Valid consent and orthodontic treatment
Maurice J Meade, Annalene Weston, Craig W Dreyer
Australasian Orthodontic Journal, May 2019; 35(1)
Abstract
Valid patient consent is a legal and ethical principle that is fundamental to healthcare provision. Oral health practitioners (OHPs) must understand the principles that need to be addressed to ensure that the consent given by a patient is valid. Failure to obtain consent may result in a negligence claim or a complaint of professional misconduct against the OHP. Orthodontic treatment is mostly elective but is not without risk to the patient. Obtaining and maintaining valid consent for orthodontic treatment presents additional challenges in comparison with other dental procedures as the treatment lasts over a longer time and is most commonly performed in adolescents. In addition, prospective patients need to be informed regarding ‘lifelong’ management in the retention phase to minimise the risk of relapse. The present paper outlines the principles of valid consent with particular regard to orthodontic treatment in the adolescent patient. OHPs must ensure that they are satisfied that the competent patient has the capacity to voluntarily consent. Clinicians must also recognise that valid consent is not a one-off ‘tick the box’ procedural exercise but an ongoing process of effective information sharing in light of changing laws and an ever-changing scientific evidence base within a patient-centred model of healthcare.
Perceptions and Perspectives of Patients regarding process of informed consent in a tertiary care hospital
Perceptions and Perspectives of Patients regarding process of informed consent in a tertiary care hospital
Original Article
Shanaz Kouser, Tahira Fatima, Zunaira Tabassum, Khushbakht Anwar
Pakistan Journal of Medical and Health Sciences, January – March 2019
Open Access
Abstract
Aim
To analyze the patient’s perceptions and perceptive about different components and procedure of taking informed consent in a tertiary care hospital
Methods
This was a cross sectional study conducted with a predesigned interview based questionnaire form. 150 patients who underwent cesarean section, were randomly selected for study at Jinnah Hospital, Lahore, which is a tertiary care multidisciplinary hospital. Patients who had some emergency surgical procedures, patients who belonged to a medical profession and the patients who refused to be interviewed were excluded from the study. Data was analyzed in SPSS Ver:17.0. Frequencies and percentages were calculated for demographic and perception process regarding informed consent.
Results
A total of 150 patients were included in the study. Age range of the patients, who were interviewed was 18-44 years. Majority of the patients were primipara 89(59.3%).Out of all cases, 64(42.7%) of patients were from rural areas and 88 patients (58.7%) belonged to poor socioeconomic class. Almost half of the patients 77(57.3%) were uneducated. It was observed that husbands, parents in law and patient’s own parents were somehow or other were involved in the decision making process. In 107 cases (71.3%), the consent form was signed by the husband. The other forms were signed by mother in law 12( 8%) and by patient’s own parents 31(20.7%), surprisingly none of the patients signed her own consent form as primary consenting person though they were told about the reasons for cesarean section (n=134, 89.3%) by the signatory.
Conclusion
Majority of the patients in our set-up were satisfied with the process of informed consent, though at times, some of them were not fully aware about indications, risks and benefits of the surgery.
Informed Consent: A Monthly Review
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July 2019
This digest is intended to aggregate and distill key content around informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.
Informed Consent: A Monthly Review is a service of the GE2P2 Global Foundation’s Center for Informed Consent Integrity, which is solely responsible for its content. Comments and suggestions should be directed to:
Editor
Paige Fitzsimmons, MA
Associate Fellow
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
Publisher
David R. Curry
President & CEO
GE2P2 Global Foundation
david.r.curry@ge2p2global.org
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_July 2019
Gavi, NEC, and Simprints to deploy world’s first scalable child fingerprint identification solution to boost immunisation in developing countries [PRESS RELEASE]
Gavi, NEC, and Simprints to deploy world’s first scalable child fingerprint identification solution to boost immunisation in developing countries [PRESS RELEASE]
gavi.org, 6 June 2019
Excerpt
Gavi, the Vaccine Alliance, NEC Corporation, and Simprints Technology Ltd. have signed a memorandum of understanding on the use of biometrics to improve immunisation coverage in developing countries.
Despite enormous progress over the past two decades, there are still approximately 20 million children who do not receive a basic course of vaccines worldwide, leaving them exposed to some of the world’s deadliest diseases.
One key cause is the fact that only half of all children under 5 in sub-Saharan Africa are currently registered at birth, leaving many without an official identity. This makes it difficult for health practitioners to ensure these infants get the vaccines they need at the right time.
Guided by Gavi’s experience and expertise in immunisation, this new project will combine Simprints’ biometric fingerprint technology and NEC’s reinforced authentication engine to help create digital identities for children 1-5 years of age and boost immunisation coverage in developing countries.
