IRB : Synopsis

IRB : Synopsis

Trial Design Stage

Published Date: April 29, 2025

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Helpful Terms and Definitions

ClinicalTrials.gov Glossary Terms

NIH Glossary of Common Terms

FDA Drug Development and Review Definitions

Resources

Synopsis

Questions To Ask

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  • How does the IRB assess the risk/benefit ratio of the study, and what factors are most critical in this evaluation?
  • What specific guidelines and requirements does the IRB have for my type of study?

Why involve IRBs now?

During the synopsis stage, sponsors should ensure that the high‑level study design aligns with ethical principles and is likely to pass IRB review once fully drafted.

Helpful actions at this stage:

  • Clearly define study objectives, endpoints, population, and overall approach.
  • Outline participant activities, visit burden, and data to be collected.
  • Begin early assessment of whether proposed procedures align with minimal‑risk or greater‑than‑minimal‑risk categories.
  • Identify aspects that may require special ethical justification (e.g., placebo use, invasive procedures, sensitive populations).

The goal is to anticipate IRB concerns early, even if there is no formal IRB interaction yet.

 

Questions to answer before drafting a protocol:

Study Design and Objectives
  • What are the primary and secondary objectives of my study?
  • Is my study design robust and scientifically sound?
Participant Selection
  • Who are the target participants, and why are they chosen?
  • Are there any vulnerable populations involved, such as children or the elderly, and how will their rights and safety be protected?
Risk-Benefit Analysis
  • What are the potential risks to participants, and how do they compare to the potential benefits?
  • What measures are in place to minimize risks?
Informed Consent
  • Is the informed consent process clear and comprehensive?
  • Are the consent documents easy to understand for participants?
Ethical Considerations
  • How will participant confidentiality and data protection be ensured?
  • How will adverse events be handled and reported?
Regulatory Compliance
  • Does my protocol comply with relevant regulations and guidelines (e.g., FDA, ICH)?
  • Have I included all necessary documentation for IRB submission?
Feasibility and Resources
  • Is the study feasible with the available resources and expertise?
  • Do I have pilot data or other evidence to support the study's feasibility?
Monitoring and Reporting
  • How will the study be monitored for compliance and safety?
  • What are the plans for reporting study progress and results to the IRB?
Financial Considerations
  • What are the costs associated with the study, and how will they be covered?
  • Are there any financial incentives for participants, and are they ethically justified?
Pre-Submission Consultation
  • Have I considered engaging in a pre-submission consultation with the IRB to receive feedback and guidance on my protocol?

 

Recommended methods of engagement

What aspects of the synopsis should they inform?

IRB Resources