Barriers to Informed Consent in Interventional Radiology: A Pilot Study
Sara Silberstein, Eric J.Keller
Journal of Radiology Nursing, 9 May 2022
Abstract
Background
Informed consent is a central part of the relationships between patients and interventional radiology teams, but consent practices are variable and limited.
Purpose
This study explored consent practices among clinicians and staff in an academic IR department to identify barriers to informed consent.
Methods
Systematic interviews were conducted with 17 clinicians and staff about their roles in obtaining informed consent, perceptions of what informed consent and capacity determinations entail, and barriers to patients’ understanding of IR procedures.
Findings
Results revealed four key barriers to adequate informed consent: limited procedural experience/knowledge by the consenting clinician, unclear division of responsibilities, inconsistent approaches to assessing capacity and surrogate decision making, and wide variation in patients’ baseline understandings.
Discussion
This variation seemed to stem from a lack of shared understanding about consent processes and responsibilities, highlighting an important area for quality improvement in IR that would benefit from a larger multipractice investigation of consent practices.
Month: June 2022
Poor compliance documenting informed consent in trauma patients with distal radius fractures compared to elective total knee arthroplasty
Poor compliance documenting informed consent in trauma patients with distal radius fractures compared to elective total knee arthroplasty
Scott M Bolam, Leigh Munro, Mark Wright
Royal Australasian College of Surgeons, 4 May 2022
Open Access
Abstract
Background
The purpose of this study was (1) to evaluate the adequacy of informed consent documentation in the trauma setting for distal radius fracture surgery compared with the elective setting for total knee arthroplasty (TKA) at a large public hospital and (2) to explore the relevant guidelines in New Zealand relating to consent documentation.
Methods
Consecutive adult patients (≥16 years) undergoing operations for distal radius fractures and elective TKA over a 12-month period in a single-centre were retrospectively identified. All medical records were reviewed for the risks and complications recorded. The consent form was analysed using the Flesch Reading Ease Score (FRES) and the Simple Measure of Gobbledygook (SMOG) index readability scores.
Results
A total of 133 patients undergoing 134 operations for 135 distal radius fractures and 239 patients undergoing 247 TKA were included. Specific risks of surgery were recorded significantly less frequently for distal radius fractures than TKA (43.3% versus 78.5%, P < 0.001). Significantly fewer risks were recorded in the trauma setting compared to the elective (2.35 ± 2.98 versus 4.95 ± 3.33, P < 0.001). The readability of the consent form was 40.5 using the FRES and 10.9 using the SMOG index, indicating a university undergraduate level of reading.
Conclusions
This study has shown poor compliance in documenting risks of surgery during the informed consent process in an acute trauma setting compared to elective arthroplasty. Institutions must prioritize improving documentation of informed consent for orthopaedic trauma patients to ensure a patient-centred approach to healthcare.
A Systematic Review on Improving the Family Experience After Consent for Deceased Organ Donation
A Systematic Review on Improving the Family Experience After Consent for Deceased Organ Donation
Review Article
Sonja Bjelland, Krista Jones
Progress in Transplantation, 2 May 2022
Abstract
Introduction
The demand for transplanted organs outweighs the supply and intensifies the need to improve care for donor families. Studies have shown inadequate care by hospital staff can increase posttraumatic stress disorder and complicated grief in these families but putting solutions into practice remains slow.
Objective
This systematic review identified factors that relieve or contribute to distress for deceased organ donor families in the time since the decision to donate. Additionally, it provides insights into potential improvements at public health, educational, and health system levels to address these deficiencies.
Methods
Search terms included organ don*, famil* or relati*, family-centered, grief, and experience*. The search covered original research articles, published in English, from 2014 to July 2021.
Results
Four key themes emerged among the studies. (a) Understanding factors that affect the emotional aftermath can help staff prevent posttraumatic stress disorder and complicated grief. (b) Improving communication by hospital staff includes: avoiding medical jargon, providing adequate audio and visual explanations, and understanding that the next of kin is struggling to comprehend the tragedy and the information they are being told. (c) End-of-life care such as memory making, bringing in palliative care resources, and parting ceremonies can assist with familial coping as well as staff interactions. (d) Families want more support in the months and years after the donation decision.
Discussion
Changes at multiple levels can improve the quality of care for families whose relative gave the gift of life, but more research and translation into practice are needed.
