The protocol description is a BRIEF summary that describes the specific objectives of the proposed research in plain language understandable to all DOH IRB committee members.
Write in plain language, and translate technical terms into easily understood langauge. Avoid using jargon, technical terms, or scientific language.
The description should be written in a way that is understandable to members from the local community, non-scientists, as well as scientists with varied backgrounds.
For consistency in the review of research, the DOH IRB requires that research plans be submitted in the form of a research protocol. A protocol serves as the reference point for review of a DOH IRB application. The IRBWise application is not intended to serve as the research protocol/plan; rather, it is an overview of the proposed project.
Investigators must attach a research protocol that provides information sufficient to allow the IRB to make required regulatory determinations. Information in the protocol should include, but not necessarily be limited to the following:
background
rationale and specific aims
description of research methods
inclusion/exclusion criteria
enrollment and retention plans
study procedures
plans for safety monitoring
plans for reporting problems
plans for follow-up and providing information to participants