New researchers

Applying to do research at VA Pittsburgh

Are you conducting research?

1. Does the project you are proposing constitute research? In order to constitute research both of the following must be true:
   (a) The activity is a systematic investigation, including research development, testing and evaluation
   (b) The activity is designed to develop or contribute to generalizable knowledge.
2. If yes, your research must be submitted to the VAPHS Research and Development Committee (R&DC).  Your research may also require review from one or several of our other research subcommittees, continue reading below for instructions.
3. If the answer to "b" is yes, proceed to Submission to Research Review  Committee(s).
4. If the answer to "a" or "b" is no, review by a VAPHS Research Review Committee is not necessary.
5. If you are uncertain as to whether or not the proposed activity constitutes research, please  refer to the QA/QI project section for additional guidance.

Employment, training, and credentialing Verification

In order to conduct research at VAPHS, all staff must hold VA appointments (Without Compensation (WOC), VA full-time or part-time, and must be appropriately trained and credentialed. Contact VHAPTHResearchOffice@va.gov to initiate this process.

Submission to Research Review Committee(s)

All VA research must be reviewed by the VAPHS Research and Development Committee, and may require additional review by VAPHS subcommittees. There are 3 subcommittees charged with the review of research at VAPHS: The VAPHS Institutional Review Board (IRB), the Institutional Animal Care and Use Committee (IACUC), the Institutional Biosafety Committee (IBC), and the Research Scientific Evaluation Committee (RSEC). Please see below for additional information regarding your next steps:

1. For Animal Research being submitted to the VAPHS IACUC: P Laboratory/Science Safety Research being submitted to the VAPHS IBC; and

   For Human Subjects Research projects utilizing the VAPHS IRB or VA Central IRB: You must register for a VAIRRS/IRBNet account. VAIRRS/IRBNet is the online submission system used for ALL Research and projects which require a not human subjects determination.

    To Register, access VAIRRS/IRBNet. Instructions for Creating an Account in VAIRRS/IRBNet:

   1. Go to gov.irbnet.org

   2. Click New User Registration under the login boxes

   3. Accept the Individual User Terms of Use

   4. Continue to the next page
   5.  Accept the Individual User Terms of Use
   6. Search for the Pittsburgh VA Health Care System, Pittsburgh, PA and select it as Your Organization
   7. Continue to the next page
   8. Add your telephone number and VA email
   9. Continue to the next page
   10. Confirm the information is correct and click Register
   11. Clink Continue on the next page to send your Activation Email
   12. Click on the link in the email to activate your account
2. Initial questions regarding the submission process may be directed to the appropriate committee staff contacts noted under Committee member information below.
3. If you believe your project is research, but does not involve human subjects or animal subjects, you will need to submit to the VAPHS IRB for a not human subjects determination. These projects are submitted via VAIRRS/IRBNet. You must register for a VAIRRS/IRBNet account to initiate your submission. Initial questions regarding the submission process may be directed to the IRB Staff.
4. VAPHS also utilizes the following Commercial IRBs: NCI Central IRB; Advarra IRB; WIRB-Copernicus IRB; Sterling IRB. More information regarding the use of Commercial IRBs is available on VAIRRS/IRBNet under the VA Pittsburgh Healthcare System Research and Development Committee library of forms. Questions may be directed to the R&DC Coordinator.

Project review and determination 

The appropriate review committee(s) will evaluate your submission and make a determination regarding the status of your project.

Associate Chief of Staff for Research and Development (ACOS/R&D) notification

The ACOS for Research and Development or his/her designee must ensure that you have received all appropriate approvals. You will be notified in writing (by the ACOS) when all approvals have been granted.

Once all required approvals have been received (all subcommittee, R&D Committee, any other applicable committee/entity, and ACOS/R&D), you may begin your project.

Human subjects research

VAPHS IRB office information

Email: vhapthIRB@va.gov

Research and Development Office

Research Office Building
Mail Code: 151
University Drive, PA 15240

Email: VHAPTHResearchOffice@va.gov

Human subjects research defined

Human Subjects Research is defined as:

Research involving the collection of data through intervention or interaction with living individuals or the collection of identifiable private information (or specimens) from such persons.

With the exception of animal research proposals, all new submissions are initially reviewed by the VAPHS Institutional Review Board (IRB) to determine whether or not the proposal meets the definition of human subjects research or if a "Not Human Subjects Determination" is appropriate.

The IRB also reviews Quality Improvement/Quality Assurance (QA/QI) projects and requests for Reviews Preparatory to Research.

If you are unsure if your project requires review by the IRB, please contact the IRB Office for assistance.

VAPHS IRB submission information

New submissions

All new research protocols involving human subjects (including Full Board, Expedited and Exempt studies) and those which do not include animal subjects must be submitted using VAIRRS/IRBNet, the online submission system at VAPHS. Any project deemed Human Subjects will be reviewed by the IRB. Any project that is deemed not human subjects, will be forwarded on to the proper review committee(s).

Other activities reviewed by VAPHS IRB

Quality Assurance/Quality Improvement (QA/QI) Projects and Other Operational Activities

These types of projects are generally undertaken by a service line or department to evaluate the quality of a particular procedure or process. QA/QI projects and Operational Activities are not considered research, however, there are times at which the lines between QA/QI/Operational Activities and Research may become blurred.

Therefore it is suggested that you review the QA/QI Policy (see below) as well as the VAPHS Guidance on Operational Activities (see below) versus Research to help you determine whether your project is research or not. If you have any doubt as to the status of a project, you should submit a copy of the Operations Activity Worksheet, along with the materials requested on the form to the IRB for a formal determination.

Reviews preparatory to research

Reviews preparatory to research are generally small reviews (NOT PILOT PROJECTS) conducted in preparation for a research project in which access to personally identifiable information is needed in order to design a research study or assess the feasibility of conducting a study. Individuals interested in conducting a review preparatory to research should follow the Guidance on Reviews Preparatory to Research (see below).

Committee contact information

Questions regarding the VAPHS Research Review Committees should be directed to the appropriate committee coordinator:

For R&D Committee questions contact:
Genna Mauro

For IRB Committee questions, contact:
VHAPTHlRB@va.gov

For IACUC or IBC questions, contact:
Beth Toth

VA funded Animal Investigators are responsible for reporting Noncompliance issues to the VA IACUC-even when they occur at the University of Pittsburgh.  A reportable events package must be created and submitted in VAIRRS/IRBNet, including the Research Incident Report Form (found below).

And any other supporting documentation (CAP, sanction letter, etc.).

For general research/education questions, contact: VHAPTHRESEARCHEDUPOLICY@va.gov

Contact us

Research and Development Office
Research Office Building #30
Mail code: 151
University Drive
Pittsburgh, PA 15240

Email: VHAPTHResearchOffice@va.gov

Administration

Walid Gellad, MD, MPH
Associate Chief of Staff for Research and Development (ACOS/R&D)

Vacant
Deputy Associate Chief of Staff for Research and Development

Kimberly Toland
Business Manager for Research and Development
Phone:

Kathleen Parks
Administrative Officer for Research
Phone: