical trials. The data was analyzed using open code utilizing the thematic approach to qualitative data.
Results
This study identified that researchers have good awareness of the role of informed consent, how important it is for participants to understand the given information and ways to adjust their practice accordingly when obtaining it in order to enhance participant understanding. According to the research staff, most participants do not really understand all the concepts of the study at the initial visit, they gain more understanding during subsequent visits. It was emphasized that the best method of facilitating informed consent is reading the informed consent to the participant, thus a face-to-face conversation. Long and complex informed consent was identified as one of the barriers to participant understanding of the informed consent. Shortening the informed consent form and having additional conversation with the participants was suggested as one way of improving participant comprehension.
Conclusion
Most of the participants understand much of the information during subsequent visits as you keep reminding them since informed consent is an ongoing process. Existing relationship or trust between a participant and a researcher, may influence participants’ decision and misguide their understanding on the purpose of the study. Adequate time should be allocated to informed consent discussions. Shortening the informed consent forms and having additional conversations with potential participants may help improve their understanding.
Year: 2024
Comparison of informed consent for breast cancer surgery in the UK and the Czech republic and patients’ satisfaction with the process
Comparison of informed consent for breast cancer surgery in the UK and the Czech republic and patients’ satisfaction with the process
Monika Rezacova
BMJ Surgery, Interventions, & Health Technologies, 27 September 2024
Abstract
Background
Informed consent is a concept accepted largely in the world, however its interpretation varies. Understanding the diagnosis and process of treatment should be a crucial part of doctor-patient relationship.
Methods
We have assessed 100 patients with a new breast cancer diagnosis (50 in each centre). We have compared the consent forms, risks mentioned to the patient and proposed surgery. A questionnaire was given to patients following the consent process to assess patients‘ satisfaction with information given and possibility of outcome change.
Results
In the UK, patients were given a surgical management plan with multiple potential risks listed on consent. Patients in Czech were given all possible surgical options without specific plan and only few complications. Patients in the UK were satisfied although some of them would appreciate fewer information on risks. Patients in Czech had trust in the doctor’s decision however majority of them would appreciate the exact procedure proposed and more information regarding risks.
Conclusion
Although patients had very different experiences, the vast majority would like to hear the exact type of procedure that is being done and list of significant risks.
Practices of Informed Written Consent for Elective Urological Procedures at a Tertiary Care Hospital in Sudan
Practices of Informed Written Consent for Elective Urological Procedures at a Tertiary Care Hospital in Sudan
Mohammed Elsiddig, Mohammed Hassan
Cureus, 26 September 2024
Abstract
Objective
This study aimed to assess informed consent practices in elective urological surgeries at a tertiary care facility.
Materials and methods
A retrospective cross-sectional survey was carried out between March 1, 2023 and April 1, 2023, at the Department of Urology, Omdurman Military Hospital, Sudan. We included all patients who had undergone elective urological procedures under local, spinal, or general anesthesia. The medical records were accessed to analyze the consent forms’ standards. A total of 42 consent forms were included and analyzed. We use the General Medical Council’s (GMC) Guidance on Professional Standards and Ethics for Doctors: Decision Making and Consent, and the Royal College of Surgeons (RCS) of England’s Consent: Supported Decision-Making as the standard for our study. The GMC and the RCS of England have provided comprehensive and standardized guidelines for obtaining informed written consent, including indications, benefits, risks involved, and alternatives in addition to demographics, patient details, responsible consultant, diagnosis, and title of the surgery, intended benefits, probable risks, type of anesthesia, consenting doctor’s name, designation, and signature, and the patient’s signature and name.
Results
A total of 42 consent forms were included. The diagnosis and the intended surgical procedure were mentioned in all consents. The potential benefits and risks were discussed in 36 (85.7%) and 18 (42.9%) cases, respectively. The type of anesthesia was discussed in 39 (92.9%) of cases. The likely result of not having the procedure and the alternative treatment: Recorded completion rates of 10 (23.8%) and 12 (28.6%), respectively. Patient demographics were completely documented in 41 (97.6%) forms. Senior doctors were only involved in 14 (33.3%) of the consents. Details of the consenting doctor, including name, title, and signature, were present in 30 cases (71.4%), and the date of signing the consent was documented in 38 cases (90.5%). The completeness of the consent form correlated with the level of the doctor obtaining it, with consultants achieving the highest completion rates (100%), followed by registrars (66.7%) and medical officers (35.7%).
