Informed Consent for Laser Therapy in Scar Management
Youssof Oskrochi, David Bodansky, Kayvan Shokrollahi, Adeyinka Molajo
Laser Management of Scars, 25 November 2020; pp 107-110
Abstract
The aim of this chapter is to provide an overview of consent as relevant to laser therapy. This is especially relevant because lasers and laser treatment can be complex and difficult to explain, may require multiple sessions and have a distinct risk of complications that can be mitigated through good communication, safe practice and appropriate documentation.
Consent for Medical Autopsy
Consent for Medical Autopsy
Adrian Charles
Practical Manual of Fetal Pathology, 17 November 2020; pp 19-25
Abstract
In many countries as well as the consent as above, legally the autopsy is authorized by a human tissue act officer or medical director or their nominee, who legally allows the postmortem to go ahead. This is done after parental consent. There are variations throughout the world, and some of these are discussed. Consent is now recognised to be a process, a communication and understanding, and not just a simple signature to an official form.
Presumed consent and the implications for eye donation
Presumed consent and the implications for eye donation
Editorial
Parwez Hossain
Eye, 9 November 2020
Open Access
Excerpt
…In this issue, Dimitry et al. remind us of the recent change in the law for England. In their letter, they provide an overview of the implications of the opt-out system on eye donation rates in countries in mainland Europe where there is a longer track record of this kind of legal change. Despite providing benefits to organ donation, increases in eye donation are not similarly matched. The authors highlight that in some countries, more specific measures such as education and infrastructure changes could be more effective. From personal experience of running an eye donation service, the training of allied health professionals such as trained eye retrievers, end of life care professionals would increase the capacity of a healthcare system to identify and retrieve potential eye donations. In many hospitals and healthcare organisations, this human infrastructure appears to be the rate limiting factor for higher eye donations…
Incorporating Evidence-Based Practice Into Informed Consent Practice
Incorporating Evidence-Based Practice Into Informed Consent Practice
Research Article
James W. Drisko
Families in Society: The Journal of Contemporary Social Services, 6 November 2020
Abstract
This conceptual article argues that evidence-based practice (EBP) is best understood as a component of the informed consent process preceding treatment. The legally mandated informed consent/consent to treat process requires that professionals disclose to clients the nature of services along with potential risks, benefits, and alternatives. Informed consent is a long-standing part of professional practice ethics with over a century of legal precedents. The more recent EBP process also requires discussion with the client of the best research-supported treatments, which are explored in combination with the client’s values and preferences and the professional’s expertise, to develop a treatment plan. Yet, EBP has not been clearly linked to informed consent for treatment. EBP can be usefully understood as part of the more comprehensive informed consent ethics process. New practice and ethics competencies are examined.
Informed Consent for Percutaneous Coronary Intervention: A Patient Perspective of a Complex Process
Informed Consent for Percutaneous Coronary Intervention: A Patient Perspective of a Complex Process
Howard T. Blanchard, Diane L. Carroll, Felicity Astin
Cath Lab Digest, 4 November 2020; 28(11)
Open Access
Abstract
Background
Percutaneous coronary intervention (PCI) involves a complex informed consent process. Consent is sought simultaneously for a diagnostic angiography and the potential treatments that follow, including PCI, and fosters shared decision making. This process involves several healthcare providers, yet there has been limited data from the United States regarding the patient’s perspective of informed consent for PCI.
Objective
To describe U.S. patients’ perception of their PCI informed consent process, and of PCI treatment risks and benefits.
Methods
Patients admitted for coronary angiography were approached and if they volunteered for the study, completed a survey on their informed consent experience for PCI following their procedure. The survey asked about purpose of consent, attitudes, risks, benefits, and outcomes of PCI.
Results
There were 82 participants who had undergone PCI, with a mean age of 65 years. Participants included 64 males and 17 females. The majority of participants recognized the key components of choice (88%), risks (94%), and benefits (87%), and 65% of participants were aware of the alternatives for PCI from the informed consent experience. Participants expressed a desire for more information, but also admitted that they had trouble retaining the information. Eighty-nine percent had misconceptions that PCI would prevent a future myocardial infarction. Forty percent of the participants stated that they preferred family to be present during informed consent.
