Informed Consent: A Monthly Review
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:
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_September 2020
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
…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 . 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
Toney Jose, Arya Joy
Indian Journal of Surgery, 3 August 2020
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
Holly Fernandez Lynch, Mohamed Abdirisak, Megan Bogia, Justin Clapp
American Journal of Bioethics, 21 August 2020
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.
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.
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.
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
Jason McMullan,Christopher Droege,Col. Richard Strilka, Christopher Lindsell, Michael J. Linke
Prehospital Emergency Care, 13 August 2020
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
Marah Elfghi, Fionnuala Jordan, Sherif Sultan, Wael Tawfick
Journal of Evidence-Based Medicine, 15 June 2020
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.
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.
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
Erin T. Paquette, Seema K. Shah
Perspectives in Biology and Medicine, Spring 2020; 63(2)
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.
Informed Consent, Therapeutic Misconception, and Unrealistic Optimism
Lynn A. Jansen
Perspectives in Biology and Medicine, Spring 2020; 63 (2) pp 359-373
The Belmont Report attested to the cardinal importance of informed consent for ethical research on human subjects. Important challenges to securing informed consent have emerged since its publication more than 40 years ago. Among some of the most significant of these challenges are those that highlight social psychological factors that have the potential to impair the appreciation of relevant information disclosed in the informed consent process. Responding to these challenges requires us to think harder about the content of the principle of informed consent and the demands that it imposes on investigators. This article focuses on two challenges in particular, that presented by the so-called therapeutic misconception, and that presented by the psychological bias of unrealistic optimism. After outlining an account of the principle of informed consent as it applies to the research context, the article briefly reviews the empirical literature on the therapeutic misconception and the bias of unrealistic optimism. It then relates these phenomena to the principle of informed consent, paying special attention to the ethical demands they impose on investigators. The article concludes by considering how recent trends to integrate research and clinical care affect the main points it has advanced.
Evaluating survey consent to social media linkage in three international health surveys
Zeina N. Mneimneh, Ronny Bruffarets, Yasmin A. Altwaijri, Colleen McClain
Research in Social and Administrative Pharmacy, 10 August 2020
The use of Twitter data for health-related research has been increasing over time. While the organic nature of the data offer new opportunities, the limited understanding of how and by whom the data are generated poses a challenge for advancing health-related research. Individual-level data linkage could shed light into the data generation mechanism.
This paper investigates whether consent to link survey data with Twitter public data is associated with socio-demographic and Twitter use pattern factors and whether consenters and non-consenters differ on health-related outcomes.
Data from three health related surveys that use probability samples of the target population were used: 1) A college population web survey in KU Leuven University, 2) An adult population web survey of the US population, and 3) A population face-to-face survey in the Kingdom of Saudi Arabia (KSA). In all surveys, respondents reported whether they have a Twitter account, and Twitter users were asked to provide consent for linking their survey responses to their public Twitter data.
Consent rate estimates from the two web surveys in Belgium and the US were 24% and 27% respectively. The face-to-face survey in KSA yielded a higher consent rate of 45%. In general, respondent’s sociodemographic characteristics were not significantly associated with consent to link. However, more use of social media and reporting sensitive information in the survey were found to be significantly correlated with higher consent. Consenters and non-consenter were not found to be statistically different on any of the health related measures.
Very few differences were found between those who consented to link their survey data with their Twitter public data and those who did not. Modifiable design variables need to be investigated to maximize consent while maintaining balance between consenters and non-consenters.
A Novel Framework Using Remote Telesimulation With Standardized Parents to Improve Research Staff Preparedness for Informed Consent in Pediatric Critical Care Research
Denise LaMarra, Jaclyn French, Christine Bailey, Martha T. Sisko, Kerry Coughlin-Wells, Michael S. Agus, Vijay Srinivasan, Vinay M. Nadkarni
Pediatric Critical Care Medicine, 28 July 2020
The Heart And Lung Failure—Pediatric INsulin Titration study was experiencing poor subject enrollment due to low rates of informed consent. Heart And Lung Failure—Pediatric INsulin Titration investigators collaborated with the Perelman School of Medicine Standardized Patient Program to explore the novel use of telesimulation with standardized parents to train research staff to approach parents of critically ill children for informed consent. We describe the feasibility, learner acceptance, and financial costs of this novel intervention and performed a post hoc analysis to determine if this intervention improved study consent rates.
Observational, comparative effectiveness study.
Heart And Lung Failure—Pediatric INsulin Titration study enrolling sites.
Research staff (at the remote site).
Individual 90-minute Skype telesimulation sessions with standardized parent and simulation facilitator (at the training site).
Measurements and Main Results
Forty telesimulation sessions with 79 Heart And Lung Failure—Pediatric INsulin Titration research staff (participants) at 24 remote sites were conducted. Despite some technical delays, 40 out of 40 simulations (100%) were completed. Based on feedback surveys, 100% of respondents agreed (81% strongly agreed) that telesimulation sessions achieved intended learning objectives to prepare research staff to approach parents of eligible critically ill children to obtain informed consent. Additionally, 100% of respondents agreed (74% strongly agreed) that they would use lessons from the telesimulation when approaching parents to obtain informed consent for research. Telesimulation with standardized parents achieved lower financial costs (approximately $85 per session) compared with traditional in-person site visits for training research staff. There was no significant improvement in study consent rates with the intervention (pre: 46% vs post: 48%; p = 0.78).
Remote telesimulation with standardized parents is feasible, acceptable, and associated with lower financial costs to prepare research staff to obtain informed consent from parents of critically ill children eligible for clinical research trials. Despite this novel approach, Heart And Lung Failure—Pediatric INsulin Titration study consent rates did not improve, suggesting that other factors influence parental consent and decision making in complex multicenter clinical research trials.