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Submissions :: Submitting a Protocol :: Process

Protocol Submission Process

Putting together a new protocol can be a complicated task.  If you haven’t organized your materials and ideas before this point, you will certainly need to now.  However, understanding what you need to submit, how your documents will be processed through our office, and how the review process works can help you to better understand the IRB review and its purpose.  Hopefully your submission process will be a chance to refine some of your research ideas and anticipate any issues that potentially will put your research participants at risk.

What do I submit?
How do I submit my protocol?
When do I submit my protocol?

What do I submit?

Protocol Form
The foundation of your submission is the protocol form.  This form is the road map to your study, helping the Board to understand what you intend to do. When the Board approves your protocol, you are committed to follow the procedures outlined therein.  There are two versions of the Protocol Form:

  • Standard Protocol Form: This form explains your protocol and helps you to answer the basic questions that the Board will have about your study procedures. This form can be used for any study.
  • Archival Data Protocol Form: The Archival Data Protocol Form is an abbreviated version of the full protocol form, focusing on the information needed specifically for archival data studies.  If your study includes only archival data, you can use this form. For a complete definition and more information about archival data, please see Archival Data.  If your study includes other types of data in addition to the archival data (i.e. confidential interview, anonymous survey), you need to submit the full protocol form.  If you have additional data beyond the archival data, you do not need to submit both forms; the full protocol form covers archival data as well.  The review process for the Archival Data Protocol Form is the same for the Protocol Form. Although most archival data protocols will qualify for exemption and expedited review, completing this form does not guarantee that your protocol will be expedited.  For more information about the IRB review process, please see Protocol Review Process.
  • Ethnography Protocol Form: This version of the protocol form is specifically for Anthropology faculty and graduate students conducting ethnographic research; if you are not an Anthropology faculty member or graduate student, please use the Standard Protocol Form even if you are conducting ethnographic research.

For tips on completing the protocol and protocol samples, please see Tips. The Protocol Form must be submitted in Word format.  Please do not alter the format. (The one exception is that you may submit a PDF version of the signature pages.)

Researcher Certification and Agreements:
The following must be completed with your submission:

  • CITI Training: The IRB-SBS requires that all researchers be certified to conduct human studies research.  In order to certify, they ask that you and any other researcher listed on the protocol complete the CITI Training.  Training is valid for three years.  For more information, please see CITI Training.
  • Investigator’s Agreement: This form outlines the rules for conducting research with an IRB approval or exemption. (This form is included in the Protocol Form word document.) In order to submit your protocol for review, you must submit a signed version of this document. For more information on how to submit signed documents to our office, please see How to Submit below .

Additional Materials and Requirements:
The materials that you will submit depend on the type of study you are doing.  For example, an archival study may only need a protocol form but an in-depth education study may include consent forms for kids, parents, teachers, principals, as well as instruments and surveys.  A good rule of thumb is that if you mention it in your protocol, most likely the Board will want to see it. This includes submitting:

  • Consent Form(s): We have several templates for creating consent forms. For more information on consent forms, please see Consent.
  • All materials used to contact participants, including flyers, advertisements, letters, and emails.  If you will contact them in person, please provide an oral script outlining what you will say to participants (this script can be included in the protocol under 3a). Please include your IRB-SBS number on the materials (you will receive your number after you submit; include the number on the final draft). For more information on recruitment materials, please see the Consent: Recruitment
  • All instruments, surveys, interview questions, observation checklists, data extraction forms, etc, to be used in study.  The IRB-SBS has a collection of instruments in our SBS Library. If you are using one of the listed instruments, you don’t need to submit it, but instead indicate in Instruments section which instrument you will use. Please note that if you list an instrument in our library in your protocol, you are not automatically approved to use the instrument in your study. Using the instrument simply saves you the hassle of submitting the document to our office.

How do I submit my protocol?

  • Email one electronic copy of your protocol and all additional materials (i.e. consent forms, instruments, advertisements) to irbsbs@virginia.edu.
  • Submit one signed copy of the Investigator’s Agreement (Part A of the Protocol Form). Signed materials can be submitted by mail, fax {924-1992}, or email {scanned document to irbsbs@virginia.edu}. For more information about submitting materials to our office, please see Mail Submission.

When do I submit my protocol?

A protocol is generally sent to the full board because of the level of risk to participants. If your protocol is likely to be more than minimally risky to the participants, and if you need to have the protocol reviewed by a certain meeting, we recommend that you submit your protocol two weeks prior to the meeting date. The protocol will go through a pre-review process which can take 3-7 business days. Our office sets the agenda for a meeting by 9 A.M. on Monday the week prior to the meeting; in order to make a meeting, you must submit a revised version of your protocol and its accompanying materials to your pre-reviewer at that time.

In order for our office to process the protocols and for our reviewers to have time to adequately review the protocols, we must adhere to this cut-off schedule. It is likely that the Board will have revisions for your protocol (which can be reviewed outside of a full board meeting), or they may ask that you resubmit to the full board. We recommend that you plan for at least a month’s time for your review. The IRB-SBS cannot accommodate last-minute review requests. There are no exceptions to this policy.

If you have any questions, please contact our office. For the current meeting calendar, please see Events.

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