The University of Texas at Houston
gray bar graphic
  UTHSC-H     People Directory 
Search

Frequently Asked Questions
Frequently Asked Questions
Guidelines
Investigator Training
Human Subjects Research Policies
Investigator Resources
Contact the ORSC Staff
Return to ORSC Main Page


Log in to iRIS Register for iRIS Training iRIS Guidelines Helpful iRIS Tips

Revisions and Amendments

Changes to an approved protocol include changes to the:
  • Letter of Information
  • Protocol
  • Informed Consent Form
  • Addition or removal of Investigators or Collaborators
  • Educational Literature
  • Telephone scripts
  • Any other changes to the Research
  • Recruitment flyer

A request for approval of such changes must be submitted in the iRIS system. Your submission must also include a revised protocol with the changes highlighted and if the changes affect the consent/assent/parental permission, then the revised consent/assent/parental permission must also be submitted with the changes highlighted.

All changes must be approved by the CPHS before being implemented.

** Please note that if revisions to the informed consent form (ICF) are made and approved, then old unsigned copies of the ICF MUST be destroyed. Only copies of the appropriately dated, stamped approved informed consent form can be used when obtaining consent.

 

 

 

For other questions, please call us at 713-500-7942.

 


 

Copyright © 2008 by The University of Texas Health Science Center at Houston
Site Policies | State of Texas | Site Publisher
Office of Research Support Committees | 6410 Fannin, Suite 1100, Houston, Texas 77030
phone 713.500.7943 | IRIS Support 713.500.7960 | fax 713.500.7951 | email orsc@uth.tmc.edu
last modified March 26, 2008

University of Texas Houston Health Science Center Logo
#ReadTopStory