Crisis at the Pregnancy Center: Regulating PseudoClinics and Reclaiming Informed Consent
Teneille R. Brown
Yale Journal of Law & Feminism, 2019; 30(2)
Abstract
Crisis Pregnancy Centers (CPCs) adopt the look of medical practices-complete with workers in scrubs, ultrasound machines, and invasive physical exams-to deceive pregnant women into thinking they are being treated by licensed medical professionals. In reality, CPCs offer exclusively Bible- based, non-objective counseling. Numerous attempts to regulate CPCs have faced political roadblocks. Most recently, in NIFLA v. Becerra, the Supreme Court held that state efforts to require CPCs to disclose that they are not medically licensed are unconstitutional violations of CPCs’ First Amendment right to free speech. In the wake of that decision, pregnant women in crisis-a disproportionate percentage of whom are low-income women, minority women, or women in vulnerable or dangerous situations-continue to be subject to CPCs’ ideological marketing, masquerading as medical advice.

Informed Consent: A Monthly Review
___________________________

March 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_March 2019

A Survey on Including Risks in the New “Key Information” Section of an Informed Consent Form
Katelyn Le, Stacy Kopka, Doreen Chaitt, Jerome Pierson, Martha Nason, Tracey Miller
Clinical Research (Alex), December 2018; 32(10) pp 18–29
Abstract
Informed consent forms (ICFs) are growing longer and more complex.{1–4} The forces behind this trend may be well-intentioned, such as the desire to disclose more accurate and complete information{1}; however, it raises questions about whether important information is buried in lengthy documents, as well as whether ICFs can be structured to better emphasize the information that is most relevant to a study participant.

Recent updates to what is generally known as the Common Rule for protection of human subjects in research are in part meant to respond to this trend. Among these updates is the introduction of a new section called “Key Information”—every ICF now must open with the most important information that potential subjects would want to know when deciding to join a study. But what exactly should this new section contain?

This question is crucial to us, a group of writers and reviewers who work with investigators to develop ICFs (the program was described in a 2013 issue of the ACRP Monitor{5}). For groups like ours, it is important to explore how best to implement the new regulations in a way that promotes consistency across different ICFs.

As an initial step, we wanted to understand how to objectively decide which risks to provide as Key Information. A survey was conducted to investigate how institutional review board (IRB) members, medical monitors, and principal investigators (PIs) view which risks should be considered Key Information. The hypothesis was that cohorts would have differing viewpoints on selecting these risks.

While the findings of this exploratory study demonstrate variability in viewpoints, they also suggest a number of points of consensus to consider when writing Key Information.

The ethics of consent
Peter Ellis
Journal of Kidney Care, 13 February 2019; 4(1)
Abstract
As healthcare professionals, we come into contact with patients on a daily basis, and it is important that the professional relationship we develop with our patients is one built on respect and trust. One important element of this is gaining consent. In this article, Peter Ellis explores what consent is, why it is important and when and how it should be gained.

The Ever-Changing Landscape of Informed Consent and Whether the Obligation to Explain a Procedure to the Patient May Be Delegated
Samuel D. Hodge, Maria Zambrano Steinhaus
Arkansas Law Review, January 2019; 71(3)
Abstract
Informed consent is an integral part of the shared decision making process and requires a patient be informed of the benefits, risks and alternatives to a medical procedure. This information, which requirement has been codified into the law and practice of every healthcare provider, helps a patient decide whether to proceed with the recommended treatment plan. Informed consent has its foundation in the ethical notion of patient autonomy and fundamental human rights. After all, it is the patient’s decision to determine what may be done to his or her body and to ascertain the risks and benefits before undertaking a procedure. On the other hand, a physician’s role is to act as a facilitator in the patient’s decision making process by providing information about the planned treatment and to answer questions. While the roles of the patient and physician seem clearly defined, a number of barriers present challenges in creating a process that guarantees a patient understands a test or procedure. This includes ineffective communication between the doctor and patient. The first part of this article will explore the liability of various health care providers who participate in the informed consent process, such as the physician, nurse, physician assistant and hospital. The second section will examine whether the treating physician may delegate the duty to explain the risks and alternatives of a procedure to another. The controversial decision of Shinal v. Toms, which mandates that the doctor must have a one-on–one exchange with the patient in order to secure a valid informed consent, will also be explored. This recent ruling has sent shock waves throughout the medical community causing a reexamination of their informed consent policies.

