The Conceptual Legal Structure of The Patient’s Right to Informed Consent
Noelia Martínez-Doallo
European Journal of Health Law, 12 May 2022
Abstract
Informed consent has been inconsistently conceptualised as a right, an immunity or even a power in the hands of the patient, which leaves its legal definition as partially indefinite. From the norms of the CHRB, a legal theory stance and the proposals of celebrated authors — namely, W.N. Hohfeld, H. Kelsen and R. Alexy, I will provide a steady conceptual structure for the subjective legal positions of the parties involved in the healthcare relationship regarding informed consent.
Month: June 2022
Informed Consent in Pringsewu Regional General Hospital: Legal Evidence Perspective
Informed Consent in Pringsewu Regional General Hospital: Legal Evidence Perspective
Samino Samino, Agung Aji Perdana, Selamet Kuntoro
Jounral Ilmu Kesehatan, 2022; 7(1)
Abstract
Quality health care is the right of every patient and his family. One of the indicators of quality services is the fulfillment of informed consent in accordance with the laws and regulations. Preliminary studies of several informed consent documents at Pringsewu Hospital found that all of them were not filled out completely. This study aims to analyze informed consent documents from the perspective of legal evidence.The study was conducted at Pringsewu Hospital in July 2021. The research method used a qualitative descriptive analysis approach, with 75 informed consent documents and two informants. How to collect data by reviewing the informed consent document that has been filled in at the hospital medical record installation, by checking the completeness of filling out the informed consent document for the five most types of actions, and in-depth interviews with the responsible leadership.The results showed that 75 informed consent documents were reviewed, none of which were filled out completely. The five most important indicators were not filled in completely, consecutively: name and signature of witness II, name and signature of witness I, gender of the patient, and gender of the giver of consent. To improve the completeness of filling out documents, the hospital will provide education to doctors, nurses, and administrative staff, as well as strict supervision. It was concluded that incomplete informed consent documents, as legal evidence, were low quality. The hospital leaders should conduct socialization to doctors, nurses and administrative staff regarding the importance of filling out the medical treatment approval form properly and completely.
The Extraction Industry in Latin America and the Protection of Indigenous Land and Natural Resource Rights: From Consultation Toward Free, Prior, and Informed Consent
The Extraction Industry in Latin America and the Protection of Indigenous Land and Natural Resource Rights: From Consultation Toward Free, Prior, and Informed Consent
Kylah Staley
Hastings Law Journal, May 2022; 73(4)
Open Access
Abstract
Resource extraction and exploitation threaten the survival of Indigenous and tribal peoples, who are amongst the most marginalized communities in the world. This is both a human rights issue and an environmental issue. There are around 300 million people that make up Indigenous communities worldwide, the majority of whom live in forests. Furthermore, Indigenous customary lands contain 80% of the world’s biodiversity. Traditionally, Indigenous communities have been stewards of their lands, where they regard the land as means for their own physical, spiritual, and cultural survival rather than a commodity to be exploited. The only protection Indigenous Peoples have against resource extraction in international law, under the Indigenous and Tribal Peoples (ILO) Convention 169, is the right to consultation and participation. Effectively, Indigenous communities have limited decision-making power in this context. This narrow protection of Indigenous Peoples’ lands and natural resources under ILO Convention 169 is inadequate and informed by a colonial past. For there to be adequate protections of Indigenous Peoples’ land and resource rights, Indigenous Peoples must hold actual decision-making power, not just participatory power. Free, prior, and informed consent (FPIC) is the principle and right that is critical to safeguarding Indigenous lands and resources as it is grounded in the foundational right of self-determination. Thus, I argue operationalizing FPIC would provide a comprehensive protection of Indigenous rights by ensuring that affected Indigenous communities (1) design the procedures for obtaining their consent (2) retain negotiating power and (3) actually agree to proposed projects.
Principle of Free, Prior and Informed Consent as a Resolution of Land Conflicts Between Oil Palm Plantation Companies and Indigenous Peoples in Kampar Regency
Principle of Free, Prior and Informed Consent as a Resolution of Land Conflicts Between Oil Palm Plantation Companies and Indigenous Peoples in Kampar Regency
Rahmad Hendra, Firdaus Firdaus, Samariadi Samariadi
Advances in Social Science, Education and Humanities Research, 2021; 659
Open Access
Abstract
The research was conducted in Bencah Kelubi Village and Subarak Village. In both villages there are oil palm plantation companies. In Subarak Village, oil palm plantation investors implement the principle of free, prior and informed consent (FPIC) at the beginning before the start of investment, while in Bencah Kelubi Village the oil palm plantation companies that make investments do not follow the FPIC principle. The writing method used by the author is descriptive analysis with a qualitative research pattern. The author found that FCPIC is significantly reduces the conflict between oil palm plantation companies and indigenous peoples.
