Part 2: Submitting a protocol
The IRB reviews research protocols submitted by investigators. These protocols must describe the research activity and especially the plan for ensuring the protection of human subjects. The protocol form is available on-line at http://www.uwstout.edu/rs/humnsubjform.doc.
The IRB is unlikely to reject a protocol without first discussing its concerns about the research with the investigator. However, protocols may be deferred for a full-board review at an IRB meeting if substantial issues need to be resolved.
In general, protocols will include description and discussion of:
- Proposed research activity
- Potential risks to human subjects
- Anticipated benefits to subjects and society
- Subject selection, recruitment procedures, and anticipated number of subjects
- Proposed consent process
- Additional safeguards for working with potentially vulnerable subjects