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.

Study of Awareness and Practice of Informed Consent Process Among Clinical Trial Participants and Their Motives Behind Participation
Research Article
Rajesh Ranjan, Nidhi B. Agarwal, Prem Kapur, Amit Marwah, Rizwana Parveen
Asia Pacific Journal of Public Health, 3 November 2019
Abstract
Process to obtain informed consent is an essential component in research involving human subjects. However, much is not known about the level of awareness participants have about optimal consenting process and the motives that drive their participation in the trials. A cross-sectional study was conducted among volunteers who had been participating in clinical trials in contract research organizations of Delhi. Validated questionnaires were used to assess their knowledge, attitude, and practice of informed consent process. Most of the volunteers, 226 (56.5%), had participated in 1 to 3 clinical trials. Majority (54%) were unaware about any informed consent document. None of them were aware of their right of profession competence, privacy and integrity, transparency, nonexploitation, and nonusage of their biological samples. Effective implementation of principles of informed consenting is largely lacking among contract research organizations in Delhi, India. This could potentially cause risk to the participants.

Ethical Challenges of Risk, Informed Consent, and Posttrial Responsibilities in Human Research With Neural Devices
Review
Saskia Hendriks, Christine Grady,  Khara M. Ramos, Winston Chiong, Joseph J. Fins, Paul Ford, Sara Goering, Henry T. Greely, Katrina Hutchison, Michael L. Kelly, Scott Y. H. Kim, Eran Klein, Sarah H. Lisanby, Helen Mayberg, Hannah Maslen, Franklin G. Miller, Karen Rommelfanger, Sameer A. Sheth, Anna Wexler
JAMA Neurology, 17 October 2019
Abstract
Importance  
Developing more and better diagnostic and therapeutic tools for central nervous system disorders is an ethical imperative. Human research with neural devices is important to this effort and a critical focus of the National Institutes of Health Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative. Despite regulations and standard practices for conducting ethical research, researchers and others seek more guidance on how to ethically conduct neural device studies. This article draws on, reviews, specifies, and interprets existing ethical frameworks, literature, and subject matter expertise to address 3 specific ethical challenges in neural devices research: analysis of risk, informed consent, and posttrial responsibilities to research participants.
Observations  
Research with humans proceeds after careful assessment of the risks and benefits. In assessing whether risks are justified by potential benefits in both invasive and noninvasive neural device research, the following categories of potential risks should be considered: those related to surgery, hardware, stimulation, research itself, privacy and security, and financial burdens. All 3 of the standard pillars of informed consent—disclosure, capacity, and voluntariness—raise challenges in neural device research. Among these challenges are the need to plan for appropriate disclosure of information about atypical and emerging risks of neural devices, a structured evaluation of capacity when that is in doubt, and preventing patients from feeling unduly pressured to participate. Researchers and funders should anticipate participants’ posttrial needs linked to study participation and take reasonable steps to facilitate continued access to neural devices that benefit participants. Possible mechanisms for doing so are explored here. Depending on the study, researchers and funders may have further posttrial responsibilities.
Conclusions and Relevance  
This ethical analysis and points to consider may assist researchers, institutional review boards, funders, and others engaged in human neural device research.

Enhancing the Informed Consent Process Using Shared Decision Making and Consent Refusal Data from the CLEAR III Trial
Amanda L. Porter, James Ebot, Karen Lane, Lesia H. Mooney, Amy M. Lannen, Eugene M. Richie, Rachel Dlugash, Steve Mayo, Thomas G. Brott, Wendy Ziai, William D. Freeman, Daniel F. Hanley
Neurocritical Care, 30 September 2019; pp 1–8
Abstract
Background
The process of informed consent in National Institutes of Health randomized, placebo-controlled trials is poorly studied. There are several issues regarding informed consent in emergency neurologic trials, including a shared decision-making process with the patient or a legally authorized representative about overall risks, benefits, and alternative treatments.
Methods
To evaluate the informed consent process, we collected best and worst informed consent practice information from a National Institutes of Health trial and used this in medical simulation videos to educate investigators at multiple sites to improve the consent process. Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III) (clinicaltrials.gov, NCT00784134) studied the effect of intraventricular alteplase (n = 251) versus saline (placebo) injections (n = 249) for intraventricular hemorrhage reduction. Reasons for ineligibility (including refusing to consent) for all screen failures were analyzed. The broadcasted presentation outlined best practices for doctor–patient interactions during the consenting process, as well as anecdotal, study-specific reasons for consent refusal. Best and worst consent elements were then incorporated into a simulation video to enhance the informed consent process. This video was disseminated to trial sites as a webinar around the midpoint of the trial to improve the consent process. Pre- and post-intervention consent refusals were compared.
Results
During the trial, 10,538 patients were screened for eligibility, of which only three were excluded due to trial timing. Pre-intervention, 77 of 5686 (1.40%) screen eligible patients or their proxies refused consent. Post-intervention, 55 of 4849 (1.10%) refused consent, which was not significantly different from pre-intervention (P = 0.312). The incidence of screen failures was significantly lower post-intervention (P = 0.006), possibly due to several factors for patient exclusion.
Conclusion
The informed consent process for prospective randomized trials may be enhanced by studying and refining best practices based on trial-specific plans and patient concerns particular to a study.