To explore the experience of research nurses who obtain consent from adults in emergency settings to participate in clinical trials, either prospectively or post enrolment
Brown P, Newham R, Hewison A
Journal of Clinical Nursing, 22 May 2020
Abstract
Aim
To explore the understanding and experiences of research nurses who obtain informed consent from adult patients participating in emergency care research.
Design
Qualitative phenomenographic descriptive study.
Methods
Ten research nurses from six hospitals in England were recruited. Data were collected using semi-structured face-to-face and telephone interviews between January 2019 and March 2019. Interviews were transcribed verbatim and analysed thematically, informed by phenomenography. COREQ was followed.
Results
Three main themes were identified (1) Emergency research is different (2) Protecting the patient and (3) Experience and confidence with recruitment. It was found that obtaining patient consent in emergency care research was challenging and timing of the process was crucial. Nurses with more experience of emergency care were more confident in approaching patients and their families. There was variability in out-of-hours recruitment which was a consequence of the range of informed consent processes used and the different levels of engagement of clinical teams.
Conclusion
There is a variety of organisational cultures, processes and procedures which affect the way consent is obtained in emergency care research. A team approach was evident in the hospitals where consent rates were high and was more successful than those reliant solely on the presence of a research nurse. Organisations were able to recruit successfully to emergency care research studies irrespective of size and configuration. Further investigation of their models of working and strategies for engagement is needed. Experienced research nurses made a positive difference to recruitment and were more likely to approach patients to obtain consent.
Relevance to Clinical Practice
The understanding and experiences of recruitment to clinical trials in emergency care research by research nurses can help identify barriers to recruitment. This study provides useful insights for healthcare practitioners, clinical trials coordinators and sponsors about how best to develop protocols and policies to increase recruitment to emergency care research.

Patient and Surrogate Postenrollment Perspectives on Research Using the Exception From Informed Consent: An Integrated Survey
Ethics/brief research report
Victoria M. Scicluna, Michelle Biros, Deneil K. Harney, Elizabeth B. Jones, Andrea R. Mitchell, Rebecca D. Pentz, Robert Silbergleit, Candace D. Speigheit, David W. Wright, Neal W. Dickert
Annals of Emergency Medicine, 21 May 2020
Abstract
Study objective
It is important for researchers interested in trials using the exception from informed consent to understand the views and experiences of enrolled individuals. Previous studies have shown that patient and surrogate attitudes are generally positive. These studies were small and did not include pediatric patients, and interviews were often conducted long after trial enrollment. This study sought to explore attitudes toward exception from informed consent in a larger sample and more contemporaneous setting.
Methods
A 10-item paper-and-pencil survey was integrated into the Established Status Epilepticus Treatment Trial, a randomized trial of 3 treatments for benzodiazepine-refractory status epilepticus in pediatric and adult patients. Primary domains included attitudes toward trial enrollment, exception from informed consent, and community consultation. Simple descriptive statistics, χ2, and Fisher’s exact tests were conducted.
Results
Of 317 patients and surrogates, 90% agreed with or were neutral about the statement “I am glad that I/my family member was included in the Established Status Epilepticus Treatment Trial research study,” whereas 10% disagreed. Twenty-seven percent disagreed with enrollment in the study without prospective consent. Black participants were more likely than white, other race, and unknown-race participants to disagree with enrollment without prospective consent (36% versus 23%, 14%, and 14%, respectively). Participants indicated that patients (81%), their families (65%), and those at risk for seizures (51%) were most important to include in community consultation.
Conclusion
This study aimed to explore attitudes toward exception from informed consent enrollment among participants at all sites in a large, multicenter exception from informed consent trial. General acceptance of trial enrollment was high; acceptance of exception from informed consent specifically was somewhat lower, especially among black participants. Our findings provide further support for targeted community consultation focusing on individuals with connections to the disease under study. Future research should focus on communication in the postenrollment period, especially with individuals who may have concerns about exception from informed consent.

IRB Policies for Obtaining Informed Consent from Non‐English‐Speaking People
Gianna McMillan
Ethics & Human Research, 18 May 2020
Abstract
United States regulations for the protection of human research subjects prescribe parameters for documentation of valid informed consent, which include the stipulation that the process be in a “language understandable to the subject.” While significant energy has been devoted to improving the readability of consent documents, supplemental educational tools, and nuanced measurements of individual decisional capacity, there is little guidance about how to best meet the informational needs of adults with decisional capacity who do not speak English. This article reviews the institutional review board policies from the twenty‐one research centers that received the most funding from the National Institutes of Health in 2018 and compares their guidelines for obtaining informed consent from non‐English speakers. Inconsistent practices suggest the need for more assertive federal direction on what parameters constitute valid consent for this population. These practices also indicate a reluctance to directly engage the ethical underpinnings of consent policies for non‐English speakers.

Can Consent to Participate in Clinical Research Involve Shared Decision Making?
Case and Commentary
Haley Moulton, Benjamin Moulton, Tim Lahey, Glyn Elwyn
AMA Journal of Ethics, May 2020
Open Access
Abstract
Shared decision making honors patient autonomy and improves patient comprehension and therefore should be a part of every clinical decision a patient makes. Use of shared decision making in research informed consent conversations is more complicated due to diverse and potentially divergent investigator and patient interests, along with the presence of clinical equipoise. This article clarifies these different interests and discusses ways in which shared decision making can be applied in research. Provided there is transparency about competing interests, patient-centered and values-focused communication approaches embodied in shared decision making can support the ethical recruitment of patients for clinical research.