Visualising the risks of clinical trials for fair treatment and appropriate informed consent of participants

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.

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Informed Consent and the Elusive Dichotomy Between Standard and Experimental Therapy

American Journal of Law & Medicine ◽

10.1017/s0098858800002690 ◽

2002 ◽

Vol 28 (4) ◽

pp. 361-408

Author(s):

Lars Noah

Keyword(s):

Clinical Trials ◽

Informed Consent ◽

Patient Autonomy ◽

College Campuses ◽

Human Experimentation ◽

Experimental Therapy ◽

Academic Literature ◽

Medical Experimentation ◽

Disclosure Rules ◽

Near Unanimity

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.

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Public Approval of Exception From Informed Consent in Emergency Clinical Trials

JAMA Network Open ◽

10.1001/jamanetworkopen.2019.7591 ◽

2019 ◽

Vol 2 (7) ◽

pp. e197591 ◽

Cited By ~ 1

Author(s):

William B. Feldman ◽

Spencer P. Hey ◽

Jessica M. Franklin ◽

Aaron S. Kesselheim

Keyword(s):

Clinical Trials ◽

Informed Consent ◽

Public Approval

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Informed consent in European multicentre randomised clinical trials — Are patients really informed?

European Journal of Cancer ◽

10.1016/0959-8049(94)90111-2 ◽

1994 ◽

Vol 30 (7) ◽

pp. 907-910 ◽

Cited By ~ 65

Author(s):

C.J. Williams ◽

M. Zwitter

Keyword(s):

Clinical Trials ◽

Informed Consent ◽

Randomised Clinical Trials

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The myth of informed consent: in daily practice and in clinical trials.

Journal of Medical Ethics ◽

10.1136/jme.15.1.6 ◽

1989 ◽

Vol 15 (1) ◽

pp. 6-11 ◽

Cited By ~ 54

Author(s):

W A Silverman

Keyword(s):

Clinical Trials ◽

Informed Consent ◽

Daily Practice

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Abstract 3769: Barriers to Obtaining Informed Consent in Acute Stroke Clinical Trials

Stroke ◽

10.1161/str.43.suppl_1.a3769 ◽

2012 ◽

Vol 43 (suppl_1) ◽

Author(s):

Sacha R Masuca ◽

Devsmita S Das ◽

Deji Delano ◽

Malcom Irani ◽

Renga Pandurengan ◽

...

Keyword(s):

Clinical Trials ◽

Informed Consent ◽

Acute Stroke ◽

Single Center ◽

Severe Stroke ◽

Single Center Study ◽

Investigational Therapies ◽

Clinical Trial Enrollment ◽

Barriers To Enrollment ◽

Clinical Research Trials

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.

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