Get the protocol structure right before you submit
IRB submissions are most often delayed not by bad science but by missing or vague sections — an underspecified consent process, an honest-looking but incomplete risk assessment, or a data plan that just says “kept secure”. This builder lays out the sections almost every board expects, so you draft complete content the first time and spend revision rounds on substance rather than structure.
How it works
You provide the study details and the tool organises them into the standard protocol sections:
Purpose — aims, hypotheses, significance
Design — observational / interventional / survey / trial
Participants — recruitment, inclusion/exclusion, sample size
Vulnerable — minors, patients, or other protected groups
Risks/Benefits — foreseeable harms, mitigation, and benefits
Consent — who, how, voluntariness, right to withdraw
Confidentiality — de-identification, access, secure storage
Data mgmt — storage, retention, sharing, destructionEach section maps to a question a reviewer will ask. Naming the design clarifies what level of review applies; the risks, consent, and confidentiality sections are where boards focus hardest, because that is where participant protection lives. The outline gives you a complete skeleton to fill with your study’s specifics.
Tips and example
Be specific and honest in the risks section — list real, foreseeable harms and exactly how you reduce each one, because boards distrust protocols that claim “minimal risk” with no analysis. In the consent plan, name who obtains consent, how, and how participants can withdraw without penalty; if you are requesting a waiver of consent or documentation, justify it explicitly. For confidentiality, describe coding or de-identification, where data is stored, who can access it, how long it is kept, and what happens at the end. Always move the finished content into your own institution’s IRB form — this outline is a drafting aid, not your submission.