Human Research Protections Office (HRPO)
HRPO Office Closed November 26th & 27th
The Human Research Protections Office will be closed for the Thanksgiving holiday on Thursday, November 26th and Friday, November 27th. We will re-open for business on Monday, November 30th at 8:30am. In the event of an emergency during this closure, please call 410-706-5037 for special instructions.
Update October 26, 2009
FDA Authorizes Emergency Use of Influenza Medicines to Treat H1N1
The FDA has granted EMERGENCY USE AUTHORIZATIONS (EUA) for certain drugs and devices used to treat H1N1 at the request of the Centers for Disease Control (CDC).
These include:
Relenza (Zanamivir)
Peramivir IV
Use of these drugs must be in accordance with the Emergency Use Authorizations issued by the FDA.
COMPLETE INFORMATION is found on the CDC website: http://www.cdc.gov/h1n1flu/eua/
PLEASE NOTE:
- Use of these drugs according to the EUA does NOT require IRB approval:
- Zanamivir (Relenza) Inhalation Powder
- Peramivir IV
- IV Formulation of Zanamivir (Relenza) is NOT APPROVED UNDER THE CURRENT EUA. If IV treatment is desired, this must be used in accordance UMB HRPP Policy I.5.C. Emergency Use of Investigational or Unlicensed Test Article.
- Contact the IRB at 410-706-5037 to let them know there is an Emergency Use for IV Zanamivir.
The UMMS Investigational Drug Service (IDS) has prepared INSTRUCTIONS for PROCUREMENT of these Agents. Click here to Download.
Please contact the IDS for questions and updates at 410-328-5468.
BRAAN will be INACTIVATED on November 30, 2009
As of 11:59 pm on Monday, November 30, 2009, BRAAN will be INACTIVATED and will be available as “Read Only.”
This means that YOU WILL BE UNABLE TO SUBMIT ANY TRANSACTIONS in BRAAN after that date. This includes new studies, continuing renewals, modifications, reportable events, and closure reports.
Therefore, ALL PROTOCOLS still active in BRAAN must be CONVERTED to CICERO AS SOON AS POSSIBLE REGARDLESS OF THE EXPIRATION DATE assigned to your current study.
For example, if your study expires February 2010, you must still convert it to CICERO before November 30, 2009 as you will have no means for submitting further transactions in BRAAN.
If you have a study in BRAAN, that has been determined to be “Exempt,” it does not have to be converted into CICERO unless you anticipate any modifications to the study after November 30, 2009.
If you need additional assistance with the conversion process, please view the instructional videos on the HRPO website:
http://medschool.umaryland.edu/ORAGS/hrpo/cicero.asp
Mission of the Human Research Protections Program (HRPP)
The mission of the UMB’s HRPP is to cultivate a culture of conscience in the research community to ensure the highest levels of protections and advocacy for research participants by:
» actively engaging and working cooperatively with the Institutional Official, Institutional leaders, and all components of the HRPP
» facilitating ethical and scientifically sound research institutional oversight and IRB review processes
» contributing to the knowledge of investigators and research personnel through education and training programs
» communicating with sponsors, and
» serving as a consistent resource for all current, past, and prospective participants.
The UMB HRPP and IRB Policy and Procedure Manual
August 15, 2008 Updated Version
CICERO - cicero.umaryland.edu
Comprehensive Institutional Collaborative Evaluation of Research On-line
As of December 1st, 2008, no new studies can be submitted in BRAAN. All new studies must be submitted in CICERO
Submit continuing reviews in CICERO 90 days prior to the BRAAN expiration date
Submit modifications and reportable events in BRAAN until that study has been converted into CICERO
BRAAN website will be accessible to view and print documents
Click here to view the 10 minute introductory video clip illustrating how to obtain an account along with the new features and functions of the site.
In response to your feedback about BRAAN and its limitations, we are bringing you a new electronic protocol management system called CICERO. This system was selected after extensive evaluation of 8 systems by key individuals and groups in the UMB research organization. It is the best product currently on the market and is in use by a variety of organizations. The new system is quite different from BRAAN. While the technology of CICERO is universal, it is being developed internally to meet the specific needs of the UMB research community. The system is flexible and can be modified and expanded as needs change.
To access CICERO, click here: cicero.umaryland.edu.
HRPO Newsletter
Download and read the Summer 2009 HRPO Newsletter.
If you have upcoming events, and other stories of a general nature. Email your submissions to hrpoeducation@som.umaryland.edu.
To receive periodic policy updates, monthly newsletters, and information on upcoming educational events from the Human Research Protections Office (HRPO), please subscribe here:
If you are using GroupWise, or if the button doesn't work for you, simply send an email to HRPOEducation@som.umaryland.edu with the words "Subscribe Me" in the subject line.
