OSP Personnel

Federal regulations require that all institutions receiving federal money for human subjects research have an Institutional Review Board (IRB), made up of qualified individuals, to review human subjects protocols.  The IRB has the authority to approve protocols, require modifications to secure approval, or to disapprove protocols.  Human subjects protocols may not be initiated without IRB approval.

Virginia Tech is committed to protecting the rights of and ensuring the safety of human subjects participating in research conducted by faculty, staff, and students of the University. To fulfill this mission, Virginia Tech, as required by federal laws, regulations, and policies, has an IRB with a required Federal-wide Assurance on file in the federal Office of Human Research Protections. Virginia Tech’s IRB reviews issues related to a research project, such as selection of participants, privacy of participants, confidentiality of collected data, recruitment practices, data collection techniques, informed consent process, vulnerability of participants, and risks and benefits of the research.

OSP post award administrators are required (by VT Internal Audit) to complete the "IRB Tutorial for OSP Administrators." Completing the tutorial on Scholar (Blackboard prior to November 2009) is required for documentation purposes.

To complete the tutorial:

1. Log into Scholar here: https://learn.vt.edu/
2. Click on "Membership" on the lefthand side
3. Click on "Joinable Sites" (red text in the top of the membership box)
4. Type in "IRB Tutorial for OSP" in the Search box on the righthand side and hit "Search"
5. Click the "Join" link to enter the tutorial

If you are having difficulty accessing the tutorial, email the IRB office (irb@vt.edu).

Whom Should I Contact?

Before a researcher may be allocated funds for a grant that indicates the use of human subjects, he or she must provide OSP with an IRB approval letter for inclusion in the grant files. This IRB approval letter basically indicates that the research protocol has been reviewed and found to meet minimum specified guidelines designed to protect and ensure the rights and safety of research volunteers.

There are several different types of IRB approval letters that may be issued for a particular grant. We will describe five different approval letter types in the next section. Any IRB approval letter, regardless of its type, allows for the initial release of funds under a particular grant.

Interim Approval

Direct researchers to the following link if they'd like to request Interim approval: http://www.irb.vt.edu/pages/researchers.htm.

An IRB approval letter is required before the release of funding for proposals involving human subjects. When applying to the IRB, a researcher must have developed his or her study documents to allow thorough review by the IRB. Sometimes, researchers will seek sponsored funding from external organizations with the intent to: (1) develop the research plan using a portion of the funding, then (2) subsequently submit a developed protocol to the IRB for approval. You may notice that this presents a serious dilemma - the researcher cannot develop the human subjects research protocol without the funding; however, OSP has been told not to release funding without IRB approval.

To resolve this issue, the IRB may grant interim approval. Interim approval allows OSP to release grant funds to the researcher to allow development of study procedures and protocol documents. Interim approval does not allow the researcher to "start" their research activities involving human subjects. Before initiating the human subjects research, they must submit the developed protocol to the IRB to obtain regular (e.g., Exempt, Expedited, or Full) IRB approval.

Granting Interim approval is supported by 45 CFR 46.118 (after clicking on this link, scroll down the new page to 46.118).

Exempt Approval Versus Expedited & Full IRB Approval

The below information is not intended to instruct you in the specific criteria the IRB uses for reviewing protocol submissions as Exempt, Expedited, or Full.  Of greater importance to your job function is the understanding of the length of approval granted for each of those categories, as funding may need to be withdrawn from projects whose IRB approval has lapsed.  You should understand that IRB approval expires for Expedited and Full IRB approval (usually 12 months from the initial approval date), and that approval does not expire for Exempt approved protocols.

At the time of IRB approval, the IRB assigns an approval date and an expiration date for research that is granted either Expedited or Full IRB approval. This expiration date must be no more than one year from the initial approval date. Any continuation of the research project beyond the initial approval period requires annual/continuing approval by the IRB for another 12 month approval period.

Please note that the approval and expiration dates are found on Expedited and Full IRB approval letters only. Those dates are located in a grey shaded box on the approval letters. [Note: Older IRB approval letters, pre-2006, will not have these dates.]  You will note that Exempt approval letters do not have an expiration date, and do not “expire”.

Continuation Approval

For Expedited and Full IRB approvals, if the research continues beyond the designated expiration date, the researcher must apply for continuing review and approval of the project by the IRB. [Note: This is not required for Exempt approval.] Therefore, for Expedited and Full IRB approvals, the researchers must receive a Continuation Approval Letter from the IRB before continuing the research activities involving human subjects beyond the original IRB-assigned expiration date.

OSP is required, by Internal Audit, to have on file all IRB-issued initial Approval letters and Continuation Approval letters for a particular grant. To facilitate tracking those required approvals, OSP staff assigned to grant files involving human subjects must enter into Banner the related IRB number or numbers for each grant involving human subjects.

It should be noted that the IRB approval number and the OSP (proposal or grant) number are different.  There are a multitude of reasons for having different numbers, but that difference creates problems in tracking protocols for the other organization.

For the IRB office to send OSP all appropriate IRB approval letters (e.g., initial Approval and Continuation Approval letters) and related correspondence for OSP files for a particular grant, the IRB office needs OSP to provide specific information which, unfortunately, our mutual customers, the researchers, frequently fail to provide to us.  On occasion, a researcher will turn in a protocol application to the IRB office before knowing what his or her OSP number (proposal, grant, or fund) is.  In other instances, a researcher will not notify the IRB office that the research is externally sponsored. In both of those cases, the IRB office does not have an OSP number to match up to a particular IRB number. This inability to cross-reference IRB protocols with funded grant submissions was cited by Internal Audit as a significant deficiency.

