Public Deliberation as a Novel Method for an Exception From Informed Consent Community Consultation
Original Contribution
Patricia E. Powers, Karen K. Shore, Susan Perez, Dominique Ritley, Nathan Kuppermann, James F. Holmes, Leah S. Tzimenatos, Hiwote Shawargga, Daniel K. Nishijima
Society for Academic Emergency Medicine, October 2019; 26(10) pp 1158-1168
Open Access
Abstract
Objectives
Community consultation is required for clinical trials considering federal exception from informed consent (EFIC) procedures. Questions remain about the value of the community consult process and whether it adds intended protections to study subjects. Public deliberation methods that provide baseline participant education and elicit values and opinions about consent options is a novel approach for community consultation. This study evaluated the use of structured public deliberation methods to assess a community’s values and opinions about informed consent procedures for a pediatric trauma trial.
Methods
This was a mixed‐methods descriptive study of public deliberation sessions assessing participants’ opinions about informed consent procedures for a pediatric trauma randomized controlled trial (RCT). Participants from communities with high rates of pediatric trauma were recruited via community‐based organizations and social media. Deliberation focused on three consent options for a proposed RCT: 1) enrollment using EFIC procedures with no attempt to obtain informed consent, 2) enrollment using EFIC procedures after attempting to reach a parent, or 3) enrollment only with informed consent. Participant demographic data and their opinions about the proposed study and deliberative session were also collected.
Results
There were 102 participants across eight sessions (range of nine to 15/session, mean of 13). Most participants were female (n = 78, 76%) and a plurality were black (n = 48, 47%). The majority of participants preferred enrollment using EFIC procedures only after an attempt was made to reach a parent and informed consent was not possible (n = 56, 55%), followed by enrollment using EFIC procedures with no attempt to obtain informed consent (n = 32, 32%), and enrollment only with written informed consent (n = 13, 13%). One participant declined all options. Eighty‐four participants (82%) agreed or strongly agreed that the RCT was important to do, and 79 participants (77%) said that the sessions provided enough information to make an informed decision about the proposed RCT.
Conclusions
Structured public deliberation is an effective approach when consulting communities for trials considering EFIC procedures. Future studies are needed to evaluate whether public deliberation methods provide participants with enhanced understanding of clinical trials compared to other community consultation methods.

Informed consent and comprehensibility issues
Research Project
Gianni De Nardi, Maureen Ehrensberger-Dow, Igor Matic, Felix Steiner
ZHAW Zurich, University of Applied Sciences Publications, 2019
Open Access
Abstract
The Federal Office for Public Health has commissioned a project to investigate a key requisite for research with humans: Any person who consents to participate in health-related research must have understood the purpose, the risks and the course of the study in question. Building on the research reports, the present summary is intended to separately illustrate each of the following three levels of the problems associated with the understanding of Informed Consent, namely the results and the recommendations relating thereto. We forego any detailed derivation and discussion of the results that are contained in the four research reports. 1. Intelligibility of the written Informed Consent explanation 2. Intelligibility of the oral Informed Consent explanation 3. Combination of the oral and written Informed Consent explanation.

The Role of Informed Consent for Thrombolysis in Acute Ischemic Stroke
Comer AR, Damush TM, Torke AM, Williams LS
Journal of Clinical Ethics, 2019; 30(4) pp 338-346
Abstract
Although tissue plasminogen activator (tPA) is the only medication approved by the United States Food and Drug Administration (FDA) for acute ischemic stroke, there is no consensus about the need for informed consent for its use. As a result, hospitals throughout the U.S. have varying requirements regarding obtaining informed consent from patients for the use of tPA, ranging from no requirement for informed consent to a requirement for verbal or written informed consent. We conducted a study to (1) determine current beliefs about obtaining patients’ informed consent for tPA among a large group of stroke clinicians and (2) identify the ethical, clinical, and organizational factors that influence tPA consent practices. Semi-structured interviews were conducted by trained and experienced investigators and research staff to identify key barriers to implementing acute stroke services. Part of the interview explored current beliefs and practices around informed consent for tPA. This was a multicenter study that included 38 Veterans Health Administration (VHA) hospital locations. Participants were 68 stroke team clinicians, serving primarily on the neurology (35 percent) or emergency medicine (41 percent) service. We conducted thematic analysis based on principles of grounded theory to identify codes about consent for tPA. We used interpretive convergence to ensure consistency among the individual investigators’ codes and to ensure that all of the investigators agreed on coding and themes. We found that 38 percent of the stroke clinicians did not believe any form of consent was necessary for tPA, 47 percent thought that some form of consent was necessary, and 15 percent were unsure. Clinicians who believed tPA required informed consent were divided on whether consent should be written (40 percent) or verbal (60 percent). We identified three factors describing clinicians’ attitudes about consent: (1) legal and policy factors, (2) ethical factors, and (3) medical factors. The lack of consensus regarding consent for tPA creates the potential for delays in treatment, uneasiness among clinicians, and legal liability. The identified factors provide a potential framework to guide discussions about developing a standard of care for acquiring the informed consent of patients for the administration of tPA.

Informed Consent in Diagnostic and Therapeutic Lumbar Puncture: Are Patients Aware of the Risks?
Muhammed Nur Ögün, Merve Önerli, Şule Aydın Türkoğlu, Serpil Yıldız
Turkish Journal of Neurology, 2019; 25(4) pp 229-232
Open Access
Abstract
Objective
To determine whether the type of informed consent (verbal or written and verbal) influenced the awareness of patients about the risks of lumbar puncture (LP).
Materials and Methods
An “informed consent form” was given to the patients in group 1 24 h before the procedure, and the patients were requested to read and sign the form. The informed consent form was given to patients in group 2, and then, a neurologist verbally explained the complications mentioned in the form to the patients. After the procedure, patients in both groups were asked whether they were aware of the complications mentioned in the consent form.
Results
We included 43 patients (group 1, n=23 and group 2, n=20) in the study; 14% (n=6) of the patients were university graduates, 18% (n=8) had completed high-school education, and 67% (n=29) had completed primary education. No significant difference was observed between the two groups in terms of age, sex, and education level. The mean value of the number of complications that the patients were aware of was 1.17±1.02 and 7.35±1.26 in groups 1 and 2, respectively. We observed a significant difference in the number of complications that the patients were aware of between both groups (p<0.001).
Conclusion
The responsibilities of physicians are not solely limited to giving the informed consent form to the patients before LP. Physicians should explain the contents of the form verbally to the patients.