IRB Wish List: What New PIs Should Know Before Their First IRB Submission

May 2026 Issue

Author(s):

  • BMC/BUMC IRB Office

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Introduction

Every week, new Principal Investigators (PIs) join the BMC/BUMC research community and begin navigating our local IRB submission process for the first time. While CITI Human Subjects Protection training and Good Clinical Practice (GCP) training provide a foundational introduction to human subjects research, it cannot fully prepare a new PI for the practical realities of working with an institutional IRB, and the policies and processes specific to that institution. Common knowledge gaps lead to avoidable stipulations, delays, and rework that slow the path to study approval.

In reflecting on the patterns we observe most frequently, the BMC/BUMC IRB staff compiled a list of foundational concepts, processes, and resources that, if understood at the outset, would meaningfully improve the quality and efficiency of IRB submissions. This month’s Feature Article shares that list, organized across four areas: Training & Education, IRB Application & Submission, Research Conduct & Data Management, and Available Resources.

 

Training & Education

1. Participate in Available BMC/BUMC Education Opportunities

Beyond the requirement to complete CITI human subjects training, new PIs should be aware of the institutional training programs offered through the Clinical Research Resources Office (CRRO) within the Office of Human Research Affairs (OHRA). These programs go beyond CITI’s foundational content to offer practical, context-specific training grounded in local Human Research Protection Program (HRPP) policies, real-world examples, and best practices in human subjects research and Good Clinical Practice:

2. Understand PI Responsibilities Under HRPP Policies

PIs should be familiar with their responsibilities as outlined in HRPP policies, including obligations when a research study ends or when a PI leaves the institution. Relevant resources include:

 

IRB Application & Submission

3. Identify the Correct Level of Review

Understanding the different levels of IRB review (Not Human Subjects Research [NHSR], Exempt, Expedited, and Full Board) is essential before drafting an INSPIR application. Section 4.1 “Review Path” drives the remainder of the form; selecting the wrong review path creates downstream complications throughout the application that can be difficult to untangle. If you ever have any questions about the appropriate review path for your study, contact the IRB at medirb@bu.edu to discuss, and avoid either providing too much information (if you submit a full non-exempt application when one is not needed), or too little (if you do not submit a full non-exempt application when necessary).

4. Review and Harmonize All Application Materials Before Submitting

One of the most common sources of stipulations is inconsistency between study documents (including the consent form and protocol) and the information entered in the INSPIR application. PIs and their teams should re-read and carefully edit all components of an application prior to submission to ensure alignment. Any copy-pasted content from prior studies that is not applicable to the current submission should be removed before submitting. For more information about this, see this month’s May 2026 THE CRRO CORNER article entitled: Consistency Matters: Avoiding a Common IRB Submission Pitfall.

5. Use Built-In Application Instructions and Resources

Many questions in INSPIR are answered within the text of the question itself. PIs should take time to read the application carefully, rather than relying solely on prior submissions or informal guidance. The instructions are there to help.

6. Use Institutional Templates (and Revise Properly)

Institutional IRB templates exist for a reason. PIs should use them rather than creating documents from scratch. The full template library is available here:

Additionally, when revisions to approved documents are needed, they must be made through the proper revision process, not by uploading new standalone documents, which creates version control problems. Resources on how to revise existing documents are available on the IRB website:

 

Research Conduct & Data Management

7. Operationalize Recruitment and Informed Consent Processes

Recruitment methods and the consent process should be translated into a concrete, step-by-step workflow that specifies methods and materials used, location, timing, how eligibility is determined, and who will conduct consent. It is not sufficient to state that the study team will “identify eligible participants”; the IRB needs to understand exactly how that will happen. For guidance, see:

8. Distinguish Clinical vs. Research Use of Data

PIs should be able to:

  • Clearly articulate and demonstrate the difference between accessing medical data for clinical purposes versus research purposes, which is often central to IRB determinations about waivers of consent and HIPAA Authorization.
  • Understand how the IRB distinguishes between retrospective and prospective data collection, including the different expectations for consent and HIPAA Authorization that apply to each.
  • Clearly delineate the standard-of-care components of a clinical trial from the research procedures, as this distinction is critical to the IRB’s risk assessment.

9. Reference Institutionally Approved Data Storage Systems

When describing confidentiality protections in an INSPIR application, PIs should reference specific, institutionally-approved data storage systems by name. Generic language such as stating that data will be “stored securely” is not sufficient and will typically result in a stipulation. The Confidentiality section includes Help (?) text, referenced above in #5, that provides the available options.

 

Available Resources

10. Utilize Key Institutional Resources

Several standing institutional resources are available to help PIs and their teams stay current on best practices and meet regulatory standards. Familiarity with all three is strongly encouraged:

  • CRRO Tools & Templates: The Clinical Research Resources Office maintains a library of study documentation tools, templated forms, and self-assessment checklists to help teams meet ICH GCP and general best practice standards. Use of these tools and processes (such as conducting regular self-assessments) is strongly encouraged, and saves teams from reinventing the wheel. Examples include:
  • Institutional Standard Operating Procedures (SOPs): PIs should be familiar with the institutional SOPs, which provide authoritative guidance on research conduct and documentation requirements. SOP CITI training is also an institutional requirement for studies that target BMC patients, use BMC patient data, or utilize BMC facilities and/or services.

11. Register Clinical Trials and Engage the CRRO

For PI-initiated clinical trials at BMC/BUMC, PIs should:

  • Contact Karla Damus (the CTgov PRS Administrator) for assistance with ClinicalTrials.gov registration requirements: ClinicalTrials.gov Requirements
  • Request a CRRO consult, which is both a requirement for local PI-initiated clinical trials and a valuable resource for preparing for IRB review.

 

Moving Forward

The items described above are not meant to be overwhelming. Most represent habits and resources that, once established, become second nature. The IRB staff hopes that by sharing this list, new PIs will have a clearer picture of what to expect and how to hit the ground running. Questions about any of the above may be directed to the BMC/BUMC IRB office at medirb@bu.edu.