Division of Research
Prepare Your Human Subjects Research Study
Where to Begin
Conducting research involving human participants requires thoughtful planning and thorough preparation before submitting your study materials for HRPP/IRB review. Careful study design helps ensure that your research is ethical, scientifically valid, and compliant with federal regulations. Review the key first steps:
Define Your Research Question or Objective
Clearly identify:
What you want to study
Why it matters
Who or what your study will involve
A focused, well-defined research question sets the foundation for your entire protocol.
Determine Whether IRB Review is Required
Ask yourself:
- Does your project involve human participants?
- Are you collecting data through interaction, intervention, or identifiable private information?
If yes, your study likely needs IRB review. Use your institution’s Human Subjects Research Determination Tool [PDF] if available, or contact your HRPP office for guidance.
Conduct a Literature Review
Explore existing research to:
- Justify your study's purpose
- Avoid duplication
- Identify appropriate methods and gaps in knowledge
Design Your Study
Create a research plan that includes:
- Study population (who will participate and how they’ll be recruited)
- Methods (how data will be collected and analyzed)
- Timeline
- Risks and how you will minimize them
- Informed consent process
Draft the Research Protocol
The research protocol is a detailed document describing your study’s background, objectives, design, procedures, and ethical considerations. This is the core document IRB reviewers will assess. Use the protocol templates found in the HRPP Toolkit to ensure complete information is provided. For additional assistance, consult Brown’s Protocol Template guidance.
Prepare Supporting Documents
In addition to your 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 tools
- Letters of support or permissions (if using external sites or populations)
Complete Required Training
All study team members must complete human subjects protection training (e.g., through CITI Program) before IRB submission.
Access the IRB Submission System
Log in Brown’s Huron IRB to begin your application. Follow step-by-step instructions and attach all required documents.
Submit and Track
After submission, you can:
- Track the review status
- Respond to reviewer comments
- Access approval letters
Once submitted, a study goes through stages of pre-review, review and post-review. Details about each of these stages of the process, including important forms and resources, can be found in the following section.
Steps to Prepare Your Human Subjects Research Study
Review Brown’s principal investigator (PI) eligibility policies to ensure you are qualified to serve as a PI or research advisor.
Review guidance for collaborative research if your study will be conducted at any location other than Brown or with investigators from outside the University.
Learn more about the IRB and its review times, meeting dates and relevant deadlines.
Review IRB guidance to ensure the applicable policies are incorporated into your study.
Determine which offices, boards and committees (e.g., Conflict of Interest Review Board, Export Control) will need to provide ancillary reviews of your submission.
New applications must be reviewed and approved by the IRB prior to conducting research with human participants. Depending on the details of the proposed research, supplemental forms and approvals may be required. Download and prepare the necessary templates, forms and other supporting documents. Use the Search page on this site to find resources by keyword or topic.
Complete all required human subjects research training.
Once you have all your materials and reviews completed, you will submit your study in Huron, the electronic submission system used for HRPP/IRB review.