The Role of Informed Consent for Thrombolysis in Acute Ischemic Stroke
Comer AR, Damush TM, Torke AM, Williams LS
Journal of Clinical Ethics, 2019; 30(4) pp 338-346
Although tissue plasminogen activator (tPA) is the only medication approved by the United States Food and Drug Administration (FDA) for acute ischemic stroke, there is no consensus about the need for informed consent for its use. As a result, hospitals throughout the U.S. have varying requirements regarding obtaining informed consent from patients for the use of tPA, ranging from no requirement for informed consent to a requirement for verbal or written informed consent. We conducted a study to (1) determine current beliefs about obtaining patients’ informed consent for tPA among a large group of stroke clinicians and (2) identify the ethical, clinical, and organizational factors that influence tPA consent practices. Semi-structured interviews were conducted by trained and experienced investigators and research staff to identify key barriers to implementing acute stroke services. Part of the interview explored current beliefs and practices around informed consent for tPA. This was a multicenter study that included 38 Veterans Health Administration (VHA) hospital locations. Participants were 68 stroke team clinicians, serving primarily on the neurology (35 percent) or emergency medicine (41 percent) service. We conducted thematic analysis based on principles of grounded theory to identify codes about consent for tPA. We used interpretive convergence to ensure consistency among the individual investigators’ codes and to ensure that all of the investigators agreed on coding and themes. We found that 38 percent of the stroke clinicians did not believe any form of consent was necessary for tPA, 47 percent thought that some form of consent was necessary, and 15 percent were unsure. Clinicians who believed tPA required informed consent were divided on whether consent should be written (40 percent) or verbal (60 percent). We identified three factors describing clinicians’ attitudes about consent: (1) legal and policy factors, (2) ethical factors, and (3) medical factors. The lack of consensus regarding consent for tPA creates the potential for delays in treatment, uneasiness among clinicians, and legal liability. The identified factors provide a potential framework to guide discussions about developing a standard of care for acquiring the informed consent of patients for the administration of tPA.
Informed Consent in Diagnostic and Therapeutic Lumbar Puncture: Are Patients Aware of the Risks?
Muhammed Nur Ögün, Merve Önerli, Şule Aydın Türkoğlu, Serpil Yıldız
Turkish Journal of Neurology, 2019; 25(4) pp 229-232
To determine whether the type of informed consent (verbal or written and verbal) influenced the awareness of patients about the risks of lumbar puncture (LP).
Materials and Methods
An “informed consent form” was given to the patients in group 1 24 h before the procedure, and the patients were requested to read and sign the form. The informed consent form was given to patients in group 2, and then, a neurologist verbally explained the complications mentioned in the form to the patients. After the procedure, patients in both groups were asked whether they were aware of the complications mentioned in the consent form.
We included 43 patients (group 1, n=23 and group 2, n=20) in the study; 14% (n=6) of the patients were university graduates, 18% (n=8) had completed high-school education, and 67% (n=29) had completed primary education. No significant difference was observed between the two groups in terms of age, sex, and education level. The mean value of the number of complications that the patients were aware of was 1.17±1.02 and 7.35±1.26 in groups 1 and 2, respectively. We observed a significant difference in the number of complications that the patients were aware of between both groups (p<0.001).
The responsibilities of physicians are not solely limited to giving the informed consent form to the patients before LP. Physicians should explain the contents of the form verbally to the patients.
Making clinical trials more patient-centered using digital interactive e-consent tools
Barbara Bowles Biesecker, Melissa R. Raspa, Douglas J. Rupert, Rebecca Munch Moultrie, Robert D. Furberg, Lauren A. McCormack
Occasional Paper, RTI International (published by RTI Press), October 2019
Research participants are required to give their consent to participate in clinical trials and nonexempt government-funded studies. The goal is to facilitate participant understanding of the intent of the research, its voluntary nature, and the potential benefits and harms. Ideally, participants make an informed choice whether to participate; one that is based on having sufficient relevant knowledge and that is consistent with their values and preferences. Achieving this objective can be challenging, and as such, many scholars have declared the consent process flawed or “broken.” Moreover, clinical trials are complex studies, and compelling evidence suggests that current consent processes are inadequate in achieving informed choice. E-consent offers a dynamic, engaging consent delivery mode that can effectively support making informed decisions about whether to participate in a trial.
Improved parental understanding by an enhanced informed consent form: a randomized controlled study nested in a paediatric drug trial
Nut Koonrungsesomboon, Chanchai Traivaree, Charnunnut Tiyapsane, Juntra Karbwang
BMJ Open, 26 November 2019; 9(11)
This study was designed to evaluate the applicability and effectiveness of the enhanced informed consent form (ICF) methodology, proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), in paediatric research requiring parental consent. The objective of this study was to compare the parental understanding of information between the parents who read the SIDCER ICF and those who read the conventional ICF.
