C.3.9 IRB Approval Letter LOI3-PHYS-01

ATTACHMENT C.3.9 IRB APPROVAL LETTER

Date

May 31, 2011

To:

Pamela R. Wood, M.D.
Dept. of Pediatrics,
F 3725 3rd Fl, Center for Children and Families, CSR
UTHSCSA, MC 7808

From:

Institutional Review Board

Subject:

Expedited Approval of a Modification to Ongoing Research (Amendment)

OMB #: 0925-0593
EXPIRATION DATE: 07/31/2013

Protocol Number: HSC20110139H
Title: Tools for screening pulmonary function in the National Children’s Study
Funding Type: HHS (NIH-CDC); Sponsor: NIH-Diabetes/Digestive/Kidney Diseases; Grant Title(s): NCS-Tools for screening pulmonary
function; Grant #: HHSN267200700006C/WA No. 5 LOI13-PHYS-01-B

Dear Principal Investigator,
Your request to modify this study (amendment), dated May 20, 2011, was reviewed by the Institutional Review Board on May
27, 2011 and approved.
In addition to the amendment form the following documents were reviewed: Signature Assurance Sheet; Form B - General
Information; Form B-2 - Personnel List; Form D - HSC Consent, 1 English ICD Lamar County (new); Form L - Recruitment
Material; Form M - Data Collection Instrument(s); Other: Form H-1 Translation Certification; Form L Lamar County Parent
Letter; Form L Lung Study Flyer Lamar County Head Start; Form L Lung Study Flyer Lollypop Daycare; Form M Baseline
Quest; Form M Spanish Baseline Quest; Form M Spanish Pulmonary Function Testing; Form M Spanish Specialist visit
Questionnaire; Form M Specialist visit Questionnaire, UT Centralized IRB Review Notification to Relying Organization Intent
to Submit for Centralized Review (signed 05-23-11).
Summary of the main modifications to your study: Added Lamar County as a study site with Dr. Deborah Cherry as Principal
Investigator for that site; added a consent form, two flyers and a parent letter for Lamar County; added study staff from
UTHSC Tyler; submitted Spanish translation for 3 questionnaires; and revised 2 questionnaires.
The attached informed consent document(s) digitally stamped with IRB APPROVED May 27, 2011 must be used.
Affiliated institutions which are engaged in this research: UTHSCSA UTHSCS-Tyler

Sincerely,
Debbie Etter, CIP
I am the author of this
document
2011.05.31 15:26:03 -05'00'

Senior IRB Coordinator
cc: Debbie Fielder
University of Texas Health Science Center at Tyler
[email protected]

Please retain this document in your IRB correspondence file

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