Researching consent in veterinary practice: The use of interpretive description as a multidisciplinary methodology
Carol A Gray
Methodological Innovations, September-December 2020
Open Access
Abstract
Informed consent in the veterinary sphere has been surprisingly under-researched, despite it being a professional ethical requirement. As consent is given by animal owners on behalf of patients who are unable to consent for themselves, its underpinning ethical basis cannot exactly mirror consent given by adult human patients with capacity. Any attempt to research consent in the veterinary context requires consideration of its legal, ethical and practical applications. This investigation of consent practices in veterinary settings in the United Kingdom was undertaken using interpretation of medicolegal cases, together with three discrete empirical studies comprising the textual analysis of consent forms, consent discussions for the elective neutering of companion animal patients, and interviews with key participants in the consent process. The chosen approach required a methodology that would facilitate triangulation between empirical data analysis and doctrinal legal research. Here, I describe the first use of interpretive description as a methodology of veterinary socio-legal studies, in the context of practice-based research. With foundations in traditional social science methodologies such as hermeneutics, grounded theory, ethnography and symbolic interactionism, interpretive description provided a multi-disciplinary methodological perspective. Its underpinning methodologies informed the methods that were used for data collection, and for subsequent analysis. I combined interpretation of legal decisions and professional ethical guidance with thematic surveys of empirical data to reach higher levels of analysis. The resulting conceptual description of consent in veterinary practice enabled the production of normative guidance appropriate for those in practice, thus fulfilling the methodological aims of interpretive description. Specifically, the key findings were that the consent form should act as a fuller record of the consent discussion, that attention should be paid to achieving an appropriate balance between client autonomy and patient ‘best interests’ and that consent should provide protection to all three parties (client, patient and veterinary professional).
Year: 2020
More than consent for ethical open-label placebo research
More than consent for ethical open-label placebo research
Original Research
Laura Specker Sullivan
BMJ Medical Ethics, 3 September 2020
Abstract
Recent studies have explored the effectiveness of open-label placebos (OLPs) for a variety of conditions, including chronic pain, cancer-related fatigue and irritable bowel syndrome. OLPs are thought to sidestep traditional ethical worries about placebos because they do not involve deception: with an OLP, patients or subjects are told outright that they are not given an active substance. As deception is framed as the primary hurdle to ethical placebo use, the door is ostensibly opened to ethical studies of OLPs. In this article, I suggest that even though OLPs seemingly do not involve deception, there are other ethical considerations in their clinical investigation and subsequent use. Research ethics often focusses on informed consent—of which, deception and honesty are a piece—as a means to justify research practices with human subjects. Yet, it is but one of the ethical considerations that should be taken into account. With research into placebo effects in particular, I argue that the history of clinical placebo use grounds special considerations for OLP research that go beyond respect for the autonomy of individual patients through informed consent and encompass structural concerns about the type of patient for whom a placebo has historically been thought appropriate.
The Cohen problem of informed consent
The Cohen problem of informed consent
William Simkulet
BMJ Medical Ethics, 26 August 2020; 46(9) pp 617-622
Abstract
To avoid potential abuse and respect patient autonomy, physicians have a moral obligation to obtain informed consent before performing any significant medical intervention. To give informed consent, a patient must be competent, understand her condition, options and their expected risks and benefits and must freely and expressly consent to one of those options. Shlomo Cohen challenges this conception of informed consent by constructing cases based on Edmund Gettier’s classic counterexamples to traditional theories of knowledge. In this paper, I argue Cohen-style cases are not genuine threats to the concept of informed consent, however they provide an interesting challenge to theories of conscientious objection.
