I. Investigator Qualifications, Roles, and Training

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).

I. Investigator Qualifications, Roles, and Training

In order to approve this research, the IRB needs to determine that research personnel are adequately trained and knowledgeable regarding the study procedures and the protection of human research participants.

1.  Investigator Qualifications

  • Provide a brief description for all key research personnel (i.e., Principal Investigator, Faculty Advisor, Co-Investigators or any other research personnel with responsibility for study oversight and research design). Include all of the following:

    • Academic background

    • Research experience

    • Experience with the proposed participant population

    • Experience with the proposed procedures and methodology

    • For students, include any applicable coursework (e.g., research methodology courses)

2.  Roles and Research Duties

  • Describe the roles and the associated research activities/duties (e.g., "Research Assistants will consent participants and administer surveys.")

  • Do not list individual names. Limit roles to Principal Investigator, Co-Investigator, Faculty Advisor, Research Assistant, and Project Coordinator.

3.  Training and Oversight

  • Describe how the study personnel will be adequately trained to conduct research activities in accordance with the approved protocol and in compliance with federal regulations and university policy.

  • Describe any specific training or expertise required for procedures proposed in this research. Explain all of the following:

    • Training standards or requirements that must be met.

    • Who will be providing the training?

    • How will the training be tracked/documented?

4.  Translator

  • If a translator will be used for any aspects of the research, provide the translator’s name and qualifications for translation (e.g., native speaker, student of the language, etc.).