The Prior Consultation of Indigenous Peoples in Latin America: Inside the Implementation Gap [BOOK]
Claire Wright, Alexandra Tomaselli
Routledge, 22 August 2019
Summary
This book delves into the reasons behind and the consequences of the implementation gap regarding the right to prior consultation and the Free, Prior and Informed Consent (FPIC) of Indigenous Peoples in Latin America…
Month: September 2019
A History of Physician “Truth Telling,” Informed Consent, Legal and Religious Perspectives on End-of-Life Care [BOOK CHAPTER]
A History of Physician “Truth Telling,” Informed Consent, Legal and Religious Perspectives on End-of-Life Care [BOOK CHAPTER]
Russell Searight
Ethical Challenges in Multi-Cultural Patient Care, 14 August 2019; pp 29-44
Abstract
While patients’ and family preferences for nondisclosure of life-threatening illness found among contemporary Native Americans and Asian Americans may seem to be a cultural anomaly, a brief review of physician practices and legal rulings in the 20th century suggests that disclosure of this information to patients is a relatively recent practice.
Consent is everybody’s business; Why banks need to act on free, prior and informed consent
Consent is everybody’s business; Why banks need to act on free, prior and informed consent
Shona Hawkes
Oxfam Library, August 2019
Open Access
Summary
A community’s choice to give, or withhold, their free, prior and informed consent (FPIC) to a project or activity planned to take place on their land is a recognized right of Indigenous peoples under international law. It is also a best practice principle that applies to all communities affected by projects or activities on the land, water and forests that they rely on. Free, prior and informed consent has additional benefits for banks involved in such projects, and their clients, in helping to avoid a diverse array of potential risks…
Editor’s note: This paper is published by Oxfam International as a “part of a series of papers written to inform public debate on development and humanitarian policy issues.”
Getting youth PrEPared: adolescent consent laws and implications for the availability of PrEP among youth in countries outside of the United States
Getting youth PrEPared: adolescent consent laws and implications for the availability of PrEP among youth in countries outside of the United States
Taggart T, Bond KT, Ritchwood TD, Smith JC
Journal of the International AIDS Society, July 2019; 22(7)
Open Access
Abstract
Introduction
Youth under the age of 25 are at high risk for HIV infection. While pre-exposure prophylaxis (PrEP) has the potential to curb new infections within this population, it is unclear how country-specific laws and policies that govern youth access to sexual and reproductive health (SRH) services impact access to PrEP. The purpose of this review was to analyse laws and policies concerning PrEP implementation and SRH services available to youth in countries with a high HIV incidence. To the best of our knowledge this is the first systematic assessment of country-level policies that impact the availability of PrEP to adolescent populations.
Methods
We conducted a review of national policies published on or before 12 June 2018 that could impact adolescents’ access to PrEP, SRH services and ability to consent to medical intervention. Countries were included if: (1) there was a high incidence of HIV; (2) they had active PrEP trials or PrEP was available for distribution; (3) information regarding PrEP guidelines were publicly available. We also included a selected number of countries with lower adolescent HIV incidence. Internet and legal database searches were used to identify policies relevant to adolescent PrEP (e.g. age of consent to HIV testing).
Results and Discussion
Fifteen countries were selected for inclusion in this review. Countries varied considerably in their respective laws and policies governing adolescents’ access to PrEP, HIV testing and SRH services. Six countries had specific polices around the provision of PrEP to youth under the age of 18. Five countries required people to be 18 years or older to access HIV testing, and six countries had specific laws addressing adolescent consent for- and access to- contraceptives.
Conclusion
Adolescents’ access to PrEP without parental consent remains limited or uncertain in many countries where this biomedical intervention is needed. Observational and qualitative studies are needed to determine if and how adolescent consent laws are followed in relation to adolescent PrEP provisions. Intensified efforts to amend laws that limit adolescent access to PrEP and restrict the establishment of national guidelines supporting adolescent PrEP are also needed to address the epidemic in this group.