Informed Consent: A Monthly Review
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September 2020
This digest aggregates and distills key content adressing 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 Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:
Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_September 2020
Surgical consent during the COVID19 pandemic: Saving lives while in crisis editorial
Surgical consent during the COVID19 pandemic: Saving lives while in crisis editorial
Evander Meneses, Mark McKenney, Dessy Boneva, Adel Elkbuli
Annals of Medicine and Surgery, September 2020; (57) pp 163–165
Open Access
Excerpt
…At our institution, all patients who are admitted are tested for COVID-19 and results return usually within 24 hours. For emergent surgeries on trauma patients near death from hemorrhage, we proceed to the operating room without consent, as is the case at any trauma center. In this situation the patient is in extremis and lacks capacity due to exsanguination and altered mental status. For urgent surgeries, however we must obtain informed consent. We follow the ACS principles for informed consent, providing the patient information pertaining to the nature of their illness and consequence of no treatment, nature of proposed operation, commonly known complications, alternative forms of treatment, and a discussion of the different types of qualified medical providers who will participate in the care [5]. At our institution, the surgical resident and attending surgeon are the initial contact to the patient and/or family members when obtaining informed consent for surgical procedures. The attending surgeon provides information to the patient and/or family members and signs the physical consent form prior to the patient rolling into the operating suite. We now additionally speak with the patient and/or family members regarding COVID-19, explaining that we are unsure how it may impact their perioperative morbidity and possible mortality. We also explain that there is a risk for transmission within the hospital as well as further transmission after hospital discharge if they were to become infected in the hospital…
Surgical Consent during COVID Pandemic: COVID Times—Surgical Consent Checklist
Surgical Consent during COVID Pandemic: COVID Times—Surgical Consent Checklist
Toney Jose, Arya Joy
Indian Journal of Surgery, 3 August 2020
Open Access
Abstract
COVID-19 caused many countries to stop their elective procedures to allow preservation of resources for COVID-19 care. With restriction being gradually lifted, the surgical services have to face the pending burden of elective cases alongside the pandemic. The true impact of the pandemic and the COVID-19 on perioperative outcomes is still being discovered. This demands a COVID-specific consenting process in addition to the routine surgical consent, to ensure that the patients are able to make informed decisions. The first ever COVID-specific checklist for surgical consent ‘COVID times—surgical consent checklist’ is introduced. This checklist enables the surgeon to ensure that a discussion detailing the impact of COVID-19 on surgical services is made. It also acts as a documentation of the discussions carried out during the consenting process.
Evaluating the Quality of Research Ethics Review and Oversight: A Systematic Analysis of Quality Assessment Instruments
Evaluating the Quality of Research Ethics Review and Oversight: A Systematic Analysis of Quality Assessment Instruments
Holly Fernandez Lynch, Mohamed Abdirisak, Megan Bogia, Justin Clapp
American Journal of Bioethics, 21 August 2020
Abstract
Background
Research ethics review committees (RERCs) and Human Research Protection Programs (HRPPs) are responsible for protecting the rights and welfare of research participants while avoiding unnecessary inhibition of valuable research. Evaluating RERC/HRPP quality is vital to determining whether they are achieving these goals effectively and efficiently, as well as what adjustments might be necessary. Various tools, standards, and accreditation mechanisms have been developed in the United States and internationally to measure and promote RERC/HRPP quality.
Methods
We systematically reviewed 10 quality assessment instruments, examining their overall approaches, factors considered relevant to quality, how they compare to each other, and what they leave out. For each tool, we counted the number of times each of 34 topics (divided into structure, process, and outcome categories) was mentioned. We generated lists of which topics are most and least mentioned for each tool, which are most prevalent across tools, and which are left unmentioned. We also conducted content analysis for the 10 most common topics.
Results
We found wide variability between instruments, common emphasis on process and structure with little attention to participant outcomes, and failure to identify clear priorities for assessment. The most frequently mentioned topics are Review Type, IRB Member Expertise, Training and Educational Resources, Protocol Maintenance, Record Keeping, and Mission, Approach, and Culture. Participant Outcomes is unmentioned in 8 tools; the remaining 2 tools include assessments based on adverse events, failures of informed consent, and consideration of participant experiences.
Conclusions
Our analysis confirms that RERC/HRPP quality assessment instruments largely rely on surrogate measures of participant protection. To prioritize between these measures and preserve limited resources for evaluating the most important criteria, we recommend that instruments focus on elements relevant to participant outcomes, robust board deliberation, and procedures most likely to address participant risks. Validation of these approaches remains an essential next step.
