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.

​VALBHS Research Submission Guidance - hyperlink?

SUBMISSION REQUIREMENTS

All research to be conducted at VA Long Beach Healthcare System MUST be approved by the R&D Committee and any applicable sub-committees (IRB, SRS, and IACUC) before research can begin. The guidance below will help you understand the requirements for obtaining regulatory approval to conduct research at VA Long Beach 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, please complete the Research vs. Non-Research Operations Evaluation form (ask Neil about this part) for a determination.
requirements for submitting a new research study for review, including procedures and a list of required forms/documents. 

 

VALBHS Research Submission Guidance

* These links use regular email and are not secure. Do not send personal or medical information unprotected over the Intern.

STUDY FORMS

The majority of required study forms are available for download within VAIRRS. Certain forms must be submitted directly to the Research Office; 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 VHALONresearchFCOI@va.gov when you create your submission in VAIRRS. Per VA Office of Research & Development, FCOI forms MUST NOT be uploaded into VAIRRS. (check with the Neil)

  • 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, the processing of your COI will be delayed.​

Financial Conflict of Interest Disclosure (for electronic signature) - check hyperlink

Financial Conflict of Interest Disclosure (when printing and signing with pen and ink) - check hyperlink

 

​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 VALBHS, you will need to complete a New Investigator Packet and submit it to the Research Office prior to submitting your study package. Email this packet to tamara.bon@va.gov – DO NOT upload it into VAIRRS.

New Investigator Packet (for all first time VA PIs)​ - check hyperlink

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.​

  • Research Roadmap - check these bullets for hyperlinks

  • AU-PI Application

  • AU-PI Amendment

  • Human Research Involving Ionizing Radiation Application

​For questions regarding Radiation Safety:

Radiation Safety Officer Bryan Garrison*​

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ADDITIONAL FORMS

If you will be taking sensitive or patient health-related data offsite you will need the following forms:

  • Request to Store/Transport Sensitive Data - check hyperlinks

    • 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.

  • Data Transfer Agreement

  • Data Use Agreement

For questions regarding New Studies:

R&D Coordinator/Project Manager Tamara Bon*

​For questions regarding VA funding applications:

Administrative Officer Alicia Del Villa*

* These links use regular email and are not secure. Do not send personal or medical information unprotected over the Internet.