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Related Experiment Video

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Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability

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Published on: October 7, 2017

How important is surrogate consent for stroke research?

M L Flaherty¹, J Karlawish, J C Khoury

¹Department of Neurology, University of Cincinnati Academic Health Center, 260 Stetson St., Room 2316, Cincinnati, OH 45267-0525, USA. matthew.flaherty@uc.edu

|August 30, 2008

Summary

Surrogate consent was crucial for the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA Stroke Trial. Excluding patients unable to provide self-consent would have significantly delayed completion and limited generalizability.

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Area of Science:

Neurology
Clinical Trials
Informed Consent

Background:

Cognitive deficits post-stroke can impair informed consent capacity.
Some IRBs restrict surrogate consent to legally authorized individuals.
The NINDS rt-PA Stroke Trial investigated a key acute ischemic stroke treatment.

Purpose of the Study:

To assess the importance of surrogate consent in the NINDS rt-PA Stroke Trial.
To determine the impact of excluding patients requiring surrogate consent on trial completion and generalizability.

Main Methods:

Randomized subjects with ischemic stroke to recombinant tissue plasminogen activator (rt-PA) or placebo.
Compared baseline characteristics and clinical outcomes between self-consent and surrogate-consent groups.

Main Results:

Surrogate consent enrolled 70% (439/624) of subjects.
Surrogate-consent subjects were older, had more severe strokes, and poorer recovery.
No interaction found between consent method and rt-PA response.

Conclusions:

The NINDS rt-PA Stroke Trial's timely completion depended on surrogate consent.
Excluding patients unable to provide self-consent would have limited generalizability and trial value.