Every new research project review shall begin with the investigator submitting a completed Protocol Application form (either the Application for Request for Exemption (DOC ) or Standard Application for Non-Exempt Research (DOC)) along with all required documentation attached. The review of a protocol application typically takes five to ten business days. If revisions are required to acquire approval and/or if additional documentation is required for the application to be complete, the process may take more time. In some instances, the entire membership of the IRB may need to discuss a protocol before a final decision can be made (see Non-Exempt Reviews: Full Board Review). This type of review might also cause the review period to be longer.
Note: Protocols should be submitted well in advance for projects to be carried out over the summer months, holiday breaks or during the first few weeks of the semester, as IRB members may not be available to review protocols at these times.
Federal Guidelines and the Davidson College IRB Policy permit certain types of research to proceed without IRB approval. However, this determination must be made by the IRB. See Request for Exemption for more details.
When a research project does not meet the criteria for being exempt from further review, it must be reviewed and approved by the IRB through either an expedited or full board procedure.
Under an Expedited Review procedure, review of certain types of research which meet the specified criteria may be carried out by the IRB Chair and by one or more experienced reviewers selected from members of the IRB (not Full Board) outside of the time of a convened IRB Committee meeting. Most applications submitted at Davidson qualify for an expedited review. See Non-Exempt Expedited Review for more details.
When an IRB reviewer determines that a study does not meet the criteria for Exempt or Expedited Review and is usually greater than minimal risk, a Full Board Review is requested. Some examples are: studies that could potentially put a person at risk of physical, legal, or social harm, even if the probability of that risk is small. See Non-Exempt Full Board Review for more details.
There are two types of review which might be required of a previously approved protocol:
A continuing review shall be performed once a year by the Institutional Review Board (IRB) for every ongoing human subject research project. See Continuing Review for more details.
A Notice of Approval from the IRB states that investigators must promptly report any proposed material changes in research activity to the IRB for evaluation and approval. See Request for Modification for more details.