Before funds are released to the researcher, OSP should have in its files an IRB approval letter that the researcher delivers to OSP for his/her particular grant file.  To ensure that cross-referencing of the IRB protocol number and the grant number is accomplished, the IRB office requests that OSP enters the IRB number (a five-digit number [e.g., IRB# 06-001] found on the approval letter) into Banner (FRAGRNT) under the “alternative description” space.

This simple step will allow the IRB office to directly link the OSP grant number with its corresponding IRB number, so that all future approval letters and important correspondence is more readily identified for inclusion in the appropriate grant file. Subsequent IRB approval letters (e.g., Continuation Approval letters) will be directly sent to the responsible OSP personnel via email, specifying the OSP grant number, making it easier for OSP personnel to place the correspondence in the appropriate file.

It is important to note that one OSP grant number may have several associated IRB numbers, since some researchers, with grants involving several distinct phases or components performed by/with collaborators, must submit individual IRB applications for each of the separate phases. To ensure that adequate cross-referencing and tracking occurs (and to ensure compliance with Internal Audit directives), OSP will need to enter all IRB numbers related to a particular grant in the “alternative description” space in Banner (FRAGRNT).

As of March 1st, 2007 the IRB office will send an email notification to the OSP post award administrator to inform him or her that the researcher has reported to the IRB office that human subjects related activities under a particular IRB number have been completed. This email notification must be printed and placed in the OSP file identified in the email notification (in other words, the OSP grant number will be specified in the email notification). This will let the OSP administrator know that no future Continuation Approval letters need to be placed in his/her files for a particular IRB number. In this situation, funding may continue to be expended for completion of the grant, but activities will not include continued involvement of human subjects. Those remaining activities do not require further IRB approval.

If a researcher does not obtain a Continuation Approval letter, and does not report the IRB status as complete, the IRB office will issue an Expiration letter. As with other IRB letters, the Expiration letter will be sent to the OSP post award administrator of the particular grant for inclusion in the specific OSP grant file. The Expiration letter signals that approval for a project is no longer in place, and, if the project is ongoing, funding may be withheld until re-approval is sought and granted by the IRB.

When the IRB Chair informs OSP to cease funding for a particular grant, this will be accomplished with a formal letter sent to the Director of Sponsored Programs and to the post award administrator.

The federal government requires that the IRB compare the proposal submission to the IRB application/protocol for all federally funded non-exempt research. As required in federal regulations, this must be done before funds are released for a particular grant.

To confirm that the IRB has conducted this comparison for a federally funded project, you will note that the IRB approval letter (Expedited or Full IRB) will contain the following language:

As indicated on the IRB application, this study is receiving federal funds. The approved IRB application has been compared to the OSP proposal listed above and found to be consistent. Funds involving procedures related to human subjects may be released. Visit our website at www.irb.vt.edu for further information.

If you receive an Expedited or Full IRB approval letter for a federally funded project that does not contain this language, please contact the IRB Administrator, Carmen Green, at ctgreen@vt.edu before releasing the funds.

Additionally, there will be a “Grant Compared” date on the top right hand corner of the Expedited and Full IRB initial approval letters, directly over the grey shaded box containing approval and expiration dates. Note that the Grant Compared date will not be included on the Continuation Approval letters, as the comparison was documented during the initial approval.

Please also note that this comparison is not required for Exempt or Interim approvals. It is only required for Expedited and Full IRB approvals receiving federal funds.

1. Where may I direct a researcher who needs to submit an IRB application?

Provide the researcher with the following URL: http://www.irb.vt.edu/pages/researchers.htm

2. What should I tell a researcher who cannot prepare an IRB application without the receipt of grant funds?

Advise the researcher to apply for IRB Interim approval, and provide the researcher with the following URL so he/she may start an IRB Interim application: http://www.irb.vt.edu/pages/researchers.htm

What is Interim?

3. Instead of receiving a VT IRB approval letter, I received an IRB approval letter from another institution. What should I do?

Contact Carmen Green ((a href="mailto:ctgreen@vt.edu">ctgreen@vt.edu) and wait for either confirmation that VT IRB approval is not required or a VT IRB approval letter before releasing funds. Please file the correspondence you receive from the IRB office.

4. Why is it important that I enter the related IRB number under a grant's (involving human subjects) record in Banner?

Entering the related IRB number under a grant's (involving human subjects) record in Banner allows the IRB office to export that data from Banner on a regular basis and use that data to update the IRB's database. Often times, researchers do not inform the IRB that a particular IRB protocol is funded or provide the related OSP number. It is important for the IRB to link IRB protocols to related OSP proposals because it allows the IRB to send all future approval letters and related correspondence directly to the post award administrator for his/her files. Also, having that link allows the IRB to ensure all required comparisons of proposals to protocols have been conducted.

5. Why is it important that I retain IRB approval letters and IRB-related correspondence in my files?

Retention of IRB approval letters and IRB-related correspondence in OSP files is required by VT Internal Audit (IA) and will facilitate future audits by VT IA or a government agency.

6. What are possible consequences if funding for a grant involving human subjects is released prior to the receipt of appropriate IRB approval, or before a comparison of proposals to protocols has been conducted by the IRB?

An incident of institutiohnal noncompliance will be documented. If one or both of the above-described scendarios occurs, the IRB Chair indicates that the incident of noncompliance is serious, and the related grant is funded by an agency which has adopted the Common Rule, a report of serious noncompliance must be sent to the Office for Human Research Protections (under DHHS).