IRB Review Process

Loading...

Pre-review & Feedback

To prepare for committee review, the IRB pre-reviews applications and provides feedback. Here they screen exemption requests, which require approval from the IRB Program Director or Associate Director.

Loading...

Review

Protocols are reviewed by Campus IRB Staff or the IRB Review Board.

The review process generally takes about 4-6 weeks. 

Loading...

Approval

After IRB review, the PI and other personnel requesting notifications will receive a notice from the IRB regarding project approval. Engagement with human subjects or their data may only begin once the IRB has approved the project.


Choosing the Correct Form

 

When to Submit New Protocols

  • Protocols requiring full review must be submitted at least 2 weeks before scheduled IRB meetings.
  • Protocols eligible for expedited review or exemption screening can be submitted at any time.

Resources for Protocol Preparation

  • This site offers guides, samples, and FAQs to help researchers prepare new protocols.
  • We encourage in-person meetings to discuss your study. Office hours are available at Gross Hall on Thursday mornings, or we can arrange another location and time.
  • Reach out via phone or email at your convenience.

Review Criteria for Expedited and Full Reviews

  • Informed consent will be sought and appropriately documented.
  • Risks to subjects are minimized and reasonable relative to anticipated benefits.
  • Subject selection is equitable, ensuring fair distribution of risks and benefits.
  • Adequate provisions are in place to protect subject privacy and data confidentiality.
  • For vulnerable subjects, additional safeguards are included to protect their rights and welfare.

Screening for Exemption

  • Exempt research is not subject to the regulations, but must adhere to the University’s ethical principles for human subject research.
  • Exemption screening determines research eligibility for exemption and evaluates the consent process, which can be oral or written, depending on the population.

Certification Requirements

Meet the Campus IRB certification requirement through one of the following:

  1. Attend a class presentation or workshop conducted by IRB staff.
  2. Complete CITI’s History and Ethical Principles module for social and behavioral sciences (see: Required Training).
  3. Document Duke University Health System (DUHS) certification (for researchers submitting protocols to both DUHS and the Campus IRB).

Special Note for Undergraduate Summer Researchers

Undergraduates conducting summer research funded by a Duke program are required to meet with an IRB staff person to discuss their research and start preparing their protocols. These meetings satisfy the certification requirement, although additional CITI module completion may be required by a staff member.