Conclusion
The current practices of informed consent were found to be substandard. Handwritten consent forms do not adhere to the recommended guidelines for informed consent in elective urological procedures. It is preferable to utilize a pre-designed consent form, allowing for personalized additions based on the patient’s specifics. Our recommendation is to organize an educational session for junior doctors to emphasize proper consent procedures, and deepen their knowledge of common urological elective procedures, and associated risks. This approach promotes adherence to best clinical practices and minimizes the risk of legal challenges.
Nova Scotia’s Deemed Consent for Deceased Organ Donation: Family Member Perspectives and Experiences in the ICU Setting
Nova Scotia’s Deemed Consent for Deceased Organ Donation: Family Member Perspectives and Experiences in the ICU Setting
Aimee J. Sarti, Stephanie Sutherland, Matthew J. Weiss, Alain Landry, Heather Hemming, Jade Dirk, Ken Lotherington, Stephen Beed
Transplantation Direct, November 2024
Abstract
Background
The purpose of this study was to explore the experience of family members of potential organ donors in the intensive care unit following the change to deemed consent legislation in Nova Scotia.
Methods
This was a qualitative study with semistructured, in-depth interviews with 17 family members who were asked to make an organ donation decision on behalf of patients admitted to the intensive care unit in Nova Scotia. We analyzed themes using a descriptive approach. Participants were recruited from the organ donation organization in Nova Scotia, Canada.
Results
Participant awareness and knowledge of the Human Organ and Tissue Donation Act legislation varied from individuals having no awareness and knowledge of the bill to those who had awareness and optimism that the legislation would be beneficial for increasing organ donation rates in the province. Other themes emerging from the interviews included (1) COVID context, (2) quality of healthcare professional care, (3) family support, and (4) barriers to donation (waiting, consent questionnaire, and patient transfers).
Conclusions
The Human Organ and Tissue Donation Act legislation included enhanced support, which was viewed positively by family members. There is a need for continued evaluation as most participants felt it was too early to see the tangible impacts of the newly implemented legislation.
Rethinking with Onora O’Neill the Kantian Concept of Autonomy in Biolaw
Rethinking with Onora O’Neill the Kantian Concept of Autonomy in Biolaw
Book Chapter
María Jesús Vázquez Lobeiras
The Discourse of Biorights, 1 October 2024; Chapter 6 [Springer]
Abstract
The concept of autonomy plays a significant role in Bioethics as well as in Biolaw, the Kantian conception of autonomy being an unavoidable element in the debate. Some of the most relevant contributions in this discussion stem from Onora O’Neill’s work. Prof. O’Neill promotes an anti-individualist interpretation of autonomy and, in order to increase its ethical efficiency, suggests reconsidering the meaning of autonomy as closely linked to trust. This chapter tries to show how intertwined information, autonomy and trust are at a time when medical technologies and care need to be interpreted and disclosed in order to be properly understood.
Introduction
…Informed consent and the ethical and legal principle of autonomy are closely linked, since the former is usually considered a genuine expression of the latter…Considering informed consent to be one of the main expressions of autonomy, although not the only one, in what follows we will analyse it from the perspective of Onora O’Neill. Kant’s texts will be consulted once again in order to clarify what the eminent thinker of Königsberg understands by autonomy and to what extent his concept of application can be applied in the field of biolaw.
