Research Compliance

Research Using Humans

Researchers conducting human subjects research are REQUIRED to comply with:

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

State legislation:
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

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 Procedures for Review of Human Subjects Research.

Application Process and IRB Meeting Dates
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. See the Application Form for Exempt Research. Submit 5 copies of the application and associated materials to your college committee chair. Check your Dean's office for details.

All others must complete the Human Subject Research Review Application Form. The responsible project investigator (RPI), or a member of the research team familiar with the project, should attend the Institutional Review Board (IRB) meetings regarding the project.

Research protocols should be e-mailed to Adam Rubenstein (arubenst@odu.edu) as .pdf files. The protocols should be separated into the following separate files:

• Application Form
• Human Subjects Training Documentation
• Informed Consent Documents
• Recruitment Documents
• Study Materials and/or Instruments - separate .pdf files should be created for each distinct cluster of materials or instruments (i.e. - separate files for multiple surveys)
• Grant/Contract Information (if applicable)

Files should be saved with the investigator's last name followed by the information in the .pdf (ex - "Rubenstein_application", "Rubenstein_trainingdoc", etc...)

A single, signed hardcopy of the application and all other materials should be sent to the Office of Research in 4111 Monarch Way, Suite 203. All electronic and hardcopy submissions are due in the Office of Research by 5 p.m. on Monday of the week prior to the IRB meeting. All meeting dates are on Thursdays.

Expedited Reviews
 
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 one copy of the research application to the IRB Chair, George Maihafer. Protocols that have received approval at another institution should include the IRB application and approval letter from that institution.

Approval Period
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, which is typically 1 year. Researchers must submit the Progress Report to the Office of Research 2 months prior to the study's expiration following the electronic submission procedure. 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 1 copy of the Close Out Report to the Office of Research 1 month after the study is complete.

Forms
All forms pertaining to research involving human subjects can be downloaded from our Forms section.

Training
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" at:

http://privacyruleandresearch.nih.gov/pr_02.asp

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.

Resources
Researchers can view a power point presentation about Human Subjects Research at Old Dominion University or review a list of Frequently Asked Questions about Human Subjects Research at Old Dominion University.