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For Physicians
Institutional Review Board (IRB)

The Holy Cross Hospital Institutional Review Board (IRB) is comprised of highly qualified members with significant experience and knowledge in the scientific, legal and ethical aspects of clinical trials. The mission of the IRB is to protect the rights and welfare of human research subjects.

We operate under all applicable federal and state regulations, including the Food and Drug Administration (FDA), and the guidance of the Office of Human Research Protection (OHRP). Holy Cross Hospital IRB abides by the International Committee on Harmonization (ICH) guidelines and Good Clinical Practice (GCP) guidelines.

For more information, contact Dawn Roy at 301.754.7795.

IRB Submission Forms

Full Board Review:

• IRB Initial Review Submission Form
• Investigator Research Agreement Form
• Investigator Financial Disclosure Form
• Elements of Informed Consent
• HIPAA Authorization

Annual Review:

• IRB Continuing Review Submission Form
• Investigator Research Agreement Form
• Investigator Financial Disclosure Form

Additional Forms:

• IRB Change in Research Form
• IRB HIPAA Authorization Waiver
• IRB Informed Consent Waiver
• IRB Serious Adverse Event Report
• IRB Study Completion Report