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.:
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. The researcher shall submit at least ten (10) copies of the entire proposal and at least ten (10) copies of the proposed informed consent document to the Office of Research in 4111 Monarch Way, Suite 203. All submissions are due in the Office of Research by 5 p.m. on Monday one week prior to the IRB meeting. All meeting dates are on Thursdays.
Meetings are held on Thursdays in the Webb Center, Board of Visitors' Room. Exceptions are noted below.
| Submission Date |
Meeting Date and Time |
| January 7, 2008 |
January 17, 2008, 10:00 a.m.- noon, Virginia Rice Webb Room |
| February 11, 2008 |
February 21, 2008, 10:00 a.m.- noon, Virginia Rice Webb Room |
| March 10, 2008 |
March 20, 2008, 10:00 a.m.- noon, Board of Visitors Room |
| April 7, 2008 |
April 17, 2008, 10:00 a.m.- noon, Rector's Room |
| May 5, 2008 |
May 15, 2008, 10:00 a.m.- noon, Virginia Rice Webb Room |
| June 9, 2008 |
June 19, 2008, 10:00 a.m.- noon, Board of Visitors Room |
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 10 copies of the Progress Report to the Office of Research 2 months prior to the study's expiration. 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. Online training is available via the National Institutes of Health through the Human Participant Protections Education for Research Teams course.
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.
