SBS FAQ
What is the first step towards receiving IRB-SBS approval?
All key personnel on protocols involving human subjects research are required to take CITI training before IRB-SBS approval or exemption can be issued. The federal government defines key personnel as all individuals responsible for the design and conduct of the study. Please note that this training is mandatory for ALL researchers at the University of Virginia, not just those applying for federal grants. The training will be required every three years.
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What research must be reviewed by the IRB-SBS?
All non-medical, social and behavioral research involving human participants (studies which are considered medically non-invasive) must be reviewed by the IRB-SBS. Review is required for funded and non-funded projects and grants proposed by faculty and students.
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How do I get a proposal reviewed?
Download and complete a protocol form describing the proposed project and send this form, an investigator's agreement form, and the required completed supporting materials (consent, debrief, post-debrief consent, data release, etc.) to irbsbs@virginia.edu. For more information, please see Submitting Protocols.
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Are there some "exempt" projects that do not require review?
Some research studies in the social and behavioral sciences may be classified by the IRB-SBS as exempt projects, but the Board must make the determination of exempt status. For more information, please see Exemption.
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Do I need IRB approval before submitting a grant?
Investigators submitting grant proposals without a fully developed human subjects protocol can apply for a grant approval using the Grant Approval Form (DOC) . Grant approvals are a type of "pre-approval" which can be expedited for the investigator. Grant approvals inform the funding agency that the research project has been preliminarily reviewed by the IRB-SBS Review Board. Grant approvals DO NOT allow the investigator to enroll participants for study. In order to proceed with the research, the investigator MUST submit a protocol for full committee review. Please see Grant Approvals for more information on submission and review.
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Can I submit a grant proposal to a funding agency before the SBS Review Board has given final approval to my full protocol?
Yes. Mark "pending" on the grant proposal and give the date of submission to the IRB. This lets the funding agency know that your human subjects protocol is currently being reviewed by the IRB-SBS. The final IRB approval or exemption letter can be forwarded to the funding agency as an addendum to the grant proposal.
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When are continuation reviews needed?
Approvals are given only for a one-year period. This period begins on the date of the Board's action (i.e., IRB-SBS meeting date), not on the date that researchers begin to collect data. Studies must remain active through both the data collection and analysis phases. If the project continues beyond a one-year period, a Protocol Status Form (DOC) and any supporting materials must be submitted to the IRB for review and approval prior to the expiration date. A Protocol Status Form will be sent to the principal investigator by email prior to the study expiration date, or a copy can be downloaded from the Forms web page. Requests for approval of continuation for projects extending beyond the third year must be submitted using the full protocol template, which is available on the Forms web page. If a Certificate of Confidentiality was obtained for the original protocol, one copy of the Certificate of Confidentiality must be included with the resubmission for continuation.
For information on submitting a Protocol Status Form, please see Continuation Requests.
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What materials must be submitted for a new protocol, to re-open an expired protocol, or for the fourth year continuation of an approved protocol?
Please see Submission: New Protocol: What do I submit? for a list of submission materials.
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How do I submit my completed proposal packet?
For submitting a new protocol, please see Submission: New Protocol How do I submit?
For submitting a modification to your protocol, please see Maintaining a Protocol: Modifications.
For submitting a continuation request, please see Maintaining a Protocol: Continuations.
For mailing information, please see Contact.
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What are some common errors in project submission that may delay review by the Board or require protocol modification or further action prior to approval?
The SBS Review Board is required to assess the risks and benefits for each protocol and check for the completion of all required elements in the proposal and consent forms. Delays in approval often occur when:
Protocol and consent forms lack required elements (e.g., forms missing or protocol questions not answered).
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Research hypothesis or question is missing from the proposal or the proposal lacks clarity. Clearly stating the research hypothesis or question and demonstrating its relationship to the data collected allows the SBS Review Board to fully assess the risks and benefits to the participant.
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Coercion. Investigators must avoid situations in which hierarchical relationships between recruiter and human subjects or monetary incentives might unduly affect participation rates.
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Incorrect use of terminology in protocol (e.g. "anonymous" and "confidential" are not interchangeable.) Please see instructions in protocol template for more information.
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Guidelines for preparing consent form not followed, and standard statements not included in the consent form (e.g. statement informing participant that should he/she withdraw from the study, all tapes will be erased.)
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Protocol contains unacknowledged deception. Researchers must fully disclose all aspects of the study to the participant. If deception is used in the protocol, then a debrief and data release form must be included in the protocol.
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Noncompliance with the SBS training requirement. Please see CITI Training for more information.
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The lack of faculty advisor and principal investigator signatures on the original protocol.
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The use of forms no longer accepted by the IRB-SBS. Please note that templates for protocol and grant submission to the IRB-SBS are updated as needed to maintain compliance with federal regulations and standards. The updated versions are posted to this website. Researchers are strongly advised to either download forms directly from the site prior to submission or to verify form compliance by matching the revision date (in small type in each form footer) on forms they intend to submit to the IRB-SBS with the forms on the website.
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Handwritten protocols. Please note that handwritten protocols are no longer accepted for review.
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Please review the Submission and Consent section for more detailed information on how to construct your protocol and consent forms. For tips on writing your protocol, please see Submission: Tips. For tips on writing your consent forms, please see Consent: Tips.
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How will I know if my project was approved?
For an expedited or exempt protocol, your pre-reviewer will notify you of the status of your protocol. You will also receive an official letter and email indicating that the protocol was approved or exempted. For more information, please see Review: Expedited.
Following a full board meeting, the principal investigator and faculty advisor (if applicable) will receive notification (usually within 4 business days after the meeting) of the IRB-SBS's finding by email. For more information, please see Review: Full Board Review.
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How do I obtain approval for any modifications made to the study after the initial IRB-SBS approval?
Submit a Modifications Submission Form (DOC) to the IRB-SBS office via irbsbs@virginia.edu for review and approval prior to making any modifications to an approved/exempt protocol. Modifications include any changes made to the protocol as originally described to and approved by the IRB-SBS. The changes can include new researchers, changes to instruments and/or consent forms, and modifications to the methods described in the original protocol. Modifications are subject to the pre-review process. Modifications that do not change the level of risk in comparison to the previously approved procedures and do not significantly change the original protocol can be reviewed administratively; all other modifications must be reviewed by the full board.
For information on submiting a modification request, please see Modification Requests.
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Do I need to notify the IRB-SBS Administrative Office when my project is complete?
Yes. The IRB-SBS Administrative Office must be notified when a study is completed. This notification should be sent when enrollment of participants and collection of data is complete and data analysis is to the point that participants' records will no longer be needed. Please complete the Study Closure Form (DOC) and submit it to the IRB-SBS Administrative Office within 30 days of closure of the study. For studies classified Exempt we need only notification that the study has been closed. For more information, please see Study Closure.
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