Impact of Informed Consent and Education on Care Engagement After Opioid Initiation in the Veterans Health Administration
Tigran Avoundjian, Lara Troszak, Jennifer Cohen, Mary Beth Foglia, Jodie Trafton, Amanda Midboe
Journal of Pain Research, 25 May 2022; 15 pp 1553-1562
To ensure all patients receiving long-term opioid therapy (LTOT) understand the risks, benefits and treatment alternatives, the Veterans Health Administration (VHA) released a national policy in 2014 to standardize a signature informed consent (SIC) process. We evaluated the impact of this policy on medical follow-up after LTOT initiation, a guideline recommended practice.
Using VHA administrative data, we identified patients initiating LTOT between May 2013 and May 2016. We used an interrupted time series design to compare the monthly rates of medical follow-up within 30 days and primary care visits within 3 months after LTOT initiation across three periods: 12 months before the policy (Year 1); 12 months after policy release (Year 2); and 12– 24 months after policy release, when the SIC process was mandatory (Year 3).
Among the 409,895 patients who experienced 758,416 LTOT initiations, medical follow-up within 30 days and primary care engagement within 3 months increased by 4% between Year 1 and Year 3. Compared to Year 1, patients in Year 3 were 1.12 times more likely to have any medical follow-up (95% CI: 1.10, 1.13) and 1.13 times more likely to have a primary care visit (95% CI: 1.12, 1.15). Facilities with a greater proportion of patients receiving SIC had increased medical follow-up (RR: 1.04, 95% CI: 1.01, 1.07) and primary care engagement (RR: 1.06, 95% CI: 1.03, 1.10).
The VHA’s SIC policy is associated with increased medical follow-up among patients initiating LTOT, which may result in improved patient safety and has implications for other healthcare settings.
The Conceptual Legal Structure of The Patient’s Right to Informed Consent
European Journal of Health Law, 12 May 2022
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.
Informed Consent in Pringsewu Regional General Hospital: Legal Evidence Perspective
Samino Samino, Agung Aji Perdana, Selamet Kuntoro
Jounral Ilmu Kesehatan, 2022; 7(1)
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.
Who Decides?: Informed Consent Doctrine Applied to Denial of Reproductive Health Care Information at Crisis Pregnancy Centers
Iowa Law Review, March 2022; 107(3) pp 1253-1281
Crisis pregnancy centers are largely religiously affiliated organizations that advertise pregnancy support but often do not provide full and accurate information about abortion or contraception. Often attacked for false advertising and operating without medical licenses, crisis pregnancy centers recently have begun converting to medical centers with medical staff on site. Since medical providers owe additional duties to their patients, crisis pregnancy centers operated by medical staff must follow additional procedures, such as providing informed consent. Informed consent doctrine is based on the idea of autonomous decision-making and requires medical providers to accurately inform patients of their viable medical options. Even though crisis pregnancy centers often fail to inform people about critical reproductive health care, people who visit crisis pregnancy centers still would have difficulty bringing a claim of informed consent against these centers. Applying informed consent doctrine to crisis pregnancy centers highlights the discrepancy between the philosophical purpose of informed consent and the doctrine in practice today. Courts should loosen the causation and injury requirements for informed consent doctrine, at least in reproductive health care cases. Making this change would be the first step in holding crisis pregnancy centers accountable and could help courts more accurately apply reproductive-specific tort claims generally.
Consent to Treatment for Transgender Youth: The Next Chapter – Bell & Anor v The Tavistock and Portman NHS Foundation Trust & Ors
Modern Law Review, 25 February 2022
In September 2021, the Court of Appeal reversed the controversial decision of Quincy Bell v Tavistock and Portman NHS Trust in a victory for transgender rights. At first instance, the Divisional Court had set a high legal threshold for transgender children to attain Gillick competence to consent to treatment with puberty blockers – effectively restricting access to treatment for many. On appeal, the Court of Appeal held that children are capable in law of giving valid consent to treatment for gender dysphoria, and court authorisation would not be routinely required before children could access such treatment. This note considers the implications of the Court of Appeal decision for the law on minors and consent to medical treatment in the transgender health context.
Our data? An examination of the possible role of individual consent in the regulation of posthumous medical data donation (PMDD)
Computer Law & Security Review, 17 February 2022
This article considers the regulation of posthumous medical data donation (PMDD) and examines the extent to which the law should require the opt-in ante-mortem consent of deceased persons for their medical data to be retained and used as part of PMDD initiatives. The article considers arguments on either side of this debate (i.e., pro-consent vs. anti- consent) before tentatively suggesting that, as a general matter, opt-in consent should not be required for medical data of deceased persons to be used for PMDD purposes. It is also proposed, however, that whilst opt-in consent should not be required by law, individuals should be provided with a qualified right through which they can object or “opt out” of their medical data being used in this way.
Health care providers’ ethical perspectives on waiver of final consent for Medical Assistance in Dying (MAiD): a qualitative study
Caroline Variath, Elizabeth Peter, Lisa Cranley, Dianne Godkin
BMC Medical Ethics, 30 January 2022; 23(8)
With the enactment of Bill C-7 in Canada in March 2021, people who are eligible for medical assistance in dying (MAiD), whose death is reasonably foreseeable and are at risk of losing decision-making capacity, may enter into a written agreement with their healthcare provider to waive the final consent requirement at the time of provision. This study explored healthcare providers’ perspectives on honouring eligible patients’ request for MAiD in the absence of a contemporaneous consent following their loss of decision-making capacity.