This new partnership will deploy the world’s first scalable fingerprint identification solution to give children aged 1-5 a digital ID linked to an accurate, complete medical record. All biometric records will be stored securely by Simprints, a UK-based non-profit social enterprise, after caregivers give informed consent to having their children’s biometric data taken…
Editor’s note: The Foundation has expressed concern to GAVI about the management and potential misuse of this digital ID system beyond its intent to support infant immunization.
Lack of informed consent for surgical procedures by elderly patients with inability to consent: a retrospective chart review from an academic medical center in Norway
Lack of informed consent for surgical procedures by elderly patients with inability to consent: a retrospective chart review from an academic medical center in Norway
Research
Jorgen Dahlberg, Vegard Dahl, Reidun Forde, Reidar Pedersen
Patient Safety in Surgery, 22 June 2019; 13(24)
Abstract
Background
Respect for patient autonomy and the requirement of informed consent is an essential basic patient right. It is constituted through international conventions and implemented in health law in Norway and most other countries. Healthcare without informed consent is only allowed under specific exceptions, which requires a record in the patient charts. In this study, we investigated how surgeons recorded decisions in situations where the elderly patient’s ability to provide a valid informed consent was questionable or clearly missing.
Method
We investigated all medical records of patients admitted to surgical departments in a Norwegian large academic emergency hospital over a period of 38 days (approximately 5000 patients). We selected records of patients above the age of 70 (570 patients) and searched through these 570 medical records for any noted clear indications of inability to consent such as “do not understand”, “confused” etc. (102 patients). We read through all the medical records on these 102 patients noting any recordings on lack of informed consent, any recordings on reasoning and process hereto. We also took note whether there were clear indications on the use of coercion.
Results
None of the 102 included patients´ charts contained legally valid recorded assessments (for example related to the patients´ competence to consent) when patients without the ability to consent were admitted and provided healthcare. Some charts contained records that the patient resisted treatment, thus indicating treatment with coercion. In these situations, we did not find any documentation related to legal requirements that regulate the use of coercion.
Discussion and conclusion
We found a substantial lack of compliance with the legal requirements that apply when obtaining valid informed consent. There are many possible reasons for this: Lack of knowledge of the legal requirements, disagreement about the rules, or that it is simply not possible to comply with the extensive formal and material legal requirements in clinical practice. The results do not point out whether the appropriate measures are amending the law, educating and requiring more compliance from surgeons, or both.
Questions about informed consent related to the use of haptic suits as assistive technologies for people with intellectual and developmental disabilities
Questions about informed consent related to the use of haptic suits as assistive technologies for people with intellectual and developmental disabilities
Fiachra O’Brolcháin, Aviva Cohen
International Journal of Applied Ethics, 31 May 2019; 30
Open Access
Abstract
Technological innovation is witnessing the convergence of haptic technologies with real-time 3D virtual environments and / or augmented reality technologies. Among the diverse applications of these innovations is their use as assistive technologies for people with intellectual and developmental disabilities, or people with cognitive deficits, such as dementia.
This article focuses on the issue of informed consent in relation to research and the use of these technologies (hereafter referred to simply as haptic suits). Informed consent is a standard requirement in the ethics of research, as well as in care settings, so it will be necessary for tests with haptic suits in general and, when used as assistive technology. Given the emphasis on the participation of people with intellectual or developmental disabilities in the research and design of assistive technologies for their use, the issue of informed consent is compelling.
Editor’s note: This is a Spanish language publication. In reviewing available definitions for haptic technologies we found the following: “the science of applying touch sensation and control to interact with computer developed applications”.
Research ethics for mobile sensing device use by vulnerable populations
Research ethics for mobile sensing device use by vulnerable populations
Samantha Breslin, Martine Shareck, Daniel Fuller
Social Science & Medicine, July 2019; 232 pp 50-57
Abstract
Devices equipped with sensors to track mobility, such as through Global Position Systems (GPS) and accelerometery, are increasingly being used for research. Following Canadian, US, and International guidelines there is a need to give special consideration when conducting research with vulnerable populations. This paper examines specific ethical concerns for conducting research with mobile sensing devices for use by vulnerable populations, considering aspects of both research design and research process. Drawing on insights from feminist design and aligned fields, such as participatory design and action research, we contend that any research design and process for working with vulnerable populations must be developed in collaboration with the particular groups and communities who are part of the research. As part of this process of collaborative research, we discuss risks in terms of the lack of control over data associated with choosing commercial devices, as well as practicality and obtrusiveness of devices for the wearer. We also discuss the significance of informed consent and refusal and issues relating to security and safety during research. As part of the collaborative research design and process, we argue that participants should be given as much control over their data as possible. Based on this discussion, we provide recommendations for researchers to consider, which are broadly relevant for research using mobile sensing devices but particularly significant in relation to vulnerable populations.
