VA Portland Health Care System

Research & Development
Committee (R&DC)

Basic Information on the VAPORHCS R&D Committee

The Research and Development Committee acts as the governing body of the Research Service at the VA Portland Health Care System (VAPORHCS). The Committee is responsible through the Chief of Staff to the Director of the medical center for maintaining high standards throughout the facility's R&D program. These standards include those that assure the scientific quality of the R&D projects, protection of human rights, laboratory safety, and welfare of animal subjects in research and development. It advises the Director on professional and administrative aspects of the R&D program. All R&D activities within the facility, whether funded or unfunded, are within its purview.

Policies and Procedures

Standard Operating Procedures for the Research & Development Committee (112KB, PDF) at the VA Portland Health Care System

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R&D Committee Roster (100KB, MSWord)

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R&D Committee Meeting Dates for 2016

All meetings start at 4:00 pm and are held in Building 101, Room 433.

November 6, 2017
December 4, 2017
January 8, 2018
February 5, 2018
March 5, 2018
April 2, 2018
May 7, 2018
June 4, 2018
July 2, 2018
August 6, 2018
August 27, 2018
September 24, 2018
November 5, 2018
December 3, 2018

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R&D Site Map

HSR&D Research Review Committee

The research review process for HSR&D (Health Services Research) activities at the VA Portland Health Care System (VAPORHCS) is designed to provide scientific review of HSR&D-related proposals and to provide assistance to VA HSR&D-funded investigators. The goals of the review are to improve the quality of proposals and to increase the likelihood of funding.

HSR&D Research Review Committee (RRC)

The VAPORHCS RRC membership includes:

• HSR&D-funded investigators
• HSR&D Career Development awardees
• Selected ad hoc investigators from OHSU and the Kaiser Permanente Center for Health Research (KPCHR)

The sessions are open, however, to any member of the VAPORHCS research community. Investigators planning their initial grant applications using Health Sciences Research methodologies may find the meetings especially helpful.

The RRC provides peer-review for all portions of HSR&D proposals: letters of intent, grant applications (regardless of funding source), and final reports.

The results of the RRC review are forwarded to the VAPORHCS R&D Committee who are responsible for granting final approval.

Submission Process

• The investigator notifies Heather Marsh (heather.marsh1@va.gov, x58251), the Administrative Officer of the Portland COIN, that materials will be submitted for review. This notification should be done by the 2nd Friday of the month.
• Materials are due to the AA by 9:00 am on the 3rd Friday of the month
• Submissions can include:
  • Letter of Intent
  • Final Report
  • Grant Application Materials
• If a grant application is to be submitted, the submission must include:
  • The VA PPQ
  • Administrative Review materials (if applicable)
  • The grant application materials:
    • Abstract
    • Budget
    • Description of Resources
    • Draft of Proposal/Application

RRC Meetings

• Meetings are held the 4th Friday of the month
• The meetings are held in Building 6, Room 336
• The Director or Co-Director of the Portland Center REAP serves as Chair
• Attendance is required for all VAPORHCS HSR&D researchers and Career Development awardees
• An agenda and documents to be reviewed are circulated to members approximately one week before the meeting
• The meetings are coordinated by the AA of the Portland Center REAP

Review and Approval Process

• When materials are submitted for review the RRC Chair identifies two primary reviewers from the members of the RRC, with the aim to match reviewer expertise to proposal topics.
• The Chair may identify reviewers from outside the RRC when needed. These reviewers will attend the review meeting.
• The reviewers submit their written reviews to the AA by the day before the meeting to allow time for duplication.
• The review at the RRC meeting proceeds as follows:
  • The proposal or document is discussed by the Committee with the investigator present
  • The Committee asks questions of the investigator
  • The investigator is excused from the meeting room
  • Any additional needed discussion is conducted by the Committee
  • A motion is made by one of the Committee members
  • A vote is taken
• The RRC review and vote on a proposal or document will result in one of the following decisions:
  • Approve
    • The proposal or document requires no revisions
  • Approve with Executive Review
    • The proposal or document is approved contingent upon revisions that will be reviewed and approved by the Primary Reviewers
  • Revise and Resubmit
    • The proposal or document must be revised and then resubmitted for review by the entire Committee
  • Disapprove
    • The proposal or document is viewed as having minimal chance of eventual funding
      (Note: the investigator can, however, request that disapproved proposals or documents be sent to the R&D Committee anyway)
• Immediately following the meeting, the AA and Chair prepare and send a letter electronically to the investigator. The letter includes the Committee’s vote and a summary of key suggestions made by the Committee during its discussions. The letter also includes the reviewers’ written reviews.

