Why involve IRBs now?

During the synopsis stage, the goal is to ensure that the high-level study design aligns with ethical principles and is likely to meet IRB expectations once fully developed.

Although formal IRB review does not typically occur at this stage, early alignment helps reduce delays and avoid major revisions later in the submission process.

Helpful actions at this stage:

• Clearly define study objectives, endpoints, population, and overall design
• Outline participant activities, visit burden, and data collection plans
• Assess whether proposed procedures are likely to fall into minimal risk or greater than minimal risk categories
• Identify elements requiring additional ethical justification (e.g., placebo use, invasive procedures, vulnerable populations)

Key considerations before drafting a protocol:

• Study design and objectives: Ensure the study is scientifically sound and clearly justified
• Participant selection: Confirm the population is appropriate and protections are in place for any vulnerable groups
• Risk–benefit profile: Identify potential risks and define mitigation strategies
• Informed consent: Plan for a clear, understandable, and appropriate consent process
• Privacy and confidentiality: Ensure participant data protection approaches are defined
• Safety oversight: Outline how adverse events will be monitored and reported
• Regulatory alignment: Confirm the study approach aligns with applicable regulations and guidance (e.g., FDA, ICH)
• Feasibility: Ensure the design can be executed with available resources and expertise
• Monitoring and reporting: Anticipate requirements for oversight and IRB reporting
• Participant compensation: Ensure any incentives are appropriate and ethically justified