Process

Research Reviewed by the DKU IRB

The DKU IRB reviews non-medical research, including behavioral interventions. It does not review medical interventions or any clinical or device studies

Social and behavioral scientists sometimes collect non-invasive physiological samples, for example, they may induce anxiety in a study of effective air filtration methods, and such studies may be reviewed by the DKU IRB. However, studies with the primary goal of collecting biological samples, for example, collecting cortisol, cannot be reviewed by DKU IRB.

The Process

Research with human subjects must be approved before any research activities begin. To secure approval you must submit a form describing your research in detail and attaching appendices such as research instruments and consent form.

The Form

Submit a Request for Protocol Approval (available here) to DKU IRB (dku-irb@dukekunshan.edu.cn).

Assurances

In addition to the description of your research plan, you will be asked to sign assurances about the conduct of the research. For example, you attest that you will conduct the research in accordance with the approved protocol and will report any unanticipated risks of harm to your subjects.

IRB Review

Each protocol will be assigned a primary reviewer who will be your primary contact for the IRB process.

All protocols will be reviewed using criteria developed to ensure the protection of research subjects.

When your protocol is reviewed, there are 4 possible outcomes. The protocol may be (1) approved with no changes, (2) approved pending the receipt of minor modifications, (3) deferred pending receipt of major modifications, or (4) disapproved. If a protocol is deferred that means that the protocol is too incomplete to be reviewed and will need significant revisions. The goal of the IRB is to work with researchers to help them secure approval; therefore, it is very unlikely that any protocols will be disapproved. Modifications, both minor and major, are very commonly requested. While DKU IRB will endeavor to deliver initial feedback to all researchers as quickly as possible (usually about 1 week from submission, with exceptions over summer and in between sessions), final approval can take a significant amount of time. For that reason please begin this process as far in advance of the planned research activity as possible.

Approval

When your protocol is approved, you will receive a formal approval letter via email. The notification will include an approved start date. That is when you can begin your research.

End Date

When your protocol is approved you will be given an expiration date, usually 12 months after the approval date. If you wish to continue the research beyond the expiration date, you may need to submit a Request to Renew an Approved Protocol. Requests to Amend an Approved Protocol must be submitted if you anticipate making any changes to your approved protocol. Do not implement changes without IRB Approval.