Current policies related to the Duke Health IRB and Human Research Protection Program (HRPP) are located here. View the complete list of policies.The policies are below, and you can search for policies in the following categories:
Appropriate Study Personnel to Conduct the Consent Process
This policy describes the requirements for a study team member to conduct the consent process in a research study over which the DUHS Institutional Review Board (IRB) serves as the IRB-of-Record. The requirements described in this policy also apply to any study conducted by a Duke investigator that has external IRB oversight.
Consent and Its Documentation
This policy discusses the various methods and processes for obtaining and documenting informed consent, including use of the short form consent. The policy also presents a listing of the basic elements of consent, as specified in federal regulations.
Consent Monitoring
The policy describes the IRB's authority to observe or monitor the consent process, and discusses the kinds of research for which such monitoring may be especially appropriate.
IRB Approval Stamp on Consent Forms
The policy explains the absence of a formal IRB stamp on the consent form. The iRIS-generated footer on the bottom of each page of the consent form serves as the IRB approval stamp or watermark.
Legally Authorized Representative (LAR)
The policy defines a Legally Authorized Representative (LAR) and describes Investigator and IRB considerations for using the LAR in research.
Placement of a Research Consent Form in the Participant's Medical Record
This policy defines when the research consent form should be filed within the participant's medical record and when it should not be placed there.
Translation Policy
The policy describes requirements related to the informed consent process in research involving participants who speaks a language other than English. The policy discusses translation requirements, documents needed for IRB review, and use of the short and long form consents.
Undergraduates Conducting the Consent Process
This policy outlines the limited circumstances under which Duke undergraduate students (work-study, unpaid, or engaged in research for class credit) may conduct the informed consent process, as part of studies submitted to the DUHS IRB. The policy discusses the training required before undergraduates may conduct the consent process, and the oversight required for these students.
Waivers or Alteration of Consent & HIPAA Authorization
This policy defines when the IRB can approve a waiver of informed consent and HIPAA authorization. The policy also outlines the requirements for a waiver of documentation of consent, thus waiving the requirement for the investigator to obtain a signed and dated consent form for some or all participants.