Capacity to Consent of People with Dementia: a Narrative Review from an Ethical Perspective
Urfa Khairatun Hisan, Nurul Qomariyah, Kristina Elizabeth
Jurnal Profesi Medika, 2022
People with dementia have impairment to execute daily life activities by presenting as a deterioration of mental processes, such as memory, thinking, reasoning, and judgment. Many participants in dementia research may lack the capacity to provide informed consent. Additional safeguards are needed for dementia research participants’ protection because of their vulnerability. Only after carefully weighing the risks and possible benefits for the participants in the research may it be decided to use vulnerable participants. The intention to prevent harm pushes against the removal of autonomy. This dilemma is the driving force behind this article’s narrative review of the capacity to consent problems in dementia research. For this critical narrative review, we conducted a thorough search of Scopus, PubMed, and Wiley Open Library for literature addressing the ethical and legal issues on the capacity to consent of people with dementia. We outline the dilemmas and difficulties that surround them including the related ethical principles, the informed consent process, capacity to consent, and safeguards for the participant in research involving people with dementia.
Editor’s note: Jurnal Profesi Medika is an Indonesian journal published by by the Faculty of Medicine UPN Veteran Jakarta
Adolescent Capacity to Consent to Participate in Research: A Review and Analysis Informed by Law, Human Rights, Ethics, and Developmental Science
Laws, 23 December 2022; 12(1)
Contemporary societies pose major challenges for adolescents and it is essential to conduct research with them to understand their experiences, identify their needs, and discover solutions to major social problems. Social science, humanities and health-related research into violence, technology, and climate change exemplify vital research endeavours requiring adolescent participation to advance Sustainable Development Goals and enhance individual lived experience and societal flourishing for current and future generations. International and national research ethics guidelines emphasise the necessity to conduct research to advance societal benefit, while upholding principles of autonomy and justice, and promoting participant welfare and avoiding harm. International human rights instruments promote adolescents’ freedom of expression and right to participate in matters affecting them. The rapid generation of robust research findings is essential, but it remains commonly assumed that adolescents cannot provide their own consent to participate in research studies, and the belief that parental consent is required can impede and impair the entire research process. Debate continues about the proper interpretation of legal principles and research ethics guidelines about who may provide consent. Continuing confusion about who must provide consent, and why, impedes the protection of adolescents’ interests and the advancement of society. This article adds to knowledge by providing a multidisciplinary overview of evidence from developmental science, social science, law, human rights, and bioethics about decision-making capacity and entitlements in the context of research participation, and an updated evidence-based analysis of adolescents’ capacity to provide their own consent to participate in social, humanities and health-related research. A conservative application of knowledge from these domains both individually and collectively supports conclusions that adolescents aged 16 are able to provide their own consent to participate in research, and no legal or ethical principle requires the provision of parental consent on their behalf. Practical considerations may support parental involvement in conversations about participation, and some types of research require trauma-informed approaches, but adolescents are developmentally, legally and ethically entitled to make their own decision about whether or not to participate.
Disability or Death: A Focused Review of Informed Consent in Pediatric Neurosurgery
Nathan A. Shlobin, John Paul G. Kolcun, Brian D. Leland, Laurie L. Ackerman, Sandi K. Lam, Jeffrey S. Raskin
Seminars in Pediatric Neurology, 22 December 2022
The management of pediatric neurosurgical disease often requires families to choose between long-term disability and premature death. This decision-making is codified by informed consent. In practice, decision-making is heavily weighted toward intervening to prevent death, often with less consideration of the realities of long-term disability. We analyze long-term disability in pediatric neurosurgical disease from the perspectives of patients, families, and society. We then present a pragmatic framework and conversational approach for addressing informed consent discussions when the outcome is expected to be death or disability. We performed a focused review of literature regarding informed consent in pediatric neurosurgery by searching PubMed and Google Scholar with search terms including “pediatric neurosurgery,” “informed consent,” and “disability.” The literature was focused on patients with diagnoses including spina bifida, neuro-oncology, trauma, and hydrocephalus. Patient perspective elements were physical/mental disability, lack of autonomy, and role in community/society. The family perspective involves caregiver burden, emotional toll, and financial impact. Societal considerations include the availability of public resources for disabled children, large-scale financial cost, and impacts on global health. Practical conversational steps with patients/caregivers include opening the discussion, information provision and acknowledgement of uncertainty, assessment of understanding and clarifying questions, decision-making, and decision maintenance, all while remaining sensitive to the emotional burden commensurate with these decisions. The “death or disability” paradigm represents a common challenge to informed consent in pediatric neurosurgery. Patient, family, and societal factors that inform surrogate decisions vary and sometimes conflict. Pediatric neurosurgeons must use a comprehensive approach to address the informational and relational needs of caregivers during the informed consent process.
