Share

February 07, 2023; 100 (6) Research Methods in NeurologyOpen Access

Protocol for Deferral of Consent in Acute Stroke Trials

Hannah Faris, Brian Dewar, Mark Fedyk, Dar Dowlatshahi, Bijoy Menon, Richard H. Swartz, Michael D. Hill, Michel Shamy
First published November 22, 2022, DOI: https://doi.org/10.1212/WNL.0000000000201533
Full PDF
Citation
Permissions

Make Comment

See Comments

Downloads
0

Share

Article Information

vol. 100 no. 6 292-300
DOI: 
https://doi.org/10.1212/WNL.0000000000201533
PubMed: 
36414423
Published By: 
Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology
Print ISSN: 
0028-3878
Online ISSN: 
1526-632X
History: 
  • Received June 10, 2022
  • Accepted in final form September 23, 2022
  • First Published November 22, 2022.

Article Versions

Copyright & Usage: 
Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology. This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND), which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Author Disclosures

    1. Hannah Faris, BSc,
    2. Brian Dewar, MLIS,
    3. Mark Fedyk, PhD,
    4. Dar Dowlatshahi, MD, PhD, FRCPC,
    5. Bijoy Menon, MD, MSc,
    6. Richard H. Swartz, MD,
    7. Michael D. Hill, MD, MSc, FRCPC and
    8. Michel Shamy, MD, MA, FRCPC
  1. Hannah Faris, BSc,
    2. Scientific Advisory Boards:

    1. None

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. None

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. None

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  2. Brian Dewar, MLIS,
    3. Scientific Advisory Boards:

    1. None

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. None

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. None

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  3. Mark Fedyk, PhD,
    4. Scientific Advisory Boards:

    1. None

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. None

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. None

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  4. Dar Dowlatshahi, MD, PhD, FRCPC,
    5. Scientific Advisory Boards:

    1. Astra Zeneca Canada

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. None

    Editorial Boards:

    1. International Journal of Stroke

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. (1) Heart & Stroke Foundation of Canada

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  5. Bijoy Menon, MD, MSc,
    6. Scientific Advisory Boards:

    1. Biogen, Neurostasis, (Commercial)

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. None

    Editorial Boards:

    1. Associate Editor, Journal of Stroke

    Patents:

    1. A patent for triaging systems in ischemic stroke

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. 1. Commercial Entity (Circle NVI).

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. Research funding from 1) Canadian Institute of Health Research, 2) Heart and Stroke Foundation of Canada, 3) Alberta Innovates Health Solutions, 4) Hotchkiss Brain Institute and the 5) Faculty of Medicine, University of Calgary

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. 1) Commercial Entity Circle NVI, 20212)Neurostasis (Commercial), 2022

    Legal Proceedings:

    1. NONE

  6. Richard H. Swartz, MD,
    7. Scientific Advisory Boards:

    1. None

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. None

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. Founder, owner, FollowMD Inc., a virtual vascular risk reduction clinic.

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. Grant and personnel funding from (1) Heart and Stroke Foundation of Canada, (2) Canadian Institute of Health Research (CIHR), (3) Ontario Brain Institute, (4) Department of Medicine at Sunnybrook Health Sciences Centre and the University of Toronto, (5) SE Black Centre for Brain Resilience and Recovery.

    Research Support, Foundations and Societies:

    1. None

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  7. Michael D. Hill, MD, MSc, FRCPC and
    8. Scientific Advisory Boards:

    1. Commercial (paid activities)Tenecteplase Advisory Board - Boehringer Ingelheim 2019-currentBrainsgate Advisory Board - 2021-2022Academic studies (unpaid activities)ONCOVIR study - DSMB chair - ongoingSELECT2 study - medical safety monitor - ongoingDUMAS study DSMB - chair - ongoingARCADIA study - medical safety monitor - ongoingBRAIN-AF study DSMB - ongoingARTESIA study DSMB - ongoingTIPS trial DSMB chair - ongoingPLUTO study - DSMB - ended 2021RACECAT study DSMB - chair - ended 2020

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. None

    Editorial Boards:

    1. Editorial board - Stroke (ongoing), Can J Neurological,Sciences (ongoing), Precision Medicine (ongoing), International Journal of Stroke (Associate Editor - ended Sep 2020)

    Patents:

