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VCU IRB Submission Tips and Instructions

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Helpful Tips Applicable to All Study Types

• Occasionally the forms change.  Make sure you are using the most up to date form.  A grace period of 30 days is allowed when forms are updated.
• Submit the correct number of copies.
• Make sure all research personnel have completed the CITI required online training in human participant protections and that continuing education requirements are current.
• Conflict of Interest Disclosure form submission is required for the principal investigator and all other research personnel who are involved in the design, conduct or reporting of the research.
• Submit all supporting study documents such as:
• Informed consent(s)
• Recruitment materials
• Survey instruments and interview questions
• Be sure all submission documents include version numbers and/or dates in the footer.  When documents are changed, a new version number and/or date should be applied.  This helps the IRB track approved versions most efficiently.
• When requesting changes to documents, submit the track changes version AND clean copy, as well as the last approved document.
• Submit all forms to:
  VCU Office of Research Subjects Protection
  BioTech Building One    
  800 East Leigh Street, Suite 114
  Box 980568
  Richmond, VA 23298

Exempt Studies

• Exempt studies should be submitted to ORSP using the Exempt Review Submission Form for an exempt determination. 
• Number of Copies:  Submit 3 copies of the exempt form and all supporting documents.
• The principal investigator must sign the exempt form.  A department chair signature is not required for Exempt submissions.

Exempt Changes in Research – (FOR EXEMPT RESEARCH ONLY)

• Not all changes to exempt studies must be submitted for review.  For EXEMPT research, only the following types of changes should be submitted to ORSP:

• Change in principal investigator
• Any change that increases the risk to the participant
• Addition of children, wards of the state, or prisoner participants
• Changes in survey or interview questions (addition or deletion of questions or wording) that change the level of risk or adds  questions related to sexual activity, abuse, past or present illicit drug use, illegal activities, questions reasonably expected to provoke psychological anxiety, or would make participants vulnerable, or subject them to financial, psychological or medical risk
• Changes that change the category of exemption or add additional exemption categories
• Changes that add procedures or activities not covered by the exempt category(ies) under which the study was originally determined to be exempt
• Changes requiring additional participant identifiers that could impact the exempt category or determination
• Change in inclusion dates for retrospective record reviews if the new date is after the original approval date for the exempt study.  (ex:  The approval date for the study is 9/24/10 and the original inclusion dates were 01/01/08-06/30/10.  This could be changed to 01/01/06 to 09/24/10 but not to end on 09/25/10 or later. )
• Addition of a new recruitment strategy
• Increase in the planned compensation  to participants

• Changes noted above should be submitted to ORSP using the Change in Research Form
• Number of Copies:  Submit 3 copies of the Change in Research Form and all supporting documents with updated version numbers / dates as applicable.

Exempt Continuing Review

• Exempt studies are not subject to continuing review requirements.  No submission is required.

Exempt Study Closure

• If the study is complete and meets the conditions for study closure found at http://www.research.vcu.edu/irb/wpp/flash/X-4.htm, submit 4 copies of the Study Closure Form

Expedited Studies

• Expedited studies should be submitted to ORSP using the following forms as applicable:
• Initial Review Form
• Research Plan Template
• Study Personnel Roster (effective 6/1/11)
• Study Personnel Information and Change Form(s) (effective 6/1/11)
• Vulnerable Population supplemental form(s) as appropriate (e.g., children, pregnant women & fetuses, and prisoners)
• Number of Copies:  Submit 4 copies of all submission forms and supporting documents.
• The principal investigator (PI) and the department chair must sign the Initial Review Form (designee signatures are not allowed for initial review).  The date of the department chair signature should not be before the date of the PI signature. If this is a trainee or student project, the student must also sign the Trainee or Student Investigator Statement of Compliance section.

Expedited Changes in Research

• Changes should be submitted to ORSP using the Change in Research Form.
• Effective 6/1/11 - Changes to study personnel other than the PI should be submitted to ORSP using the Study Personnel Information and Change Form(s) and revised Study Personnel Roster. 
• Changes to the PI should be submitted to ORSP using the Change in Research Form along with an updated Research Plan Template AND Study Personnel Roster.   
• Number of Copies:  Submit 4 copies of the appropriate Change Form and all supporting documents.
• The Change Form(s) must be signed by the principal investigator or a designee.