Paediatric surgeons’ current knowledge and practices of obtaining assent from adolescents for elective reconstructive procedures
Krista Lai, Nathan S Rubalcava, Erica M Weidler, Kathleen van Leeuwen
JME, 21 December 2022
Adolescents develop their decision-making ability as they transition from childhood to adulthood. Participation in their medical care should be encouraged through obtaining assent, as recommended by the American Academy of Pediatrics (AAP). In this research, we aim to define the current knowledge of AAP recommendations and surgeon practices regarding assent for elective reconstructive procedures.
An anonymous electronic survey was distributed to North American paediatric surgeons and fellows through the American Pediatric Surgical Association (n=1353).
In total, 220 surgeons and trainees responded (16.3%). Fifty per cent of the surgeons who are familiar with the concept of assent had received formal training; 12% of the respondents had not heard of assent before the survey. Forty-seven per cent were aware of the 2016 AAP policy statement regarding assent in paediatric patients. Eighty-nine per cent always include adolescents as part of the consent discussion. Seventy-seven per cent solicit an expression of willingness to accept the proposed care from the patient. The majority (74%) of the surgeons perceived patient cooperation/understanding as the biggest barrier to obtaining assent. Over half of the respondents would consider proceeding with elective surgery despite the adolescent patient’s refusal. Reasons cited for proceeding with elective surgery include surgeons’ perception of medical necessity, perceptions of disease urgency, and lack of patient maturity.
Paediatric surgeons largely acknowledge the importance of assent, but variably practice the principles of obtaining assent from adolescent patients undergoing elective reconstructive procedures. Fewer surgeons are explicitly aware of formal policy statements or received formal training. Additional surgeon education and institutional policies are warranted to maximise inclusion of adolescents in their medical care.
Adolescent Confidentiality and Consent in an Emergency Setting
Mientkiewicz L, Grover P
Pediatric Emergency Care, 1 December 2022; 38(12) pp 697-699
The adolescent population comprises a large volume of emergency department visits each year. A recent study showed that 20% of the ambulatory care visits of adolescent patients aged 15 to 25 years were made to the emergency department. This specific population often has poor access to health care and often is a vulnerable population, causing medical care to be a challenge. The purpose of this article was to review the standard practice and the specific laws regarding confidentiality and consent when treating an adolescent patient to provide the best possible care and treatment.
A comprehensive literature search was done to examine key aspects of adolescent confidentiality and informed consent in an emergency setting. The literature was then compiled into a review article.
The article outlines the specific laws for emergency providers to be aware of regarding patient confidentiality and consent. The adolescent patient can consent to medical care without parental consent, when involving emergency care, contraceptive services, sexually transmitted infections, prenatal care, drug or alcohol related care, mental health services, and sexual assault services. Also, emancipated minors and mature minors are both situations in which a minor has the legal authority to refuse care and make decisions regarding their health care.
Patient confidentiality and informed consent are complex and complicated topics when dealing with the pediatric patient. Although some laws may vary state to state, there are specific details regarding adolescent confidentiality and informed consent that every provider should be aware of. The adolescent population is more likely to seek emergency care if the visit is confidential and the patient feels a sense of trust. Although it is important for providers to respect patient confidentiality when treating adolescents, it is also important for providers to encourage adolescents to confide in their parents regarding health issues.