Unraveling a Political Technology: Free, Prior, and Informed Consent in Peruvian Oil and Mining Sectors
Unraveling a Political Technology: Free, Prior, and Informed Consent in Peruvian Oil and Mining Sectors
Research Article
Roger Merino
Journal of Politics in Latin America, 27 September 2024
Open Access
Abstract
The worldwide dissemination of the right to free, prior, and informed consent (FPIC) has fostered discussions about its significance for removing the social exclusion of indigenous peoples. Most studies address problems in the regulation and implementation of FPIC, but less attention is paid to how the strengths and weaknesses of indigenous organizations and their different political engagements influence FPIC processes and outcomes. Based on the analysis of consultation agreements in the mining and oil sectors in Peru (2011–2022) and the evaluation of two case studies, this article explains how FPIC might be a tool for indigenous politics and state governance.
Ethical, Psychological and Social Un/certainties in the Face of Deemed Consent for Organ Donation in England
Ethical, Psychological and Social Un/certainties in the Face of Deemed Consent for Organ Donation in England
Original Article
Laura L. Machin, Elizabeth Wrench, Jessie Cooper, Heather Dixon, Mark Wilkinson
Health Care Analysis, 24 September 2024
Open access
Abstract
Deemed consent legislation for deceased organ donation was introduced in England in 2020, and is considered a vital part of the new UK NHS Blood and Transplant’s 10-year strategy to increase consent for organ donation. Despite the legislation containing safeguards to protect the public, the introduction of deemed consent creates ethical, psychological and social un/certainties for healthcare professionals in their practice. In this paper, we offer insights into healthcare professionals’ perspectives on deemed consent, drawn from interview data with 24 healthcare professionals in an NHS Trust in England, prior to the introduction of the legislation. Whilst participants supported deemed consent in principle, they were concerned that it would present a threat to the nature of donation as a ‘gift’; the notion of informed consent (or non-consent); and the autonomy of donors, their relatives, and their own roles as health professionals, posing dilemmas for practice. We argue that healthcare professionals present themselves as guardians of potential (non)donors and thus as having ethics and integrity in their own practice. We draw conclusions around the values and principles that matter to healthcare professionals when contemplating consent in deceased donation which will be useful for organ donation committees and ethics forums.
The requirement to obtain the consent of a legal guardian for the provision of reproductive health pharmacist services to minors under the pilot program
The requirement to obtain the consent of a legal guardian for the provision of reproductive health pharmacist services to minors under the pilot program
Marek Tomków, Radosław Balwierz, Opole University, Adam Majewski,Aleksandra Szopa
Polish Journal of Public Health, September 2024
Abstract
Emergency contraception in Poland is often referred to as the “morning-after pill”. Its legal status has changed many times. In Poland, it has only been available on prescription since 2017. Attempts have been made to change the legal status in 2024. A draft amendment to the Pharmaceutical Act was then submitted to Parliament. However, the bill was vetoed by the President of the Republic of Poland. In response to the veto, the Minister of Health issued a decree on a pilot programme in the field of pharmacists’ services related to reproductive health. In connection with this regulation, a question arose for pharmacists: whether it is necessary to obtain the consent of the legal guardian of minors who want to use the programme. Therefore, the aim of the work was a legal-comparative and dogmatic-legal analysis of legal acts in the field of reproductive health. A review of the data shows that while the pharmacist carries out the activities indicated in the pilot programme for pharmacist services about reproductive health, health services are provided to patients. Therefore, in the case of minor patients under 16 years of age, or who are over 16 but under 18 years of age, the consent of their legal representatives is required. It should also be noted that the term “pharmacist service” used in the title is not defined in any way in the law (unlike the term “pharmaceutical service”) and does not constitute a definition that would allow the statement to be made that it is another unlisted activity that exempts the pharmacist from the obligation to obtain the consent of the legal guardian. It should therefore be assumed that this consent is necessary to provide the service.
The Civil Law Aspects of Informed Consent to Medical Procedures
The Civil Law Aspects of Informed Consent to Medical Procedures
Gede Agus Kurniawan, Ade Chandra
SASI, September 2024
Abstract
Introduction
Informed consent is a communication process between healthcare providers and patients regarding the medical procedures to be performed. Its aim is to provide sufficient information so that patients can make informed decisions, and it is regulated by various laws and regulations in Indonesia.