Food and Drug Administration and Institutional Review Board Approval of a Novel Prehospital Informed Consent Process for Emergency Research
Food and Drug Administration and Institutional Review Board Approval of a Novel Prehospital Informed Consent Process for Emergency Research
Jason McMullan,Christopher Droege,Col. Richard Strilka, Christopher Lindsell, Michael J. Linke
Prehospital Emergency Care, 13 August 2020
Abstract
Research on the management of acute pain in the prehospital setting is fraught with challenges. The prehospital setting is complex due to constrained time, resources, and training. Research activities must not interfere with the underlying clinical priorities of immediate patient stabilization and rapid transport to an appropriate hospital. The patient’s pain, fear, and anxiety immediately after a traumatic event may interfere with undertaking an adequate informed consent process.
Pain management trials do not satisfy the criteria for application of the U.S. Food and Drug Administration (FDA) 21 CFR 50.24 exception from informed consent. While non-standard informed consent processes exist, waiver or alteration of informed consent may be limited if Institutional Review Boards or the FDA consider these studies to involve more than minimal risk related to the setting of the study, even if the interventions themselves might involve no more than minimal risk in other settings. In addition, any study requiring an Investigational New Drug application requires fully documented standard informed consent.
Emergency Medical Services agencies and fire departments become research institutions, and paramedics become study staff, but both the institutions and the staff often lack experience conducting human subjects research and are rarely formally affiliated with the academic institution overseeing the research. As such, additional administrative burdens must be overcome in interventional prehospital studies, including additional training in the study protocol, research operations, and human subjects protections. Institutions conducting federally funded studies commit to regulations covering human subjects protections in the form of a Federalwide Assurance (FWA); prehospital organizations participating in research must either obtain an FWA or have coverage extended to them from an academic partner.
We describe how these challenges were addressed during Institutional Review Board review and approval of an FDA-regulated randomized placebo-controlled trial of intranasal ketamine (vs. placebo) in acutely injured patients receiving standard of care fentanyl for prehospital pain management (NCT02866071). To our knowledge, this trial is the first instance in the United States of paramedics screening, consenting, enrolling, and administering study medications to patients without direct, real-time support from a dedicated clinical research team.
Study within a trial protocol: Same‐day consent vs. delayed consent in a randomized trial
Study within a trial protocol: Same‐day consent vs. delayed consent in a randomized trial
Marah Elfghi, Fionnuala Jordan, Sherif Sultan, Wael Tawfick
Journal of Evidence-Based Medicine, 15 June 2020
Abstract
Background
Randomized trials are designed to evaluate the effects of health care interventions. The recruitment process in a randomized trial can be challenging. Poor recruitment can have a negative impact on the allocated budget and estimated completion date of the study and may result in an underpowered research that will not adequately answer the original research question.
Aim
We aim to perform a Study Within A Trial (SWAT) to evaluate the impact of same‐day consent or delayed consent on recruitment and retention in the host trial.
Methods
This SWAT is designed as an observational study. However, the host trial is a randomized controlled trial evaluating the effectiveness of an intensive lifestyle modification program in patients with peripheral arterial disease. For this trial and SWAT, same‐day consent is defined as the patient giving consent on the same day, after the investigator has fully explained the predesigned information leaflet for the host trial. Delayed consent is defined as the patient feeling they still need further time to consider their decision to participate or not.
Towards Identifying an Upper Limit of Risk: A Persistent Area of Controversy in Research Ethics
Towards Identifying an Upper Limit of Risk: A Persistent Area of Controversy in Research Ethics
Erin T. Paquette, Seema K. Shah
Perspectives in Biology and Medicine, Spring 2020; 63(2)
Abstract
Whether there is an upper limit of net risk that volunteers can consent to in research, and what that limit happens to be, has been the subject of persistent controversy in research ethics. This article defends the concept of an upper limit of risk in research against recent critics and supports the most promising approach for identifying this limit, that of finding comparator activities that are generally accepted in society and pose high levels of risk. However, high-risk activities that have been proposed as relevant comparators involve more certain benefits and confer considerable social esteem to those who take on the risks. This suggests that developing a robust approach to identifying social value, whether by developing a procedural safeguard or a systematic framework, could more effectively identify research with sufficient social value to justify high net risk. Additionally, the social status of research participants should be elevated to be more on par with others who laudably take on high risk for the benefit of others. By attending to the benefits necessary for the justification of high-risk research, the level of allowable risk will no longer be so controversial.
Center for Informed Consent Integrity 