A prospective, randomized, controlled design.
Paediatric Outpatients Department, Phramongkutklao Hospital, Thailand.
210 parents of children with thalassemia (age=35.6 ± 13.1 years).
The parents were randomly assigned to read either the SIDCER ICF (n=105) or the conventional ICF (n=105) of a paediatric drug trial.
Primary and secondary outcome measures
Parental understanding of trial information was determined using 24 scenario-based questions. The primary endpoint was the proportion of parents who obtained the understanding score of more than 80%, and the secondary endpoint was the total score.
Forty-five parents (42.9%) in the SIDCER ICF group and 29 parents (27.6%) in the conventional ICF group achieved the primary endpoint (relative risk=1.552, 95% CI 1.061 to 2.270, p=0.021). The total score of the parents in the SIDCER ICF group was significantly higher than the conventional ICF group (18.07±3.71 vs 15.98±4.56, p=0.001).
The SIDCER ICF was found to be superior to the conventional ICF in improving parental understanding of trial information.
What is needed to obtain informed consent and monitor capacity for a successful study involving People with Mild Dementia? Our experience in a multi-centre study [CONFERENCE PAPER]
Jennifer Lim, Rosa Almeida, Vjera Holthoff-Detto, Geke Ludden, Kristina Niedderer
International MinD Conference 2019, 19-12 September 2019; Dresden, Germany
Strategies on informed consent process and capacity monitoring for mild dementia research are at developing state. We reflected on our experience in the MinD project, and found that the successful collection of informed consent and full participation of PwD required the involvement of familiar healthcare professionals/care workers/staff at the recruitment and data collection stages and this needs to occur in an active support environment. Time is another important factor affecting the success of the study.
Research without prior consent in paediatric emergency and critical care medicine
Aled Picton, Kerry Woolfall, Mark D. Lyttle, Stuart Hartshorn
Paediatrics and Child Health, 14 December 2019
Children and young peoples’ healthcare should be evidence-based yet many treatments are unlicensed or prescribed off-label. Research is needed, but prospective informed consent for many emergency and critical care trials is neither feasible nor ethical – treatments are time critical, and delays for research discussions may cause harm. Research without prior consent (RWPC) is a practical approach which facilitates such research. Trial interventions are administered immediately to eligible patients, and consent for ongoing study involvement is sought after the emergency situation has passed. This has been permitted in the United Kingdom since an amendment to legislation in 2008, and subsequently employed by several trials. Studies demonstrate that most parents are supportive of this approach provided their child’s safety is not compromised, and research discussions are appropriately timed. Practitioners with no experience of RWPC often initially report anxiety about taking this approach, but study experience and training helps change perspectives. Sadly, some children enrolled into such studies will die. Approaching bereaved families for consent requires a bespoke approach, conducted with care and sensitivity. Future research should explore the acceptability of higher risk trials, the viewpoints of children with first-hand experience of this method, and international perspectives.
Adolescent Consent to Vaccination in the Age of Vaccine-Hesitant Parents
Tony Yang, Robert S. Olick, Jana Shaw
JAMA Pediatrics, 7 October 2019;173(12) pp 1123-112
As children of vaccine-hesitant parents become adolescents, they develop their individual perspectives on vaccination. One of these adolescents, Ethan Lindenberger, researched vaccines, discussed them with trusted adults, and ultimately got vaccinated.1 His testimony to the Senate Committee on Health, Education, Labor and Pensions made national headlines.1 Many other adolescents are similarly seeking advice on how to get vaccinated. While vaccination against measles and other conditions occurs in early childhood, vaccine-hesitant parents have also refused human papillomavirus vaccination, routinely provided for adolescents beginning at age 11 or 12 years. And they have refused to let their children catch up on any missed early childhood vaccinations. Prior research has shown that adolescents feel generally marginalized in the decision-making process, yet they desire to participate in decisions.2 Their main obstacle to vaccination is that most states require an individual to be 18 years or older to consent to medical procedures.3 We argue for expansion of the rights of adolescents to make their own decisions to be vaccinated against serious and potentially life-threatening diseases without requiring parental consent and involvement…
Consent in children’s intensive care: the voices of the parents of critically ill children and those caring for them
Phoebe Aubugeau-Williams, Joe Brierley
Journal of Medical Ethics, 27 November 2019
Despite its invasive nature, specific consent for general anaesthesia is rarely sought—rather consent processes for associated procedures include explanation of risk/benefits. In adult intensive care, because no one can consent to treatments provided to incapacitated adults, standardised consent processes have not developed. In paediatric intensive care, despite the ready availability of those who can provide consent, no tradition of seeking it exists, arguably due to the specialty’s evolution from anaesthesia and adult intensive care. With the current Montgomery-related focus on consent, this seems untenable. We undertook a qualitative study in a specialist children’s hospital colocated paediatric/neonatal intensive care (same medical team) in which parental acceptance of admission and entailed procedures is considered implied by virtue of that admission. Semistructured interviews were carried out with both staff and parents to investigate their views about consent, the current system and a proposed blanket consent system, in which parents actively consent at admission to routine procedures. Divergent views emerged: staff were worried that requiring consent at admission might prove a further emotional burden, whereas parents found providing consent a way of coping, feeling empowered and maintaining control. Inconsistencies were found in the way consent is obtained for your routine procedures. Practice does seem inconsistent with contemporary consent standards for medical intervention. Our findings support the introduction of a blanket consent system at admission together with ongoing bedside dialogue to ensure continuing consent. Both parents and staff expressed concern about avoiding possible harmful delays to children due to parental emotional overload and language difficulties.
