November 27, 2012
IRB News: This is a notification to inform you that there are revisions to the eIRB internal adverse event form. The implementation of the revised version will be on the eIRB during February 2013.
Internal Adverse Event Form Update click here
Old Adverse Event Form click here
New Adverse Event Form click here
November 20, 2012
FDA News: FDA has issued the draft guidance, "IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed." The document is available on FDA's website: Click here
FDA is issuing this guidance to remind institutional review boards (IRBs) of their longstanding role in the review of 1) the qualifications of the clinical investigator, 2) the adequacy of the facility in which the research will take place, and 3) the determination of whether an investigational new drug application (IND) or investigational device exemption (IDE) application is necessary for the proposed clinical investigation.
To enhance human subject protection 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 This draft guidance document was developed as a part of these efforts and in consultation with OHRP.
November 5, 2012
Revised 2012 IRB Roster
2012 IRB Roster
October 22, 2012
2013 IRB Meeting Schedule (Submission Deadlines)
August 23, 2012
IRB News: Please note that there are changes to the conflict of interest (COI) policy and eIRB COI form. The revised policy and form will take effect August 24, 2012. Please go to the Texas Health Research Policies webpage to view the revised Policy. All new submissions (initial reviews) created or not yet submitted to the IRB by 8/24/12 will need to complete the revised COI form.
The policy was modified to reflect revised National Institutes of Health Conflict of Interest regulations that take effect on August 24, 2012. For more information regarding these changes click here.
July 26, 2012
IRB News: Please note that there will be changes to the research conflict of interest policy. The revised policy will take effect August 24, 2012. Please see the notable changes below. Please go to the Texas Health Research Policies webpage to view the revised Policy.
The Policy was modified to reflect revised National Institutes of Health Conflict of Interest Regulations that take effect on August 24, 2012. For more information regarding these changes click here.
June 12, 2012
OHRP News: Announces the Availability of a Draft Guidance Document on Transferring a Previously-Approved Research Project to a New IRB or Institution
On June 12, 2012, the Office for Human Research Protections (OHRP) announced in the Federal Register the availability of a draft guidance document entitled, "Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution" and is seeking comment on the draft guidance.
OHRP's Federal Register notice of availability can be accessed here.
The draft guidance can be accessed here.
The Federal Register's notice of availability of FDA's draft guidance document can be accessed here.
FDA News: May 29, 2012
A May 2012 update to the Human Subject Protection (HSP)/Bioresearch Monitoring (BIMO) Initiative Accomplishments Report has been issued. The report highlights FDA's significant accomplishments and initiatives relating to the conduct of clinical trials from September 2010 through the present. Click here to view the report.
May 22, 2012
Do you have questions about the IRB or IRB processes? Check out our new Frequently Asked Questions page!
Click here to view the web page.
FDA News: May 1, 2012
FDA is amending the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food and Drugs determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon recommendations from the Government Accountability Office, and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted. This rule is effective May 30, 2012.
The final rule is now available here.
FDA News: March 3, 2012
FDA has issued the final guidance, "IRB Continuing Review after Clinical Investigation Approval." This guidance is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility under 21 CFR 56.108(a) and 56.109(f) by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of human subjects enrolled in clinical investigations. This guidance should also help clinical investigators and sponsors better understand their responsibilities related to continuing review.
To enhance human subject protection 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.
Click here to view the document.
FDA News: Feb. 9, 2012
FDA has issued the guidance, "Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c)." This guidance is intended to help sponsors, investigators and Institutional Review Boards better understand the new informed consent requirement set forth in 21 CFR 50.25(c). The guidance will assist those involved in applicable FDA-regulated clinical trials better understand the new informed consent requirement, including small businesses.
Click here to view the document.
Texas Health IRB Roster Update Effective January 5, 2012 Jan. 5, 2012
Title: Training Requirements for IRB Members, IRB Office Staff, Research Investigators and Research Study Staff
Notable Changes to the Training Policy 12/29/11
Training Requirements for IRB Members, IRB Office Staff, Research Investigators and Research Study Staff
Title: Changes to Research Compliance Policies Effective 11/15/11
Corporate Policy for Protection of Human Research Subjects
Corporate Policy on Research Privacy under HIPAA
Corporate Policy on Conflicts of Interest Involving Human Subject Research
Research Compliance Program - Structures, Monitoring and Audits
Glossary
Texas Health Resources IRB Training Policy Update Effective December 29, 2011 10/5/2011
Training Requirements for IRB Members, IRB Office Staff, Research Investigators and Research Study Staff.
Click here
Dec. 29, 2011
Texas Health Resources IRB Training and Education Courses 12/29/2011
Beginning January 2012 the IRB will begin having training classes.
If you want to learn more about the IRB processes or how to use the eIRB system here is your opportunity!
