Regulatory guidelines for research

HCA-HealthONE is guided by the ethical principles set forth in the Belmont Report. (Ethical Principles and Guidelines for the Protection of Human Subjects of Research). The minimum standards are set by the Department of Health and Human Services regulations at 45 CFR 46 and the Food and Drug Administration’s regulations at 21 CFR 50 and 21 CFR 56.

Office of Human Research Protections (OHRP)

Formerly the Office for Protection from Research Risks (OPRR). OHRP has primary responsibility for developing, monitoring and overseeing compliance with Health and Human Services (HHS) regulations for the protection of human subjects in research conducted or supported by any component of the Department of Health and Human Services, including the National Institutes of Health (NIH).

Federal Wide Assurances

To view the HCA-HealthONE FWA information, go to the OHRP website. Select the Assurances (FWAs) radio button for document type. Enter FWA Number: 00002864.

DHHS Regulations

Guidance Documents

The FDA, as it relates to human subject research, is the federal agency responsible for ensuring that human drugs, biological products, and medical devices are safe and effective; and these products are honestly, accurately and informatively represented to the public.

All IRBs reviewing FDA-regulated research are required to provide FDA-specific information to the federal OHRP. HCA-HealthONE IRB is fully compliant with the FDA registration requirements.

• Center for Drug Evaluation and Research (CDER)
• Regulatory Guidance
• IND — Guidance on the preparation of an investigator-held Investigational New Drug (IND) Application
• Center for Devices and Radiological Health (CDRH)
• Device Advice
• IDE — Guidance on how to obtain an investigational device exemption (IDE)
• Center for Biologics Evaluation and Research (CBER)
• Guidance and Guidelines
• Clinical Trials and Good Clinical Practice (GCP)
• FDA Regulations
• Guidance for Institutional Review Boards and Clinical Investigators — Compilation of current FDA Guidance documents for IRBs, including investigator responsibilities. Includes information on both drug and device studies.

• CenterWatch — a private organization posting information on ongoing private sector clinical trials
• ClinicalTrials.gov — the NIH’s directory of (mostly) publically-funded clinical trials
• The IRB Discussion Forum — promotes the discussion of ethical, regulatory and policy concerns with human subjects research