This page provides the information needed to develop a well-designed Research Plan to submit for Institutional Review Board (IRB) review. The purpose of the Research Plan is to describe the proposed research in sufficient detail so that the IRB can determine if approval criteria for human subjects research defined in federal regulations is met (45 CFR Part 46 and 21 CFR Parts 50, 56, 312 and 812)

Overview

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.

The guidance on this page attempts to account for different types of research from varying disciplines, but some aspects may not be relevant to a particular research area, or details relative to a particular research area might not be reflected in this guidance.

See the Research Compliance Services (RCS) website and the Guidance Library for additional topical guidance, details about how to submit through the Research Administration Portal (RAP), and other resources. Be sure to incorporate relevant information from relevant guidance into the Research Plan. RCS staff are available to discuss your project and to assist you in addressing relevant information in your research plan. Contact RCS by emailing researchcompliance@uoregon.edu, by calling 541-346-2510 or by attending remote office hours.

Timing

For non-exempt studies, the Research Plan must be submitted with the initial application. If proposing a change to the study, update the Research Plan and get IRB approval through a modification before implementing the changes.

Design and Content

• Start your plan from scratch
  • We understand that studies conducted by a specific researcher or lab may be similar. We strongly recommend against copy/pasting research plans for use as a base document. Copy/paste artifacts in study materials cause confusion and inconsistencies that can delay the review process.
• Don't rely on information from grant applications oly
  • Funding proposals often have some information relevant to human subjects protections but do not have the level of detail needed for IRB review and should not be used in lieu of a complete research plan. Please avoid submitting grant applications/proposals instead of a research plan. Research plans must be able to be revised if needed during IRB review and we advise against providing too much granular detail about human research protections in your grant proposals if not required as it can create inconsistencies between grant materials and the materials ultimately reviewed and approved by the IRB.
• Focus your plan on the research
  • The focus of the Research Plan should be the activities taking place between the investigator(s) and the participants/subjects for research purposes. When applicable, please ensure the research plan clearly notes which activities/procedures would otherwise occur regardless of the research, which activities/procedures are taking place solely for research purposes and how the research impacts standard activities/procedures (see research plan guidance for more examples).
• Be clear and use correct terminology
  • The plan must be written in such a way as to be understood by readers who may be unfamiliar with your field of research. Explain discipline-specific terms, procedures, and concepts.
  • See the commonly used human subject research definitions for details about terminology.
• Provide detail and be consistent
  • The plan must provide sufficient detail for IRB reviewers to understand the research and evaluate the research for the ethical protection of human subjects.
  • The information in the plan should be internally consistent (i.e., information in each section of your research plan should match what you have in other sections) and should also be consistent with what you have in your other documents (e.g., recruitment materials, consent forms, data collection tools). Once drafts are in their final stages of revision, we recommend a quick read through of all materials with a focus on consistency. Materials with inconsistencies may delay reviews.

Formatting

• Whenever possible, upload the Research Plan (and other documents) in the RAP as Microsoft Word documents.
• Avoid using highlighting and hyperlinks. If hyperlinks are included in the text, upload screenshots of the relevant webpage.
• Do not embed additional documents in the research plan. Supporting materials like recruitment and consent forms should be uploaded as standalone materials unless otherwise requested.
• There is no minimum or maximum length requirement for your research plan.

After Approval

All research team members should have access to the Research Plan (once approved) and the PI is responsible for ensuring all team members understand the details of an approved Research Plan and any subsequent changes. This minimizes non-compliance and facilitates research integrity.