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The UVA Institutional Review Board for Health Sciences Research (IRB-HSR) is an oversight committee that is responsible for reviewing medically related research involving humans that is conducted by UVA faculty, employees and students. The IRB-HSR is administratively independent of UVA and its role is to safeguard the rights and welfare of research subjects by evaluating the risks and benefits of the research to assure an acceptable balance.

In accordance with federal, state and local regulations and institutional policies an IRB must review all research regardless of sponsorship, involving human subjects prior to initiation of the project in order to ensure the rights and welfare of the subjects. Related activites that also require review include advertising, recruitment and/or screening of potential subjects. The IRB-HSR also serves as the HIPAA Privacy Board for research involving Protected Health Information (PHI).

The administrative staff for the IRB consists of paid professionals who write procedures and guidance, handle correspondence with relevant federal agencies, process applications for review, and request progress reports from researchers, conduct training for researchers and IRB members, arrange IRB meetings, and generally provide support services needed for the oversight of research at UVA. When full board approval is required, the IRB members makes final decisions regarding a research project that has been submitted for consideration. In order for the IRB-HSR to approve a protocol, the study must meet the approval criteria found in Federal Administrative Laws 45CFR45.111/ 21CFR56.111.

If you are trying to decide if IRB-HSR review is required for your project, you may find it helpful to review either of these pages:

• Determining IRB-HSR submission type.

If this you need assistance submitting or managing your IRB-HSR protocol, you may find these pages helpful:

• IRB-HSR Protocol Writing Assistance
• IRB Online: Human Subject Research Protocol Database

For more information about January 21st, 2019 implementation of changes to the "Common Rule" which have impacted a number of IRB processes and templates, visit these pages:

• Common Rule Revisions Guidance - UVA IRB-HSR
• Protection of Human Subjects and "The Common Rule"

The IRB-HSR has developed a library of "Learning Shorts" which are brief, voiced-over Powerpoint presentations on a variety of topics related to human subject research at the University of Virginia. Many IRB-HSR Learning Shorts are integrated into this portal and you can find them through the search feature by filtering for this resource type. The full index is available on the IRB-HSR website:

• IRB-HSR index of Learning Shorts