Institutional Review Board (IRB)
Request for Continuation Approval of Protocol

Date Rec’d in HSO                                 
Instructions:     Use this form when submitting protocols for continuing review.  Review is required AT LEAST annually; however, the IRB may have determined that your protocol will need to be reviewed more often.  Please submit this form electronically along with the current consent form and a copy of the protocol (if changed since last year) and any supporting documents (if changed since last year) to the CIO designated staff official.  However, if submitted in hardcopy, please send the original and three copies all documents to the CIO designated official.  Consecutively number ALL pages, beginning with the title page of the protocol (if applicable), followed by any consent form(s) and any applicable ancillary documents. Complete all applicable items or the form will be returned.		

Date Submitted by Investigator:                                           	Protocol No.                                 
	
Title of Protocol:                                                                                                                                                        		
Proposed Dates for Project - Begin:                                                      End:                                                              		
Name of CDC Employee Serving as Principal Investigator (PI) and Degrees:
                                                                                                                                                                                    
9 Check if PI has changed		
Scientific Ethics Verification No.:                              Telephone:                                  Fax:                                      
CIO:                  Division:                  MS:                   Email Address:                                                                      		
Names of Other CDC Employee Co-investigators (use supplemental page if > than 3):		
1.                                                                                 Scientific Ethics Verification No.:                                           		
2.                                                                                 Scientific Ethics Verification No.:                                           		
3.                                                                                 Scientific Ethics Verification No.:                                           		
1.  Current Status	
            Study not yet begun (Provide explanation in item 5.  Complete item 8, if applicable)	
            Active research; contact with subjects continuing (Complete items 2-10)	
            Active research with subjects completed; study activities involve only data analysis and/or report writing                (Complete items 2,5,6,7,8 & 10)	
            Study does not involve contact with subjects (e.g., research using existing records); study  activities                        involve only data analysis and/or report writing (Complete items 5,6,7,10)	
2.  Study Population (If an international study, provide race/ethnicity of subjects by percentages: 
                                                                                                                                                                                    		
            Enrolled this past year	For individuals who were enrolled this year:

Gender distribution:
            % Female                      % Male	
            Total number of subjects to date		
            Declined enrollment this past year		
            Withdrawn from project this past year		
		
Race/ethnicity distribution of enrolled subjects for domestic studies:		
            % American Indian or Alaskan Native
            % Asian or Pacific Islander
            % Black or African American, not of Hispanic                            origin	            % Hispanic
            % White, not of Hispanic Origin	
Vulnerable Populations Have any of these populations been added to the study?             YES              NO
(If YES, please check all that apply):		
            Pregnant women (as a SPECIFIC target group)
            Fetuses (Ref: 45CFR46, Subpart B)
            Prisoners (Ref: 45CFR46, Subpart C)	            Children 17 years of age or younger 
               (Ref: 45CFR46, Subpart D)
            Mentally disabled
            Educationally or economically disadvantaged	
3.  Collaborating Sites (Use additional sheets if necessary):
3a.  List any collaborating sites by name and location (including state) that were added since last continuation
       approval:		
            None added	OPRR Assurance No.:	
1.		
2.		
3.		
4.		
5.		
3b.  List any collaborating sites by name and location (including state) that were deleted since last continuation
       approval:		
            None deleted		
1.		
2.		
3.		
4.		
5.		
4.  Funding (check one):	

            PGO Funding Mechanism Used:	
                        Cooperative Agreement No(s).:                                                                                                          	
                        Contract No(s).:                                                                                                                                  	
                        Grant:                                                                                                                                                  	
                        Purchase Order (a.k.a. Simplified Acquisition):	
            Other funding mechanism:	
                        Memorandum of Understanding (MOU) (With whom):                                                                    	
                        Interagency Agreement (IAA) (Name of other agency):                                                                    	
                        Other (Specify type and with whom):                                                                                                 	
            Only CDC investigators performing study	
            Collaborative (Non-CDC investigators & CDC investigators; no funding involved)	
5. Summary of Activities to Date (Use additional sheets as necessary):

	
6.  Summary of Study Modifications Reviewed and Approved This Past Year (Use additional sheets as  necessary):
            None

	
7.  Summary of Any New Literature, Findings, or Other Relevant Information (Use addition sheets as necessary):
            None

	
8.  Summary of Adverse Events or Unanticipated Problems (Use additional sheets as necessary):
            None

	
9.  Consent Documents (Attach a copy of each current consent form, telephone consent text, and/or                      consent letter):	
10. Summary of Remaining Activities (Use additional sheets as necessary):

	
Approvals (Signature and Position Title):	Date:	Remarks:	
Branch Chief:
			
Division Director:
			
CIO Human Subjects Contact: