How to Strengthen Patients’ Meaning Response by an Ethical Informed Consent in Psychotherapy

How to Strengthen Patients’ Meaning Response by an Ethical Informed Consent in Psychotherapy
Conceptual Analysis Article
Manuel Trachsel, Martin grosse Holtforth
Frontiers in Psychology, 31 July 2019
Open Access
Abstract
Healthcare professionals including psychotherapists are legally and ethically obliged to ensure informed consent for the provided treatments comprising type and duration or potential benefits and possible risks (e.g., side effects) among others. In the present contribution, we argue that as potential benefit, informed consent can foster the patient’s meaning response. Moerman’s notion of the meaning response as the physiological or psychological effects of meaning in the course and treatment of an illness is a useful concept in explaining the effects of communicating a treatment rationale as part of the informed consent procedure. The more compelling the rational explanation of the targeted treatment effects including an explanatory model and a model of unique and common change mechanisms, the stronger the meaning response is expected to be resulting in increased hope and positive expectations with regard to the treatment.

Privacy, Sensitive Questions, and Informed Consent: Their Impacts on Total Survey Error, and the Future of Survey Research

Privacy, Sensitive Questions, and Informed Consent: Their Impacts on Total Survey Error, and the Future of Survey Research
Eric Plutzer
Public Opinion Quarterly, 28 June 2019; 83(1) pp 169-184
Abstract
Survey science is driven to maximize data quality and reduce Total Survey Error (TSE). At the same time, survey methodologists have ethical and professional obligations to protect the privacy of respondents and ensure their capacity to provide informed consent for their participation, for data linkage, passive data collection, and the archiving of replication data. We have learned, however, that both sensitive topics and the consent process can contribute to errors of representation and errors of measurement. These compound threats to data quality that arise due to broader concerns about privacy, the intrusiveness of surveys, and the increasing number of participation requests directed to the same respondents. This article critically assesses the extant literature on these topics—including six original articles in this issue—by viewing these challenges through the lens of the TSE framework. This helps unify several distinct research programs and provides the foundation for new research and for practical innovations that will improve data quality.

Informed Consent: A Monthly Review
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July 2019

This digest is intended to aggregate and distill 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_July 2019

Playing by the rules: Impact of the new General Data Protection Regulation on retrospective studies: A researcher’s experience 

Playing by the rules: Impact of the new General Data Protection Regulation on retrospective studies: A researcher’s experience 
M H van der Ree, R A Scholte, P G Postema, J R de Groot
European Heart Journal, 21 June 2019; 40(24) pp 1900–1902
Excerpt
…Despite the retrospective nature of the study, informed consent is required for the reuse of care data in the context of scientific research. For participants of the PREDICT-AF study, consent for the reuse of care data was available as part of the informed consent form of this prospective study. For the control cohort, however, no such consent was available. This was our first barrier: only a physician who is directly involved in the patient’s medical care, and not an investigator, is allowed to approach potential study participants and ask for informed consent. This physician is also allowed to ask for the patient’s permission for another person to approach him or her and ask for consent. As the control patients of our retrospective study were no longer under the treatment of the two hospitals that performed the PREDICT-AF study, this implied approaching approximately 50 referring cardiologists of the control patients and ask for their cooperation. These cardiologists would then have to personally ask their patients permission to be approached by the investigator, who could then ask for informed consent. This procedure put some serious constraints on the timelines of our envisioned data collection…

Concise Consent Forms Appreciated—Still Not Comprehended: Applying Revised Common Rule Guidelines in Online Studies

Concise Consent Forms Appreciated—Still Not Comprehended: Applying Revised Common Rule Guidelines in Online Studies
Research Article 
Evan K. Perrault, Seth P. McCullock
Journal of Empirical Research on Human Research Ethics, 6 June 2019 
Abstract
As informed consent documents have historically gotten lengthier, recent revisions to federal Common Rule guidelines now require consent forms that are “concise” and presented in ways that “facilitate comprehension.” The current research sought to apply these guidelines by developing a consent process for an online study that was only 71 words and also allowed participants a choice to either continue directly to the study or learn more about the study to which they were consenting. All participants (100%, N = 429) decided to continue directly to the study, choosing to forgo additional information about the study and the institutional review board (IRB) approval process. Participants indicated they liked this streamlined consent process, even though on average they only comprehended about half of the information this streamlined process contained. A plurality of participants indicated they would like to see this style of streamlined consent continued in future online studies. However, if we want to continue referring to informed consent as informed, future research should be welcomed and supported by IRBs to seek ways to apply the newest Common Rule guidelines while increasing comprehension; otherwise, informed consent will likely always remain an oxymoron.

