The Review Process

All submissions are pre-reviewed by an IRB staff member who may provide feedback. The intent is to prepare the protocol for an expedited or full committee review.

Screenings for exemption are pre-reviewed and feedback may be provided, but they are approved by the Campus IRB Program Director or Associate Director.

Submissions may be sent to campusirb@duke.edu or directly to a staff member if you have already established a working relationship with them.

The review process, from pre-review to approval, generally takes about 4-6 weeks.

Choosing the Correct Form

There are five forms for initial review. Within the forms are links to attachments that may be required, for example, for researchers using prisoners as a target population.

Faculty, graduate students, post-docs, and staff should submit one of the following forms:

• Request for Protocol Approval
• Request for Protocol Approval for the Analysis of Existing Data
• Ethnography Form
• Request for a Screening for Exemption

Undergraduate students should submit one of the following forms:

• Undergraduate Student Request for Protocol Approval
• Request for Protocol Approval for the Analysis of Existing Data

If you have any question about which form to use, consult the IRB staff.

When to Submit New Protocols

Protocols that require full review must be submitted at least 2 weeks before scheduled IRB meetings. Protocols that may be expedited or screened for exemption may be submitted at any time.

Resources for Protocol Preparation

This site includes guides, samples, and FAQs to help researchers prepare new protocols.  We encourage you to contact us if you would like to meet in person to discuss your study.  We have office hours at Gross Hall on Thursday mornings, but will be happy to meet in our offices, elsewhere on campus, or a café near campus. We can also talk about projects over the phone or via email at any time.

Review Criteria

Expedited and Full Review

1. Informed consent will be sought from each prospective subject or the subject's legally authorized representative.
2. Informed consent will be appropriately documented.
3. Risks to subjects are minimized.
4. Risks to subjects are reasonable in relation to anticipated benefits.
5. Selection of subjects is equitable. Risks and benefits are fairly distributed among populations for which the results might be applicable.
6. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
7. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, developmentally challenged, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

Screening for Exemption

Exempt research is not subject to the provisions of the regulations, including the review criteria. However, it is subject to the ethical principles adopted by the University for conducting research with human subjects.  Therefore, informed consent is required.  Screening for exemption will 1) determine whether the research falls into a category of research eligible for exemption, and 2) evaluate the consent process. Basic information about the study needs to be provided so the consent process can be assessed.

In many cases, an oral consent process is acceptable; for some populations a written consent form may be more appropriate.

Certification

The Campus IRB certification requirement may be met in any of the following ways:

1. Attending at a class presentation or workshop conducted by IRB staff.
2. Completing CITI’s History and Ethical Principles module for social and behavioral sciences. (For instructions, see: Required Training)
3. Documenting Duke University Health System (DUHS) certification (for researchers who submit protocols to DUHS as well as to the Campus IRB)

Undergraduate students conducting summer research funded by a Duke program, center, or institute are required to meet with an IRB staff person to discuss their research and begin preparing their protocols.  These one-on-one meetings satisfy the certification requirement, although a staff member may ask that a study-relevant CITI module be completed as well.