INSTRUCTIONS AND GUIDANCE

Word     PDF       Ethical Guidelines and Principles                                                                                             

Word     PDF       Guidance for Faculty/Research Staff on How to Submit                                                                

Word     PDF       Guidance for Students on How to Submit                                                                                                         

Word     PDF       IRB Categories of Review (Expedited, Exempt, Full Board, etc.)                                                                     

Word     PDF       Checklists for Form Submission                                                                                                                      

CONSENT DOCUMENTS

Word     PDF      HU-IRB Instruction for Preparing Consent Documents 

PREAMBLE TEMPLATE    

Word      PDF      Sample Survey and or  Interview Preamble 7-11-19                                                     

CONFLICT OF INTEREST DISCLOSURE STATEMENT

Word     PDF      Conflict of Interest Disclosure Statement                                                                                

PRINCIPAL INVESTIGATOR ASSURANCE FORM

Word    PDF       Principal Investigator Assurance Form                                                                                    

FORMS FOR GREATER THAN MINIMAL RISK STUDIES

Word    PDF    Form A1: For studies with Greater than Minimal Risk                                                                           

Word    PDF    Form A2: Renewal/Continuation for A1 Studies                                                                                   

FORMS FOR CHART REVIEWS/MEDICAL DATA

Word                   Form B1: HIPAA/Chart Review Form                                                                                                  

Word    PDF        Cancer Registry Data Request Pre-Interview Form                                                                

Word    PDF        Cancer Registry Data Request Applications                                                                           

Word    PDF        Cancer Registry Available Data Fields                                                                                    

FORMS FOR MINIMAL RISK STUDIES

Word      PDF     Form C1: For Studies with Minimal Risk Studies                                                                         

Word      PDF      Form C2: Renewal/Continuation of C1 Studies                                                                               


EXEMPT STUDIES/NON-HUMAN PARTICIPANTS/DATA

Word      PDF      Form D1: Request for Exemption (Non-Research/Not Involving Humans)                                       

IRB INFORMATION

Word      PDF       HU-HPS Development                                                                                                               

Word      PDF       Standard Operating Procedures                                                                                                 

NOTIFICATION OF PROTOCOL DEVIATION AND MODIFICATION FORMS

Word      PDF       Notification of Protocol Development/Violation Form                                                                  

Word      PDF       Modification Form                                                                                                                        

NOTIFICATION OF EXCLUSION FORMS

Word      PDF       Notification of Exclusion Form                                                                                                      

SUPPLEMENTAL FORMS

Word      PDF    Supplemental Form E: Waiver of Informed Consent                                                                               
                                                                                                                                                                                                                                                                                                            
Word      PDF    Supplemental Form F: Waiver of Doc of IC                                                                                              

Word      PDF    Supplemental Form G: HIPAA DE-Identification Certification Form                                                                                    

Word      PDF    Supplemental Form H: Pregnant Women Neonates Fetuses                                                                                     

Word      PDF    Supplemental Form I: Prisoners                                                                                                            

Word      PDF     Supplemental Form J: Children                                                                                                      

Word      PDF     K1 Assent Form                                                                                                                                  
                                                                                                                                                                                                        
IBC DETERMINATION FORM

Word      PDF    IBC Determination Form

​SERIOUS ADVERSE EVENT (SAE) REPORTING FORM

Word     PDF     SAE Reporting Form
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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.

Institutional Review Board (IRB) 
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       Office of Regulatory Research Compliance
​                     IRB Forms and Tools

​The forms below are the most common documents used to manage research that include the use of human subjects.  







Please make sure that you have the lastest version of Adobe Reader.
Please Note: IRB is requesting that ALL investigators (principal, student, study coordinators) to not take snapshot pictures of their D1 Exclusion application and email us. All IRB applications should be scanned to theorrc@howard.edu.  Thank you!
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