A randomized, controlled trial of video supplementation on the cataract surgery informed consent process
A randomized, controlled trial of video supplementation on the cataract surgery informed consent process
Journal Article
Zhang MH, Haq ZU, Braithwaite EM, Simon NC, Riaz KM
Graefe’s Archive for Clinical and Experimental Ophthalmology, 30 May 2019; pp 1-10
Abstract
Purpose
To assess the effects of the American Academy of Ophthalmology’s 2015 patient education video on patient information retention and anxiety preoperatively, on the day of surgery and postoperatively.
Methods
This is a prospective, surgeon-blinded randomized controlled trial at the University of Chicago Medical Center. Ninety-one patients with a diagnosis of first-eye cataract were randomized into either a video or control group. Subjects in both groups received face-to-face discussion with the surgeon and an informational brochure at the preoperative evaluation. Participants in the video group then viewed a four-minute educational video at the preoperative evaluation and on the day of surgery. Both groups completed an information retention quiz and a state anxiety assessment at the preoperative visit, on the day of surgery, and on the postoperative week one visit. Subject understanding of cataract surgery was measured using a twelve-question multiple choice quiz. State anxiety was measured by State Trait Anxiety Inventory-Y1 survey score.
Results
Participants in the video group did not score significantly higher on the information retention quiz compared with the control group at the preoperative evaluation (8.7 ± 2.4 vs 7.7 ± 2.5, P = 0.07), but did so on the day of surgery (11.2 ± 0.8 vs 8.4 ± 1.7, P < 0.001) and postoperative week 1 visit (10.8 ± 1.5 vs 9.0 ± 2.0, P < 0.001). Subjects in the video group were significantly less anxious on the day of surgery (26.4 ± 5.1 vs 41.1 ± 10.3, P < 0.001).
Conclusions
Video supplementation to the traditional informed consent process demonstrated an improvement in patient understanding of cataract surgery at multiple timepoints and decreased anxiety on the day of surgery.
Clinical Image Consent Requirements: Variability among Top Ten Medical Journals
Clinical Image Consent Requirements: Variability among Top Ten Medical Journals
Juan N. Lessing, Nicholas M. Mark, Matthew K. Wynia, Ethan Cumbler
Journal of Academic Ethics, 21 June 2019; pp 1–5
Abstract
The consent process for publication of clinical images in medical journals varies widely. The extent of this variation is not known. It is also not known whether journals follow their own stated best practices or the guidance of the International Committee of Medical Journal Editors (ICMJE). We assessed consent requirements in a sample of 10 top impact factor general medicine journals that publish clinical images, examining variability in consent requirements for clinical image publication and congruence of requirements with the recommendations of the ICMJE. Clinical image consent requirements varied widely from journal to journal. None of the studied journals, even amongst n = 4 ICMJE members or n = 8 journals who self-report adherence to ICMJE guidelines, comply with all of the recommendations of the ICMJE. Half of studied journals require a journal-specific consent form. Among top medical journals there is significant heterogeneity in consent requirements for clinical images. Variability of consent requirements is neither practical nor rational; inconsistent requirements create uncertainty for authors, present impediments to dissemination of scholarship, and undermine a shared professional understanding of how best to protect patient privacy. We propose adopting a standardized consent form and process for publication of identifiable images in medical journals, with uniform elements and explicit definitions.
The Effect of Framing and Placement on Linkage Consent
The Effect of Framing and Placement on Linkage Consent
Joseph W Sakshaug, Alexandra Schmucker, Frauke Kreuter, Mick P Couper, Eleanor Singer
Public Opinion Quarterly, 20 June 2019
Abstract
Numerous surveys link interview data to administrative records, conditional on respondent consent, in order to explore new and innovative research questions. Optimizing the linkage consent rate is a critical step toward realizing the scientific advantages of record linkage and minimizing the risk of linkage consent bias. Linkage consent rates have been shown to be particularly sensitive to certain design features, such as where the consent question is placed in the questionnaire and how the question is framed. However, the interaction of these design features and their relative contributions to the linkage consent rate have never been jointly studied, raising the practical question of which design feature (or combination of features) should be prioritized from a consent rate perspective. We address this knowledge gap by reporting the results of a placement and framing experiment embedded within separate telephone and Web surveys. We find a significant interaction between placement and framing of the linkage consent question on the consent rate. The effect of placement was larger than the effect of framing in both surveys, and the effect of framing was only evident in the Web survey when the consent question was placed at the end of the questionnaire. Both design features had negligible impact on linkage consent bias for a series of administrative variables available for consenters and non-consenters. We conclude this research note with guidance on the optimal administration of the linkage consent question.
Center for Informed Consent Integrity 