Scientific Review and Project Authorization

Each project must have an accountable principal investigator and a written protocol before data collection or analysis begins. The protocol specifies the question, design, population, inclusion criteria, outcomes, sample rationale, data provenance, procedures, analysis, privacy, safety, resources, investigator competence, and dissemination plan.

At least two qualified reviewers independent of the study team assess the scientific rationale, methods, feasibility, and proportionality of participant burden. At least one reviewer must have statistical or methodological expertise appropriate to the design. Decisions and conditions are documented.

Scientific review and ethics review are separate. Neither a Board vote nor a scientific adviser’s endorsement constitutes IRB approval.

Before human-participant recruitment or research access to identifiable private information, the project must have an applicable written determination from the designated independent review process: approval, exemption, or a finding that the activity is not human-subjects research. Investigators may not self-authorize these determinations.

Fight Medicine Research Institute uses an independent external IRB for human-participant research requiring IRB review. Written agreements define institutional and IRB responsibilities, reporting, records, communication, and oversight. Provider names and approval identifiers are published only when actual agreements or determinations exist.

A Federalwide Assurance is obtained when Fight Medicine Research Institute is engaged in nonexempt human-subjects research conducted or supported by HHS. Other funding, FDA, and jurisdictional requirements are assessed for the actual project. An assurance, an IRB registration, and a study approval are recorded as separate matters.

The Director maintains a project register containing title, investigator, funding, protocol version, scientific review, ethics determination, registry identifier where applicable, dates, conditions, safety responsibilities, and current status. Confidential information is restricted; public project records accurately describe authorized work.

Research cannot begin until required contracts, competent staff, data access, safety arrangements, and institutional authorization are documented.