Assent in Pediatric Critical Care Research: A Cross-Sectional Stakeholder Survey of Canadian Research Ethics Boards, Research Coordinators, Pediatric Critical Care Researchers, and Nurses
Katie O’Hearn, Florence Cayouette, Saoirse Cameron, Dori-Ann Martin, Anne Tsampalieros, Kusum Menon
Pediatric Critical Care Medicine, 13 October 2022
Survey of four stakeholder groups involved in defining and obtaining assent for research in Canadian PICUs to better understand their perspectives and perceived barriers to assent.
Fourteen tertiary-care pediatric hospitals in Canada.
Research Ethics Board Chairs, pediatric critical care nurses, research coordinators, and researchers.
Measurements and Main Results
A total of 193 participants responded. Thirty-seven percent (59/159) thought it was “Never/Almost Never” (59/159, 37%) feasible to obtain assent during the first 48 hours of PICU admission, and 112 of 170 (66%) indicated there are unique barriers to assent at the time of enrollment in PICU studies. Asking children for assent was most frequently rated as Important/Very Important for interviews/focus groups with the child (138/180, 77%), blood sample collection with a needle poke for research (137/178, 77%), and studies involving genetic testing with results communicated to the child/legal guardian (134/180, 74%). In two scenarios where a child and legal guardian disagreed about study participation, most respondents indicated that whether the child should still be enrolled would depend on the patient’s age (34-36%), and/or the risk of the study (24-28%). There was a lack of consensus over how the assent process should be operationalized, and when and for how long children should be followed to seek assent for ongoing study participation. Most stakeholders (117/158, 74%) thought that children should have the opportunity to decide if their samples could stay in a biobank once they are old enough to do so.
There was an overall lack of consensus on the feasibility of, and challenges associated with, obtaining assent at the time of study enrollment and on how key aspects of the assent process should be operationalized in the PICU. This highlights the need for guidelines to clarify the assent process in pediatric critical care research.
Digitalizing the Clinical Research Informed Consent Process: Assessing the Participant Experience in Comparison With Traditional Paper-Based Methods
Michael T. Buckley, Molly R. O’Shea, Sangeeta Kundu, Allison Lipitz-Snyderman, Gilad Kuperman, Suken Shah, Alexia Iasonos, Collette Houston, Stephanie L. Terzulli, Joseph M. Lengfellner, Paul Sabbatini
JCO Oncology Practice, 19 December 2022
Consent processes are critical for clinical care and research and may benefit from incorporating digital strategies. We compared an electronic informed consent (eIC) option to paper consent across four outcomes: (1) technology burden, (2) protocol comprehension, (3) participant agency (ability to self-advocate), and (4) completion of required document fields.
We assessed participant experience with eIC processes compared with traditional paper-based consenting using surveys and compared completeness of required fields, over 3 years (2019-2021). Participants who consented to a clinical trial at a large academic cancer center via paper or eIC were invited to either pre-COVID-19 pandemic survey 1 (technology burden) or intrapandemic survey 2 (comprehension and agency). Consent document completeness was assessed via electronic health records.
On survey 1, 83% of participants (n = 777) indicated eIC was easy or very easy to use; discomfort with technology overall was not correlated with discomfort using eIC. For survey 2, eIC (n = 262) and paper consenters (n = 193) had similar comprehension scores. All participants responded favorably to at least five of six agency statements; however, eIC generated a higher proportion of positive free-text comments (P < .05), with themes such as thoroughness of the discussion and consenter professionalism. eIC use yielded no completeness errors across 235 consents versus 6.4% for paper (P < .001).
Our findings suggest that eIC when compared with paper (1) did not increase technology burden, (2) supported comparable comprehension, (3) upheld key elements of participant agency, and (4) increased completion of mandatory consent fields. The results support a broader call for organizations to offer eIC for clinical research discussions to enhance the overall participant experience and increase the completeness of the consent process.