Ethical obligation and legal requirements: On informed consent practices in Bangladesh
Ethical obligation and legal requirements: On informed consent practices in Bangladesh
Original Article
Sonia Mannan, Jobair Alam, K. M. Ashbarul Bari, S. M. A. A. Mamun, Rehnuma Mehzabin Orin
Developing World Bioethics, 19 May 2022
Abstract
Informed consent to medical intervention is fundamental in both ethics and law. But in practice it is often not taken seriously in developing countries. This paper provides an appraisal of informed consent practices in Bangladesh. Following a review of the ethical and legal principles of informed consent, it assesses the degree to which doctors adhere to it in Bangladesh. Based on findings of non-compliance, it then investigates the reasons for such non-compliance through an appraisal of informed consent practices in Bangladesh and provides recommendations aimed at improving such practices. The significance of this paper lies in unveiling the interdependence between the ethical and legal traits of informed consent and their ramifications on strengthening the patient-oriented approach of duty to care.
Understanding of Critical Elements of Informed Consent in Genomic Research: A Case of a Paediatric HIV-TB Research Project in Uganda
Understanding of Critical Elements of Informed Consent in Genomic Research: A Case of a Paediatric HIV-TB Research Project in Uganda
Research Article
Francis Anyaka Amayoa, Frederick Nelson Nakwagala, John Barugahare, Ian Guyton Munabi, Erisa Sabakaki Mwaka
Journal of Empirical Research on Human Research Ethics, 12 May 2022
Abstract
Several studies have reported inadequate comprehension of informed consent for genomic research. This study aimed to assess research participants’ understanding of critical elements of informed consent for genomic research. A cross-sectional survey involving 123 parents/caregivers of children participating in a paediatric genomic TB/HIV study was conducted. Only 47.2% of the participants had adequate understanding of consent information. The mean objective (actual) and subjective (perceived) understanding scores were 78.7% and 91.7% respectively. Participants adequately understood most elements of consent however, some elements were poorly understood including foreseeable risks, protection of confidentiality and compensation for research related injury. Overall there was inadequate comprehension of critical elements of informed consent and there was dissonance between actual and perceived comprehension of informed consent.
Awareness of Knowledge, Attitude and Practices of Medical Students and Surgical Trainees Regarding Surgical Informed Consent: A Cross-sectional Multicentric Study from Northern India
Awareness of Knowledge, Attitude and Practices of Medical Students and Surgical Trainees Regarding Surgical Informed Consent: A Cross-sectional Multicentric Study from Northern India
Nishtha Singh, Sudhir Kumar Jain, Tariq Hameed, Kanwal Preet Kochhar, Param Jit, Chandra Bhushan Singh
Asian Journal of Medicine and Health, 22 March 2022; 20(3) pp 25-31
Open Access
Abstract
Background
Informed Consent is the cornerstone of modern medical and surgical care. All patients have the right to be involved in decisions about their treatment and care. Obtaining SIC (surgical informed consent) is an important and essential skill that one must acquire in medical training, yet many residents receive very little formal education.
Methods
Multiple choice questionnaire designed and after pretesting circulated on Google formsTM having questions pertaining to knowledge, attitude and practice. Total 463 responses obtained and appropriate statistical tests applied in Microsoft Excel and StataSE.
Result
Knowledge-score remained constant for medical students and trainees, Attitude-score (18.59 to 18.93) and Practice-score (2.30 to 3.62) statistically significant increase in score with clinical exposure was noted. Gender wise difference were in A-score, females scored higher 18.87 and males scored 18.49. For trainee doctors unlike P scores, K and A scores did not increase with experience.
Discussion
Early intervention in undergraduate years and continuous upskilling is the need tobridge the hiatus of doctor-patient relationship. This necessitates scenario and role play based teaching, student teaching patient based learning regarding the SIC.
Conclusion
There is a Knowledge attitude practice gap present not only in undergraduate students but postgraduates residents regarding SIC, for which the current curriculum and the ongoing practical training is insufficient to bridge. Indian curriculum must make amendments to bridge it.
Evolution of Investigating Informed Assent Discussions about CPR in Seriously Ill Patients
Evolution of Investigating Informed Assent Discussions about CPR in Seriously Ill Patients
Renee D. Stapleton, Dee W. Ford, Katherine R. Sterba, Nandita R. Nadig, Steven Ades, Anthony L. Back, Shannon S. Carson, Katharine L. Cheung, Janet Ely, Erin K. Kross, Robert C. Macauley, Jennifer M. Maguire, Theodore W. Marcy, Jennifer J. McEntee, Prema R. Menon, Amanda Overstreet, Christine S. Ritchie, Blair Wendlandt, Sara S. Ardren, Michael Balassone, Stephanie Burns, Summer Choudhury, Sandra Diehl, Ellen McCown, Elizabeth L. Nielsen, Sudiptho R. Paul, Colleen Rice, Katherine K. Taylor, Ruth A. Engelberg
Journal of Pain and Symptom Management, June 2022; 63(6) e621-e632
Abstract
Context
Outcomes after cardiopulmonary resuscitation (CPR) remain poor. We have spent 10 years investigating an “informed assent” (IA) approach to discussing CPR with chronically ill patients/families. IA is a discussion framework whereby patients extremely unlikely to benefit from CPR are informed that unless they disagree, CPR will not be performed because it will not help achieve their goals, thus removing the burden of decision-making from the patient/family, while they retain an opportunity to disagree.
