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.
Want to learn more about conducting research?
The IRB offers research education classes. Learn what's needed to do research at Texas Health.
May 2013 Schedule click here.
August/September 2013 Schedule click here. |
News
May 10, 2013
IRB News
Please note that as of Friday, May 24, 2013, the eIRB submission system will be updated. Click here to view the listing of planned changes and related attachments.
May 8, 2013
Revised 2013 IRB Roster
2013 IRB Roster
April 9, 2013
IRB NEWS
UPDATE (Change in June Meeting Date)
Revised Meeting Dates for 2013
Febraury 27, 2013
FDA News
Proposed Rule: Acceptance of Data from Clinical Studies for Medical Devices
The Food and Drug Administration (FDA) is proposing to amend its regulations on acceptance of data from clinical studies for medical devices. We are proposing to require that clinical studies conducted outside the United States as support for an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application be conducted in accordance with good clinical practice (GCP), which includes obtaining and documenting the review and approval of the study by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of study subjects. The proposed rule is intended to update the standards for FDA acceptance of data from clinical studies conducted outside the United States and to help ensure the protection of human subjects and the quality and integrity of data obtained from these studies. As part of this proposed rule, we are also proposing to amend the IDE and 510(k) regulations to address the requirements for FDA acceptance of data from clinical studies conducted inside the United States. The proposed amendments are intended to provide consistency in FDA requirements for acceptance of clinical data, whatever the application or submission type.
Click here to view the proposed rule.
Comments are due by May 28, 2013.
February 25, 2013
Revised 2013 IRB Roster
2013 IRB Roster
February 25, 2013
HIPAA HITECH Changes
On January 25, 2013, the Department of Health and Human Services published the much-anticipated Omnibus Final Rule (the “Final Rule”), which, with respect to business associates and their subcontractors, conforms HIPAA’s Privacy and Security Rules to a number of changes brought about by the HITECH Act, implements a number of regulatory changes seen in HHS’s proposed rule-making, and modifies a number of other proposed regulatory changes. The Final Rule will take effect March 26, 2013. Click here for more information.
February 25, 2013
Sunshine Act Changes
Centers for Medicare and Medicaid Services has issued a final rule that implements a provision in the health care reform law requiring drug and device manufacturers and group purchasing organizations (GPOs) to report payments or gifts of $10 or more made to physicians, hospitals and other providers on a yearly basis. Click here for more information.
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