Click here
New Source for Research Training 12/21/2011
This is a notification that beginning January 1, 2012, Texas Health Resources will no longer subscribe to CITI Human Subjects Research Training. We will begin using Health Care Compliance Strategies (HCCS) for Human Subjects Protection Training. You will not need to complete this until your current CITI Training expires. A direct link to HCCS training modules is forthcoming. Please do not hesitate to contact the Texas Health Research Compliance Office if you have any questions at 682-236-6747 or AdrienneCharlot@texashealth.org.
Research Compliance Policy Changes 11/15/2011
Please note that changes have been made to Research Compliance Policies and they have taken effect today, November 15, 2011.
Research Compliance Policy Changes 11/1/2011
Please note that there will be changes to Research Compliance Policies and they are scheduled to take effect on November 15, 2011.
Texas Health IRB Roster Update Effective October 5, 2011 10/5/2011
NOTE: The December IRB meeting date has been changed to 12/9/11 and the submission deadline is now 11/11/11.
OHRP News: 9/22/2011
OHRP has posted a new item of correspondence on its website regarding "non-engaged" scenarios. Click here
2012 IRB Meeting Schedule (New Submission Deadlines) 9/6/2011
Submission Review Tool 8/31/2011
Please note that the Research Compliance Office/IRB Staff has developed a submission review tool.
OHRP News: 7/11/2011
OHRP has posted on its website a finalized guidance document entitled, "Guidance on Reporting Incidents to OHRP" This guidance replaces OHRP'S May 27, 2005 guidance entitled "Guidance On Reporting Incidents To OHRP" Click here. This guidance has been updated to clarify what information regarding serious or continuing noncompliance by the institutional review board needs to be reported, and to update OHRP's contact information. We are also pleased to announce a new email box for sending incident reports. The address is IRPT.OS@hhs.gov We encourage institutions to submit incident reports to this email address, PDF or Word format preferred.
OHRP News: 7/11/2011
OHRP has updated its Guidance on Written IRB Procedures. The July 1, 2011 guidance document replaces OHRP's January 15, 2007 guidance on this topic. Specifically, the updated document has been changed as follows; updated sections are identified in the parenthetical following each description of the changes:
1. Guidance related to continuing review has been replaced with content from OHRP's November 10, 2010 document, "Guidance on Continuing Review of Research," and a cross-reference to the continuing review guidance document has been added (see Section A.(2)(b) and Section B.(2)(b)).
2. A cross-reference to OHRP's January 15, 2007 document, "Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events," has been added (see Section A.(3)).
3. Guidance related to the approval of research with conditions has been replaced with content from OHRP's November 10, 2010 document, "Guidance on IRB Approval of Research with Conditions," and a cross-reference to the guidance document on approval of research with conditions has been added (see Section A.(5)).
4. All URLs referenced in the document have been updated to link to OHRP's new website.
5. A closing paragraph was added to the end of the document to provide OHRP's contact information.
Texas Health IRB Roster Update Effective July 7, 2011 7/7/2011
Revised Informed Consent Form Template 7/6/2011
This is a notification to make you aware that the informed consent form template has been revised and that this revised version will become effective as of July 20, 2011. Click here
OHRP News: 6/27/2011
OHRP has posted on its website a revised set of Frequently Asked Questions and Answers (FAQs) on the Assurance Process that can be accessed at: Click here. These FAQs include information on recent changes in the Federalwide Assurance (FWA) form and Terms of Assurance, which have been approved by the Office of Management and Budget (OMB). On June 21, OHRP sent out a list serve notification announcing the availability of the OMB-approved revised FWA form and Terms. That notification lists the key changes in the form and terms and can be accessed at: Click here.
Texas Health IRB Roster Update Effective May 13, 2011 5/13/2011
Policy and Form Updates and New Protocol Template 4/19/2011
This is a notification to inform you that the following Policies/Forms have been updated/completed and that the revised versions/new template will become effective as of May 3, 2011. Click here
FDA News: 4/5/2011
FDA has issued the final guidance, "Exception from Informed Consent Requirements for Emergency Research." The document is now available using the following web link: Click here
FDA News: 3/22/2011
FDA has issued a revised Compliance Program Guidance Manual (CPGM) for inspections of Sponsors, Contract Research Organizations and Monitors (CP 7348.810).
The document is now available using the following web links:
Click here or here
Policy Updates Effective February 1, 2011 1/18/2011
FDA News: 1/6/2011
New FDA Rule Requires Consent Forms to Reflect Database Entry
The Food and Drug Administration has issued a final rule, effective March 7, requiring consent forms signed by participants in certain clinical trials to contain "a specific statement that clinical trial information will be entered into a databank." The databank is clinicaltrials.gov, maintained by the National Institutes of Health and the National Library of Medicine. The rule, in the Jan. 4 Federal Register, amends a proposed rule issued Dec. 29, 2009, on which FDA received nearly 70 comments. Data submissions to clinicaltrials.gov were mandated under 2007 legislation modernizing the FDA, which also required the agency to revise its regulations for informed consent documents and procedures.
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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