Protocol Guidance

Version Date: July 24, 2008

Elements of a Protocol guidance

The Health Sciences IRBs now require the submission of a formal protocol for research studies submitted using an Application for Initial Review for Research Involving Human Subjects.  Formal protocols are being required in order to facilitate scientific review of the research study.  For some studies, the protocol may be brief.  Below is guidance regarding the elements that should be included in protocols for most research studies.  These guidelines are based on the National Institutes of Health and National Science Foundation grant applications. For further assistance in drafting a protocol, please see ICTR's Protocol Templates

Protocols are not required for Applications for Initial Review for Research Involving Human Subjects that are limited to seeking approval for the purposes of a grant (e.g., core or training).  In the case where the UW is serving as a reading center, a data analysis center, or sample analysis center, the protocol for the study for which UW is acting in a supportive role should be provided.  If a formal protocol already has been developed for a research study, please ensure that the elements identified below are addressed.

See Also: