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

IRB News



December 18, 2013
New CV/Resume Template
There is a new CV template available. View on the Forms and Templates page. Click here

November 7, 2013
CDRHNews
The following new items were added to the CDRH web pages on November 6, 2013. Previous CDRH New Items can be found on the CDRHNew Page.

Design Considerations for Pivotal Clinical Investigations for Medical Devices - Guidance for Industry, Clinical Investigators, Institutional Review Boards and Food and Drug Administration Staff

October 31, 2013
Revised 2013 IRB Roster
2013 IRB Roster

October 30, 2013
IRB News
Update to Protocol Template: Addition of Minimal Risk Template
Click here

October 17, 2013
IRB News
Update to Human Subject Research Records and Documents policy.
Click here

October 10, 2013
Revised 2013 IRB Roster
2013 IRB Roster

September 23, 2013
IRB News
Update to Corporate Policy on Research Privacy under HIPAA.
Click here

August 27, 2013
FDA News
FDA Issues Final Guidance on IRB Responsibilities

On August 27, 2013, FDA issued final guidance, "IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed." All of the parties who conduct or have oversight responsibilities for biomedical research—sponsors, clinical investigators, and institutional review boards (IRBs)—have responsibility for ensuring that the research complies with applicable laws and regulations and that risks to subjects are minimized. Although selection of clinical investigators and research sites, and determining if an investigational new drug application (IND) or investigational device exemption (IDE) is required are viewed primarily as sponsor responsibilities, FDA is issuing this guidance to clarify IRBs' responsibilities related to these activities and to encourage all parties to work together in order to protect the rights and welfare of study subjects.

Many of the recommendations in this guidance have appeared in other FDA guidance documents. FDA has compiled the recommendations from these various sources into this guidance to ensure that all IRBs have access to it. In addition, FDA provides guidance on how IRBs may efficiently fulfill these important responsibilities.

To enhance protection of human subjects and reduce regulatory burden, the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and FDA have been actively working to harmonize the agencies’ regulatory requirements and guidance for human subject research. This guidance document was developed as a part of these efforts and in consultation with OHRP and is now available on FDA’s website. Click here


August 22, 2013
IRB News
2014 IRB Meeting Schedule (Submission Deadlines)


August 21, 2013
OHRP NEWS
For those who cannot attend the August 28, 2013 HHS Public Meeting on the Protections of Human Subjects and Research Studying Standard of Care Interventions, HHS is providing an option to view the public meeting via live streaming technology. To view the HHS public meeting live on August 28, 2013, go to the HHS live streaming site, then hit the "Click to Play" arrow.



July 15, 2013
Revised 2013 IRB Roster
2013 IRB Roster



June 21, 2013
IRB News
Are you sure if your project needs IRB approval? Use this tool, Does my Proposed Activity Require IRB Approval, to determine if your project needs to be submitted to the IRB. If you have questions please contact the IRB office.


June 5, 2013
IRB News Update
The eIRB update implementation date has been extended to Friday, June 14, 2013. Click here to view the listing of planned changes and related attachments.



May 28, 2013
IRB News Update
Due to unforeseen technical difficulties, please note that the eIRB submission system update has been moved to Friday, June 7, 2013. Click here to view the listing of planned changes and related attachments.


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.


February 20, 2013
IRB News
Please note that the below human subject research policies re-issued as of today, February 20, 2013.
-Corporate Policy for the Protection of Human Research Subjects
-Corporate Policy for IRB Training
-Corporate Policy on Research Privacy Under HIPAA
-Glossary
No major changes were made to the policies.  The Corporate Policy for IRB Training contains revisions from previous version. 
Please see the IRB website’s Texas Health Research Policies webpage for additional information.


January 28, 2013
Revised 2013 IRB Roster
2013 IRB Roster



January 18, 2013
2013 IRB Roster
2013 IRB Roster

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