scholarly journals Rethinking Consent for Stroke Trials in Time-Sensitive Situations

Stroke ◽  
2021 ◽  
Author(s):  
Mayank Goyal ◽  
Johanna Maria Ospel ◽  
Aravind Ganesh ◽  
Martha Marko ◽  
Marc Fisher
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Patient Autonomy ◽  
Routine Care ◽  
Patient Benefit ◽  
Checks And Balances ◽  
Patient Consent ◽  
Challenging Situation ◽  
Physician Workload

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.

Informed Consent and the Elusive Dichotomy Between Standard and Experimental Therapy

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.

scholarly journals Respecting patient autonomy: voluntary informed consent in modern medicine

2021 ◽  
Author(s):  
EG Grebenshchikova ◽  
AG Chuchalin
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Patient Autonomy ◽  
Legal Regulation ◽  
Modern Medicine ◽  
Cultural Factors ◽  
Autonomous Choice ◽  
Voluntary Informed Consent

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.

Cyber-Situational Awarenss in Clinical Trials Using Wearable Device Technology

2021 ◽  
Vol 10 (1) ◽  
pp. 33-36
Author(s):  
Elizabeth A. Johnson ◽  
Jane M. Carrington
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Best Practices ◽  
Situational Awareness ◽  
Implantable Devices ◽  
Wearable Device ◽  
Sleep Habits ◽  
Privacy Issues ◽  
Trial Participants ◽  
Device Technology

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.

scholarly journals Public Approval of Exception From Informed Consent in Emergency Clinical Trials

2019 ◽  
Vol 2 (7) ◽  
pp. e197591 ◽  
Author(s):  
William B. Feldman ◽  
Spencer P. Hey ◽  
Jessica M. Franklin ◽  
Aaron S. Kesselheim
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Public Approval

scholarly journals Are survival and mortality rates associated with recruitment to clinical trials in teenage and young adult patients with acute lymphoblastic leukaemia? A retrospective observational analysis in England

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e017052 ◽  
Author(s):  
Rachael Hough ◽  
Sabrina Sandhu ◽  
Maria Khan ◽  
Anthony Moran ◽  
Richard Feltbower ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Clinical Trials ◽  
Acute Lymphoblastic Leukaemia ◽  
Lymphoblastic Leukaemia ◽  
Relative Survival ◽  
Data Repository ◽  
Trial Participation ◽  
Patient Benefit ◽  
Cancer Data

ObjectiveParticipation rates in clinical trials are low in teenagers and young adults (TYA) with cancer. Whilst the importance of clinical trials in informing best practice is well established, data regarding individual patient benefit are scarce. We have investigated the association between overall survival and trial recruitment in TYA patients with acute lymphoblastic leukaemia (ALL).DesignRetrospective.SettingNational (England) TYA patients treated for ALL.Participants511 patients aged 15–24 years diagnosed with ALL between 2004 and 2010 inclusive, of whom 239 (46.7%) participated in the UKALL2003 trial.Outcome measuresPatients were identified using National Clinical Trial (UKALL2003) and Cancer Registry (National Cancer Data Repository, English National Cancer Online Registration Environment) Databases. Relative survival rates were calculated for trial and non-trial patients and observed differences were modelled using a multiple regression approach. The numbers and percentages of deaths in those patients included in the survival analysis were determined for each 3-month period, p values were calculated using the two-tailed z-test for difference between proportions and 95% CIs for percentage deaths were derived using the binomial distribution based on the Wilson Score method.ResultsPatients treated on the trial had a 17.9% better 2-year survival (85.4% vs 67.5%, p<0.001) and 8.9% better 1-year survival (90.8% vs 81.9%, p=0.004) than those not on the trial. 35 (14.6%) patients recruited to the trial died in the 2 years following diagnosis compared with 86 (32.6%) of those not recruited (p<0.001).ConclusionsTYA patients recruited to the clinical trial UKALL 2003 in England had a lower risk of mortality and a higher overall survival than contemporaneous non-trial patients. These data underline the potential for individual patient benefit in participating in a clinical trial and the importance of international efforts to increase trial participation in the TYA age group.Trial registration numberISRCTN07355119.

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

Stroke ◽  
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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