Objectives
Determine the acceptability and efficacy of IA discussions about CPR with older chronically ill patients/families.
Methods
This multi-site research occurred in three stages. Stage I determined acceptability of the intervention through focus groups of patients with advanced COPD or malignancy, family members, and physicians. Stage II was an ambulatory pilot randomized controlled trial (RCT) of the IA discussion. Stage III is an ongoing phase 2 RCT of IA versus attention control in in patients with advanced chronic illness.
Results
Our qualitative work found the IA approach was acceptable to most patients, families, and physicians. The pilot RCT demonstrated feasibility and showed an increase in participants in the intervention group changing from “full code” to “do not resuscitate” within two weeks after the intervention. However, Stages I and II found that IA is best suited to inpatients. Our phase 2 RCT in older hospitalized seriously ill patients is ongoing; results are pending.
Conclusions
IA is a feasible and reasonable approach to CPR discussions in selected patient populations.
Consent in Interventional Radiology—How Can We Make It Better?
Consent in Interventional Radiology—How Can We Make It Better?
Review Article
Tia Forsman, Sara Silberstein, Eric J. Keller
Canadian Association of Radiologists Journal, 25 May 2022
Abstract
Informed consent is an important part of the clinician-patient relationship. However, studies suggest consent practices tend to be limited in consistency and completeness. This may be particularly challenging for interventional radiology given more limited public awareness and the often fast-paced, dynamic nature of our practices. This article reviews these challenges as well as ideal consent practices and potential approaches to improve consent in interventional radiology.
Development of Shared Decision-Making Training Module for Patients Facing Preference-Sensitive Decisions regarding Major Surgical Procedures
Development of Shared Decision-Making Training Module for Patients Facing Preference-Sensitive Decisions regarding Major Surgical Procedures
Poster Abstracts
Ryan Gainer, Greg Hirsch, Elias Hirsch
International Journal of Integrated Care, 16 May 2022
Abstract
Introduction
Studies of surgical decision making demonstrate poor decisional quality, especially patient comprehension and expression of preferences. Shared decision making (SDM), a formalized approach wherein patients are educated about risks, benefits to treatment options, and supported to share personal preferences, has been shown to improve comprehension, reduce decisional conflict, and better align patient expectations with outcome, however multiple systematic reviews have demonstrated almost no sustained uptake of this approach in surgery. The goal of this study is to implement SDM with relevant training aimed at the surgical team with a pre-post design that measures effectiveness through Option-5 scoring of informed-consent interactions.
Aims Objectives Theory or Methods
Five focus groups with patients (n=2) and health care providers (HCPs) (n=3) were carried out to determine barriers and facilitators of SDM and learning preferences for HCPs. Common barriers and facilitators identified in focus groups using thematic analysis were used to develop communication and logistical strategies included in the training. HCP learning preferences identified informed format and presentation style of the training to improve participant engagement. Informed consent discussions were audio recorded and analyzed using Option-5 methodology which comprises a 5 item measure of SDM used to assess the extent to which clinicians involve patients in the decision making process.
Highlights or Results or Key Findings
Common barriers to SDM identified in thematic analysis included; lack of time during surgeon patient interaction; authoritative imbalance between patients and clinicians; and deficits in patient comprehension. HCPs expressed preferences regarding presentation style and format specifically; synchronous short events with relevant examples. Pre-intervention OPTION-5 scoring (n=40) demonstrated low decisional quality (average score 27/100) with almost no perceptible elicitation or incorporation of patient preferences during consent discussions. Following the training of cardiac surgeons and multidisciplinary team members, 62 more informed consent discussions will be audio-recorded and evaluated using the OPTION-5 scoring metric. OPTION-5 scores before and after training will be compared by item and total score to determine change in informed consent discussion quality.
Conclusions
Informed consent in surgery is lacking in SDM approaches. Barriers have been identified and SDM training has been developed with a team based approach in mind. Effectiveness of the training intervention on the improvement of surgical consent discussion quality will be measured using OPTION-5 and if successful broader implementation will
Implications for applicability/transferability sustainability and limitations
Successful implementation of SDM training showing measurable improvement in cardiac surgery informed consent discussion quality will substantiate the implementation of SDM training modules specified for other surgical disciplines as well as subsequent evaluation of long term sustainability of the effects of SDM training.
Center for Informed Consent Integrity 