Reflecting on three creative approaches to informed consent with children under six
Lorna Arnott, Loreain Martinez, Kate Wall, Caralyn Blaisdell, Ioanna Palaiologou
British Educational Research Journal, 10 March 2020
Abstract
In an era where children’s rights are paramount, there are still few practical examples to guide us when seeking informed consent from children. This paper therefore makes a significant contribution to the field by examining three practical approaches to negotiating informed consent with young children under 6 years old. We draw on researcher field notes, images and observations from four research projects that employed creative methods for seeking informed consent from young children. We take a reflexive approach, considering how successful the three techniques have been in facilitating young children’s decision making around research participation. Our findings suggest that innovative approaches to informed consent create spaces for children to engage in dialogue and questioning about the research project. However, in order for the approaches to be meaningful they need to be pedagogically-appropriate to the maturity and capabilities of the children. We also demonstrate that irrespective of the approach devised, researchers have a responsibility to ensure consent is continuously negotiated throughout the project through reflexive questioning.
Year: 2020
Children’s ability to consent to medical management in South Africa
Children’s ability to consent to medical management in South Africa
J van Heerden, R Delport, M Kruger
South African Journal of Child Health, 23 April 2020; 14(1) pp 25-29
Open Access
Abstract
Background
The South African Children’s Act No. 38 of 2005 requires paediatric medical consent from 12 years of age
Objective
To determine children’s ability to provide informed consent for medical treatment.
Methods
Assessment used hypothetical treatment storyboards and structured interviews for assessment of 100 children (aged 10 -17 years), and 25 adult controls, using a tandardized scoring tool to test understanding, ability to deliberate treatment choices, and provide rational reasons. Statistical analysis involved multivariate analyses of variance (MANOVAs) and analysis of variance (ANOVA).
Results
The female:male ratios for children and adults were 1:0.92 and 1:0.98, respectively. Children ≥12 years were competent with regard to treatment choices (p<0.001), while 10-year-olds could deliberate reasonable outcomes, similar to adults (p<0.001). However, only children 12 years and older could provide rational reasons, where abstract concepts were not involved, whereas children who were ≥14 years old were able to provide rational reasons involving abstract concepts. The actual understanding of choices, compared with adults, was only observed in children older than 14 years (p<0.001). Gender was not a statistically significant denominator.
Conclusion
Children of 12 years and older are competent to make medical decisions, but the understanding of medical treatment choices under the age of 14 years is not clear.
A Survey of Current Practices of Informed Consent by Pediatric Anesthesiologists
A Survey of Current Practices of Informed Consent by Pediatric Anesthesiologists
Short Report
Allison M Fernandez, Scott C Watkins, David J Clendenin, Erik B Smith, Jenny E Dolan, Ernest Amankwah, Ali Jalali, Luis Ahumada, Anh Thy H Nguyen, Mohamed Rehman, Richard A Elliott
Pediatric Anesthesia, 22 April 2020
Abstract
Informed consent is fundamental to the ethical practice of medicine and carries important legal implications. Of particular relevance to pediatric anesthesia is the Food and Drug Administration’s Drug Safety Communication (DSC), which highlights potential yet theoretical adverse effects on brain development of repeated or prolonged anesthesia administration to children younger than 3 years of age.
Risk disclosure and informed consent: practice caveats in the post‐Montgomery era
Risk disclosure and informed consent: practice caveats in the post‐Montgomery era
Original Article
Danny WH Lee, Paul BS Lai
Surgical Practice, 1 April 2020
Abstract
The UK Supreme Court decision in Montgomery v Lanarkshire Health Board has overturned the use of the “accepted practice test” (Bolam) in deciding breach of duty cases related to risk disclosure and informed consent. Following Montgomery, a doctor is under a legal duty to take reasonable care to ensure his patient is aware of any material risks involved in the recommended treatment, and of any reasonable alternative or variant treatments. Based on Montgomery and a number of relevant published cases, this article highlighted some practice caveats for surgeons to take note of when they participate in the consent process with the following headings: the objective and subjective elements of the legal test of materiality of risks; postoperative risks, follow‐up and management; timing and adequacy of risk disclosure; withholding information and therapeutic exception; and the incorporation of Montgomery into local professional code and case law. In order to minimize legal risks, surgeons are also encouraged to keep abreast of the medico‐legal development in this area, to reflect on their own practices, and to take proactive steps to enhance their interactions with patients.