A Professional Standard for Informed Consent for Stem Cell Therapies
A Professional Standard for Informed Consent for Stem Cell Therapies
Viewpoint
Jeremy Sugarman, Roger A. Barker, R. Alta Charo
JAMA, 12 August 2019
Open Access
Excerpt
In November 2018, the US Food and Drug Administration (FDA) issued a press release that stated: “The potential health benefits of regenerative medicine have spurred major progress in stem-cell biology over the past several decades. But we continue to see bad actors exploit the scientific promise of this field to mislead vulnerable patients into believing they’re being given safe, effective treatments; when instead these stem cell producers are leveraging the field’s hype to push unapproved, unproven, illegal, and potentially unsafe products.”
Over the last decade, there has been an increase in the number of “clinics” (570 in the United States alone according to a recent estimate) offering what is portrayed as “stem cell therapy” for conditions ranging from orthopedic injuries to Alzheimer disease. The unproven nature of these interventions suggests that patients who received them were, at a minimum, misled. At worst, they were severely injured, as in the case of at least 3 women who were left legally blind after intravitreal injections of platelet-rich plasma derived from tissue obtained through liposuction…
Mapping HIV laws and policies
Mapping HIV laws and policies
Press Release
UNAIDS
Lawsandpolicies.unaids.org, 31 July 2019
Excerpt
A new website that enables people to identify national laws and policies related to the AIDS response has been launched by UNAIDS.
Covering areas as diverse as a country’s ability to diagnose HIV among young babies, the existence of laws that discriminate against transgender people and whether people are prosecuted for carrying condoms, the Laws and Policies Analytics website aims to give a full overview of a country’s laws and policies related to the HIV response. It also allows to view policy data jointly with other data on the HIV epidemic and response.
“We must better understand legal and policy environments to drive effective responses to the HIV epidemic. This new tool will provide access to data on national laws and policies and allow for joint analysis with data on the epidemic and response, so that we can drive more deeply-informed decision-making,” said Shannon Hader, UNAIDS Deputy Executive Director, Programme…
Editor’s note: In addition to surveying the literature we continue to monitor for other resources such as this web based, non-bibliographic resource.
Informed consent, shared-decision making and a reasonable patient’s wishes based on a cross-sectional, national survey in the USA using a hypothetical scenario
Informed consent, shared-decision making and a reasonable patient’s wishes based on a cross-sectional, national survey in the USA using a hypothetical scenario
Research
John T James, Darwin Jay Eakins, Robert R Scully
BMJ, 30 July 2019; 9(7)
Open Access
Abstract
Objective
In approximately half the states in the USA, and more recently in the UK, informed consent is legally defined as what a reasonable patient would wish to know. Our objective was to discern the information needs of a hospitalised, ‘reasonable patient’ during the informed-consent process.
Design
We performed a cross-sectional study to develop a survey instrument and better define ‘reasonable person’ in relation to informed consent in a hypothetical scenario where an invasive procedure may be an option.
Setting
A 10-question survey was administered from April 19 through 22 October 2018 to three groups: student nurses (n=76), health professions educators (n=63) and a US national population (n=1067).
Primary and secondary outcome measures
The primary outcome measure was the average intensity, on a 5-point scale, by which survey groups wished to have each of 10 questions answered. The secondary outcome was to discern relationships between survey demographics and the intensity by which participants wanted an answer.
Results
Despite substantial demographic differences in the nursing-student group and health-professions-educator group, the average intensity scores were within 0.2 units on nine of 10 questions. The national survey revealed a strong desire to have an answer to each question (range 3.98–4.60 units). It showed that women desired answers more than men and older adults desired answers more than younger adults.
Conclusions
Based on responses to 10 survey questions regarding wishes of people in a situation where an invasive procedure may be necessary, the vast majority want an answer to each question. They wanted to know about all treatment options, risky drugs, decision aids, who will perform the procedure, and the cost. They wanted their advocate present, periodic review of their medical record, a full day to review documents and expected outcomes and restrictions after the procedure.