A critical qualitative methodology, using a feminist ethics theoretical lens with its focus on power and relationality, was used to examine how socio-political and environmental contexts influenced healthcare providers’ moral agency and perspectives. Semi-structured interviews were conducted with 30 healthcare providers (13 physicians, six nurse practitioners, nine nurses and two social workers) from across Canada who provide MAiD-related care.
Themes identified include; (1) balancing personal values and professional responsibilities, (2) anticipating strengths and limitations of the proposed waiver of final consent amendment, (3) experiencing ethical influences on decisions to enter into written agreements with eligible patients, (4) recognizing barriers to the enactment of MAiD in the absence of a contemporaneous consent and (5) navigating the potential for increased risks and burden.
To our knowledge, this is the first study in Canada to explore healthcare providers’ perspectives on waiving the final consent for MAiD using a written agreement. Most participants supported expanding eligible people’s access to MAiD following loss of capacity, as they believed it would improve the patients’ comfort and minimize suffering. However, the lack of patients’ input at the time of provision and related ethical and legal challenges may impact healthcare providers’ moral agency and reduce some patients’ access to MAiD. Providers indicated they would enter into written agreements to waive final consent for MAiD on a case-by-case basis. This study highlights the importance of organizational, legal and professional support, adequate resources, clear policies and guidelines for the safety and wellbeing of healthcare providers and to ensure equitable access to MAiD.
Amending Federal Regulations to Counteract Language Barriers in the Informed Consent Process
Voices in Bioethics, 8 January 2022; 8
As English is the predominant language of research protocols in the United States, non-English speaking subjects face language barriers during clinical trial enrollment. Federal regulation 45 C.F.R. 46 requires that a research subject receive information about a clinical trial “in language understandable to the subject or the legally authorized representative.” A researcher may enroll a subject using short-form consent when a long-form translation in the subject’s native language is not available. However, the abbreviated short form does not adequately inform the subject of the study’s purpose and potential risks. United States Department of Health and Human Services (HHS) leaders should amend federal guidance to provide specific details on obtaining proper informed consent when there is a language barrier. The code of federal regulations should also establish a standard for quality translation services and interpreters. This paper will review current federal regulations and draft policy, analyze literature describing hospital experiences, and discuss non-compliance areas. This author recommends an amendment to federal policy, which is important because it helps ensure the rights of study participants under the principle of justice.
Editor’s note: “Voices in Bioethics operates in partnership with Columbia University Libraries.”
The Unbearable Lightness of Informed Consent in Post Mortem Fertilization
European Review of Private Law, 2021; 29(6) pp 945 – 968
The current increase in global infertility rate and the consequent access to medically assisted procreation have contributed to the fragmentation of the reproductive process. This is also due to the development of cryopreservation techniques for gametes and embryos, whose use is therefore progressively delayed over time, sometimes even after the death of one of the partners. However, few European countries permit post mortem fertilization. Following a reconstruction of the legislation of those EU Member States allowing the practice, this contribution focuses on the jurisprudential reaction in countries, such as France, Germany and Italy, where post mortem fertilization is prohibited by the legislature. In doing so, the role of informed consent is highlighted, especially where it was not expressed by the deceased, due to an unexpected and sudden fatal event, and the surviving partner wants a child from the deceased. Based on a comparison with the findings of US scholars, this article elaborates further on the advantages of the default option in gamete retrieval for procreative purposes, which is increasingly requested also by parents looking for genetic continuity. Perceived differently outside the Western legal tradition, the lack of offspring opens the doors to recognize the interest of pursuing by post mortem fertilization a family genetic heritage.
Bell v Tavistock: Rethinking informed decision-making as the practical device of consent for medical treatment
Abeezar I. Sarela
Clinical Ethics, 27 December 2021
The decision of the High Court in Bell v Tavistock has excited considerable discussion about lawful consent for puberty-blocking drug treatment for children with gender dysphoria. The present paper draws attention to a wider question that surfaces through this case: is informed decision-making an adequate practical tool for seeking and obtaining patients’ consent for medical treatment? Informed decision-making engages the premises of the rational choice theory: that people will have well-crystallised health goals; and, if they are provided with sufficient information about medical treatments, then they will be able to choose the treatment that satisfies their goals. Whilst appealing, the informed decision-making paradigm is assailed by various fallacies, which apply not only to children but also to adults. In Bell v Tavistock, the High Court seems to have recognised such fallacies, and it rejected informed decision-making as an adequate tool for consent from children with gender dysphoria. Similar considerations apply to adults in various situations. Thus, Bell v Tavistock can be seen as an attempt to refine the views on the consent that were expressed by the Supreme Court in Montgomery. It can be inferred that the Supreme Court did recognise the limitations of informed decision-making, but it did not develop this point. Further work is required to formulate an adequate model of decision-making, and Bell v Tavistock serves as a useful reminder to rethink informed decision-making as the device for consent.