1. Define Your Research Question or Objective

Begin by clearly identifying:

• What you want to study
• Why the research is important
• Who or what your study will involve

A focused, well-defined research question provides the foundation for your study design, methods, and ethical considerations.

2. Determine Whether IRB Review Is Required

Ask yourself:

• Does the project involve human participants?
• Will you collect data through interaction or intervention?
• Will you use identifiable private information?

If the answer to any of these questions is yes, IRB review is likely required. Investigators are encouraged to use Brown's Human Subjects Research Determination Tool [PDF], when available, or to contact the HRPP for guidance before proceeding.

3. Review PI and Advisor Qualifications

Confirm that the proposed Principal Investigator (PI) and, when applicable, faculty advisor meet Brown’s eligibility requirements. Review institutional policies related to PI and advisor roles early in the planning process to avoid delays later.

4. Conduct a Literature Review

A thorough review of existing literature helps to:

• Justify the purpose of your research
• Avoid unnecessary duplication of prior work
• Identify gaps in knowledge
• Select appropriate study methods

This background information will be incorporated into your research protocol and reviewed by the IRB.

5. Design Your Study

Develop a research plan that clearly describes:

• The study population and recruitment methods
• Study procedures and data collection methods
• Data analysis plans
• Study timeline
• Potential risks to participants and how those risks will be minimized
• The informed consent and assent process, when applicable

Thoughtful study design supports both ethical conduct and efficient IRB review.

6. Plan for Collaborative Research

If your study involves investigators from outside Brown or will be conducted at another institution or site, review guidance on collaborative research. Additional agreements, permissions, or reliance arrangements may be required before IRB approval can be issued.

7. Draft the Research Protocol

The research protocol is the core document reviewed by the IRB. It provides a detailed description of your study’s background, objectives, design, procedures, and ethical considerations.

Investigators are strongly encouraged to use the protocol templates available in Brown’s HRPP Toolkit to ensure all required elements are addressed. Additional guidance on completing protocol templates is also available through the HRPP.

8. Prepare Supporting Documents

In addition to the protocol, you may need to prepare:

• Informed consent and assent forms
• Recruitment materials (e.g., flyers, emails, scripts)
• Surveys, questionnaires, or interview guides
• Data collection instruments or tools
• Letters of support or permission for external sites or populations

All materials submitted to participants must be reviewed and approved by the IRB before use.

9. Consider Ancillary Reviews

Some studies require review and approval from additional offices or committees, such as:

• Conflict of Interest Review Board
• Export Control
• Data security or privacy offices

Determine early which ancillary reviews apply to your study, as these approvals may be required before IRB approval can be finalized.

10. Complete Required Education and Training

All members of the study team must complete required human subjects protection training (such as the CITI Program) before submitting a study to the IRB. Ensure training is current for all personnel listed on the application.

11. Address Conflicts of Interest

Investigators must disclose any real or perceived conflicts of interest related to the research. Report conflicts as required to ensure transparency and compliance with institutional policies.

12. Submit Your Study in Huron

Once all materials, training, and ancillary reviews are complete, submit your study through Huron, Brown’s electronic HRPP/IRB submission system. Follow the step-by-step instructions and upload all required documents.

Access Huron

13. Track Review and Respond to Requests

After submission, investigators can:

• Track the status of their study
• Respond to HRPP or IRB reviewer questions
• Access outcome and approval letters

Submitted studies typically move through pre-review, review, and post-review stages. Information about each stage, along with forms and resources, is available throughout the HRPP and Division of Research websites.

Understanding Brown’s policies, procedures, submission requirements, and timelines will help you prepare a complete and high-quality application for HRPP/IRB review. Careful preparation supports efficient review and helps ensure your research activities can begin as soon as possible following approval.