    1. Patent granted.62/086,077Systems and Methods for Assisting in Decision-Making and Triaging for Acute Stroke Patients

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. Canadian Stroke Consortium - Director - ongoing [Not-for-profit sector, volunteer]Canadian Neuroscience Federation - 2012-2020Board of Directors, 2021-current (Chair) [Not-for-profit sector, volunteer]Circle NVI - 2019-2022 (completed) - Board of Directors (for profit sector)

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. SUN Pharma - adjudication committee for clinical trials outcomes. Paid work. [For profit sector]

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Grant funding from industry - Hoffmann-La RocheCanada 2004 & 2009, Bayer Canada 2007, Merck Canada 2003-2007, Covidien(Medtronic) 2013-2017, Boehringer-Ingelheim 2016-present, Stryker 2017-2020, NoNO Inc 2019-present, Biogen 2019-present, Medtronic 2022-ongoing

    Research Support, Government Entities:

    1. NIH (NINDS) (2001-ongoing)CIHR (1999-ongoing) (Public funding sector)Alberta Innovates Health Solutions 2014-ongoing (Public funding sector)Heart & Stroke Foundation Canada (Public funding sector)

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. Heart & Stroke Foundation Alberta (1999-2020) [Charitable funding sector]

    Stock/Stock Options/Board of Directors Compensation:

    1. Circle NVI

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. Pure Web (private company - hold stock)Basking Neuroscience (stock options)

    Legal Proceedings:

    1. NONE

  8. Michel Shamy, MD, MA, FRCPC
    9. Scientific Advisory Boards:

    1. None

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. None

    Editorial Boards:

    1. (1) The Neurohospitalist, associate editor, 2017-2022

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. New Frontiers in Research Fund Project Grant 2022-2023Role: PIFeasibility of Advance Consent for Acute Stroke Trials$232,000No relation to this projectCIHR SPOR Grant 2021-2022Role: PIAdvance Consent for Acute Stroke Trials$98,000No relation to this projectCIHR Project Grant 2019-2022Role: Co-IAcT Quicr Trial - indirectly related to this paper - no specific funding for this work$1.7 million

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. None

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  1. From the Ottawa Hospital Research Institute (H.F., B.D., D.D., M.S.), Ottawa, Ontario, Canada; School of Medicine (M.F.), University of California, Davis; Department of Medicine (D.D., M.S.), University of Ottawa & the Ottawa Hospital, Ontario; Department of Clinical Neurosciences (B.M., M.D.H.), University of Calgary and Calgary Stroke Program, Alberta; and Department of Medicine (R.H.S.), University of Toronto & Sunnybrook Health Sciences Centre, Ontario, Canada.
  1. Correspondence
    Dr. Shamy mshamy{at}toh.ca
View Full Text

Article usage

Article usage:

No statistics are available.

Letters: Rapid online correspondence

No comments have been published for this article.
Comment

REQUIREMENTS

If you are uploading a letter concerning an article:
You must have updated your disclosures within six months: http://submit.neurology.org

Your co-authors must send a completed Publishing Agreement Form to Neurology Staff (not necessary for the lead/corresponding author as the form below will suffice) before you upload your comment.

If you are responding to a comment that was written about an article you originally authored:
You (and co-authors) do not need to fill out forms or check disclosures as author forms are still valid
and apply to letter.

Submission specifications:

  • Submissions must be < 200 words with < 5 references. Reference 1 must be the article on which you are commenting.
  • Submissions should not have more than 5 authors. (Exception: original author replies can include all original authors of the article)
  • Submit only on articles published within 6 months of issue date.
  • Do not be redundant. Read any comments already posted on the article prior to submission.
  • Submitted comments are subject to editing and editor review prior to posting.

More guidelines and information on Disputes & Debates

Compose Comment

More information about text formats

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
Author Information
NOTE: The first author must also be the corresponding author of the comment.
First or given name, e.g. 'Peter'.
Your last, or family, name, e.g. 'MacMoody'.
Your email address, e.g. higgs-boson@gmail.com
Your role and/or occupation, e.g. 'Orthopedic Surgeon'.
Your organization or institution (if applicable), e.g. 'Royal Free Hospital'.
Publishing Agreement
NOTE: All authors, besides the first/corresponding author, must complete a separate Publishing Agreement Form and provide via email to the editorial office before comments can be posted.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

Vertical Tabs

You May Also be Interested in

Back to top
Advertisement

Related Articles

Topics Discussed

Alert Me