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.

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Non-Research Determinations

If you are uncertain whether your project constitutes research, you can use the VA Electronic Determination Aide (VAEDA)

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If you receive a VAEDA determination that your project is not research, a review will be conducted by Quality Management to validate the VAEDA determination and provide next steps for initiating your project. Non-research projects are under the oversight of Quality Management and do not require any review or oversight from the Research Service.  You will need to submit through the My Determinations page of the VAEDA Tool, on the right you will see a submit button for final determination and approval.

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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.

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STUDY FORMS

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.

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Forms That Must Be Submitted OUTSIDE the VAIRRS System:

1. New Investigator Packets

2. Radiation Safety Forms

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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.

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All COI disclosures (including revisions and renewals) must be submitted electronically via IRBNet, and all decisions will be issued electronically via IRBNet. 

 

Instructions and guidance for the new MyCOI process can be found in the IRBNet Forms and Templates library (VANEOHS Research Administration, Cleveland, OH – Documents for Researchers) and below for reference.

How To: COI Step 1 - Creating Your COI Disclosure

How To: COI Step 2 - Submitting COI Disclosures

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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 VHACLEVAIRRS@va.gov – DO NOT upload into VAIRRS.

 

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

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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.

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Research Roadmap

AU-PI Application

AU-PI Amendment

Human Research Involving Ionizing Radiation Application

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For questions regarding Radiation Safety:

Radiation Safety Officer

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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

  • 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 Use Agreement

 

For questions regarding New Studies:

R&D Committee Administrator

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For questions regarding VA funding applications:

Administrative Officer (216) 791-3800 x64657