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Forms & Standard Language

 

 

e-IRB - ALL new studies, renewals, amendments, and safety events 

must be submitted via the e-IRB.

Forms are also available at the e-IRB web site.

If you need help logging in to the e-IRB,
please go to the e-IRB Home Page and click the Log in Help link.

If you are unable to access the e-IRB Home Page,
please call the DHTS Help Desk at 919-684-2243.

 

DUHS Principal Investigator Agreement:

This document outlines the basic responsibilities of a Principal Investigator (PI) at Duke.  It is a part of the eIRB submission form, and when the PI electronically signs off to submit a protocol in the eIRB, he or she is agreeing to assume the responsibilities belonging to a PI.

 

 

Standard Language

 
 
 
 

Submission Forms

Continuing Review Progress Report (revised version posted 10/23/2012)
Final Progress Report for Closure of an IRB-Approved Study
Pediatric Risk Assessment
IRB Personal Data Disclosure (revised version posted 07/31/2012)          Personal Data Disclosure Form Guidance
Research Summary Template and Instructions (revised version posted 07/31/09)
 
QI Summary Template and Instructions  (NEW - posted on 04/30/2013)
 
Telephone Script for MaestroCare Scheduling Prior to Consent  (NEW - posted on 7/24/2013)
 
 

Consent Form Templates and Tools

Sample Consent (revised version posted 10/22/2013)
 
Sample Consent - Spanish (revised version posted 10/22/2013)
 
Short Form Consent  (revised version posted 10/21/2013)
Short Form Consent - Spanish (Adults)  (revised version posted 10/21/2013)
Short Form Consent - Spanish (Minors)  (revised version posted 10/21/2013)
 
Database/Repository Consent  (revised version posted 10/21/2013)
Template M0345 for Adults  (revised version posted 09/11/2013)
Template M0345 for Minors  (revised version posted 09/11/2013)
HIPAA Language for Consent Forms
Common Consent Form Errors
 
 

Templates for Advertisements and Flyers 

Click directly above to see templates for study advertisements and flyers, developed by the Duke Medicine Office of Creative Services & Publications.  It is not required that you use these templates, just strongly suggested.
 
If you have questions about the templates, call Duke Medicine Creative Services:  919-419-3270.
 

Reporting to the IRB

Prompt Reporting (formerly UPIRTSO) Form - "Notification of a Problem or Event Requiring Prompt Reporting to the IRB as a New or Increased Risk" (Use this form only for "paper" studies that are not in the e-irb system.  If your study is in the e-irb system, please submit your problem or event requiring prompt reporting directly on-line in e-irb, by clicking on the Safety Events tab.)
 
Guidance on How to Complete the Prompt Reporting (formerly UPIRTSO) Form
 
Protocol Deviation/Violation Report (Use this form only for "paper" studies that are not in the e-irb system.  If your study is in the e-irb system, please submit your deviation/violation report directly on-line in e-irb, by clicking on the Safety Events tab.)
 
Notification of Nonreportable Adverse Events
 
 

Checklists

Consent Form Checklist
PI Checklist
Departmental Reviewer Checklist
 
Checklist to Determine If an IND Is Needed (for Investigators & Study Teams)   (revised version posted 01/31/2014)
Checklist to Determine If an IND Is Needed (for IRB Reviewer)   (revised version posted 01/31/2014)
 
 

Primary Reviewer Checklists

 
 

Waiver Requests

Waiver or Alteration of Consent and HIPAA Authorization
Waiver of Documentation of Informed Consent   (revised version posted 10/23/2013 - PI signature line at the end was removed)
Waiver of HIPAA Authorization
Waiver of Consent
Decedent Research Notification
 
Notification of Review Preparatory to Research (RPR)
 
 

Checklists for IRB Reviewers or Principal Investigators

Checklist for Expedited Review (for IRB Reviewer)
Checklist for Use of a Humanitarian Use Device (for IRB Reviewer or Principal Investigator)
Checklist to Determine if Research May Be Declared Exempt from IRB Review (for IRB Reviewer or Principal Investigator)
Checklist for Waiver of Requirement for Written Documentation of Informed Consent (for IRB Reviewer)
Checklist for Waiver or Alteration of Requirement to Obtain Informed Consent (for IRB Reviewer)
Checklist for Research Involving Adults Unable to Consent (for IRB Reviewer)
Checklist for Research Involving Cognitively Impaired Persons  (for the Principal Investigator)
Checklist on Adequate Provisions for Soliciting the Permission of Parents or Guardians and Checklist on Adequate Provisions for Soliciting the Assent of Children (for IRB Reviewer)
Checklist for Research Involving Prisoners (for IRB Reviewer)
Checklist for Review of Research Involving Children (for IRB Reviewer)
Checklist for Research Involving Neonates of Uncertain Viability, Placenta, Dead Fetus, or Fetal Material (for IRB Reviewer)
Checklist for Research Involving Pregnant Women or Fetuses (for IRB Reviewer)
 
Checklist for DoD-Supported Research  (posted 6-8-2011)
 
 

Pathology Review Form

Request for Department of Pathology Approval for Research Involving Human Tissues (REVISED - posted on 8-23-2013) (biopsies, resection, or excess/waste tissues)  As applicable to your protocol, complete this form and submit to Tom Dod, Dept. of Pathology, for their review and approval.  Then attach the completed form, indicating Dept. of Pathology approval, to your protocol submission in the eIRB. 
 
 

Duke Regional Hospital/Duke Raleigh Hospital Site-Specific Forms

Protocols involving the use of Duke Regional Hospital or Duke Raleigh Hospital facilities need to receive administrative approval from those hospitals, in addition to approval by the DUHS IRB. Please complete the following forms as applicable to your protocol and submit them to Duke Regional Hospital and/or Duke Raleigh Hospital, at the time you send in your IRB submission to the DUHS IRB.
 
Duke Regional Hospital (formerly Durham Regional Hospital)
Send all DRH forms to:                                        Scott Brewner
                                                                         Clinical Pharmacist
                                                                         Duke Regional Hospital 
                                                                         Phone:  919-470-4168
                                                                         Fax:  919-470-7384  (to the attention of Scott Brewner)                      
 
Duke Raleigh Hospital

Please contact Tracy Killette for any questions about DRaH review processes:

Tracy Killette, MJ
Administrative Director
Medical Staff Affairs
Duke Raleigh Hospital
3400 Wake Forest Road
Raleigh, NC 27609
Phone:  919-862-5965
Fax:  919-954-3828
 

 

 

 
 
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