B. Specific Aims/Study Objectives

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 protocol submitted for IRB review

General Considerations
Research Plan Content 
Instructions
Appendices to the Research Plan

 

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).

B. Specific Aims/Study Objectives

The IRB must evaluate the objectives of the research in order to determine whether the risks to participants are reasonable in relation to the importance of the knowledge that may be gained.

  • Clearly outline the specific research question(s). Include the study objective(s) and/or hypothesis.