Research Using Humans

Code of Federal Regulations Title 45 Part 46 (45CFR46)

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
• 32.1-162.20. Applicability of federal policies
• 32.1-162.21. Cloning: Definitions
• 32.1-162.22. Human cloning prohibited; civil penalty
• Overview of state leglislation

All human subject researchers, research administrators, and review committee members must obtain adequate training by completing the Human Subjects Research course. Online training is available via the Collaborative Institutional Training Initiative (CITI) website. New users of this site will need to affiliate themselves with ODU.

In addition, Investigators who propose studies with patient populations are required to document HIPAA training. Investigators must access the NIH booklet entitled Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule

Investigators must submit 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.

Old Dominion University 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 Old Dominion University 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 at http://www.irbnet.org.

For tutorials, information and FAQ's, please visit our IRBNet page.

The Human Subjects Research Decision Tree indicates whether you should submit the proposal to your College Committee or the IRB. Researchers may also want to review OHRP's Human Subject Regulations Decision Charts. 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 of IRBNet.

All others must complete the Human Subject Research Review Application Form which can be found in IRBNet. 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.

**Please note Aug. 28, 2025 is the fourth Thursday of the month, instead of the normal third Thursday meeting date

***Please note Dec. 11, 2025 is the second Thursday of the month, instead of the normal third Thursday meeting date  

The Old Dominion University IRB conducts Expedited reviews in accordance with Virginia Code § 32.1-162.19(C). 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 a Progress Report if 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 collection and data analysis are complete. Researchers must submit one copy of the Closeout Report to the Office of Research one month after the study is complete.