Hormone replacement therapy: informed consent without assessment?

Hormone replacement therapy: informed consent without assessment?
Response
Toni C Saad, Bruce Philip Blackshaw, Daniel Rodger
Journal of Medical Ethics, 22 June 2019
Abstract
Florence Ashley has argued that requiring patients with gender dysphoria to undergo an assessment and referral from a mental health professional before undergoing hormone replacement therapy (HRT) is unethical and may represent an unconscious hostility towards transgender people. We respond, first, by showing that Ashley has conflated the self-reporting of symptoms with self-diagnosis, and that this is not consistent with the standard model of informed consent to medical treatment. Second, we note that the model of informed consent involved in cosmetic surgery resembles the model Ashley defends, and that psychological assessment and referral is recognised as an important aspect of such a model. Third, we suggest that the increased prevalence of psychiatric morbidity in the transgender population arguably supports the requirement of assessment and referral from a mental health professional prior to undergoing HRT.

Editor’s note: This article is a response to the viewpoint article which can be found at this link

Complexity of Clinical Decision Making: Consent, Capacity, and Ethics

Complexity of Clinical Decision Making: Consent, Capacity, and Ethics
Review Article
Annette Askren, Paula Leslie
Seminars in Speech and Language, June 2019; 40(03) pp 162-169
Abstract
Speech–language pathologists (SLPs), and really their patients, are often faced with challenging clinical decisions to be made. Patients may decline interventions recommended by the SLP and are often inappropriately labeled “noncompliant.” The inappropriateness of this label extends beyond the negative charge; the patient’s right to refuse is, in fact, protected by law. Anecdotal exchanges, social media platforms, and American Speech-Language-Hearing Association forums have recently revealed that many SLPs are struggling with the patient’s right to decline. Many are not comfortable with the informed consent process and what entails patients’ capacity to make their own medical decisions. Here, we discuss the basics of clinical decision-making ethics with intent to minimize the clinician’s discomfort with the right to refuse those thickened liquids and eliminate the practice of defensive medicine.

Moving Beyond Informed Consent to Dynamic or Shared Consent: The Clinical and Legal Framework of a More Patient-Centred Approach [MA DISSERTATION]

Moving Beyond Informed Consent to Dynamic or Shared Consent: The Clinical and Legal Framework of a More Patient-Centred Approach [MA DISSIERTATION]
Thandi S Mabeba
University of Pretoria; Faculty of Law, 28 October 2018
Abstract
Obtaining the consent of a patient is at the centre of medical practice and as such medical practitioners need to ensure proper patient’s approval in the administration of medical services or prescription of medical products. Informing a patient about the medical implications involved in the procedure they are about to undergo is not sufficient as patient needs to be fully engaged. The transcendence beyond informed consent to shared or dynamic consent is the core focus of discussion in this work. It is argued in this work, that there has to be policy that deals with specifically with consent across a broader spectrum of the provision healthcare goods and services.

Informed Consent: A Monthly Review
___________________________

June 2019

This digest is intended to aggregate and distill 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_June 2019

The concise argument: the importance of consent and choice

The concise argument: the importance of consent and choice
The concise argument
John McMillan
BMJ Journal of Medical Ethics, 13 May 2019; 45 pp 285-286
When Beauchamp and Childress articulated the necessary and sufficient conditions for informed consent, they might have thought that would be the final word on what informed consent is.1 It’s emphasis in the Belmont Report,2 the Nuremberg Code,3the Helsinki Declaration4 and numerous codes of professional ethics seems more than sufficient for emphasising its importance. Nonetheless, its place as the central issue for medical ethics appears undiminished and Pubmed lists 6192 publications with ‘Informed Consent’ in the title since 1979.

One view of this is that medical ethics has channelled too much intellectual effort into consent, perhaps at the expense of other important ethical issues. Papers in this issue of the Journal of Medical Ethics suggest that the discussion of consent continues because of the need to consider what it means in new contexts, how it can be a challenge in some contexts, how it is related to tough theoretical issues about the value of choice and autonomy and how it can blend into other debates…