Expedited Continuing Review

• A continuing review notice is sent to principal investigators 3 months prior to expiration.  PIs are ultimately responsible for submitting a timely continuing review application and for not allowing studies to expire. 
• Continuing renewals should be submitted to ORSP using the Continuing Review form. 
• Submission must include the latest approved version of:
• Research Plan Template
• Informed Consent/Assent form(s)
• Study Personnel Roster (effective 6/1/11)
• Requesting a change in research at the time of continuing review:
• Submission of the Change in Research form is not required; changes will be noted within the Continuing Review form.
• Changes to study personnel require submission of the Study Personnel Information and Change Form, as well as a revised Study Personnel Roster.
• Number of Copies:  Submit 4 copies of all submission forms and supporting documents. 
• The PI or a designee must sign the Continuing Review form.

Expedited Study Closure

• If the study is complete and meets the conditions for study closure found at http://www.research.vcu.edu/irb/wpp/flash/X-4.htm, submit 4 copies of the Study Closure Form

Full Review Studies

• Full review studies should be submitted to ORSP using the following forms as applicable:
• Initial Review Form
• Research Plan Template
• Study Personnel Roster (effective 6/1/11)
• Study Personnel Information and Change Form(s) (effective 6/1/11)
• Vulnerable Population supplemental form as appropriate (e.g., children, pregnant women & fetuses, and prisoners)
• Number of Copies: 
• Pre-Review – All full board initial submissions will undergo a pre-review process prior to IRB review.  Read more about the pre-review process here. Read more about the pre-review process here.
• Submit 1 copy of all submission forms and supporting documents for pre-review.
• Following confirmation that the pre-review process is complete:
• Submit 25 copies of all submission forms and supporting documents. 
• The principal investigator (PI) and the department chair must sign the Initial Review Form (designee signatures are not allowed for initial review).  The date of the department chair signature should not be before the date of the PI signature. If this is a trainee or student project, the student must also sign the Trainee or Student Investigator Statement of Compliance section.

Full Board Changes in Research

• Changes should be submitted to ORSP using the Change in Research Form.
• Effective 6/1/11 - Changes to study personnel other than the PI should be submitted to ORSP using the Study Personnel Information and Change Form(s) and revised Study Personnel Roster.
• Changes to the PI should be submitted to ORSP using the Change in Research Form along with an updated Research Plan Template AND Study Personnel Roster. 

The form must be signed by the principal investigator or a designee.

• Number of Copies:  Refer to the Number of Copies section of the Change in Research form and submit the requested number of copies of the Change in Research Form and/or Study Personnel Information and Change Form, and all supporting documents.  When the instructions on the Change in Research form indicate 25 copies are required, ORSP advises submitting 25 copies regardless of whether the study sponsor recommends expedited review or the PI anticipates the change to be minor.  The ORSP will attempt to determine the most expeditious way to have the submission reviewed, which may be via expedited review or full board review.

Full Board Continuing Review

• A continuing review notice is sent to principal investigators (PI) approximately 4 months prior to expiration (full board continuing reviews are to be conducted 2 months prior to the expiration date).  PIs are ultimately responsible for submitting a timely continuing review application and for not allowing studies to expire. 
• Continuing renewals should be submitted to ORSP using the Continuing Review form. 
• If requesting a change in research at the time of continuing review, submission of the Change in Research form is not required; changes will be noted within the Continuing Review form. If requesting a change to study personnel, submission of a Study Personnel Information and Change Form is also required, as well as a revised Study Personnel Roster.
• Number of Copies: 
• If the project has not yet begun, and no changes are being submitted:
• Submit 4 copies of all submission forms and supporting documents. 
• If the project has begun:
• Submit 25 copies of all submission forms and supporting documents. 
• Be sure to include the latest approved version of:
• Research Plan Template
• Informed Consent/Assent form(s)
• Study Personnel Roster (effective 6/1/11)
• The PI or a designee must sign the Continuing Review form.

Full Board Study Closure

• If the study is complete and meets the conditions for study closure found at http://www.research.vcu.edu/irb/wpp/flash/X-4.htm, submit 4 copies of the Study Closure Form