Consent: risk assessment, risk communication and shared decision making
Consent: risk assessment, risk communication and shared decision making
Jayne M. Sewell, Catherine Rimmer
Surgery (Oxford), 30 April 2022
Abstract
The consent process is the foundation of the modern doctor–patient relationship, and can present a challenge to doctors. The consent process can be complex, and often involves the interaction of many different factors, including ethical and legal considerations. A shared decision-making process allows for full consideration of the treatment options available, and takes into account individual patient’s concerns and preferences. Ensuring that the patient is fully informed requires a thorough understanding of the risks of an intervention for that particular patient; therefore, individualized risk assessment is of fundamental importance. Using a combination of individual patient information, formalized investigations, and population data, gives the most complete assessment of risk. Communicating that risk information to patients is key, and the doctor should always use clear language and avoid bias. The use of visual aids and information leaflets, and the avoidance of vague language and complex statistical terms, will help the patient to develop a more complete understanding of the risks they face.
An Ethical Defense of a Mandated Choice Consent Procedure for Deceased Organ Donation
An Ethical Defense of a Mandated Choice Consent Procedure for Deceased Organ Donation
Original Paper
Xavier Symons, Billy Poulden
Asian Bioethics Review, 29 April 2022
Open Access
Abstract
Organ transplant shortages are ubiquitous in healthcare systems around the world. In response, several commentators have argued for the adoption of an opt-out policy for organ transplantation, whereby individuals would by default be registered as organ donors unless they informed authorities of their desire to opt-out. This may potentially lead to an increase in donation rates. An opt-out system, however, presumes consent even when it is evident that a significant minority are resistant to organ donation. In this article, we defend a mandated choice framework for consent to deceased organ donation. A mandated choice framework, coupled with good public education, would likely increase donation rates. More importantly, however, a mandated choice framework would respect the autonomous preferences of people who do not wish to donate. We focus in particular on the Australian healthcare context, and consider how a mandated choice system could function as an ethical means to increase the organ donation rate in Australia. We make the novel proposal that all individuals who vote at an Australian federal election be required to state their organ donation preferences when voting.
Patient Experience of Informed Consent for Diagnostic Coronary Angiogram and Follow-On Treatments: A Research Brief
Patient Experience of Informed Consent for Diagnostic Coronary Angiogram and Follow-On Treatments: A Research Brief
Diane L. Carroll, Howard T Blanchard, Felicity Astin
Journal British Journal of Cardiac Nursing, 25 April 2022
Abstract
Background/Aims
Coronary angiography requires a complex informed consent process, a legal and ethical requirement before treatment, which may allow percutaneous coronary intervention (PCI) to be completed as a continuation of a coronary angiography. Patients are routinely consented for both interventions, but over a quarter will only receive diagnostic angiogram. Therefore, the specific aim of this study is to describe patients’ demography, views and understanding of the informed consent process, in patients who gave informed consent for coronary angiography and same setting PCI but were found to be ineligible for same setting PCI.
Methods
A descriptive cross sectional survey design was used to explore these patients’ views. Participants completed a 36-item survey on the day after diagnostic coronary angiography.
Results
Data was collected from a convenience sample of 62 subjects, 73% male, 68% college educated, 40% working with a mean age of 68.4 (11.4) years. Women reported; greater difficulty in recalling treatment information (p<.03) found discussions about alternative treatments more confusing (p<.02), and the disclosure of comprehensive risk information a deterrent to consent 2 for treatment (p<.02), when compared to men. Higher levels of education were associated with greater preference for information and involvement in treatment decisions (p<.002).
Conclusions
Patients who participate in an informed consent for diagnostic coronary angiography with, or without, a same-setting PCI need clear comprehensive information on alternatives. Recognizing patient’s need for information is an opportunity for nursing to provide individualized explanation and reinforcement of the information provided during informed consent
Information Provision for Informed Consent Procedures in Psychological Research under the GDPR: A Practical Guide
Information Provision for Informed Consent Procedures in Psychological Research under the GDPR: A Practical Guide
Dara Hallinan, Franziska Boehm, Annika Külpmann, Malte Elson
The Society for the Improvement of Psychological Science; GDPR and Consent Forms in Psychological Research, 18 May 2022
Open Access
Abstract
Psychological research often involves the collection and processing of personal data from human research participants, and there is a norm that informed consent should be obtained before such research can go ahead. The European General Data Protection Regulation (GDPR) applies, in principle, to psychological research. It elaborates a range of conditions concerning the forms of information which should be communicated to research participants whenever personal data are collected from them, in order that they might be considered to be ‘informed’. There is reason to believe, however, that the information required by the GDPR may not always be provided in consent materials. This may – at least in part – be due to the fact that psychological researchers are not aware of the exact requirements. This tutorial thus aims to provide general practical guidance to psychological researchers allowing them to understand which forms of information must be provided to research subjects in consent materials according to the GDPR.
