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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

Short Form Consent

Consent Form Templates

The federal regulations at 45 CFR 46.117(b)(2) and 21 CFR 50.27(b)(2) permit the use of a short form consent document stating that the required elements of informed consent have been presented to the subject or the subject’s legally authorized representative orally, with a witness present. Within DUHS use of a short form consent document is largely  limited to two situations:

  • when English is not understandable to a potential research subject who is considering whether to participate in a research study, and the investigator does not have an IRB-approved consent document translated into a language understandable to the potential subject, or
  • in the very unusual situation when the window of opportunity for a subject to benefit from research participation is brief, and the IRB finds that by use of the short form consent document the subject or the subject’s legally authorized representative will have sufficient opportunity to comprehend the nature of the study and the risks and benefits associated with the study to make an informed decision about study participation.

Please note the use of a “short form” also requires an alteration of HIPAA authorization unless all elements of a valid authorization are included in the “short form”.

Short Form Consent - Spanish (Adults)

Consent Form Templates

Short form consent in Spanish (Adults) 

The federal regulations at 45 CFR 46.117(b)(2) and 21 CFR 50.27(b)(2) permit the use of a short form consent document stating that the required elements of informed consent have been presented to the subject or the subject’s legally authorized representative orally, with a witness present. Within DUHS use of a short form consent document is largely  limited to two situations:

  • when English is not understandable to a potential research subject who is considering whether to participate in a research study, and the investigator does not have an IRB-approved consent document translated into a language understandable to the potential subject, or
  • in the very unusual situation when the window of opportunity for a subject to benefit from research participation is brief, and the IRB finds that by use of the short form consent document the subject or the subject’s legally authorized representative will have sufficient opportunity to comprehend the nature of the study and the risks and benefits associated with the study to make an informed decision about study participation.

Please note the use of a “short form” also requires an alteration of HIPAA authorization unless all elements of a valid authorization are included in the “short form”.

Short Form Consent - Spanish (Minors)

Consent Form Templates

Short form consent in Spanish (Minors).

The federal regulations at 45 CFR 46.117(b)(2) and 21 CFR 50.27(b)(2) permit the use of a short form consent document stating that the required elements of informed consent have been presented to the subject or the subject’s legally authorized representative orally, with a witness present. Within DUHS use of a short form consent document is largely  limited to two situations:

  • when English is not understandable to a potential research subject who is considering whether to participate in a research study, and the investigator does not have an IRB-approved consent document translated into a language understandable to the potential subject, or
  • in the very unusual situation when the window of opportunity for a subject to benefit from research participation is brief, and the IRB finds that by use of the short form consent document the subject or the subject’s legally authorized representative will have sufficient opportunity to comprehend the nature of the study and the risks and benefits associated with the study to make an informed decision about study participation.

Please note the use of a “short form” also requires an alteration of HIPAA authorization unless all elements of a valid authorization are included in the “short form”.

Suggested Format and Content for Telephone Scripts

Telephone Scripts

This is a suggested format for telephone scripts to screen potential subjects when identifiable private information, including protected health information, will be recorded or written.

VA Disclaimer to be added to Duke research recruitment materials

Advertisement & Flyer Templates

Duke IRB approved research related to Veterans may be posted at the Durham VA Medical Center. Recruitment materials must include the disclaimer (see below in bold) and must be reviewed and approved by the Durham VAMC Research Office prior to being posted on VA premises.  Contact the Durham VAMC Research Office for more information, (919) 286-0411 extension 4726.

This is not VA research, will not be conducted by VA, has not been reviewed by VA's Institutional Review Board, and is not endorsed by VA. VA is not responsible for any costs incurred by a Veteran if the Veteran enters the study as a research subject. The announcement is being provided for information only. APPROVED:________(insert approval date)

Waiver of Documentation of Informed Consent

Waivers

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

Waiver or Alteration of Consent and/or HIPAA Authorization

Waivers

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

This is the most commonly used type of waiver.  Over 90% of the time, this is the waiver form that will be appropriate for your study.

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