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Forms

Current forms related to the Duke Health IRB and Human Research Protection Program (HRPP) are located here. Click on the drop-down menu below, and you can search for forms in the following categories:

  • Advertisement and Flyer Templates
  • Continuing Review Forms
  • Consent Form Templates
  • IDE Billing Notice
  • Outside Duke Key Personnel Form
  • Research Summary Instructions and Templates
  • Review Preparatory to Research (RPR) Form
  • Telephone Scripts
  • Waivers
  • Specialty Committee Review Forms
  • CRU/Departmental Checklists
  • IRB Primary Reviewer Checklists
  • IRB Reviewer Checklists
  • Principal Investigator Checklists

Decedent Research Notification

Waivers

Please note in iRIS this form is no longer uploaded but part of the application.

In accordance with 45CFR164.512(i)(1)(iii), the IRB must approve research involving decedent's private health information.  In order for the IRB to make the determination, this is the form to be completed.

DUHS Research Summary Instructions and Template (This is the generic required template)

Research Summary Instructions and Templates

Please note in iRIS this form is no longer uploaded but part of the application.

This is the regular (generic) research summary template which is required  for all regular applications (unless your protocol fits under the other research summary templates in this category).  Use of these instructions is helpful for ensuring that the research summary contains all necessary elements.

DUHS Sample Consent

Consent Form Templates

Required DUHS Sample Consent - containing all required elements of consent and HIPAA authorization.

Please do not write in, or modify, the footer.

We have now separated the sample consent form into an Adult version and a Minor version.

Click Here for examples of the concise summary that must appear at the top of the consent form.

DUHS Sample Consent (Spanish)

Consent Form Templates

Required DUHS Sample Consent (Spanish) which contains all required elements of consent and HIPAA authorization.

Duke Raleigh Hospital Site-Specific Form (for Study Team)

Specialty Committee Review Forms

Protocols involving the use of Duke Raleigh Hospital (DRaH) need to receive administrative approval from this hospital, in addition to approval by the DUHS IRB. Please complete the following forms as applicable to your protocol and submit them to Duke Raleigh Hospital at the time you send in your IRB submission to the DUHS IRB.

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

Duke Regional Hospital Site-Specific Forms (for Study Team)

Specialty Committee Review Forms

Protocols involving the use of Duke Regional Hospital (DRH) need to receive administrative approval from this hospital, 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 at the time you send in your IRB submission to the DUHS IRB.

Send all DRH forms to Lynn Whitt:                                        
Lynn Whitt, PharmD, MHA
Duke Regional Hospital
Pharmacy Director
919-470-4172 (office)  lynn.whitt@dm.duke.edu
 

Duke University School of Nursing (DUSON) CRU Reviewer Checklist

CRU/Departmental Checklists

Duke University School of Nursing (DUSON) CRU reviewer checklist

Education Research Projects-Summary Template and Instructions

Research Summary Instructions and Templates

Please note in iRIS this form is no longer uploaded but part of the application.

Education research projects include evaluation of teaching sessions, curricula, courses, programs, simulations and surveys that represent an important means by which Duke University and Duke University Hospital/Health System (DUHS) achieves its mission of training health professionals to provide effective and safe care for their patients, loved ones and each other.  Education research projects range in scope from local efforts to improve the quality of teaching to larger trials of innovative methods designed for a more generalizable impact. Regardless of the project’s size, the education project leader(s) must determine whether the project meets the federal definition of research with humans.  If it does, the leader(s) must then consider whether the research may qualify for exemption from further review by the DUHS Institutional Review Board, and if so, consider requesting such an exemption.

Exemption Checklist

IRB Reviewer Checklists
Principal Investigator Checklists

This checklist helps Investigators and IRB Reviewers assess whether an activity constitutes research involving human subjects, and whether that activity is subject to IRB oversight. To request an exemption, the study team must submit the project in iRIS and choose the Application for Exemption from IRB Review option under application type.

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