Conclusions
Healthcare providers can improve the informed consent experience by providing clear information, clarifying concerns, and by encouraging family questions and involvement.
Informed consent, duty of disclosure and chiropractic: where are we?
Informed consent, duty of disclosure and chiropractic: where are we?
Debate
Keith Simpson, Stanley Innes
Chiropractic & Manual Therapies, 4 November 2020; 28(60)
Open Access
Abstract
Background
The COVID-19 pandemic has seen the emergence of unsubstantiated claims by vertebral subluxation-based chiropractors that spinal manipulative therapy has a role to play in prevention by enhancing the body’s immune function. We contend that these claims are unprofessional and demonstrate a disturbing lack of insight into the doctrine of informed consent. As such it is timely to review how informed consent has evolved and continues to do so and also to discuss the attendant implications for contemporary health practitioner practice.
We review the origins of informed consent and trace the duty of disclosure and materiality through landmark medical consent cases in four common law (case law) jurisdictions. The duty of disclosure has evolved from a patriarchal exercise to one in which patient autonomy in clinical decision making is paramount. Passing time has seen the duty of disclosure evolve to include non-medical aspects that may influence the delivery of care. We argue that a patient cannot provide valid informed consent for the removal of vertebral subluxation. Further, vertebral subluxation care cannot meet code of conduct standards because it lacks an evidence base and is practitioner centered.
The uptake of the expanded duty of disclosure has been slow and incomplete by practitioners and regulators. The expanded duty of disclosure has implications, both educative and punitive for regulators, chiropractic educators and professional associations. We discuss how practitioners and regulators can be informed by other sources such as consumer law. For regulators, reviewing and updating informed consent requirements is required. For practitioners it may necessitate disclosure of health status, conflict of interest when recommending “inhouse” products, recency of training after attending continuing professional development, practice patterns, personal interests and disciplinary findings.
Conclusion
Ultimately such matters are informed by the deliberations of the courts. It is our opinion that the duty of a mature profession to critically self-evaluate and respond in the best interests of the patient before these matters arrive in court.
Informed consent in neurosurgery: a systematic review
Informed consent in neurosurgery: a systematic review
Nathan A. Shlobin, Mark Sheldon, Sandi Lam
Neurosurgical Focus, 20 August 2020; 49
Open Access
Abstract
Objective
Informed consent has served as a main principle of medical ethics and laws in the United States. The 1986 American Association of Neurological Surgeons Code of Ethics implied medicolegal liability for the failure to obtain informed consent without providing practical guidance regarding the application of informed consent to individual patient encounters in a medicolegal environment. Here, the authors aimed to identify baseline patient recall after discussions with neurosurgeons and their capacity to provide informed consent, describe the effects of interventions to improve patient comprehension, and elucidate the role of informed consent in malpractice litigation in neurosurgery. Their findings may guide neurosurgeons in discussions to properly inform patients and reduce the risk of litigation.
Methods
A systematic review was conducted to explore informed consent within neurosurgery and its application to medicolegal liability using the PubMed, Embase, and Scopus databases. Titles and abstracts from articles identified in the search were read and selected for full-text review. Studies meeting prespecified inclusion criteria were reviewed in full and analyzed for study design, aim, population, interventions, and outcomes.
Results
Of 1428 resultant articles, 21 were included in the review. Baseline patient recall was low, particularly for risks and alternatives of treatments, and even decreased over time. Cognitive impairment was noted as a factor limiting the ability to provide informed consent. Interventions incorporating a combination of modalities in informed consent discussions, a specialized consent form with points for neurosurgeons to check off upon discussion, interactive websites, question prompt lists, and illustrations were found to be effective in improving patient knowledge. Lack of informed consent was a common factor for malpractice litigation. Spine surgery was particularly prone to costly lawsuits. Payments were generally greater for plaintiff verdicts than for settlements.
Conclusion
The application of informed consent to patient encounters is an important facet of clinical practice. Neurosurgeons have a duty to provide patients with all pertinent information to allow them to make decisions about their care. The authors examined baseline patient comprehension and capacity, interventions to improve informed consent, and malpractice litigation; it appears that determining the proper capacity to provide informed consent and considering informed consent as a process that depends on the setting are important. There is room to improve the informed consent process centered on baseline patient health literacy and understanding as well as clear communication using multiple modalities.
