IRB-SRB

IRB-SBS Information as It Relates to the Capstone Project
The following is a “snap-shot” of information about the IRB-SBS and how it relates to Capstone Projects.  For detailed information on the IRB process, protocols, schedules, and deadlines, please go directly to the IRB-SBS web site.

Capstone Projects involving “human subject studies” (including surveys and interviews) require considerable IRB preparation. This is your responsibility as a researcher. Be sure you fully understand the IRB requirements well before you begin your Capstone Project. Capstone proposals will not be approved unless they have, or are very close to, the necessary IRB approval. If you have not obtained IRB approval by the time you submit your final proposal, you should include your IRB protocol form with your final proposal draft.

Institutional Review Board for the Social and Behavioral Sciences
The Institutional Review Board for the Social and Behavioral Sciences (IRB-SBS) at the University of Virginia is responsible for reviewing all non-medical behavioral human research (studies which are considered medically non-invasive) for compliance with federally-mandated research guidelines. Review of research is required for funded and non-funded research and for research conducted by faculty and students. Researchers are responsible for submitting the protocol for review in accordance with University policy as stated in the Responsibilities of Research.

Researchers who familiarize themselves with the policies and procedures prior to submission of human subject studies will benefit by minimizing or eliminating the revisions required for review before a study can begin. 

IRB-SBS Review Process

The IRB-SBS must review all research involving human participants for the social and behavioral sciences before the research is begun. Review is required for funded and non-funded projects and grants proposed by faculty and students.  To submit a project for review, the researcher must complete a protocol form and send the form with original signatures and all supporting materials to the IRB-SBS for review. The deadlines for submission are 5 p.m. on the dates specified for meetings held twice a month. Specific instructions regarding form templates and the application process can be found in the FAQ and on the Protocol Submission Form (DOC).

IRB-SBS Frequently Asked Questions

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.

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, audio/video, debrief, data release, etc.) to the SBS Administrative Office for IRB-SBS Board review. The meeting schedule is posted on the SBS Schedule and Forms web page. The deadline for submitting protocols for review is 5 p.m. on the submission date listed for each meeting. All submissions which are received after the 5 pm deadline for a particular meeting will be held until the next meeting. The time required to review a project is about three weeks.

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. To request exempt status, complete the "Request for Exemption" and attach it to the package of materials you submit to the IRB-SBS. Submit the "Request for Exemption" form ONLY if you think your proposal qualifies for exemption status. Exemption criteria are defined on the "Request for Exemption" form.

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?

Submit the following packet of materials:

Fourteen (14) typed copies of the following:

Protocol form (1 original with signatures and 13 copies)
Request for Exemption Form (ONLY if the project meets exemption criteria listed on the form)
Consent forms (only the forms applicable to the study population- Adult, Child, Assent)
Debriefing and data release forms (if applicable- studies involving deception require debriefing)
Video and audio recording permission forms (if applicable)

One (1) copy of the complete grant/research proposal if outside funding is being sought.
Four (4) copies of surveys, interview questions, and tests
Each set should be collated and stapled with a copy of the protocol on top and the applicable request for exemption, consent, debriefing, video and audio forms following in the order listed above. Do not include the checklist, sample forms, or forms not applicable to this protocol.

Please Note: All forms must be word processed or typed. (Use either the existing font size and type on the IRB-SBS form, or a font size no smaller than 10). No hand-written submissions will be accepted.

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 IRB-SBS 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).
• 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 IRB-SBS to fully assess the risks and benefits to the participant.
• Coercion. Investigators must avoid situations in which hierarchical relationships between recruiter and human subjects or monetary incentives might unduly affect participation rates.
• Incorrect use of terminology in protocol (e.g. "anonymous" and "confidential" are not interchangeable.) Please see instructions in protocol template for more information.
• 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.)
• 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.
• Noncompliance with the SBS training requirement. Please see Online Training for more information. 
• The lack of faculty advisor and principal investigator signatures on the original protocol.
• 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.
• Handwritten protocols. Please note that handwritten protocols are no longer accepted for review.