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In This Section Texas Health Research & Education Institute
Institutional Review Board

Institutional Review Board

Federal regulations require that a committee called the Institutional Review Board (IRB) review, approve and monitor all research involving human subjects. Texas Health Resources operates a systemwide IRB.

The IRB protects the rights and welfare of human research participants. It monitors human subject research to determine that it is conducted ethically, and in compliance with federal regulations, state law and Texas Health Resources' policies and procedures.

IRB members include physicians, nurses, and community representatives, with Texas Health administration representatives also participating.

Log in to the eIRB web site to submit an application, find forms and help. Click here.


Follow the links at left to learn more. Click here to contact the IRB Office or IRB Staff

Research Education Online Classes

Learn more about how to conduct research at Texas Health with our online courses. Registered nurses will receive continuing education credit.
 
Role of a Study Coordinator - Improve your coordinator skills by evaluating your role as a research study coordinator.

Top 10 Responsibilities of Research Investigator - Learn the major responsibilities of research investigators, and how to fulfill them.

How to protect human subjects while conducting Research - Learn how to effectively protect your research subjects, and how to stay in compliance while conducting research.

Humanitarian Use Device - Learn the investigator’s
responsibility when using a HUD, and the IRB’s role in oversight.

Want to learn more about conducting research?

The IRB offers research education classes. Learn what's needed to do research at Texas Health.
Schedule coming soon.


News

March 17, 2014
FDA News

CDRH Industry: Humanitarian Device Exemption (HDE): Questions and Answers - Draft Guidance for HDE Holders, Institutional Review Boards, Clinical Investigators, and FDA Staff.

This draft guidance answers commonly asked questions about Humanitarian Use Devices (HUDs) and the Humanitarian Device Exemption (HDE) authorized under section 520(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Section 613 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), signed into law on July 9, 2012, amended section 520(m) of the FD&C Act. This guidance document also reflects changes in the HDE program resulting from FDASIA. For more information click here.

February 21, 2014
IRB News
See the following webpages for policy updates/effective dates, additions to template documents and new IRB fees/effective date: Texas Health Research Policies; Forms and Templates; IRB Fees.
**Training sessions are being provided for the policy change regarding reportable internal/external adverse events. 
Please contact the Research Compliance/IRB Office if you have questions and/or to request training at 682-236-6746 or irb@texashealth.org.

February 21, 2014
Revised 2014 IRB Roster
2014 IRB Roster


February 14, 2014
FDA News
CDRH Industry Update: Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with FDA Staff - Guidance for Industry and FDA Staff. To view the guidance click here.

January 24, 2014
2014 IRB Roster
2014 IRB Roster


January 24, 2014
FDA News
The Food and Drug Administration (FDA) is announcing an educational conference co-sponsored with the Society of Clinical Research Associates (SoCRA). The public workshop regarding FDA's clinical trial requirements is designed to aid the clinical research professional's understanding of the mission, responsibilities, and authority of FDA, and to facilitate interaction with FDA representatives. The program will focus on the relationships among FDA and clinical trial staff, investigators, and institutional review boards (IRBs). Click here

January 22, 2014
FDA News
On Wednesday, January 29,
2014, from 2:00PM - 3:00PM EST, FDA will present a webinar on the final guidance for industry
Electronic Source Data in Clinical Investigations.
Click here


December 18, 2013

New CV/Resume Template
There is a new CV template available. View on the Forms and Templates page. Click here

More news...

 

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