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Virginia Code 32.1-162.16 et seq.:

• 32.1-162.16. Human Research: Definitions
• 32.1-162.17. Exemptions
• 32.1-162.18. Informed consent
• 32.1-162.19. Human research review committees

All human subject researchers, research administrators, and review committee membersÌýmustÌýobtain adequate training by completing theÌýHuman Subjects ResearchÌýcourse. Online training is available via theÌýÌýwebsite. New users of this site will need to affiliate themselves with Ïã¸ÛÁùºÏ²Ê×ÊÁÏ.

In addition, Investigators who propose studies with patient populations are required to document HIPAA training. ±õ²Ô±¹±ð²õ³Ù¾±²µ²¹³Ù´Ç°ù²õÌýmustÌýaccess the NIH booklet entitled

±õ²Ô±¹±ð²õ³Ù¾±²µ²¹³Ù´Ç°ù²õÌýmustÌýsubmit an attachment to the review application stating that the material has been read and will be adhered to in the proposed research. The attachment must include the date the material was read, which must be within the 12 months prior to the application.

Ïã¸ÛÁùºÏ²Ê×ÊÁÏ has established an Institutional Review Board (IRB) and five college committees to review all proposed research involving human subjects to ensure that the subjects' rights and welfare are adequately protected. The IRB is composed primarily of faculty members from disciplines in which research involving human subjects is integral to that discipline's work, as well members from the community whose primary interests are non-scientific. The human subjects review process is administered through the Office of Research. Researchers are REQUIRED to comply with the Ïã¸ÛÁùºÏ²Ê×ÊÁÏ IRB Policies and Procedures.

All submissions to the IRB (new protocols, amendments, progress reports, and close-out reports) should be submitted electronically via IRBNet. E-mail and hardcopy submissions will not be accepted. Investigators can self-register for an IRBNet account and submit protocols atÌý.

For tutorials, information and FAQ's, please visit ourÌý.

°Õ³ó±ðÌýÌýindicates whether you should submit the proposal to your College Committee or the IRB. Researchers may also want to reviewÌý. Researchers whose study is not federally regulated (i.e., is not federally funded and does not take place on federal property) and who believe their study is exempt from state law shall complete an application for exempt research. A copy of the exempt application can be found in the Forms and Templates section ofÌýIRBNet.

All others must complete the Human Subject Research Review Application Form which can be found inÌýIRBNet. The Principle Investigator (PI), or a member of the research team familiar with the project, should attend the Institutional Review Board (IRB) meetings regarding the project.

Currently, all meetings are being held virtually.

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The Ïã¸ÛÁùºÏ²Ê×ÊÁÏ IRB conducts Expedited reviews in accordance with . According to this policy, expedited reviews are allowed in two instances:

1. The research protocol has undergone review at another institution and has obtained approval from that institution, or
2. Minor changes are being proposed to a previously approved research protocol

If your protocol qualifies for expedited review, you may submit through the IRBNet system and include a note on the submission page regarding your request for expedited review. Protocols that have received approval at another institution should include the IRB application and approval letter from that institution.

The approval period for a study is typically one year. Researchers must submit aÌýProgress ReportÌýif a non-exempt project is to last longer than the approval period. Researchers must submit the Progress Report to the Office of Research two months prior to the study's expiration following IRBNet. The study must be reviewed and re-approved by the IRB for research to continue. Non-exempt studies are considered complete when data collectionÌýandÌýdata analysis are complete. Researchers must submit one copy of the Closeout Report to the Office of Research one month after the study is complete.