Editor’s Note: Information on the Shinal v. Toms case can be found here

Autonomy Challenges in Epigenetic Risk-Stratified Cancer Screening: How Can Patient Decision Aids Support Informed Consent?
Maaike Alblas, Maartje Schermer, Yvonne Vergouwe, Ineke Bolt
Journal of Personalized Medicine, 18 February 2019; 9(1)
Abstract
Information of an individual’s epigenome can be useful in cancer screening to enable personalised decision making on participation, treatment options and further screening strategies. However, adding this information might result in complex risk predictions on multiple diseases, unsolicited findings and information on (past) environmental exposure and behaviour. This complicates informed consent procedures and may impede autonomous decision-making. In this article we investigate and identify the specific features of epigenetic risk-stratified cancer screening that challenge the current informed consent doctrine. Subsequently we describe current and new informed consent models and the principle of respect for autonomy and argue for a specific informed consent model for epigenetic risk-stratified screening programmes. Next, we propose a framework that guides the development of Patient Decision Aids (PDAs) to support informed consent and promote autonomous choices in the specific context of epigenetic cancer screening programmes.

Readability of consent forms in veterinary clinical research
Josey Sobolewski1, Jeffrey N. Bryan, Dawn Duval, Allison O’Kell, Deborah J. Tate, Tracy Webb, Sarah Moore
Journal of Veterinary Internal Medicine, 6 February 2019
Background
“Readability” of consent forms is vital to the informed consent process. The average human hospital consent form is written at a 10th grade reading level, whereas the average American adult reads at an 8th grade level. Limited information currently exists regarding the readability of veterinary general medical or clinical research consent forms.
Hypothesis/Objectives
The goal of this study was to assess the readability of veterinary clinical trial consent forms from a group of veterinary referral centers recently involved in a working group focused on veterinary clinical trial review and consent. We hypothesized that consent forms would not be optimized for client comprehension and would be written above the National Institutes of Health-recommended 6th grade reading level.
Animals
None.
Methods
This was a prospective study assessing a convenience sample of veterinary clinical trial consent forms. Readability was assessed using 3 methods: the Flesch-Kincaid (F-K) Grade Level, Flesch Reading Ease Score (FRES), and the Readability Test Tool (RTT). Results were reported as mean (±SD) and compared across specialties.
Results
Fifty-three consent forms were evaluated. Mean FRES was 37.5 ± 6.0 (target 60 or higher). Mean F-K Grade Level was 13.0 ± 1.2 and mean RTT grade level was 12.75 ± 1.1 (target 6.0 or lower). There was substantial agreement between F-K and RTT grade level scores (intraclass correlation coefficient 0.8).
Conclusions and Clinical Importance
No form evaluated met current health literacy recommendations for readability. A simple and readily available F-K Microsoft-based approach for evaluating grade level was in substantial agreement with other methods, suggesting that this approach might be sufficient for use by clinicians and administrators drafting forms for future studies.

Informed Consent: A Monthly Review
___________________________

February 2019

This digest is intended to aggregate and distill key content around informed consent from a broad spectrum of peer-reviewed and grey literature, practice domains and organization types including key agencies/IGOs, NGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this spectrum/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_February 2019

Informed Consent: No Longer Just What the Doctor Ordered? Revisited
Marc D. Ginsberg
Akron Law Review, January 2019; 52(2) pp 49-90
Abstract
The law of informed consent in medicine has evolved from the original doctrine which required the physician’s disclosure of the risks, benefits, and complications of (and alternatives to) a proposed procedure or treatment. The doctrine now implicates the disclosure of matters personal to the physician. Questions regarding the breadth of the doctrine in other respects have developed as well. This paper represents the author’s second examination of the unconventional aspects of the law of informed consent.

Consent in the face of death
Camilla L. Scanlan, Cameron Stewart, Ian Kerridge
Ethics in Medicine, 24 January 2019; 49(1) pp 108-110
Abstract
While the traditional model of consent is supported by codes and theories of ethics, is enshrined in law, and provides the core of health policy and clinical governance, it is unclear how accurately it reflects clinical practice and in particular how accurately it accounts for edition‐making in ‘high‐risk’ situations where patients are critically ill and facing death.