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R&D Site Map

Institutional Animal Care
and Use Committee (IACUC)

The Portland Veterans Affairs Medical Center recognizes the vital importance that animals fulfill in research. VAPORHCS is bound by federal mandates, namely the Animal Welfare Act, (Federal Web Site) the Public Health Service Policy, (Federal Web Site) and the Department of Veterans Affairs, to maintain an oversight committee (IACUC) that reviews and regulates the use of animals for biomedical research and teaching.

As part of quality assurance and a high standard of care, the IACUC follows the guidelines of the Office of Laboratory Animal Welfare (OLAW) (Federal Web Site) and sets its policies according to the Guide for the Care and Use of Laboratory Animals (non-Federal Web Site) and the Department of Veterans Affairs Handbook 1200.7, Use of Animals in Research (VA Web Site, PDF).

The Veterinary Medical Unit, with which the IACUC works closely, is fully accredited from the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) (non-Federal Web Site) and has letters of assurance on file with the National Institutes of Health (NIH) (Federal Web Site) and the OLAW.

The IACUC routinely evaluates the Veterinary Medical Unit facilities to assure compliance with federal, state, and local laws.

Guidelines

The IACUC has developed the following Guidelines to help investigators in project development:

Use of Adjuvants (17KB, PDF)
Use of Anesthetics and Analgesics (33KB, PDF)
Blood Collection (18 KB, PDF)
Daily Observation of Animals (16KB, PDF)
Death as an Endpoint (18KB, PDF)
EAE Studies (17KB, PDF)
Euthanasia Revised 7/10 (27KB, MSWord)
Use of Paralytic Agents (17KB, PDF)
Stabilization of Animals After Transport (16KB, PDF)
Survival Rodent Surgery (24KB, PDF)
Tissue Collection for Genotyping (38KB, MSWord)
Tumor Development (15KB, PDF)

IACUC Standard Operating Procedures (SOP) (185KB, PDF)

Principal Investigators: you must report serious occurrences to the ACOS/R&D and to the IACUC as soon as possible but no later than 5 days after you become aware of the events. See the Required Reporting in Animal and Lab Studies (29KB, MSWord) page for a list of the types of reportable events.

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Forms

Animal Component of Research Protocol (ACORP)
The ACORP should be completed when a VA PI is submitting a study/grant which uses animals AND requests VA funds (i.e., Merit Review, Career Development) AND/OR the VA PI wishes to house the animals at the VA Portland Health Care System's Veterinary Medical Unit (VMU). Visit the VA Office of R&D Animal Documents and Resources web page for further information.

Deadline for consideration at the next meeting is the 15th of the month (or the next business day).

After completion, all IACUC documents should be attached to an email and sent to PVAMC-IACUC@va.gov.

Note: VA Central Office expects a detailed literature search of alternatives to animal testing with the ACORP submission. See the following document for details:
Database Searches for Alternatives to Animal Testing (34KB, MSWord)

ACORP (263KB, MSWord)
    (ACORP Instructions) (115KB, MSWord)
ACORP Appendix 1: Use of Non-VA Animal Facility (25KB, MSWord)
    (ACORP Appendix 1 Instructions) (25KB, MSWord)
ACORP Appendix 2: Antibody Production (56KB, MSWord)
    (ACORP Appendix 2 Instructions) (32KB, MSWord)
ACORP Appendix 3: Test Substances (98KB, MSWord)
    (ACORP Appendix 3 Instructions) (46KB, MSWord)
ACORP Appendix 4: Antemortem Specimen Collection (40KB, MSWord)
    (ACORP Appendix 4 Instructions) (32KB, MSWord)
ACORP Appendix 5: Surgery (108KB, MSWord)
    (ACORP Appendix 5 Instructions) (46KB, MSWord)
ACORP Appendix 6: Special Husbandry and Procedures (61KB, MSWord)
    (ACORP Appendix 6 Instructions) (35KB, MSWord)
ACORP Appendix 7: Request to Use Patient Care Procedural Areas for Animal Studies (30KB, MSWord)
    (ACORP Appendix 7 Instructions) (35KB, MSWord)
ACORP Appendix 8: Request to Use Explosive Agent (41KB, MSWord)
    (ACORP Appendix 8 Instructions) (34KB, MSWord)
ACORP Appendix 9: Additional Local Information (27KB, MSWord)
    (ACORP Appendix 9 Instructions) (265KB, MSWord)

Continuing Reviews
A continuing review is required annually prior to the expiration of the approved ACORP. Notices are generated to investigators at least one month prior to expiration with the continuing review form. The completed continuing review form (51KB, MSWord) along with updated abstract and applicable conflict of interest form(s) should be attached to an email and sent to PVAMC-IACUC@va.gov by the date specified in the email from the IACUC Coordinator.

