FDA BIMO IRB Compliance Explainer

From the S.P.I.R.I.T. newsletter: Former FDA BIMO Investigator: What IRBs Can Do to Stay Compliant.

FDA inspections observe:

• Nonclinical testing laboratories in accordance with Good Laboratory Practice (GLP),
• Clinical Investigators in accordance with Good Clinical Practice (GCP),
• Sponsors/Contract Research Organizations (CROs)/Clinical Trial Monitors,
• In vivo bioequivalence facilities,
• Institutional Review Boards,
• Radioactive drug research committees,
• Postmarketing Adverse Drug Experience reporting (PADE), and
• Risk evaluation and Mitigation Strategies reporting (REMS).

Below is a PDF download directly from the FDA Bioresearch Monitoring Program (BIMO) Compliance Programs website. You can download this PDF directly or bookmark the website for any updates to the PDF.

FDA regulations referenced within PDF

• PART 11-Electronic Records; Electronic Signatures
• PART 50-Protection of Human Subjects
• PART 56-Institutional Review Boards
• PART 312-Investigational New Drug Application
• PART 320-Bioavailability and Bioequivalence Requirements
• PART 812-Investigational Device Exemptions
• PART 814-Premarket Approval of Medical Devices

FDA final guidance documents referenced within PDF

Draft guidance documents were excluded as these are typically released for public comment.

Note that some guidance documents mentioned were not found within FDA’s Guidance Document Search.

Note that guidance documents are not legally binding.

• Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products: Guidance for IRBs and Clinical Investigators
• Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors
• Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
• Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations: Guidance for Sponsors, Investigators, and Institutional Review Boards
• Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs
• Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs
• Considerations When Transferring Clinical Investigation Oversight to Another IRB: Guidance for IRBs, Clinical Investigators, and Sponsors
• Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND: Guidance for Clinical Investigators, Sponsors, and IRBs
• IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed: Guidance for IRBs, Clinical Investigators, and Sponsors
• Exception from Informed Consent Requirements for Emergency Research: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors
• IRB Continuing Review After Clinical Investigation Approval: Guidance for IRBs, Clinical Investigators, and Sponsors
• Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical Investigators
• IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations: Guidance for Industry
• General Principles of Software Validation: Guidance for Industry and FDA Staff
• Payment and Reimbursement to Research Subjects: Guidance for Institutional Review Boards and Clinical Investigators
• Waiver of IRB Requirements for Drug and Biological Product Studies: Guidance For Sponsors, Clinical Investigators, and IRBs
• Frequently Asked Questions About Medical Devices: Guidance For IRBs, Clinical Investigators, and Sponsors
• Recruiting Study Subjects: Guidance for Institutional Review Boards and Clinical Investigators