Implementation of Common Rule Changes to the Informed Consent Form: A Research Staff and Institutional Review Board Collaboration
Implementation of Common Rule Changes to the Informed Consent Form: A Research Staff and Institutional Review Board Collaboration
Grace Gartel, Heather Scuderi, Christine Servay
Ochsner Journal, March 2020; 20(1) pp 76–80
Open Access
Abstract
Background
The Common Rule, which governs federally funded clinical research involving human subjects, formally defines the requirements for institutional review board (IRB) membership, functions and operations, and review of research, as well as the requirements for obtaining informed consent from research participants. The revisions to the Common Rule effective in January 2019 changed some content requirements for informed consent forms.
Methods
This article summarizes the history of informed consent requirements, the changes made to the requirements by the revision to the Common Rule, and the ways in which IRBs and research staff work together to develop informed consent forms that comply with the regulations and provide all the information potential research subjects need to decide whether to participate in a study.
Results
Clinical research coordinators, under their investigators’ supervision, are responsible for ensuring that research consent forms comply with the requirements of the federal regulations and the institution. Many IRBs have provided education regarding these new requirements, as well as consent templates that contain all the required elements. To ensure that the Common Rule’s requirements are met, the IRB reviews each study submission, including the consent form. The IRB panel makes revisions to the consent forms as needed and returns the approved consent form to the investigator and clinical research coordinator.
Conclusion
Research coordinators play an essential role in developing consent forms and providing the required review information to the IRB. In turn, through optimizing and standardizing consent forms and ensuring that all requirements of the Common Rule are followed, IRBs ensure that the rights of participants are protected and upheld.
Editor’s note: The Ochsner Journal is a peer-reviewed quarterly medical journal.
Revised Common Rule Changes to the Consent Process and Consent Form
Revised Common Rule Changes to the Consent Process and Consent Form
Leah L LeCompte, Sylvia J Young
Ochsner Journal, March 2020; 20(1) pp 62-75
Open Access
Abstract
Background
The Federal Policy for the Protection of Human Subjects—the Common Rule—was revised in 2017 to reduce administrative burdens for low-risk research while enhancing protections for human subjects enrolled in greater-than-minimal-risk trials. These enhanced protections involve changes to the consent process.
Methods
We review the general requirements applicable to the consent process, as well as the additional elements of consent mandated by the revisions to the Common Rule. The regulations apply to federally funded studies and are optional for non–federally funded studies.
Results
Two new general requirements for the consent process, one basic required element for the consent form, and three optional additional elements for the consent form were added in an effort to improve potential subjects’ understanding of research studies and to facilitate the exchange of information between the research staff and potential subjects. Important information about the study should be extracted into a concise key information section to help potential subjects make informed decisions regarding participation.
Conclusion
The revisions to the Common Rule are intended to enhance human subject protection by providing more information in an understandable form during the consent process. The new consent elements aim to increase transparency and help improve clarity.
Understanding Broad Consent
Understanding Broad Consent
John W Maloy, Pat F Bass III
Ochsner Journal, March 2020; 20(1) pp 81–86
Open Access
Abstract
Background
The 2018 revisions to the Common Rule that were effective in January 2019 introduced a new category of informed consent: broad consent.
Methods
Investigators and institutional review board (IRB) members need to understand (1) what broad consent is, (2) the role of broad consent under the revised Common Rule, (3) how and when broad consent can be used, (4) exempt research categories that relate to broad consent, and (5) the scope of limited IRB review as it relates to broad consent.
Results
Under the prior regulations, researchers had two consent options: obtain study-specific informed consent or request the IRB to waive the requirement to obtain informed consent. The revision to the Common Rule introduced the third option of broad consent, but its applicability is limited. Broad consent can only be used to obtain an individual’s consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. The regulatory authority for broad consent is at 45 CFR §46.116(d). None of the required elements of broad consent can be omitted or altered because each element is considered essential. Broad consent shares many of the requirements for study-specific informed consent, but several elements are unique: a description of the types of secondary research that may be conducted; statements describing the private information or biospecimens that might be used in research, whether sharing of the information or biospecimens might occur, and the types of institutions or researchers that might conduct research with the information or biospecimens; information on how long the information or biospecimens may be stored, maintained, and used; a statement that subjects will or will not be informed of the details of any subsequent research; a statement that research results will or will not be disclosed to subjects; and contact information for obtaining answers to questions about the subjects’ rights regarding storage and use of information or biospecimens and whom to contact regarding research-related harm.