Amendment to ACORP
The ACORP may be amended to reflect changes in the approved ACORP; for example, personnel changes, addition of animals, drugs or procedures.

Amendment for ACORP (35KB, MSWord)

After completion, all documents should be attached to an email and sent to PVAMC-IACUC@va.gov by 9am Monday for consideration that week..

Standard Operating Procedures (SOPs)
These Standard Operating Procedures have been approved by the IACUC and may be referenced in your ACORP. If you intend to reference any of these SOPs in your animal protocol, please add a statement in Item C.2. that you have read and understand the guidelines in the SOP and that you will follow the procedure outlined. To obtain a copy of these SOPs, please e-mail your request to PVAMC-IACUC@va.gov or contact the Veterinary Medical Officer.

Conditioned Place Preference (or Aversion) Testing
Drinking in the Dark
IVIS Spectrum CT Imager
Three-Day Locomotor Activity Test
Vapor Inhalation

Additionally, if you would like to propose that a new SOP be reviewed and approved by the IACUC, please contact Margaret Doherty (margaret.doherty@va.gov) and Kim Neve (nevek@ohsu.edu) for additional information.

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Alternatives to the Use of Animals in Research

The Animal Welfare Act Regulations, (Federal Web Site) Section 2.31 and USDA Policies require that a written narrative be provided by the Principal Investigator (PI) to determine whether or not alternatives exist to procedures which may cause pain or distress in animals used for teaching or research. In addition, if alternatives exist but are not used, the PI must justify why this is the case. Although searching for animal alternatives may seem to be an overwhelming task, it is hoped that the information in this document will assist animal users with this federally mandated task.

Definition of Alternatives
Alternatives refer to methods or approaches which result in refinement of procedures which lessen pain and/or distress; reduction in numbers of animals required; or replacement of animals with non-whole-animal systems or replacement of one animal species with another, particularly if the substituted species is non-mammalian or invertebrate.

Animal Welfare Act Regulations
The AWA regulations require the Institutional Animal Care and Use Committee (IACUC) to determine that "the principal investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals and has provided a written narrative description of the methods and sources used to determine that alternatives were not available." The PI must provide scientific justification to the IACUC if alternatives are available but not used.

Types of Studies Requiring an Alternatives Search
Not all animal use protocols require an alternatives search. Only studies utilizing procedures which result in more than momentary or slight pain or distress require a search. Examples include: toxicity and infectious diseases research, tumor induction or transplantation studies, survival and non-survival surgical procedures, pain research, in vivo monoclonal or polyclonal antibody production procedures, fluid and/or food restriction, and prolonged restraint. This list is not exhaustive. If you are unsure whether a search is required, please consult the VAPORHCS IACUC.

Alternatives Narrative
The written narrative for the search for alternatives must include the following minimum: methods of searching, databases searched, the date of the search and years covered, and key words and/or search strategy used by the PI. If alternatives exist to the proposed animal procedures in the protocol, the PI must scientifically justify why these alternatives are not used. This information must be updated with each three-year renewal of the animal use protocol.

Database and Web Site Searching
Computerized storage of scientific information makes database searching relatively easy. Databases frequently used, and available on-line at UIUC, for alternatives searches include TOXLINE, GRATEFUL MED, Cancerlit, Bioethics, and AIDSLINE (National Library of Medicine), and CAB Abstracts and AGRICOLA. Depending on the subject, searching several of these databases for alternatives is considered adequate by the IACUC.

Problems often arise in choosing keywords and search strategies that will yield the most pertinent information. Appropriate search terms or keywords include animal testing alternatives, alternatives, tissue culture, cell culture, simulation, in vitro, and model. Additional keywords can be found on the UC Center for Animal Alternatives web page (see below). These terms are useful, but are not the only terminology possible. The following websites provide additional information PIs may find helpful in completing an alternatives search:

Searchable Databases and Web Resources:

• Animal Welfare Information Center (AWIC) (Federal Web Site)
• Johns Hopkins Center for Alternatives to Animal Testing - CAAT
• NORINA Alternatives Databases
• UC Center for Animal Alternatives
• Monoclonal Antibody Production: A Report of the Committee on Methods of Producing Monoclonal Antibodies, ILAR, National Research Council (Federal Web Site, PDF)
• AWIC Informational Resources for Adjuvants and Antibody Production
• Monoclonal Antibody Production: The Report and Recommendations of the ECVAM

Examples

Below are several examples of alternatives searches.

