Patient Reflections on the Consent Process for Donating Extra Bone Marrow Research Samples to a Hematology Biobank: A Qualitative Interview Study
Madeleine Gordon, Oksana Motalo, Erika Camilleri, Taryn Chesser, Gary Davis, Grace Fox, Katya Godard, Caryn Y Ito, Jocelyn Lepage, Krystina B. Lewis, Wendy Nuttall, Craig Peloshok, Stuart Nicholls, Mitchell Sabloff
Blood, 5 November 2024
Abstract
Background
Bone marrow samples taken at the time of diagnosis are essential for early diagnosis and treatment of acute leukemia (AL) and additionally can be used to understand the underlying biology. This requires bone marrow samples to be taken for clinical purposes as well as for research. Due to the rapid onset and progression of AL, there is a narrow time frame from initial disease suspicion to diagnosis confirmation and treatment initiation. This can present challenges with consenting patients for additional, research-specific bone marrow samples to be obtained during the diagnostic procedure. While patients with cancer are generally positive towards contributing to medical research, recruitment rates for bone marrow samples are low, hindering translational research aimed at improving patients’ outcomes in AL. Little is known about patient perspectives with respect to the informed consent process under these time-sensitive circumstances, or how these processes can improve research sample provision while also maintaining respect for patient autonomy and supporting their decision-making during a stressful time. The current study is aimed to better understand the experiences of patients with AL in relation to consenting to provide extra bone marrow samples for research during the diagnostic procedure.
Methods
Semi-structured interviews were conducted with patients treated for AL between January 1, 2017 and December 31, 2021 at The Ottawa Hospital. Patients were eligible if they were admitted to hospital urgently to confirm AL diagnosis, received intensive induction chemotherapy and spoke English or French. Interviews proceeded until data saturation was reached.
Results
Seventeen patients were interviewed. Patient experiences centred on three key areas within the consent process: Preparation and awareness of research, logistical challenges related to obtaining consent within the limited time frame and having emotional and psychological support. Patients were supportive of increasing public knowledge about research and noted the important roles that friends and family members played in providing support and retaining information. Despite the time pressure and anxiety that came with a diagnosis of AL, the decision to give a research sample did not in itself require much deliberation. Decisions were informed by proximal factors such as impact on patient health and family, the anticipated pain associated with the bone marrow procedure and its duration, as well as distal factors such as altruism and trust in the healthcare team. Patients valued as much time as possible between the consent process and the bone marrow extraction. Further, they valued information about the level of anticipated procedure-associated pain, the purpose of ongoing research and its use of samples, and details regarding the privacy and security of the research samples.
Conclusion
Our findings suggest that the success of consenting for additional bone marrow samples for research may be optimised through multiple changes, such as those pertaining to the environment where the consent discussion takes place as well as a period of time for reflection on the discussion prior to the procedure, in addition to the type of information provided, the recognition of patient concerns surrounding discomfort and how it will be mitigated and, finally, the value of current and future research.
What does a consent conversation for whole genome sequencing look like in the NHS Genomic Medicine Service? An observational study
What does a consent conversation for whole genome sequencing look like in the NHS Genomic Medicine Service? An observational study
Holly Ellard, Huda Alfardus, Saskia Sanderson, Celine Lewis
European Journal Of Human Genetics, 26 November 2024
Open Access
Abstract
Patient choice consent for whole genome sequencing (WGS) through the Genomic Medicine Service in England covers consent to diagnostic testing and an invitation to the National Genomic Research Library (NGRL). Little is known about what consent conversations for WGS look like in practice. We audio-recorded and analysed the content and structure of consent appointments (n = 26) between healthcare professionals (HCPs) and parents of children with rare disease across seven NHS Trusts. Appointments frequently covered the potential findings from testing, implications for family members, and DNA storage, but often omitted that data may be reanalysed in the future if a diagnosis is not made. Consent to the NGRL was typically sought during the same appointment; these discussions varied in content, but frequently included a background to the NGRL and data security. HCPs often tempered expectations around what WGS can achieve and asked questions to clarify parents’ understanding, but less commonly elicited parents’ values and concerns. Administrative tasks were time-consuming, but took less time when consent was recorded digitally. Future training should emphasise how to elicit patients’ values and concerns. Digital infrastructure and hiring roles such as genomic associates to support consent may be important strategies to meet the workload demands of WGS.
