Heartland IRB: ethics review

Heartland IRB, a commercial IRB, provides ethical review and support services to principal investigators (PIs) and project directors (PDs), non-profits and for-profit agencies, contract research organizations (CROs), and sponsors of human subjects research. Heartland IRB operates in accordance with research standards established by the National Institute of Health (NIH) and Food and Drug Administration (FDA).

Heartland IRB reviews in compliance with other applicable federal and state laws and regulations governing IRBs and research with humans. Heartland IRB is registered as a commercial IRB with the Office for Human Research Protections (OHRP) as IRB00007694, enabling the review of Department of Health and Human Services supported or conducted human subjects research under the Federal Assurance (FWA) of a submitting body.

FDA-regulated studies are reviewed in accordance with the regulations outlined in the Title 21 of the Code of Federal Regulations (CFR) Parts 50-56, and Good Clinical Practices (GCP), as applicable. Non-FDA regulated studies are reviewed under the provisions Title 45 CFR 46, and Good Clinical Practices (GCP), as applicable.

If you have questions or need further information, see the contact information on the left side of this page.