The Office for Human Research Protections (OHRP), the FDA and the Association for the Accreditation of Human Research Protection Programs (AAHRPP) already define what a human research protection program (HRPP) must do. What they do not show is where your own program has diverged from those requirements since the last review.

This fillable checklist gives the institutional review board (IRB) office 17 checks to run against three sources: the written procedures, current practice and the study records. Where all three agree, the item is closed. Where one is out of step, the checklist shows whether the correction belongs to the procedure, the process or the documentation, and who owns it.

What the Checklist Covers

Seventeen checks in four areas. Each one names the document to review and the regulation or best practice it is measured against.

Written procedures against current practice

Procedure revision dates, the contacts named on your Federalwide Assurance, IRB registration details, and the membership roster against the members now serving.

The right regulatory framework for each study

Common Rule and FDA-regulated classification, continuing review intervals for each framework, and where the key information requirement applies to consent forms.

Determinations against study records

A random sample of meetings and studies, checked for quorum, exempt determinations, approval criteria and additional protections for specific populations.

Responsibilities shared with other offices

Reliance agreements, certification of IRB approval to funding agencies, HIPAA authorizations and waivers, and financial conflict of interest review.

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How the Self-Check Works

The IRB office completes most items. Area D needs input from research administration and the privacy office.

Answer from a document

Each item is marked met, partially met or not met. If no document can be produced, the item is not met.

Identify what is out of step

Record whether the gap sits in the written procedure, current practice or the study record. That tells you who corrects it.

Build the corrective action plan

Move every open item into the plan, categorized and prioritized, from immediate action to the next policy review.

Items based on best practice rather than regulation are labeled and scored separately. The checklist complements the AAHRPP Evaluation Instrument and FDA's IRB inspection compliance program. It does not replace either.

Who It Is For

IRB directors, chairs and coordinators, Institutional Officials and HRPP staff at universities, academic medical centers, hospitals and health systems, independent research institutes, and federal, state and local agencies.

IRB Program Self-Check: 17 Readiness Checks