Conduct research in a particular field of knowledge

I have the draft research protocol for the environmental exposure study. Send the protocol with the data management plan to Dr. Okoye in Epidemiology and to the ethics coordinator, Pablo, requesting feedback and an internal sign-off by Friday so we can begin recruitment next month. Before sending, ensure sample size and statistical assumptions match the latest pilot data and that consent language aligns with institutional policy.

Before circulating this protocol, make it easy to approve — put the research question, primary outcome and sample size rationale on page one, summarize participant burden in a short table, and flag any points the ethics board typically queries that would delay approval.

We sent the protocol draft and the stats reviewer says the sample size assumptions are optimistic based on the pilot variance; Dr. Okoye wants to keep timelines but ethics needs a defensible calculation. I’m afraid increasing sample size will blow the timeline and budget, but keeping it risks rejection. What likely caused the discrepancy and what is the best next move to resolve it with the stats reviewer and ethics quickly?

Across multiple studies we lose time because sample size calculations are revised late and consent wording is rewritten after ethics review. What habit should I change when drafting protocols so statistical and ethical issues are anticipated and approvals happen faster?