NY IRB Approval letter

Attachment_15_NY_IRB_Approval_Letter.pdf

Lyme and other Tickborne Diseases Knowledge, Attitude, and Practice Surveys

NY IRB Approval letter

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ANDREW M. CUOMO
Governor

HOWARD A. ZUCKER, M.D., J.D.
Commissioner

SALLY DRESLIN, M.S., R.N.
Executive Deputy
Commissioner

DATE:

February 28, 2019

TO:
FROM:

Jennifer White, MPH
Robin Krause, MS, IRB Administrator I
New York State Department of Health Institutional Review Board

PROJECT TITLE:

REFERENCE #:

[1375111-1] Lyme and Other Tickborne Diseases Prevention studies (LTDPS):
Knowledge, Attitudes, and Practices of Healthcare Professionals Working in
Schools Regarding Tickborne Disease Prevention and Lyme Disease in New
York State and Maryland
19-006

ACTION:

Approval of New Study

The New York State Department of Health Institutional Review Board (NYS DOH IRB) has reviewed your
request for expedited approval of the new study referenced above. Your study is eligible for expedited
review under DHHS (OHRP) regulation 45CFR46.111, and has been designated as Expedited Criteria
7: Research on individual or group characteristics or behavior (including, but not limited to, research on
perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and
social behavior) or research employing survey, interview, oral history, focus group, program evaluation,
human factors evaluation, or quality assurance methodologies.
This is to confirm that the IRB has approved your application. This approval is based on an
appropriate risk/benefit ratio and a project design wherein the risks have been minimized. All
research must be conducted in accordance with this approved submission..
Research that poses minimal risk to study participants, and is eligible for expedited review is not required
to undergo annual continuing review (unless specifically mandated by the IRB (46.109[f][1][i])). Instead,
NYS DOH IRB requires that you submit a Continuing Review/Progress Report annually. This form will
allow the IRB to keep track of studies that are open to enrollment. The annual update for this study is due
January 27, 2020. Your study will expire on February 27, 2020 if a Continuing Review/Progress Report is
not submitted in a timely manner.
You are granted permission to conduct your study as described in your application effective immediately.
Any changes to the study must be promptly reported and approved by the IRB prior to implementation.
All Continuing Reviews/Progress Reports must be submitted in a timely manner to avoid non-compliance.
All research records must be retained for a minimum of three years after the completion of the project.
Please feel free to contact the IRB at (518) 474-8539 if you have any questions regarding this approval
notice.

CC: Michael Saglimbeni - HRI

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