Informed Consent: A Monthly Review
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October 2019

This digest aggregates and distills 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_October 2019

Informed Consent: A Monthly Review
___________________________

September 2019

This digest aggregates and distills 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_September 2019

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
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
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.

Informed Consent: A Monthly Review
___________________________

August 2019

This digest aggregates and distills 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_August 2019

Informed Consent: an Update
Biermann E
Anasthesiol Intensivmed Notfallmed Schmerzther, 25 Jul 2019; 54(7-8) pp 457-473
Abstract
An indication for a medical intervention alone is not sufficient to justify its implementation. In addition, consent has to be obtained from the patient who has been given relevant information by a doctor. If, instead of the patient, other persons are entitled to decide for him (parents for children incapable of consent, authorised representatives, carers), they must be informed. If the patient, who is aware of the significance of his decision, refuses to consent to the measure as a whole or to parts of it, the physician is bound by it – even if the patient’s refusal is based on religious, ideological or other reasons which are not comprehensible to the physician. In urgent cases, and in the case of a patient unable to give consent, the doctor can initiate treatment according to the principle of so-called presumed consent. The physician must inform the patient about all circumstances essential for the consent in a timely and comprehensible manner, i.e. also in the language of the patient in the case of patients who do not understand German. The patient must be informed about alternatives if there are other common treatment methods that are medically equally indicated, but which carry substantially different burdens, risks or chances of recovery. From a medical and forensic point of view, risk education is of the greatest importance, in particular information about the typical risks specific to interventions which are unknown to the patient and which, if they materialise, might have a lasting adverse effect on the patient’s lifestyle. The extent of risk disclosure is influenced by the urgency of the intervention; the scope of risk disclosure is in inverse proportion to its urgency. An enlightened or otherwise adequately informed patient (e.g. in the case of a series of dressing changes under general anaesthesia) does not have to be enlightened every time, provided that the risk spectrum for the patient has not changed. Consent and clarification are also verbally effective, written form is strongly recommended for reasons of preserving evidence. However, the patient’s right to self-determination also means that the patient can expressly dispense with more detailed information. Such a waiver should be carefully documented.

Editor’s note: This is a German language publication.

How Do We Really Communicate? Challenging the Assumptions behind Informed Consent Interventions
Article
Stephanie Solomon Cargill
Ethics & Human Research, 23 July 2019
Abstract
It is generally accepted that ethical research requires valid informed consent and that current informed consent practice frequently fails to attain it. Interventions concerning the content and methods of communication in informed consent have met with limited success. One explanation is that they reflect an outdated and limited model of how communication functions, the transmission model of communication. This model assumes that communication is linear, is limited in time, and succeeds when the content of a message is passed from one person to another without distortion. Later communication models have challenged the limitations and inaccuracies of this model, emphasizing the continuous, contextual, and relational nature of communication. Looking beyond these assumptions behind current interventions can open multiple paths of research and intervention that have the potential to affect and improve the informed consent process in much greater ways than have been achieved previously.

Bioethical reflexivity and requirements of valid consent: conceptual tools
Debate
John Barugahare
BMC Medical Ethics, 4 July 2019; 20(44)
Open Access
Abstract
Background
Despite existing international, regional and national guidance on how to obtain valid consent to health-related research, valid consent remains both a practical and normative challenge. This challenge persists despite additional evidence-based guidance obtained through conceptual and empirical research in specific localities on the same subject. The purpose of this paper is to provide an account for why, despite this guidance, this challenge still persist and suggest conceptual resources that can help make sense of this problem and eventually mitigate it’.
Main body
This paper argues that despite the existence of detailed official guidance and prior conceptual and empirical research on how to obtain valid consent, the question of ‘how to obtain and ascertain valid consent to participation in health-related research’ cannot always be fully answered by exclusivereference to pre-determined criteria/guidance provided by the guidelines and prior research’. To make intelligible why this is so and how this challenge could be allayed, the paper proposes six concepts. The first five of these are intended to account for the persistent seeming inadequacies of existing guidelines. These are fact-skepticism; guideline insufficiency; generality; context-neutrality and presumptiveness. As an outcome of these five, the paper analyzes and recommends a sixth, called bioethical reflexivity. Bioethical reflexivity is reckoned as a handy tool, skill, and attitude by which, in addition to guidance from context-specific research, the persisting challenges can be further eased.
Conclusions
Existing ethical guidelines on how to obtain valid consent to health-related research are what they ought to be – general, presumptive and context-neutral. This explains their seeming inadequacies whenever they are being applied in concrete situations. Hence, the challenges being encountered while obtaining valid consent can be significantly eased if we appreciate the guidelines’ nature and what this means for their implementation. There is also a need to cultivate reflexive mindsets plus the relevant skills needed to judiciously close the unavoidable gaps between guidelines and their application in concrete cases. This equally applies to the gaps which cannot be filled by reference to additional guidance from prior conceptual and empirical research in specific contexts.

Attitudes Regarding Enrollment in a Genetic Research Project: An Informed Consent Simulation Study Comparing Views of People With Depression, Diabetes, and Neither Condition
Research Article 
Jane Paik Kim, Katie Ryan, Laura Weiss Roberts
Journal of Emirical Research on Human Research Ethics, 22 July 2019 
Abstract
In this study, participants with a self-reported history of depression, diabetes, or no illness underwent a simulated informed consent process for a hypothetical genetic study related to depression or diabetes. Participants completed a survey assessing their perceived understanding of the research process, perceptions of its risks and benefits, their satisfaction with the informed consent process, and their readiness to make a hypothetical enrollment decision. All participants indicated strong readiness to make an enrollment decision regarding the research characterized in the simulation. Participants reported understanding the consent process relatively well and being generally satisfied with it. Greater concerns were expressed regarding psychosocial risks than biological risks for genetic studies on mental disorders. Our study documented positive attitudes toward volunteering for research that involved the collection of genetic data.