Patient Centric Informed Consent in Orthodontic Practice: An Overview
Patient Centric Informed Consent in Orthodontic Practice: An Overview
Research Article
Prateeksha Bora, Poonam Agrawal, Dinesh Kumar Bagga, Madhurima Nanda, Prashant Kumar Shahi
Journal of Critical Reviews, 2020; 7(17) pp 3225-3229
Open Access
Abstract
Informed consent is a fundamental component of good clinical practice and clinical governance. Dental practitioners must be aware of the principal factors that need to be addressed to ensure that consent is valid. Consent, as defined by the Webster’s dictionary, is to give assent or approval. Informed consent is not just a signature on a consent form, it is a process of dialog between the dentist and the patient. It requires a full explanation of the nature, purpose and material risks of the proposed treatment in a language that the patient understands. The patient should have the opportunity to consider the information and ask questions in order to arrive at a balanced judgement of whether to proceed with the proposed treatment. The value of obtaining informed consent is of particular importance in orthodontics. Orthodontic treatment is usually of long duration, involves a number of appointments and is extremely reliant on the patient’s co-operation, in particular with appliance wear and maintenance of good oral hygiene. This article highlights the concept of informed consent which is based on the premise that each individual has a right to make decisions concerning his health, disease and treatment.
Improving informed consent by enhancing the role of nurses
Improving informed consent by enhancing the role of nurses
Research Article
Daniel A Wilkenfeld, Grace Campbell
Nursing Ethics, 28 October 2020
Abstract
From a legal perspective, before a physician engages in a serious medical intervention they must obtain informed consent. In this paper, we argue that there are serious deficits in our processes of obtaining informed consent; it is often seen as just a bureaucratic hurdle, and people agree to interventions without being in an appropriate epistemic state. We explore some possible reasons for this, including ignorance, trust in physicians’ authority, and the minimal time physicians spend with patients. We trace many of these issues to one central cause, which is that in the United States obtaining informed consent is the purview of physicians. We argue that a simple shift in how we obtain informed consent can help to ameliorate these issues. Specifically, we argue that obtaining informed consent should be the responsibility of nurses rather than physicians. While there are several reasons for this, the central ideas are that (1) since nurses are the ones who know the patient, they will be in better position to tell when patients are genuinely informed, and (2) patients will be more comfortable asking questions and admitting ignorance to nurses rather than physicians. While we focus on US law, our conclusions are more broadly applicable.
Patient Consent Management by a Purpose-Based Consent Model for Electronic Health Record Based on Blockchain Technology
Patient Consent Management by a Purpose-Based Consent Model for Electronic Health Record Based on Blockchain Technology
Original Article
Dara Tith, Joong-Sun Lee, Hiroyuki Suzuki, W. M. A. B. Wijesundara, Naoko Taira, Takashi Obi, Nagaaki Ohyamaz
Healthcare Informatics Research, 21 August 2020
Open Access
Abstract
Objectives
Currently, patients’ consent is essential to use their medical records for various purposes; however, most people give their consent using paper forms and have no control over it. Healthcare organizations also have difficulties in dealing with patient consent. The objective of this research is to develop a system for patients to manage their consent flexibly and for healthcare organizations to obtain patient consent efficiently for a variety of purposes.
Methods
We introduce a new e-consent model, which uses a purpose-based access control scheme; it is implemented by a blockchain system using Hyperledger Fabric. All metadata of patient records, consents, and data access are written immutably on the blockchain and shared among participant organizations. We also created a blockchain chaincode that performs business logic managing patient consent.
Results
We developed a prototype and checked business logics with the chaincode by validating doctors’ data access with purpose-based consent of patients stored in the blockchain. The results demonstrate that our system provides a fine-grained way of handling medical staff’s access requests with diverse intended purposes for accessing data. In addition, patients can create, update, and withdraw their consents in the blockchain.
Conclusions
Our consent model is a solution for consent management both for patients and healthcare organizations. Our system, as a blockchain-based solution that provides high reliability and availability with transparency and traceability, is expected to be used not only for patient data sharing in hospitals, but also for data donation for biobank research purposes.
Center for Informed Consent Integrity 