Variance of Consent for Genetic Return of Results Across Sociodemographic Traits
Variance of Consent for Genetic Return of Results Across Sociodemographic Traits
Christine Jovanovic, Brynn Mayer
University of Illinois Library, 25 November 2024
Abstract
There is a gap in the literature assessing whether demographic variables are associated with uptake of genetic testing in the absence of identified barriers of referral and cost. Because the All of Us Research Program offers genetic testing and counseling at no cost, we propose to address this gap using data from the University of Illinois Chicago All of Us Research Program, which includes over 16,000 individuals. This study will aim to assess whether consent to receive genetic return of results (GRoR) varies significantly across relevant sociodemographic factors among the diverse participants in the University of Illinois Chicago (UIC) All of Us cohort.
Obtaining Informed Consent From People With Dyslexia: The Role Of Easy Language
Obtaining Informed Consent From People With Dyslexia: The Role Of Easy Language
Marija Jozipović, Mirjana Lenček
Croatian Journal of Rehabilitation Research, 19 December 2024
Open Access
Abstract
Obtaining informed consent is a standard procedure in research practice. However, it is not sufficient, even if an individual chooses to participate voluntarily in research process, for the researchers to be able to claim that they have obtained informed consent. The consent must be of sufficiently ‘high quality’: it must not only be informed, but also valid, i.e., it must contain the following three elements: adequate information, voluntariness, and competence. Although preparing informed consent is a difficult process in general, it is particularly challenging when working with certain populations, such as clinical groups who have language and literacy difficulties, e.g., dyslexia. A lack of understanding of the basis and specific characteristics of this disorder can have negative effects on people with dyslexia (PwD) such as in the form of unwanted misunderstandings, psychological stress, negative effects on their learning processes, as well as unethical treatment in the research process. Studies have shown that PwD can be particularly vulnerable to research that might exploit, imply, or attribute unsafe practices to them and their difficulties, especially in connection with research recommendations that require written informed consent. Easy language refers to the language adaptation of a text to facilitate both reading and comprehension, particularly for PwD. Therefore, the use of the easy language guidelines for language adaptation and graphical adjustment is important when obtaining informed consent from PwD.
What Is Truly Informed Consent in Medical Practice and What Has the Perception of Risk Got to Do with It?
What Is Truly Informed Consent in Medical Practice and What Has the Perception of Risk Got to Do with It?
Catherine Jane Calderwood, Geir Sverre Braut, Siri Wiig
Healthcare, 24 December 2024
Abstract
Making decisions about risk, describing and appropriately explaining risk in medical practice is complex for patients and professionals. In this paper, we investigate how the concept of consent is practiced differently in the UK and Norway and discuss pros and cons of the chosen approaches from a patient safety culture perspective. We argue that consent is a fundamental part of the safety culture and influence on health system functioning and patient and staff safety. Examples from the UK and Norway are used and discussed in terms of how risk perception influences consent processes and practices.
‘Some parts of the consent form are written using complex scientific language’: community perspectives on informed consent for research with pregnant and lactating mothers in Uganda
‘Some parts of the consent form are written using complex scientific language’: community perspectives on informed consent for research with pregnant and lactating mothers in Uganda
Research
Adelline Twimukye, Sylvia Nabukenya, Aida N. Kawuma, Josephine Bayigga, Ritah Nakijoba, Simon Peter Asiimwe, Fredrick Byenume, Francis Williams Ojara, Catriona Waitt
BMC Medical Ethics, 21 December 2024
Open Access
Abstract
Background
Appropriate language use is essential to ensure inclusion of diverse populations in research. We aimed to identify possible language-related barriers regarding the informed consent process and propose interventions to improve clarity and understanding of pregnant and breastfeeding women participating in research.
