Informed Consent and the Elusive Dichotomy Between Standard and Experimental Therapy

2002 ◽  
Vol 28 (4) ◽  
pp. 361-408
Author(s):  
Lars Noah

A rich academic literature exists about issues of informed consent in medical care, and, to a lesser extent, about a variety of issues posed by human experimentation. Most commentators regard patient autonomy as a desirable— though in practice often unattainable—goal, and near unanimity exists about the necessity for even fuller disclosure before experimenting on subjects. Although this Article intentionally side-steps the broader debate about informed consent, it challenges the conventional wisdom that special disclosure rules should apply in the experimental context.Clinical trials have become big business. Estimates suggest that as many as twenty million Americans have enrolled in formal biomedical studies, though, as a measure of the full scope of medical experimentation on humans, that figure may represent only the proverbial tip of the iceberg. Historically, sponsors of clinical trials recruited subjects informally, counting on word of mouth among physicians and also perhaps posting flyers around college campuses.

Stroke ◽  
2021 ◽  
Author(s):  
Mayank Goyal ◽  
Johanna Maria Ospel ◽  
Aravind Ganesh ◽  
Martha Marko ◽  
Marc Fisher

Informed consent is a key concept to ensure patient autonomy in clinical trials and routine care. The coronavirus disease 2019 (COVID-19) pandemic has complicated informed consent processes, due to physical distancing precautions and increased physician workload. As such, obtaining timely and adequate patient consent has become a bottleneck for many clinical trials. However, this challenging situation might also present an opportunity to rethink and reappraise our approach to consent in clinical trials. This viewpoint discusses the challenges related to informed consent during the COVID-19 pandemic, whether it could be acceptable to alter current consent processes under these circumstances, and outlines a possible framework with predefined criteria and a system of checks and balances that could allow for alterations of existing consent processes to maximize patient benefit under exceptional circumstances such as the COVID-19 pandemic without undermining patient autonomy.


2021 ◽  
Author(s):  
EG Grebenshchikova ◽  
AG Chuchalin

The article reveals the most influential in modern bioethics approach to understanding voluntary informed consent as a way to implement the principle of respect for patient autonomy, which is determined by both legal regulation and socio-cultural factors. The authors discuss the main elements of informed consent, its specificity in clinical trials, and criteria for autonomous choice.


Author(s):  
Elizabeth A. Johnson ◽  
Jane M. Carrington

It is estimated 1 in 3 clinical trials utilize a wearable device to gather real-time participant data, including sleep habits, telemetry, and physical activity. While wearable technologies (including smart watches, USBs, and implantable devices) have been revolutionary in their ability to provide a higher precision and accuracy to data acquisition external to the research milieu, there is hesitancy among providers and participants alike given security concerns, perception of cyber-related threats, and meaning attributed to privacy issues. The purpose of this research is to define cyber-situational awareness (CSA) as it pertains to clinical trials, evaluate its current measurement, and describe best practices for research investigators and trial participants to enhance protections in the digital age. This paper reviews integrated elements of CSA within the process of informed consent when wearable devices are implemented for trial procedures. Evaluation of CSA as part of informed consent allows the research site to support the participant in knowledge gaps surrounding the technology while also providing feedback to the trial sponsor as to technology improvements to enhance usability and wearability of the device.


2019 ◽  
Vol 2 (7) ◽  
pp. e197591 ◽  
Author(s):  
William B. Feldman ◽  
Spencer P. Hey ◽  
Jessica M. Franklin ◽  
Aaron S. Kesselheim

Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Sacha R Masuca ◽  
Devsmita S Das ◽  
Deji Delano ◽  
Malcom Irani ◽  
Renga Pandurengan ◽  
...  

Background Identification of barriers to enrollment in acute stroke clinical trials may identify ways to improve enrollment and expedite completion of clinical research trials. In this exploratory analysis we sought to evaluate the differences in presenting characteristics between patients who are able to provide informed consent (IC) compared with those who were enrolled by the legal authorized representative (LAR). Methods From our single center, prospectively collected registry, we identified consecutive patients with acute ischemic stroke (AIS) who presented to our emergency department and were enrolled into acute (<8hrs from symptom onset) prospective clinical treatment trials. Data collected included arrival time, thrombolysis time, IC time, source of IC (LAR or patient), aphasia or neglect and method of arrival. For analysis, the patients who were consented by a LAR were compared with patients who provided their own IC. Results From 2003 - 2011, we identified 124 patients who met inclusion criteria. There were no differences in age, sex, presentation or door to needle times (Table 1). Patients who were able to provide IC presented with less severe stroke (p<0.0001). Aphasia and neglect were significantly more common when a LAR provided IC (p<0.0001). LAR consent required a significantly longer amount of time (90 vs. 71 min., p=0.04). Conclusions In our single center study, we found that patients with milder stroke are able to provide IC and the presence of aphasia or neglect can hinder enrollment in the absence of a LAR. In addition, when patients are able to provide IC, they do so almost on average 20 minutes faster than the LAR. Additional evaluation is necessary to determine the reasons for delay. Since good outcomes with investigational therapies for AIS treatment are likely to be time dependent, further efforts should target improvement of the IC process to minimize delay in clinical trial enrollment.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e24121-e24121
Author(s):  
Celeste Cagnazzo ◽  
Veronica Franchina ◽  
Giuseppe Toscano ◽  
Franca Fagioli ◽  
Tindara Franchina ◽  
...  

e24121 Background: Barriers for low recruitment in clinical trials have been classified based on three main sources: physician, patient, system. A primary role is played by a low patient awareness, which often leads to a lack of confidence in science and a substantial inability to estimate the benefits deriving from trial participation, aggravated by the spread of fake news. A prospective observational study was conducted to investigate the views of cancer patients on aspects of clinical research, their expectations, the level of comprehensibility of informed consent and the impact of the fake news phenomenon. Methods: From January 2018, after Ethics Committees approval, the ELPIS study was initiated in 9 Italian Medical Oncology Units. After signing the informed consent, patients were asked to complete a questionnaire, consisting of a set of multiple choice and Likert-score questions. Results: As of January 2021, 115 patients were enrolled, with a balanced sex distribution and a prevalence of subjects older than 55-years (79.8%). Regarding the previous knowledge about clinical research, the average score was 3.9 (range 1-5). The vast majority of respondents (91.3%) had already started experimental therapy and many of them constantly used internet (65.2%) and social networks (34.8%). More than half (53.9%) stated the interview with the physician was sufficient for a full understanding of informed consent. In case of doubt, the majority seeked support in the clinician (39.1%) while very few (1.7%) relied on the web. The average score attributed to doctor-patient relationship was equal to 8.89 (range 1-10). Respondents were quite confident in their ability to independently search for information on their disease, discriminate fake news and identify reliable sites (average score 3.26, 3.27, 3.09 respectively, over a range of 1-5). The scores related to the presumed ability to understand the results of a clinical study and to actively collaborate to produce research were high (average score 4.72 and 4.39 over a range of 1-5). Conclusions: Preliminary data from our research show a good level of patient awareness and a fine ability to understand information, discerning real from fake news. Continuing and implementing the training initiatives of the population in the health sector will certainly contribute to further improvement, hopefully obtaining an even greater involvement of patients in the early phases of research.


BMJ ◽  
1993 ◽  
Vol 307 (6917) ◽  
pp. 1497-1497 ◽  
Author(s):  
J A Kanis ◽  
J F Bergmann

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