All research to be conducted at VA Northeast Ohio Healthcare System MUST be approved by the R&D Committee and any applicable sub-committees (IRB, SRS, IACUC) before research can begin. The guidance below will help you understand the requirements for obtaining regulatory approval to conduct research at VA Northeast Ohio Healthcare System.
All submissions to the IRB, IACUC, SRS and RDC (e.g., new protocols, amendments, continuing reviews, closures) must be submitted electronically via VAIRRS. E-mail and hard copy submissions will not be accepted. Please see the VAIRRS/IRBNet page for more information.
Does my project qualify as research?
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
A “systematic investigation” is an activity that involves a prospective study plan which incorporates data collection, either quantitative or qualitative, and data analysis to answer a study question. Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions (i.e., knowledge gained from a study may be applied to populations outside of the specific study population), inform policy, or generalize findings.
If you are uncertain whether your project constitutes research, you may request a determination from the VANEOHS Research Office.
To obtain a determination about whether your proposed project constitutes research or not research, please complete the evaluation form found below. All submissions to the Research Office are now done through VAIRRS/IRBNet, which was implemented nationally by VA Office of Research & Development. You will need to create an IRBNet account, if you do not already have one, so that you may submit this for review. This is a simple process that takes 5 minutes or less. Please see this guidance for creating a VAIRRS/IRBNet account.
Once you have an IRBNet account, please create a new project in IRBNet for non-research determination and upload the following:
The research/non-research evaluation form describing the proposed project (ensure you describe any acronyms at first use)
A copy of any relevant accompanying documentation, such as data collection forms, surveys/questionnaires, an abstract/description of your project, any letters/determinations you’ve received from other entities regarding this project, etc., as applicable
Do not complete the requirements listed in the Research Submissions guidance above; that is applicable only to research studies.
Publication of Non-Research Activities Outside the VA
The research/non-research evaluation form is only required when there is uncertainty about whether a proposed project constitutes research. If you are certain that your project does NOT constitute research, but need written attestation that the project is not research for the purposes of publication, do not submit the evaluation form for review. Instead, complete the Documentation of Non-Research Activities for Publications Outside the VA form and email to Christina.Bennett2@va.gov.
The majority of required study forms are available for download within VAIRRS/IRBNet from the Forms and Templates page. Certain forms must be submitted directly to the Research Office, outside of VAIRRS; see below.
Forms That Must Be Submitted OUTSIDE the VAIRRS System:
Conflict of Interest Statements
New Investigator Packets
Radiation Safety Forms
RESEARCH FINANCIAL CONFLICT OF INTEREST (FCOI) STATEMENTS
All investigators (PI, co-investigators, etc.) must submit a Research Financial Conflict of Interest Statement (OGE Form 450 Alt VA) for each study in which they are listed as an investigator.
This form should be completed and signed electronically.
FCOI forms must be emailed to VHACLEresearchFCOI@va.gov when you create your submission in VAIRRS. Per VA Office of Research & Development, FCOI forms MUST NOT be uploaded into VAIRRS.
When emailing your FCOI form(s), please be specific in the subject line about the type of submission (e.g., IRB continuing review, IACUC modification, new study, SRS annual review) with which your FCOI form is associated. If you do not specify, processing of your COI will be delayed.
Financial Conflict of Interest Disclosure (for electronic signature)
Financial Conflict of Interest Disclosure (when printing and signing with pen and ink)
NEW INVESTIGATOR PACKETS
Principal Investigators must have VA paid appointments and cannot be interns, residents, or fellows.
If you have not previously served as Principal Investigator on a study at VANEOHS, you will need to complete a New Investigator Packet and submit to the Research Office prior to submitting your study package. Email this packet to Christina.Bennett2@va.gov – DO NOT upload into VAIRRS.
New Investigator Packet (for all first time VA PIs)
RADIATION SAFETY FORMS
Research studies involving radiation typically require approval from the Radiation Safety Committee (RSC). Required RSC forms can be downloaded below. Please contact the Radiation Safety Officer when you are preparing your study to begin the process. If required, RSC approval must be obtained prior to IRB approval of the study.
For questions regarding Radiation Safety:
Radiation Safety Officer Ronald Leuenberger*
If you will be taking sensitive or patient health related data offsite, you will need the following forms:
This is requested through EPAS. Select Cleveland VAMC Store/Transport Sensitive Data Request. You must be logged on to the VA Network to access this website.
For questions regarding New Studies:
R&D Committee Administrator Christina Bennett*
For questions regarding VA funding applications:
Administrative Officer Holly Henry*
READ ME FIRST - Research Submission Guidance
Please download the guidance below and review this document thoroughly before preparing your submission. It contains general information that applies to all research submissions (including those for existing studies), as well as detailed guidance about requirements for submitting a new research study for review, including procedures and a list of required forms/documents.
* These links use regular email and are not secure. Do not send personal or medical information unprotected over the Internet.