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

IRB News 2011-2012



December 6, 2012
Revised 2012 IRB Roster
2012 IRB Roster


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FDA News: FDA has issued the draft guidance, "IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed."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 This draft guidance document was developed as a part of these efforts and in consultation with OHRP.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

 
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.




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