Methods
A cross-sectional qualitative study employing focus group discussions (FGD) was conducted in Uganda from August 2023 to September 2023, involving a diverse group of stakeholders from the community, including community members, research participants, and Community Advisory Board members. 19 FGD comprised adult participants representing at least six different mother tongues (Luganda, Acholi, Runyankole, Runyoro, Lugbara and English). An inductive thematic approach was utilized for data analysis using NVivo version 12 software to identify language factors that influence informed consent. A series of community validation workshops ensured concurrence.
Results
At the individual level, language barriers, and low levels of literacy contributed to poor comprehension, thus hindering ability to achieve genuine informed consent. At the health facility level, participants reported that there was use of inappropriate, unclear language including inaccurate translations, with poor and complicated grammar in some consent forms. Participants reported that complex medical terminologies are difficult to translate to local languages. Community members highlighted that social/cultural norms in language use affected cultural perceptions of informed consent. To enhance understanding for individuals without education in science, participants suggested simplification of terminologies and avoidance of complex medical jargon. Researchers should identify participants’ preferred languages and communicate in those languages whenever possible. If researchers are not fluent, trained interpreters should be identified. Informed consent documents must be translated into local languages to ensure participants comprehend the study’s purpose, procedures, risks, and benefits. Involving community members during development and translation of these documents can provide valuable insights into local dialects and culturally specific concepts, ensuring that study tools like surveys and consent forms are accurate and respectful.
Conclusion
Language barriers influence the informed consent process within communities in Uganda. These can potentially be resolved at individual, health system and community levels. Consideration of locally understandable terms in community-facing study documentation is likely to enhance understanding and could improve research participation, although further studies are needed to assess these. The use of appropriate language ensures that informed consent is genuine in keeping with principles of Good Clinical Practice, and developing a research communication strategy should be part of inclusive research design.
Patients’ satisfaction with the preoperative informed consent in elective gynecological surgery in a tertiary hospital, BMA
Patients’ satisfaction with the preoperative informed consent in elective gynecological surgery in a tertiary hospital, BMA
Thossaporn Chuaysatit, Apichaya Pradyachaipimol, Jiraporn Luengmettakul
Thai Journal of Obstetrics and Gynaecology, 18 December 2024
Abstract
Objectives
This study aimed to evaluate patients’ satisfaction with the preoperative informed consent process in elective gynecological surgery.
Materials and Methods
This cross-sectional study was conducted at Charoenkrung Pracharak Hospital, Bangkok, Thailand, from October 2023 to May 2024. Personal data and satisfaction with the preoperative informed consent process were collected on the second postoperative day. The Thai version of the Decisional Satisfaction Scale (DSS) was used to measure the satisfaction and the Informed Consent Process Questionnaire was used to assess knowledge of surgery and perception of informed consent process. Bivariate associations between highly satisfied and not highly satisfied groups were tested using Fisher’s exact test.
Results
A total of 178 participants were enrolled, with mean age of 42.48 years. Most participants agreed or strongly agreed with the statements on the DSS, a mean total score was 27.87, indicating high overall satisfaction. 135 patients (75.8%) were highly satisfied with the informed consent process. There were several factors with significant differences between the highly satisfied group and not highly satisfied group. These included being informed about the consequences of not undergoing the procedure, knowing enough about the procedure to explain it, being informed about the reasons for prolonged urine catheterization and being given the opportunity to refuse the procedure.
Conclusion
This study highlights the critical role of an effective informed consent process in elective gynecological surgery. High patient satisfaction is achieved when communication and patient participation are prioritized. Future research should explore these dynamics in different settings and diverse populations.
Assessing informed consent in surgical patients at Queen Elizabeth Central Hospital in Blantyre, Malawi: a cross-sectional study
Assessing informed consent in surgical patients at Queen Elizabeth Central Hospital in Blantyre, Malawi: a cross-sectional study
Lucy Kaomba, Wakisa Mulwafu
Malawi Medical Journal, December 2024; 36(4) pp 249-254
Abstract
Introduction
Informed consent is critical to medical practice, and a clearly outlined process that results in signing the consent form may improve the validity of the given consent. There is a paucity of studies in Malawi that have assessed the informed consent process in surgical patients.