Say what? Patients have poor immediate memory of major risks of interscalene block disclosed during the informed consent discussion
Say what? Patients have poor immediate memory of major risks of interscalene block disclosed during the informed consent discussion
Original Article
Johnny Wei Bai, Faraj W W Abdallah, Melanie Cohn, Stephanie Ladowski, Poorna Madhusudan, Richard Brull
Regional Anesthesia & Pain Medicine, 23 August 2019
Abstract
Background
Poor memory of disclosed risks can undermine informed consent and create medicolegal challenges. The extent to which patients remember the risks of peripheral nerve blockade following the informed consent discussion is unknown. This prospective cohort study evaluated patients’ immediate memory of risks related to interscalene block (ISB) that were disclosed during the preoperative informed consent discussion.
Methods
Using a standardized script, patients scheduled for arthroscopic shoulder surgery were informed of the risks of ISB by an anesthesiologist in the preoperative assessment clinic. Immediately thereafter, consenting participants were asked to identify the risks of ISB from a printed list of nine true risks (four major and five minor) and nine ‘distractor’ items, which were unrelated adverse events and not disclosed. The primary outcome was the proportion of participants who remembered all four true major risks including long-term nerve damage, seizure, life-threatening event, and damage to the covering of the lung.
Results
Among 125 participants, only 26 (21%) remembered all four major risks of ISB. The mean number of major risks remembered was 2±1 out of 4. Fifteen (12%) participants remembered all nine true risks. The mean number of true risks remembered was 6±2 out of 9. Multivariable analysis revealed that participants’ self-rated assessment of their memory was not associated with actual recall.
Conclusion
Patients have poor immediate memory of the major risks related to ISB disclosed during the informed consent discussion. Under the present study conditions, the validity of the informed consent process for patients undergoing ISB may be undermined.
Obtaining consent for obstetric procedures
Obtaining consent for obstetric procedures
KatrinaHenderson, SiânGriffiths
Anaesthesia & Intensive Care Medicine, 19 August 2019
Abstract
Consent is a process that involves information disclosure of a proposed treatment or intervention. It includes a discussion of the risks relevant to that particular patient as well as the benefits and alternative options. The process must be clearly documented to provide a legal justification for treatment. Obtaining informed consent can be a challenge when a labouring woman is in severe pain or under the influence of strong analgesics. High-risk women should be encouraged to attend pre-assessment clinics to enable adequate time to process the information discussed. Pregnant women are presumed competent and are entitled to refuse treatment even if this risks their life or the life of their fetus. Rarely, if a woman is not considered competent to make decisions for herself, clinicians should take into account the underlying reasons and consider proceeding in their best interests under the doctrine of necessity or apply to the courts for approval of an intervention. This article summarizes current guidelines in relation to consent that have been updated to reflect recent case law.
Deferred consent for delivery room studies: the providers’ perspective
Deferred consent for delivery room studies: the providers’ perspective
Original Article
Maria C den Boer, Mirjam Houtlosser, Elizabeth E Foglia, Enrico Lopriore, Martine Charlotte de Vries, Dirk P Engberts, Arjan B te Pas
Archives of Disease in Childhood: Fetal & Neonatal, 19 August 2019
Abstract
Objective
To gain insight into neonatal care providers’ perceptions of deferred consent for delivery room (DR) studies in actual scenarios.
Methods
We conducted semistructured interviews with 46 neonatal intensive care unit (NICU) staff members of the Leiden University Medical Center (the Netherlands) and the Hospital of the University of Pennsylvania (USA). At the time interviews were conducted, both NICUs conducted the same DR studies, but differed in their consent approaches. Interviews were audio-recorded, transcribed and analysed using the qualitative data analysis software Atlas.ti V.7.0.
Results
Although providers reported to regard the prospective consent approach as the most preferable consent approach, they acknowledged that a deferred consent approach is needed for high-quality DR management. However, providers reported concerns about parental autonomy, approaching parents for consent and ethical review of study protocols that include a deferred consent approach. Providers furthermore differed in perceived appropriateness of a deferred consent approach for the studies that were being conducted at their NICUs. Providers with first-hand experience with deferred consent reported positive experiences that they attributed to appropriate communication and timing of approaching parents for consent.
Conclusion
Insight into providers’ perceptions of deferred consent for DR studies in actual scenarios suggests that a deferred consent approach is considered acceptable, but that actual usage of the approach for DR studies can be improved on.
Center for Informed Consent Integrity 