National Electronic Health Record Systems and Consent to Processing of Health Data in the European Union and Australia
Legal Tech and the New Sharing Economy, 13 December 2019; pp 83-99
This study focuses on the single most important regulatory aspect of data processing, namely consent to data processing. It compares approaches to consent under the General Data Protection Regulation (EU 2016/679) of the European Parliament and of the Council on the protection of natural persons with regard to the processing of personal data (and on the free movement of such) (GDPR) in the context of European Union (EU) national electronic health record (NEHR) schemes (also referred to as “national digital health networks”) with the approach of the Australian national health record scheme called My Health Record (MHR). The GDPR, subject to derogation in limited circumstances, is binding on all 27 EU member countries. Under Articles 168 (2) and (7) of the Treaty on the Functioning of the European Union (2007), while the EU has a duty to “encourage cooperation between the Member States…to improve the complementarity of their health services in cross-border areas,” the European Union Member States retain the power to manage their own health services. However, in doing so, subject to narrow derogations, the management of their NEHR systems must conform to the GDPR. The GDPR governs the processing of data in any form including data contained in national electronic health systems (European Commission Recommendation on a European Electronic Health Record exchange format (C(2019)800) of 6 February 2019… Given that, unlike the Australian MHR scheme, national electronic medical/health records systems of EU Member States are at different stages of development, and that derogations enable a measure of variance in compliance, individual European systems will not be discussed. Australia is a non-EU jurisdiction, and does not have the European Commission’s certificate of adequate level of data protection (GDPR Article 45 empowers the European Commission to determine whether a country outside the EU offers an adequate level of data protection, whether by its domestic legislation or of the international commitments it has entered into. For further discussion, see below). One of the reasons for the absence of certification might be the effectively non-consensual nature of the My Health Record system that administers, collects, stores, and provides access to health and clinical data of Australians.
Too Dense and Too Detailed: Evaluation of the Health Literacy Attributes of an Informed Consent Document
Vanessa W. Simonds, Dedra Buchwald
Journal of Racial and Ethnic Health Disparities, 10 December 2019
The US government recently updated the Common Rule, a set of federal regulations to ensure the ethical conduct of human subjects research. The new regulations require that consent documents provide information that is clear and concise enough to enable truly informed consent. This study explores potential American Indian research participants’ understanding and perceptions of an example consent document, focusing on possible improvements to better serve the requirements of the revised Common Rule. Participants completed a survey that collected demographic data and measured health literacy, numeracy, and comprehension of the example document. Next, they participated in focus groups to answer open-ended questions regarding their views on the example document. We calculated mean scores and frequencies of response to analyze quantitative survey data and performed a qualitative thematic analysis of focus group transcripts. Results demonstrated that American Indian participants with relatively strong health literacy skills clearly understood key elements of the consent document, including the purpose of signing it, confidentiality, compensation, and whom to contact for questions. However, they were overwhelmed by details on research procedures and were concerned about the document’s layout. To make consent documents more readily comprehensible, participants recommended the addition of headings, bullets, graphics, and relevant pictures. They also recommended a two-step consent process, comprising a short introduction to the research project followed by a longer explanation of procedures. These results illustrate the potential advantages of community engagement in drafting consent materials. Health researchers would likely benefit from community recommendations like the ones we elicited as they design consent documents adherent to the revised Common Rule.