All research involving human participants conducted by VU faculty, staff, or students must be reviewed and approved by the IRB before the research is initiated. Non-VU affiliated researchers seeking to conduct research with VU faculty, staff, or students are also required to have IRB approval.
Please note: The IRB cannot approve an application submitted after the research is initiated.
Purpose and Criteria
The Institutional Review Board (IRB) at Vanguard University is responsible for reviewing, approving, modifying, rejecting and monitoring research projects involving human subjects as required by 45 CFR 46 and 21 CFR 56.
The purpose of the IRB is to ensure, both in advance and by periodic review, that appropriate steps are taken to protect rights and welfare of humans participating as research subjects. In order to approve human subjects research the IRB must determine that the research meets all federal criteria that are listed in 45 CFR 46.111.
The criteria are summarized as follows:
- Risks to subjects are minimized. Note that all risks should be considered, including the potential for economic, legal, physical, psychological and social harm.
- Risks to subjects are reasonable in relation to anticipated benefits, if any, and the importance of the knowledge that may reasonably be expected to result.
- Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, except in cases in which the requirement is waived.
- Informed consent will be appropriately documented as required.
- When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
- When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
IRB Review Dates
Exempt/Expedited applications are reviewed continuously. You will typically hear back from the chair of the committee within 2 weeks of submission. Complete applications for full board review must be received two weeks before the meeting to be considered at that meeting; please plan accordingly. Meetings occur once a month depending on need, throughout the 9-month academic calendar. Full Board Review during the summer months is on an as needed basis. Please continue to submit all applications in the correct format to InstitutionalReviewBoard@vanguard.edu.
Research that involves higher risk factors or with “vulnerable populations” (e.g., children) requires the approval of the full IRB, which meets once a month during the academic year. Research funded by federal grants must also receive a full Board review.