Without their Consent: Handling Legacy Collections and Anatomy Teaching Specimens Acquired without Informed Consent
Without their Consent: Handling Legacy Collections and Anatomy Teaching Specimens Acquired without Informed Consent
Pamela L. Geller
Federation of American Societies for Experimental Biology, 13 May 2022; 36(1)
Open Access
Abstract
Legacy collections have proven invaluable for teaching students about anatomy and standard methods. It is safe to presume, however, that ancient and historic decedents never consented to their inclusion in collections or use as pedagogical tools. A utilitarian position—that the use of these human remains serves a higher scientific purpose—becomes even harder to justify when educators acknowledge the historic necropolitical projects and suffering that underpinned the formation of legacy collections. How then to proceed scholastically with such affective and politically charged human remains?
As a complex case study, I consider the Samuel G. Morton Crania Collection. To instruct the medical students who populated his anatomy classes, the Philadelphia physician amassed over 900 crania from 1830 to 1851. After Morton’s death, the Academy of Natural Sciences purchased the collection, where it was all but forgotten. Almost a century later, in 1966, it came under the stewardship of the Penn Museum, its pedagogical purpose resurrected. While Stephen Jay Gould drew attention to the scientific racism of Morton’s research, it was not until the passage of the Native American Graves Protection and Repatriation Act of 1990 that ethical deliberations began in earnest. Here I continue these trains of thought with a discussion of the Afro-Cuban crania in the Morton Collection.
Morton acquired these decedents from his Cuban colleague Dr. José Rodriguez Cisneros in 1840. The latter designated them “negros bozales,” an indicator of their enslaved status and African origins; additional information about tribe and country was not provided. In summer 2020, in the wake of the murder of George Floyd and the racial justice protests his death catalyzed, these skulls erupted into the public consciousness. There were calls to “Return Them All.” I regard this response as well intentioned but also reactionary and unnuanced. To determine if sustained use is viable where consent is inadequate, for this case and more generally, I bring to the fore two concepts: the agentive corpse and ontological insecurity. Both concepts require educators and researchers to culturally contextualize human remains, as well as attend to the dynamic meanings attached to them—by past communities and their living descendants. With this knowledge in hand, I make some tentative recommendations about the fate of these controversial and highly sensitive human remains.
‘If we don’t have consent, we need to have beneficence’: Requiring beneficence in nonconsensual neurocorrection
‘If we don’t have consent, we need to have beneficence’: Requiring beneficence in nonconsensual neurocorrection
Emma Dore-Horgan
Bioethics, 8 April 2022
Abstract
Neurointerventions—interventions that cause direct physical, chemical or biological effects on the brain—are sometimes administered to criminal offenders for the purpose of reducing their recidivism risk and promoting their rehabilitation more generally. Ethical debate on this practice (henceforth called ‘neurocorrection’) has focused on the issue of consent, with some authors defending a consent requirement in neurocorrection and others rejecting this. In this paper, I align with the view that consent might not always be necessary for permissible neurocorrective use, but introduce a qualification I argue ought to inform our ethical and legal analysis of neurocorrection if we are to administer neurocorrectives nonconsensually. I maintain our use of nonconsensual neurocorrection should be constrained by a beneficence requirement—that it should be limited to neurocorrectives that can be expected to benefit those required to undergo them; and my argument is that a beneficence requirement is necessary in order to safeguard against offender abuse. I highlight how we afford a heightened protective role to beneficence in other instances of biomedical intervention where consent is absent or in doubt; and I argue a beneficence requirement is also necessary in the correctional context because alternative candidate protections would provide insufficiently strong safeguards on their own. I then consider whether requiring beneficence in nonconsensual neurocorrection would (a) be incompatible with penal theory, (b) be objectionably paternalistic, or (c) foreclose many fruitful avenues of crime control. I argue in each case that it would not.
Is true informed consent achievable?
Is true informed consent achievable?
Miya Matz
MacEwan University Student eJournal, 6 May 2022; 6(1)
Abstract
Imagine you have just found out that a loved one, such as a parent, sibling, or close friend, suffers from a rare and deadly genetic disorder. There are currently no successful mainstream treatments for this disorder. However, the doctor mentions a highly experimental treatment that would involve removing bone marrow from a healthy donor once a month for a full year and could potentially cause permanent damage to them. It turns out that you are a match. How would you make your decision regarding treatment? Most individuals would suggest leaving it to the doctor’s discretion, but because it is your body, it is ultimately your choice. You attempt to do further research on the internet but end up confused and frustrated. How will you ultimately decide as to whether you should give informed consent for the procedure?
Center for Informed Consent Integrity 