Institutional Review Board
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Forms & Standard Language

 

 

e-IRB - All renewals started after 4/15/2008 and all new studies 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 684-2243.

 

DUHS Principal Investigator Agreement *New*(see news on the 

e-IRB home page for information about the new PI Agreement)

 

Safety Event Reporting *New* (see the news on the e-IRB home page -- Changes Coming to Safety Event Forms April 1st)

 

Standard Language

 
Standard Language for Consent Forms - English
Standard Language for Consent Forms - Spanish
 
 

Submission Forms

Amendment
Final Progress Report for Closure of an IRB-Approved Study
Re-Open Request
Pediatric Risk Assessment
IRB Personal Data Disclosure                         Personal Data Disclosure Form Guidance
Advertisement                                              Advertisement Guidelines
Database/Repository Renewal
Research Summary Template and Instructions (revised version posted 07/31/09)
 
 

Consent Form Templates and Tools

Sample Consent (revised version posted 01/02/09)
Sample Consent - with yellow-highlighted changes, as presented at Dec 2008 Workshop (this version with yellow highlighting is posted as an informational tool only)
Sample Consent - Spanish
Short Form Consent
Short Form Consent - Spanish
Database/Repository Consent
Template M0345 for Adults
Template M0345 for Minors
HIPAA Language for Consent Forms
Common Consent Form Errors
 
 

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)
Checklist to Determine If an IND Is Needed (for IRB Reviewer)
 
 

Primary Reviewer Checklists

 
 

Waiver Requests

Waiver or Alteration of Consent and HIPAA Authorization
Waiver of Documentation of Informed Consent
Waiver of HIPAA Authorization
Waiver of Consent
Decedent Research Notification
 
Notification of Review Preparatory to Research (RPR)
 
 

Checklists for IRB Reviewers

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 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)
 

Durham Regional Hospital/Duke Raleigh Hospital Site-Specific Forms

Protocols involving the use of Durham Regional Hospital/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 Durham Regional Hospital and/or Duke Raleigh Hospital, at the time you send in your IRB submission to the DUHS IRB.
 
Durham Regional Hospital
Send the four DRH forms to:                                Lynn Whitt, PharmD
                                                                         Director of Pharmacy
                                                                         Durham Regional Hospital 
                                                                         Telephone: 919-470-4172
                                                                         Fax: 919-470-7384                      
 
Duke Raleigh Hospital
 

 

 

 
 
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