We will automatically add you to our list.
Contact Information:
The HRPO hours of operation are Monday – Friday 8:30 am – 4:30 pm.
University of Maryland School of Medicine
Human Research Protections Office
800 W. Baltimore Street, Suite 100
Baltimore, MD 21201
HRPO@som.umaryland.edu
Phone (410) 706-5037
Fax (410) 706-4189
Click HERE for a map to our new location.
To report emergency issues after office hours, please call the HRPO Main Office at 410-706-5037 for recorded instructions.
Peramivir IV
- Zanamivir (Relenza) Inhalation Powder
- Peramivir IV
- IV Formulation of Zanamivir (Relenza) is NOT APPROVED UNDER THE CURRENT EUA. If IV treatment is desired, this must be used in accordance UMB HRPP Policy I.5.C. Emergency Use of Investigational or Unlicensed Test Article.
- Contact the IRB at 410-706-5037 to let them know there is an Emergency Use for IV Zanamivir.
The UMMS Investigational Drug Service (IDS) has prepared INSTRUCTIONS for PROCUREMENT of these Agents. Click here to Download.
Please contact the IDS for questions and updates at 410-328-5468.
BRAAN will be INACTIVATED on November 30, 2009
As of 11:59 pm on Monday, November 30, 2009, BRAAN will be INACTIVATED and will be available as “Read Only.”
This means that YOU WILL BE UNABLE TO SUBMIT ANY TRANSACTIONS in BRAAN after that date. This includes new studies, continuing renewals, modifications, reportable events, and closure reports.
Therefore, ALL PROTOCOLS still active in BRAAN must be CONVERTED to CICERO AS SOON AS POSSIBLE REGARDLESS OF THE EXPIRATION DATE assigned to your current study.
For example, if your study expires February 2010, you must still convert it to CICERO before November 30, 2009 as you will have no means for submitting further transactions in BRAAN.
If you have a study in BRAAN, that has been determined to be “Exempt,” it does not have to be converted into CICERO unless you anticipate any modifications to the study after November 30, 2009.
If you need additional assistance with the conversion process, please view the instructional videos on the HRPO website:
http://medschool.umaryland.edu/ORAGS/hrpo/cicero.asp
Mission of the Human Research Protections Program (HRPP)
The mission of the UMB’s HRPP is to cultivate a culture of conscience in the research community to ensure the highest levels of protections and advocacy for research participants by:» actively engaging and working cooperatively with the Institutional Official, Institutional leaders, and all components of the HRPP
» facilitating ethical and scientifically sound research institutional oversight and IRB review processes
» contributing to the knowledge of investigators and research personnel through education and training programs
» communicating with sponsors, and
» serving as a consistent resource for all current, past, and prospective participants.
The UMB HRPP and IRB Policy and Procedure Manual
August 15, 2008 Updated Version
CICERO - cicero.umaryland.edu
As of December 1st, 2008, no new studies can be submitted in BRAAN. All new studies must be submitted in CICERO
Submit continuing reviews in CICERO 90 days prior to the BRAAN expiration date
Submit modifications and reportable events in BRAAN until that study has been converted into CICERO
BRAAN website will be accessible to view and print documents
Click here to view the 10 minute introductory video clip illustrating how to obtain an account along with the new features and functions of the site.
In response to your feedback about BRAAN and its limitations, we are bringing you a new electronic protocol management system called CICERO. This system was selected after extensive evaluation of 8 systems by key individuals and groups in the UMB research organization. It is the best product currently on the market and is in use by a variety of organizations. The new system is quite different from BRAAN. While the technology of CICERO is universal, it is being developed internally to meet the specific needs of the UMB research community. The system is flexible and can be modified and expanded as needs change.
To access CICERO, click here: cicero.umaryland.edu.
HRPO Newsletter
Download and read the Summer 2009 HRPO Newsletter.
If you have upcoming events, and other stories of a general nature. Email your submissions to hrpoeducation@som.umaryland.edu.
To receive periodic policy updates, monthly newsletters, and information on upcoming educational events from the Human Research Protections Office (HRPO), please subscribe here:
If you are using GroupWise, or if the button doesn't work for you, simply send an email to HRPOEducation@som.umaryland.edu with the words "Subscribe Me" in the subject line.
We will automatically add you to our list.
Contact Information:
The HRPO hours of operation are Monday – Friday 8:30 am – 4:30 pm.
University of Maryland School of Medicine
Human Research Protections Office
800 W. Baltimore Street, Suite 100
Baltimore, MD 21201
HRPO@som.umaryland.edu
Phone (410) 706-5037
Fax (410) 706-4189
Click HERE for a map to our new location.
To report emergency issues after office hours, please call the HRPO Main Office at 410-706-5037 for recorded instructions.
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