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

IRB News 2008-2010



Texas Health IRB Roster Update Effective December 31, 2010               12/31/2010


OHRP News:              12/2/2010
OHRP has posted on its website a finalized guidance document entitled, "Guidance on IRB Approval of Research with Conditions." The guidance document provides OHRP's first formal guidance on this topic.  The guidance document finalizes the draft guidance that was made available for public comment through a notice in the Federal Register on November 6, 2009 (74 FR 57486). The public comments submitted on our draft document were very helpful to us as we finalized this guidance document, and we thank those of you who took the time to provide us with your feedback. The finalized guidance document is available on the OHRP website at
Guidance on IRB Approval of Research with Conditions or URLs
Guidance on IRB Approval of Research with Conditions pdf

The Federal Register notice announcing the availability of this new guidance document can be found at
Guidance on Institutional Review Board Approval of Research With Conditions or
Guidance on Institutional Review Board Approval of Research With Conditions pdf



OHRP News:               12/2/2010
OHRP has posted on its website a finalized guidance document entitled, "Guidance on IRB Continuing Review of Research." The guidance document supersedes OHRP's January 15, 2007 guidance entitled "Guidance on Continuing Review." The guidance document finalizes the draft guidance that was made available for public comment through a notice in the Federal Register on November 6, 2009 (74 FR 57487). The public comments submitted on our draft document were very helpful to us as we finalized this guidance document, and we thank those of you who took the time to provide us with your feedback. The finalized guidance document is available on the OHRP website at
Guidance on IRB Continuing Review of Research or
Guidance on IRB Continuing Review of Research pdf

The Federal Register notice announcing the availability of this new guidance document can be found at
Guidance on Institutional Review Board Continuing Review of
Research
 or
Guidance on Institutional Review Board Continuing Review of
Research pdf



OHRP FWA Frequently Asked Questions (FAQs)               10/14/2010
OHRP News:
In the FWA frequently asked questions (FAQs), at OHRP FWA Frequently Asked Questions (FAQs) OHRP has revised the answer to Question #4: When is an institution considered to be "engaged in research"?  The revisions include
Adding obtaining informed consent as an activity that can make an institution engaged;
Removing the statement that pertained to awardee institutions bearing the ultimate responsibility for protecting human subjects, even when all human subjects activities are carried out by other institutions; and
Correcting the link at the end of the FAQ to link to the current guidance document.


eIRB Submission Modifications               10/4/2010


OHRP News: Clarification of "noninvasive" in expedited review category 3              
10/4/2010


IRB Fee/Invoicing Update               9/30/2010


OHRP News:
Guidance on Withdrawal of Subjects from Research               9/21/2010


Texas Health IRB Roster Update Effective August 31, 2010          8/31/2010


Changes to Policy for Protection of Human Research Subjects and eIRB              8/10/2010


OHRP News:
OHRP is pleased to announce the availability for the first time of educational videos on the HHS YouTube channel               7/14/2010


FDA News:
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs               6/4/2010


Texas Health IRB Roster Update Effective June 3, 2010               6/3/2010


FDA News:
Clinical Investigator Administrative Actions - Disqualification               6/3/2010


OHRP News:
Use of Central IRB in Multi-Site Research              5/11/2010


New IRB Fees Effective May 4, 2010               5/4/2010


Texas Health IRB Roster Update Effective March 8, 2010               3/8/2010


2010 IRB Meeting Schedule (New Submission Deadlines)                9/29/2009


Research Compliance Program Policy V.2               9/17/2009
To establish and communicate the structure and components of the Texas Health Resources (THR) Research Compliance Program, which is a component of the overall Texas Health Business Ethics and Compliance Program under the oversight of the Texas Health Chief Compliance Officer.


Texas Health IRB Roster Update(9-11-09)               9/17/2009
Texas Health IRB Roster - A Roster - No action required - No need to call the IRB Office - Added FWA number to roster and removed Chris Amaya from roster - NO ACTION REQUIRED!


Notification regarding Continuing Review CO2 Question CO-G              9/16/2009
On the continuing review application, CO-2 question G is currently displaying Draft Documents from the Documents tab. Per question G, you are currently requested to upload the currently IRB approved/stamped consent form(s) and you should continue to upload such documents under this question. The IRB Office will be resolving this issue by replacing the Draft Documents with the currently IRB approved/stamped consent form(s) in a read only format. You will no longer be required to upload the IRB currently approved/stamped consent form(s) as they will be displayed. All previously approved continuing reviews will be archived before this change is made.


Submit COI Disclosure is now available              8/5/2009
Submit COI Disclosure is now available for Studies and Continuing Reviews. There is no document to review with this notification.


eIRB Conflict of Interest Submission tool is currently unavailable             8/4/2009
The eIRB electronic Conflict of Interest submission tool is currently unavailable (our engineers are working on the issue)!


Department/Entity Reviewer Routing Implementation Date Change             7/2/2009
Due to scheduling conflicts with our eIRB software vendor, Clickcommerce. The start date for the new Department/Reviewer routing has been changed from 7/24/09 to 7/31/09. Please don't hesitate to contact the IRB Office at 682-236-6746 if we can be of further assistance. Thank you for your understanding and cooperation regarding this matter.


Changes to Department /Entity Approvals              6/16/2009
Beginning July 24, 2009 the eIRB department/entity approval process will be modified.


COI Change Announcement              5/19/2009
As of June 1, 2009, the Conflict of Interest (COI) form in the eIRB submission system will be modified to provide clearer instructions for the principal investigator and study staff to follow when completing the form. Also, these changes will allow for more complete information to be provided to the Institutional Review Board to decrease the amount of related stipulations requesting further clarification of information provided.


Clinical Research - required forms for IRB submission and hospital services              4/30/2009
Clinical Research - required forms for IRB submission and hospital services.


IRB Form Bill 1                3/18/2009


IRB Form Bill 1                3/18/2009
The Form BILL 1, "Clinical Research and Special Project Impact Assessment" is a document to be submitted with all IRB Applications. This form is used to summarize hospital related items and services related to the research study. The form gathers demographic information, items and services related to the study, hospital personnel used in the study and names external research coordinators and the principal investigator. The Form Bill 1 was updated to be a more user-friendly form. Please be sure to use this form going forward and discard the previous version. If you have any questions or comments regarding this Form you can contact the IRB Office at 682-236-6746. Thank you.


eIRB Training Slides Announcement
                  3/16/2009
Having trouble completing a new submission through eIRB? What about a Continuing Review submission? And what about an Amendment submission? Well, your problems have a solution...the IRB has just posted training slides for the submission of new studies, continuing reviews and amendments. Log in to your eIRB account and click on the HELP folder on the HOME page to access the slides.


Instructions Regarding Placing Informed Consent Forms into Medical Records                 3/6/2009
This notification is providing instructions regarding placing informed consent forms into medical records. Please click on the document link to view document.


eIRB invoice announcement                12/16/2008


eIRB Continuing Review Courtesy Notices               12/16/2008



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