Office of Legal Affairs

Open Records Request Detail

Request ID

20130516

Date

05/16/2013

Description

I hereby request the following documents:

(1) All applications for initial review, continuing review, and amendment review for the Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial (SUPPORT study; ClinicalTrials.gov number NCT00233324) that were submitted to the University of Texas Health Science Center, Houston (UTHSC) institutional review board (IRB). Please exclude from this part of the request any version of the document entitled “Protocol for the NICHD Neonatal Research Network - The Surfactant Positive Airway Pressure and Pulse Oximetry Trial in Extremely Low Birth Weight Infants - The SUPPORT Trial” because this document has been made publicly available by the National Institutes of Health.

(2) The minutes of any UTHSC IRB meetings related to the initial and continuing review of the SUPPORT study and the review of any amendments to the SUPPORT study. For these meetings, please only provide the relevant pages that indicate the date, attendance, discussion, action, and vote regarding the review of the SUPPORT study.

(3) All applications for the initial review, continuing review, and amendment review for the Transfusion of Prematures (TOP) Trial: Does a Liberal Red Cell Transfusion Strategy Improve Neurologically-Intact Survival of Extremely-Low-Birth-Weight Infants as Compared to a Restrictive Strategy (TOP study; ClinicalTrials.gov number NCT01702805) that were submitted to the UTHSC IRB.

(4) All versions of the consent/parental permission forms for the TOP study that were approved by the UTHSC IRB.

(5) The minutes of any UTHSC IRB meetings related to the initial and continuing review of the TOP study and the review of any amendments to the TOP study. For these meetings, please only provide the relevant pages that indicate the date, attendance, discussion, action, and vote regarding the review of the TOP study.

Category

Meeting Agendas