Summary
Highlights
The IRB is an administrative body that protects the rights and welfare of human subjects in research studies. Its primary role is to ensure that proposed research methods are ethical. The Duke University Health System IRB reviews various elements, including initial study submissions, continuing reviews, amendments, advertisements, adverse events, and non-compliance issues.
Research projects with human subjects require IRB review. There are three types: full, exempt, and expedited. A full review is for studies with significant deception or high risk and takes 3-6 weeks. An exempt review, typically 5-7 business days, is granted by the IRB for minimal risk studies. An expedited review, taking 2-3 weeks, is for activities with no more than minimal risk and specific procedures listed in the federal register.
Even if a PI believes a study qualifies for exemption, a new study application must be submitted to the IRB for declaration of exemption. Study activities cannot begin without written notice of exemption. The video lists eight types of exemptions, covering educational settings, surveys, benign behavioral interventions, and data/specimen collection. Maintaining continuous IRB approval is the responsibility of the Principal Investigator and study team, as lapse in approval leads to non-compliance.
The Grant and Contract Administrator (GCA) is responsible for various tasks related to IRB protocols. At the proposal stage, GCAs ensure appropriate effort for CRU staff and fill out waiver forms if necessary. They must also list the IRB status as 'pending' in SBS for new proposals and 'approved' for non-competing renewals. At the 'just in time' or pre-award stage, GCAs compile personnel lists, confirm CITI training, and provide required documentation to sponsors.
CITI (Collaborative Institutional Training Initiative) provides research ethics education. All Duke Health researchers must complete specific web-based biomedical modules for human subjects protection. This training is administered and tracked by the Duke Office of Clinical Research (DOCR). Training must be completed before protocols can be submitted to the IRB. Completion can be verified using the Research Compliance Tracker on the radapps.duke.edu website, and a verification letter is required for 'just in time' information.
To confirm an approved protocol, the PI or study coordinator should provide a copy of the congruency approval letter. The GCA must verify that the information on the letter (title, name, grant ID) matches the proposal, save a copy in the grants protocol folder, and update SPS with the approval information. The video provides an example of an IRB approval notification, highlighting the importance of recent dates and matching grant details.
The IACUC oversees the use of vertebrate animals in research, ensuring appropriate use and humane care. Its primary duty is protocol review, conducting thorough and comprehensive reviews of all new proposals and amendments. An IACUC protocol is a complete description of animal care and use activities conducted or supported by Duke involving live vertebrate animals or cephalopods for research, testing, or training.
IACUC protocols are reviewed by Full Committee Review (FCR) or Designated Member Review (DMR) at least every three years. Annual reviews are required for protocols using USDA regulated species or funded by VA. Tri-annual reviews restart the approval cycle. Animal activity cannot begin until the PI receives written or verbal approval. Amendments to approved protocols also require review, depending on their nature, via FCR, DMR, Veterinary Verification and Consultation (VVC), or administrative review.
For new proposals involving vertebrate animals, the status in SPS must be 'pending' even if an existing protocol is used. Once concordance approval is received, the status can be updated to 'approved'. Non-competing renewals require active and approved IACUC assurances. The IACUC must review grant applications involving animals before an award. Animal work cannot begin without IACUC approval. PIs with existing protocols can request a grant or award congruency review.
If animal activity is performed outside the United States by a domestic institution, PHS animal welfare requirements apply. The awardee remains responsible and must provide verification of IACUC approval, certifying that the activity at the foreign site is acceptable. The awardee's IACUC may accept the foreign entity's IACUC approval but remains responsible for the review. IACUCs must review research protocols at least every three years, and administrative extensions beyond this period are not permitted; expired protocols lack valid approval, which is a serious violation.