Ethics Committee Application Process

No. Federal regulations (45 CFR 46.109 in the U.S., equivalent in other jurisdictions) prohibit enrollment of any human subjects before the IRB/REC issues written approval. Initiating recruitment without approval violates research regulations, can result in sanctions against the researcher and institution, and may invalidate all data collected. The only exception: in a genuine emergency medical research, FDA emergency provisions allow enrollment before full IRB approval if specific conditions are met; this is extremely rare and requires prior IRB discussion. Plan your timeline assuming 4-8 weeks for ethics approval before beginning recruitment.

An amendment is a request to modify an already-approved protocol. Common amendments: adding a new site, expanding the participant age range, changing questionnaires, or extending the enrollment period. Amendments are submitted to the IRB/REC; most undergo expedited review (quicker than the original application). A new application is required when the changes are so substantial that the study becomes essentially a different protocol (e.g., switching from observational to experimental design, changing the intervention, or altering the primary outcome). Researchers unsure whether to submit an amendment or new application should contact the IRB/REC office in advance.

The answer depends on whether your project is research or quality improvement (QI). Research is defined as systematic investigation designed to develop or contribute to generalizable knowledge; QI is focused on improving a specific service or practice. If your project is QI (testing a local intervention to improve hospital workflow), ethics approval may not be required; institutional approval or QI oversight may suffice. If your project involves multiple sites, novel interventions, or is designed to generate publishable findings about effectiveness, it is likely research and requires ethics approval. If uncertain, consult your IRB/REC; many institutions have a 'research versus QI' determination process.

You have the right to respond to committee concerns with clarification or disagreement. If the committee requests a modification, you can either comply or provide a written justification explaining why the change is not feasible or not necessary. If disagreement persists, you may: (1) appeal the decision to the IRB/REC chair or an appeals process (if your institution has one), (2) seek an independent review from a different IRB/REC (less common and not advisable unless the concern is truly unjustified), or (3) modify your protocol to address the committee's concern. Outright refusal to address committee concerns will result in denial of approval. The committee has final authority over whether research at their institution can proceed.