Animation supported consent before elective laparoscopic cholecystectomy
Emre Doganay, David Wald, Sam Parker, Frances Hughes
British Journal of Surgery, 7 December 2022
Patient understanding of surgical procedures is often incomplete at the time they are performed, invalidating consent, and exposing healthcare providers to complaints and claims of failure to inform. Remote consultations, language barriers and patient factors can hinder an effective consent pathway. New approaches are needed to support communication and shared decision-making.
Multi-language digital animations explaining laparoscopic cholecystectomy were introduced at The Royal London Hospital for patients who attended for elective surgery (www.explainmyprocedure.com). Patients completed questionnaires on the day of their procedure both before and after introduction of the animations. We assessed patient-reported understanding of the procedure, its intended benefits, the possible risks, and alternatives to treatment in 72 consecutive patients, 37 before (no animation group) and after 35 after introducing the animations into the consent pathway (animation group). Patient understanding in the two groups was compared.
The two groups were well matched in respect of age, sex and whether English was their first spoken language. The proportions of patients who reported they completely understood the procedure, its benefits, risks, and alternatives in the no animation group were 54%, 57%, 38% and 24% and in the animation group, 91%, 91%, 74% and 77% respectively; p<0.01 for each comparison.
The integration of multi-language laparoscopic cholecystectomy video animations into the patient consent pathway was associated with substantial improvement in reported understanding of the procedure, benefits, risks, and alternatives to treatment. This approach can be applied across all surgical disciplines in a standardised manner in an era of accelerated elective work and remote consultations.
Digital Informed Consent: Modernising Information Sharing in Surgery to Empower Patients
Original Scientific Report
Simon L. Parsons, Prita Daliya, Phil Evans, Dileep N. Lobo
World Journal of Surgery, 3 December 2022
Despite the 2015 Montgomery Ruling highlighting key requisites for informed consent, little has changed to modernise data-sharing and documentation of the consent process. It can be difficult to gauge patient understanding and address all patient concerns in time-limited appointments. We aimed to assess the feasibility of a digital information-sharing platform to support a move towards a digital informed consent process.
All adult patients referred to a single centre with symptomatic gallstones were invited to use a digital information-sharing platform to support the informed consent process prior to their first surgical clinic appointment. The platform provided patients with multimedia information on gallstones and available treatment options. It recorded the time spent accessing information, asked patients multiple choice questions (MCQs) to allow a self-test of understanding, documented a summary medical history, and allowed free text for patient questions. This information was summarised into a clinical report to support outpatient clinic consultations.
Of the 349 patients registered to use the digital platform, 203 (58.2%) [165 (81.3%) female, mean age 47.6 years (range 19–84 years)] completed all modules necessary to generate a clinical report. Some 130 patients (64.0%) answered all 10 MCQs correctly and spent a mean of 18.7 min (range 3–88 min) reading the consent information. Most patient-reported medical histories were deemed to be accurate.
Despite difficulties with access, resulting in drop-outs, patients welcomed the opportunity to receive information digitally, prior to their consultation. Patients described feeling empowered and better informed to be involved in decision-making.
Ethics of the fiduciary relationship between patient and physician: the case of informed consent
Sophie Ludewigs, Jonas Narchi, Lukas Kiefer, Eva C Winkler
JME, 8 December 2022
This paper serves two purposes: first, the proposition of an ethical fiduciary theory that substantiates the often cited assertion that the patient–physician relationship is fiduciary in nature; and second, the application of this theory to the case of informed consent. Patients’ decision-making preferences vary significantly. While some seek fully autonomous decision-making, others prefer to delegate parts of their decision. Therefore, we propose an ethical fiduciary theory that allows physician and patient to jointly determine the physician’s role on a spectrum from fiduciary as advisor to fiduciary as agent. Drawing on legal concepts of the fiduciary relationship and on phenomenological accounts of obligation by Lévinas and Løgstrup, our theory relies on the key attributes of trust, vulnerability and otherness. Finally, practical implications of this theory for the informed consent process are developed: we propose a preassessment of patients’ risk and value profiles as well as a restructuring of the oral consent interview and the written consent materials.