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                                                                                

POST APPROVAL MONITORING FORM

Word     PDF    Post Approval Monitoring Form

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 

Institutional Review Board (IRB) 

       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 [email protected].  Thank you!

Office of Regulatory 

Research Compliance

Howard University

Manhattan Bldg. 

1328 Florida Ave. NW 

Washington, D.C. 20009

Phone: (202)-865-8597

ORRC is located on the 

second floor of the Manhattan 

Building. 

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