• Example #1: Intestinal Xenograft Model for Human Enterocytozoon bieneusi infection (infectious diseases study) (30KB, MSWord)
• Example #2: Monoclonal Antibody Production (in vivo antibody production) (35KB, MSWord)
• Example #3: Polyclonal Antibody Production (in vivo antibody production) (39KB, MSWord)

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Deadlines for 2018

July 16, 2018
August 15, 2018
September 14, 2018
October 15, 2018
November 15, 2018
December 14, 2018

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Institutional Review Board (IRB)

This link will take you to the IRB and HRPP page of the website. Institutional Review Board

R&D Site Map

Space Committee

The Research Service Space Subcommittee functions to implement the policies of the R&D committee regarding the utilization and assignment of space. Specifically, the Subcommittee will review space requests, carry out annual reviews of current utilization of space as directed by the Research and Development (R&D) committee, and recommend to the R&D Committee assignment of new space according to the Research Service Space Policy.

This Subcommittee meets whenever new space requests are submitted. Space requests should be prepared and forwarded as outlined in the Research Service Space Policy.

R&D Site Map

Subcommittee on Research Safety (SRS)

The VAPORHCS SRS

As a subcommittee of the Research & Development (R&D) Committee, the Subcommittee on Research Safety is responsible for reviewing and overseeing the biosafety of all research activities involving biological, chemical, physical, and radiation hazards for compliance with all applicable regulations, policies, and guidelines. This includes a review of all research activities (either funded or non-funded) that will be conducted at the VAMC or conducted off-site by VA personnel with VA funding.

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The Research Safety Program

As detailed in VA Handbook 1200.8 (Safety of Personnel Engaged in Research, PDF), the Research Service (through the R&D Committee and the SRS) must develop a Research Safety Program that is consistent with VA policies, Federal statutes and regulations from Occupational Safety and Health Administration (OSHA), the Environmental Protection Agency (EPA), the Nuclear Regulatory Commission (NRC), and guidelines established by the National Institutes of Health (NIH) and/or Centers for Disease Control and Prevention (CDC), as well as any applicable state and local requirements.

The duties and function of the SRS include, but are not limited to:

• Institution and overview of the Research Safety Program
• Annual review and biosafety assessment of all research activities conducted by the Principal Investigators (PIs)
• Annual or semi-annual general safety and biosafety inspections of the research laboratories
• Biosafety review of all research projects and proposals prior to submission for funding
• Providing resources for general safety training and research-specific biosafety training for Research Service personnel (both VA and non-VA)

Security and Control of Hazardous Agents in Research Laboratories (MCM 151-02) (105KB, PDF)

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SRS Roster

The SRS membership includes both Facilities Management Service and Research Service personnel, representing different areas of research experience and biosafety expertise. Biosafety issues or concerns can be communicated to any of the SRS members (41KB, MSWord).

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Responsibilities of the Principal Investigator

The PI bears the ultimate responsibility to ensure that laboratory research personnel are in compliance with all aspects of the VA Research Safety Program. In addition, the PI's responsibilities include:

• Submission of the SRS Project Safety and Hazard Assessment (PSHA) form for new projects.
• Submission of the SRS Continuing Review form on an annual basis for all ongoing projects.
• Participation in the initial and annual general safety and research biosafety training program
• Ensuring that laboratory personnel receive appropriate safety training for research activities conducted in the laboratory
• Semiannual submission of electronic copies of the laboratory chemical inventory
• Resolution/correction of any problems or concerns noted during laboratory inspections conducted by SRS and FMS personnel, as well as representative inspectors from other oversight agencies (OSHA, NRC, state DEQ, etc.)
• Review of the VAPORHCS Chemical Hygiene Plan (419KB, MSWord)
• Review of the Research Service Emergency Preparedness Plan
• Posting of emergency phone numbers and injury and spill response procedures in the laboratory

Note that you must report serious occurrences to the ACOS/R&D and to the SRS as soon as possible but no later than 5 days after you become aware of the events. See the Required Reporting in Animal and Lab Studies (29KB, MSWord) page for a list of the types of reportable events.