Conclusion
Broad consent provides flexibility that did not exist prior to the revision, giving researchers the option to obtain broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. With an understanding of the regulations, an investigator can plan how best to organize his or her research plan and decide whether to obtain study-specific informed consent, to apply for a waiver of consent, or to obtain broad consent.
Material risk: a review of informed consent in the UK
Material risk: a review of informed consent in the UK
Thomas Walton
Orthopaedics and Trauma, 24 April 2020
Abstract
Consent is a requirement for any medical or surgical intervention to be deemed appropriate. For such consent to be considered valid, it must be given voluntarily, by an individual with capacity, who has the appropriate information available to make an informed decision in line with their values. Following the Montgomery vs. Lanarkshire ruling in 2015, the legal basis from which informed consent is measured has changed. The law now reflects pre-existing professional guidelines, and advocates a patient-centred approach to informed consent. The previously paternalistic focus of informed consent, whereby it was deemed a matter for clinical judgement, has been firmly abandoned in favour of the provision of information pertaining to ‘material risks’, as determined by the significance attached to these risks by the patient themselves. This paper serves to provide an overview of consent within the medical profession, and gives an account of the implications of this landmark ruling.
A Review of Socio-Cultural Factors Affecting Patients’ Right to Informed Consent and Autonomy in Medical Practice in Nigeria
A Review of Socio-Cultural Factors Affecting Patients’ Right to Informed Consent and Autonomy in Medical Practice in Nigeria
Chinemelum Nelson Arinze-Umobi, Godwin N Okeke
African Journal Of Law And Human Rights, 2020; 4(1)
Open Access
Abstract
Today, the fundamental principle of medical law and ethics is that a medical professional should obtain the informed consent of a competent patient before administering any form of treatment on such a patient. This is in tandem with the principle of autonomy (self-determination) which is intrinsic in every individual save for circumstances wherein the observance of this principle can legally be departed from. In clinical context, ‘autonomy’ connotes a patient’s ‘right to refuse and right to participate in every decision regarding medical treatment’. This study reviewed the socio-cultural factors inhibiting patients’ right to autonomy in medical practice in Nigeria. The study found that striking a balance between the opposing interests may be a difficult tasks as patients’ right to autonomy is case-specific and that a whole lot of factors operate in the social space and as a result, alter, from time to time, the standard, such that it becomes nearly impossible to apply the same standard in all instances. The study found that certain circumstances exist in the doctor-patient relationship wherein a patient lacks capacity to grant such consent to the medical professional – hence the need for such consent to be given on his/her behalf towards his/her best interests.
Informed Consent For Surgery On Neck Of Femur Fracture: A Multi-Loop Clinical Audit
Informed Consent For Surgery On Neck Of Femur Fracture: A Multi-Loop Clinical Audit
Rohi Shah, Sharan Sambhwani, Awf Al-Shawani, Christos Plakogiannis
Annals of Medicine and Surgery, 8 April 2020
Open Access
Abstract
Background
The Montgomery case in 2015 resulted in a pivotal change in practice, leading to a patient-centric approach for informed consent. Neck of femur fractures are associated with a high rates perioperative morbidity and mortality. Using guidelines highlighted by the British Orthopaedic Association we performed a multi-loop audit within our department to assess the adequacy of informed consent for NOF fractures.
Methods
Two prior cycles had been performed utilising a similar framework. Prior interventions included ward posters, verbal dissemination of information at Doctor’s induction and amendments to the JD handbook. For the latest audit loop, a retrospective analysis of 100 patients was performed. Risk factors were classified as common, less common, rare and ‘other’. The adequacy of informed consent was evaluated by assessing the quality and accuracy of documentation in the signed Consent Form-1s.
Results
Infection, bleeding risks, clots and anaesthetic risks were documented in all patients(100%). Areas of improvement included documentation of neurovascular injuries(98%), pain(75%) and altered wound healing(69%). There was no significant change in the documentation of failure of surgery(83%) neurovascular injuries(98%). Poorly documented risk factors included mortality(21%), prosthetic dislocation(14%) and limb length discrepancy(6%).
Conclusion
Following the latest cycle, the trust has now approved the use of 2 consent-specific stickers(arthroplasty/fixation), amendable on a patient-to-patient basis. As part of the multi-loop process, the cycle will be repeated every year-in line with Junior Doctor rotations. Medical professionals have an ethical, moral and legal obligation to ensure they provide all information regarding surgical interventions to aid patients in making an informed decision.
Center for Informed Consent Integrity 