Purpose of the Research
The purpose of this research is to analyze the legal position of informed consent from the perspective of Indonesian civil law and to examine the civil law implications that arise if there is a violation of the informed consent principle in medical procedures.
Method of Research
This research uses normative legal methods with legislative and conceptual approaches, analyzing primary, secondary, and tertiary legal materials through literature study, and applying descriptive qualitative analysis.
Results of Research
Research findings indicate that informed consent holds a strong legal position within the perspective of Indonesian civil law, being viewed as a manifestation of a therapeutic agreement that must meet the valid agreement requirements according to the Civil Code (KUHPerdata) and be supported by various regulations. Violations of the principles of informed consent can lead to significant civil legal implications, including claims for damages on the grounds of breach of contract or unlawful acts, cancellation of the therapeutic agreement, liability for breach of professional standards, and claims based on consumer protection law. These implications can involve healthcare professionals and healthcare institutions, with consequences that include payment of material and immaterial damages, the burden of proof in court, and impacts on reputation and medical practice.
Editor’s note: SASI is a peer-reviewed journal published by the Faculty of Law, Universitas Pattimura, Indonesia.
Prevalence of pelvic examinations on anesthetized patients without informed consent
Prevalence of pelvic examinations on anesthetized patients without informed consent
Rachel Cutting, Varsha Reddy, Sneha Polam, Nicole Neiman, David Manna
Journal of Osteopathic Medicine, 7 October 2024
Open Access
Abstract
Context
The pelvic examination is a fundamental tool for the evaluation and diagnosis of women’s health conditions and an important skill for all medical students to learn as future physicians for the early detection of treatable conditions such as infection or cancer. Although the American College of Obstetricians and Gynecologists (ACOG) asserts that performing pelvic examinations under anesthesia for educational purposes should only occur if the patient provides explicit and informed consent, there still have been reports of medical students performing pelvic examinations on anesthetized patients across the country, and many states are now starting to pass bills requiring informed patient consents to conduct pelvic examinations under anesthesia.
Objectives
The objectives of this study are to evaluate the prevalence of pelvic examinations performed by osteopathic medical students on anesthetized patients without consent while fulfilling their third-year OB-GYN clerkship requirements.
Methods
The survey was administered and distributed to all osteopathic medical schools in the country via the Student Osteopathic Medical Association’s (SOMA’s) chapter emails, outreach emails, and SOMA’s social media accounts to collect data. Inclusion criteria included third- or fourth-year osteopathic medical students who completed their OB-GYN clerkship rotations when taking the survey. The exclusion criteria included any osteopathic medical student who had not completed their OB-GYN clerkship rotation. We utilized descriptive analysis to summarize the final data.
Results
We received 310 responses. The final number of responses was 291 after meeting the exclusion criteria. Most osteopathic medical students (94.2 %, n=274) considered the practice of performing pelvic examinations on anesthetized patients without their explicit consent unethical. Among the participants, 40.9 % (n=119) admitted to performing pelvic examinations on patients under anesthesia while on OB-GYN rotations, but most of them (57.1 %, n=68) did so without obtaining prior consent from the patients. Notably, the number of pelvic examinations performed by medical students on patients under anesthesia ranged widely from 1 to 25 with a median number of 10. Moreover, 58.9 % (n=70) indicated that they had not been properly educated to obtain specific consent before performing pelvic examinations under anesthesia. Many participants cited efficiency of practice, lack of policy awareness and personal education by medical students, and failure to refuse to perform pelvic examinations on anesthetized patients as trainees when asked by their seniors or preceptors.
Conclusions
This study demonstrates that although most osteopathic medical students consider performing pelvic examinations on anesthetized patients unethical, many still admit to practicing pelvic examinations on patients under anesthesia, while on OB-GYN rotations for efficiency of practice, lack of policy awareness and personal education, and being in unique positions in which grades are determined by seniors and preceptors for their willingness to do what is asked even if the practice does not align with their conviction. This study highlights the importance of ongoing research and implementation of policies at institutional and state levels that will procure the value of pelvic examinations while protecting and upholding the ethics of patients’ rights and autonomy of medical students.
Center for Informed Consent Integrity 