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NEW STUDIES

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 guides below will help you understand the requirements for obtaining regulatory approval to conduct research at VA Northeast Ohio Healthcare System.

Guide to Submitting Human Subjects Research (IRB)
Guide to Submitting Exempt Human Subjects Research (IRB Exempt)
Guide to Submitting Animal Subjects Research (IACUC)
Guide to Submitting a Central IRB Study for Local Research Approval (CIRB)
Guide to Submitting Basic Science/Bench Research (no human or animal subjects)
 

*First and foremost, If you are uncertain whether your project constitutes research, please complete the Research vs. Non-Research Operations Evaluation form for a determination.

If you are preparing a human subjects research study that may or will include subjects that are unable to sign the informed consent and HIPAA authorization, you should consult this guide to determine which forms to use: Informed Consent and HIPAA Authorization Determination Guide

For questions regarding New Studies:

R&D Coordinator/Project Manager Christina Bennett*

 

R&D FORMS

All proposals submitted to the R&D Committee must be accompanied by a completed Request to Review Research Proposal (RRRP) Form. Other required documents are listed below and the RRRP has more details regarding which forms are needed for which types of funding proposals.

 

RRRP: Request to Review Research Proposal

Initial Review Form

Abstract Template

Budget Template

Letter of Support of Services

Letter of Support of Services for CBOC use

Data Management and Access Plan

Conflict of Interest Disclosure (when signing with electronic signature)

Conflict of Interest Disclosure (when printing and signing with pen and ink)

New Investigator Packet (for all first time VA PIs)

Each proposal must be accompanied by a set of reviews as described below:

  • VA Funding Applications (Merit, CDA, RCS, etc) are peer-reviewed and do not require additional scientific review.

  • Non-VA Funding Applications (NIH, DoD, AHA, etc) must include the reviews by the funding agency.

  • Industry sponsored/initiated projects must include 2 scientific reviews (using the Initial Review Form). One review must be from a VA Investigator (PI or Co-Investigator on any other VA study).

  • Project is not funded/has not been submitted for funding, or other funding not listed above must include 2 scientific reviews (using the Initial Review Form). One review must be from a VA investigator (PI or Co-Investigator on any other VA study). 

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


As of July 2009, the R&DC is considered the Committee of Record for studies that do not fall under the IRB, IACUC, or SRS.  These studies should use the R&DC Continuing Review Form.

 

For questions regarding VA funding applications:

Administrative Officer Holly Henry*

IRB FORMS

STUDIES FOLLOWING THE 2018 COMMON RULE

Research Plan  

Informed Consent with HIPAA

Informed Consent with HIPAA Guidance  

Request for Exemption from IRB Review  


ALL STUDIES

Assent Guidance

Checklist for Adding Individuals to VA Approved Human Subjects Research Studies

Conflict of Interest Disclosure (when signing with electronic signature)

Conflict of Interest Disclosure (when printing and signing with pen)

Continuing Review Report

Oral Script/Letter/Information Sheet Guidance  

Request for Waiver of Documentation of Informed Consent

Request for Waiver of Alteration of Informed Consent

Request for Change in Principal Investigator

Request for Modification of IRB approved research

Status Report Update

Study Closure Form

Tracking Log for Non-Reportable Events

Unanticipated Problem Reporting Form

VA Form 10-9012 - Investigational Drug Form

HIPAA FORMS AND INFORMATION

Authorization For Release of PHI for Research Purposes (if separate from Informed Consent document)

Notice of Privacy Practices Information  

Acknowledgement of the Notice of Privacy Practices VA Form 10-0483  

Request for a Waiver of Authorization to Release of Protected Health Information for Research Purposes

Revocation of Authorization for Use & Release of Individually Identifiable Health Information

 

IRB REVIEWER CHECKLISTS

Reviewer Checklist for Initial IRB Review  

Reviewer Checklist for Continuing IRB Review  

Reviewer Checklist for Modifications to IRB Approved Research

For questions regarding IRB:

IRB Administrator Monica O'Loughlin*

 
 

IACUC FORMS

IMPORTANT: All PIs and staff listed on VA ACORPs must have completed the Mandatory IACUC Training and documentation prior to final approval by the IACUC.

 

Submission Documents

ACORP Main Body**

Appendix 1, Local Rodent Breeding Appendix***

Appendix 2, Antibody Production**

Appendix 3, Test Substances**

Appendix 4, Antemortem Specimen Collection**

Appendix 5, Surgery**

Appendix 6, Special Husbandry and Procedures**

Appendix 7, Request to Use Patient Procedural Area for Animal Studies**

Appendix 8, Request to Use Explosive Agents in Animal Facilities or in Animals**

ACORP Investigator Assurances***

ACORP Amendment (updated appendices may be required)***

ACORP Annual Review Form***

Vendor Export Form***

Vendor Import Supplemental Form***

Conflict of Interest Disclosure (when signing with electronic signature)

Conflict of Interest Disclosure (when printing and signing with pen and ink)


**Each of these forms are required nationally and are available here.

***Each of these forms are required locally -- please do not use alternate versions.

 

RESEARCH SAFETY FORMS

All VA PIs, while on official VA duty time, who are conducting research in laboratories located within the VA Northeast Ohio Healthcare System are required to complete a Research Protocol Safety Survey (RPSS VA Form 10-0398).

 

Hazards that require identification on the RPSS include:

Biological Agents, Select Agents (as identified in Title 42 Code of Federal Regulations (CFR) 72.6), Human/Non-Human cell or tissue samples, Recombinant DNA, Select Chemicals, Controlled Substances, Ionizing/Non-Ionizing Radiation, Physical Agents, and Use of Animals.

If a protocol does not involve the above noted hazards, use the RPSS Exemption.

For all non-exempt studies, complete an Investigators Checklist for Annual Review of Protocols Involving Hazardous Materials annually.

 

For questions regarding Research Safety:

Research Safety Coordinator John Schaffer*

 

RADIATION SAFETY FORMS

 

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