Office of Regulatory  Research Compliance 

Howard University
HU Research Bldg 1
1840 7th Street, NW
Suite 309
Washington, D.C. 20001

Phone: (202) 865-8597
Fax:     (202) 232-5286

ORRC is located directly across  from the Howard University  Shaw Metro  on 7th Seventh St.(Georgia Ave) on the third floor       of  the Howard University    Research Building-1.


MAINTAINING CONTINUOUS IRB APPROVAL:

Maintaining continuous IRB approval for a study is the responsibility of the Principal Investigator and the study team. It is important to note that if you allow your study’s IRB approval to lapse, you, the IRB, and Howard University as an institution are considered to be out of compliance with federal regulations.

WHAT IS THE EXPIRATION DATE?

The date noted in your approval notification – the date stamped on your consent documents by the ORRC. The expiration date represents the first date that your study is no longer approved. 

WHAT HAPPENS WHEN MY STUDY EXPIRES?

At the time of expiration of IRB approval, all study activities, including recruitment, consent, data collection, and data analysis, MUST STOP. If certain activities must be continued to ensure the safety of the participants, you must contact the ORRC to request permission to continue those activities until IRB approval is reinstated. You cannot proceed until you have a written approval to do so.  

HOW TO ENSURE THAT YOUR STUDY’S IRB APPROVAL IS MAINTAINED:

1.60 to 45 calendar days prior to expiration date: Submit your renewal application to the ORRC 
2.30 calendar days prior to expiration date: Contact the ORRC immediately. It might be too late for you to submit a continuation request. You might have to submit a deviation/violation report. You might have to submit a new application for approval.     

TO HELP YOU MAINTAIN CONTINUOUS IRB APPROVAL:

ORRC staff will send a Notice of Expiration of Approval to the principal investigator beginning in November 2012. This notice will be sent approximately 90, 60, and 30 days prior to the expiration of the approval. Renewal requests must be submitted to the ORRC 90 days before the approval expiration date. Once approval has expired, the project will be inactivated. Once a project's approval has expired, a new application MUST be completed for review and approval before research can resume. It is very important for investigators to follow their approved protocols. If a protocol is not followed as approved, the IRB may suspend those activities.


Approval for expedited and full review studies is granted for a maximum of one year. Exempt studies are granted an exemption determination for a period of one (1) year. 

The ORRC attempts to reach all investigators prior to the approval expiration date. However, principal investigators are responsible for ensuring their approval does not lapse. 









Is it Research?
Involve Human Subject?
Qualify for Exempt?
Qualify for Expedited?
Waiver
Other Resources
Case Report
Recruitment Flyer

Home
Home
Home
Home
Home
Home
Home
Home
Institutional Review Board (IRB) 
Home
Home
Home
Home
Home
Home
Home
Home
Home
Office of Regulatory Research Compliance
Home