Aim
To assess the informed consent process for patients undergoing surgery at QECH in Malawi.
Methods
A cross-sectional quantitative descriptive study was conducted among postoperative patients in the adult surgical wards at QECH through face-to-face interviews. The calculated sample size was 235. A consecutive sampling technique was used. Those below 18 years and those who didn’t or couldn’t consent were excluded. Data was entered and analyzed in Microsoft Excel 2016 and IBM SPSS 25.0. The level of significance was considered as P<0.05.
Results
A total of 222 patients were interviewed. The age range was 21 to 75 years, with a median of 38.5. Two hundred and twelve (95%) patients signed a consent form before surgery, and 21 (9%) knew the content of the form. Most patients, 100 (47%) had a primary school education, and 156 (70%) could read and write. Those with secondary or tertiary education were more likely to want to ask a question given the opportunity (OR 2.82, p= 0.0012), but there was no significant difference in the likelihood of being given time to ask questions between the two groups who had primary and no formal education vs those who had secondary and tertiary education (OR 1.4, p=0.3367)
Conclusion
This study highlights the necessity of employing effective communication strategies during the consent process for surgical procedures and the need to tailor the consent form to the patient’s education level.
Awareness of consent among Nigerian orthodontic patients; a study of perceptions and practices
Awareness of consent among Nigerian orthodontic patients; a study of perceptions and practices
Sylvia Simon Etim, Onyinye Dorathy Umeh
Acta Stomatologica Marisiensis, December 2024
Abstract
Introduction
Orthodontic treatment is elective but not without risks. Prospective patients need to be fully informed of their treatment options and understand the associated risks and benefits.
Aim of the study
To assess the perception of Nigerian orthodontic patients regarding the consent and assent-giving process before orthodontic treatment.
Material and Methods
A total of 349 patients from the University of Port Harcourt Teaching Hospital and Lagos University Teaching Hospital, who received orthodontic treatment between December 2023 and May 2024, participated in this study. A 21-item questionnaire was administered via Google Forms. The questionnaire contained demographic questions and items assessing knowledge, perception, and practice of consent in orthodontics. Data were analyzed using IBM SPSS Version 26, employing descriptive statistics (frequencies and percentages).
Results
Of the 349 participants, 99 (28.4%) were male, and 250 (71.6%) were female, with a mean age of 23.43 ± 10.49 years. Of the study population, 88% of female and 91.9% of male participants had heard of consent before treatment. A total of 93.1% of participants gave consent, with 78.5% of these being verbal. Pain (45.6%) was the most commonly explained complication, while infection (6.9%) was the least. In terms of satisfaction, 92% of participants were satisfied with the consent process.
Conclusion
Most Nigerian orthodontic patients are aware of the consent process and are generally satisfied with it. Orthodontists in Nigeria should prioritize obtaining written informed consent to ensure patient protection and avoid potential legal issues.
Editor’s note: Acta Stomatologica Marisiensis is the Journal of George Emil Palade University of Medicine, Pharmacy, Science, and Technology in Romania.
The Role of Informed Consent in Medical Disputes at State University Hospitals
The Role of Informed Consent in Medical Disputes at State University Hospitals
Putu Agus Prawira Eka Putra, Gusti Ayu Putri Kartika, R.A. Tuty Kuswardhani
Unram Law Review, 11 November 2024
Abstract
The research aims to understand how informed consent functions in the context of medical disputes at state university hospitals in Indonesia. The main benefit of the study is to provide an overview of how informed consent offers legal protection to the medical profession, particularly in resolving disputes that may arise in the hospital setting. The research utilizes a normative legal research method, focusing on the examination of written laws, regulations, and legal materials applicable in Indonesia. The research concludes that the thoroughness of informed consent documentation is crucial, especially for medical procedures that carry high risks. This thoroughness serves as a legal safeguard for medical professionals, ensuring their protection in case of disputes. Enhanced attention to the completeness of informed consent is necessary to mitigate the risks for doctors and provide legal security within the medical field at state university hospitals.
Center for Informed Consent Integrity 