A. Introduction and Background

Research Plan Content

The purpose of the Research Plan is to describe the proposed research in sufficient detail so that the Institutional Review Board (IRB) can determine if approval criteria for human subjects research defined in federal regulations (45 CFR Part 46 and 21 CFR Parts 50, 56, 312 and 812) is met.

The Research Plan is a narrative of the study and is a living document to be maintained over the life of the protocol. A Research Plan is required for every non-exempt project submitted for IRB review. It is also highly encouraged for exempt projects.

Print Research Plan Guidance

The Research Plan is a narrative of the study and is a living document to be maintained over the life of the protocol. A Research Plan is required for every protocol submitted for IRB review.

  • When drafting the Research Plan, follow the format and use the section headings (i.e. A – I) provided below, refer to the bulleted items for section content.
  • For each section, this guidance includes a description of why the information is important for IRB review (in italics).

A. Introduction and Background

In reviewing the protocol, the IRB must consider the rationale for the study and the importance of the knowledge that may reasonably be expected to result.
  • Briefly summarize the nature, scientific or scholarly rationale and significance of the proposed study and any relevant background information on the topic. Explain the relevance of the study to previous and/or continuing work in the field. Discuss why novel inquiry is necessary. If there is a gap in knowledge, explain how it is anticipated that this research will address the gap. If this research is intended to replicate previous research, provide rationale.