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Responsibilities of Laboratory Personnel

All personnel assigned to VA research laboratories, regardless of funding source (VA vs. non-VA) or funding status (paid employees, volunteers, students, WOC, etc.), must be in compliance with all aspects of the VA Research Safety Program. These responsibilities include:

• Participation in the initial and annual general safety and research biosafety training program
• Receiving appropriate safety training for all research activities conducted in the laboratory
• Maintaining an accurate, continuously updated, chemical inventory for the laboratory
• Resolution/correction of any problems or concerns noted during laboratory inspections conducted by SRS and FMS personnel, as well as representative inspectors from other oversight agencies (OSHA, NRC, state DEQ, etc.)
• Annual review of the VAPORHCS Chemical Hygiene Plan
• Annual review of the Research Service Emergency Preparedness Plan
• Knowledge of emergency phone numbers and injury and spill response procedures

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Special Authorization Requirements

BSL3 Facility use and access
The research use of any BSL3 agent at the VAPORHCS requires pre-approval of the Subcommittee on Research Safety and the R&D Committee. Likewise, similar pre-approval is required for access to and use of the BSL3 Facility. Requests for such approval should be directed to the Biological Safety Officer, Melanie Harriff, PhD.

Select Agents and Toxins
The research use of any Select Agents or Toxins requires pre-approval by the Subcommittee on Research Safety and the R&D Committee. This process also requires Select Agent and Toxin registration with the Centers for Disease Control (please refer to the CDC website). Additional information on the research use of Select Agents and Toxins can be obtained from the Biological Safety Officer, Melanie Harriff, PhD.

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SRS Forms

Biosafety Approval of Research Proposals

Submission of all forms is electronic; hard copies are not permitted. Submit all required SRS documents to research.grants@va.gov. These must be sent from the Principal Investigator’s email address as this will serve in lieu of a signed hard copy. All submissions received by the 15th of each month will be reviewed at the upcoming SRS meeting.

FOR INITIAL REVIEW: Project Safety and Hazard Assessment (1,052KB, MSWord)
This form is to be completed by the Principal Investigator and approved by the SRS prior to any work being conducted in VA space.

FOR CONTINUING REVIEW: SRS Annual Continuing Review Form (974KB, MSWord) AND Appendix 3 SOP for BSL2 Agents (24KB, MSWord)
The SRS Annual Continuing Review form is to be completed by the Principal Investigator and approved by the SRS annually for all projects that have already received initial approval by the SRS.

FOR AMENDMENTS TO ALREADY APPROVED PROJECTS: SRS Project Amendment Form (1,028KB, MSWord)
This form is to be completed by the Principal Investigator and approved by the SRS for changes made to the chemicals used or the experimental protocols conducted, including possible use of BSL2 agents, radioactive materials, or rDNA.

VA Form 10-0398 (83KB, MSWord)
This form must be completed by a PI for “Just-in-Time” review by VA Central Office following notification of award of VA funding for a previously submitted grant proposal. Also note that a Project Safety and Hazard Assessment form (above) must also be included with all submitted VA 10-0398 Forms.

Laboratory Chemical Inventories
Each investigator is required to maintain and post a hard copy of the laboratory chemical inventory. This document will be reviewed by multiple regulatory entities during the course of a year. These inventories must provide some required information, including CAS numbers for the chemicals, and all hazardous chemicals must be indicated. Hazardous Chemicals are those that are: corrosive, reactive, flammable, or toxic. This can be determined from a material safety data sheet (MSDS) or by contacting the VAPORHCS Industrial Hygienist. A Sample Chemical Inventory (23KB, Excel) is available for informational review. In addition, investigators are required to maintain their online MSDS database for hazardous chemicals within the VISN 20 online system. The VAPORHCS Industrial Hygienist in Facilities Management Service will review these documents twice yearly to ensure compliance.

Laboratory and/or Animal Scope of Work
All personnel working within a laboratory and/or with animals must have a Lab/Animal Scope of Work (47KB, MSWord) form on file with the Research Office.

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SRS Policies

SRS Standard Operating Procedure (SOP) (154KB, PDF)

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Useful Websites and References

VHA Handbook 1200.8, Safety of Personnel Engaged in Research (VA Web Site, PDF)
VHA Handbook 1200.06, Control of Hazardous Agents in VA Research Laboratories (VA Web Site, PDF)
List of Select Agents and Toxins (Federal Web Site, PDF)
CDC Select Agents and Toxins program (Federal Web Site)
NIH (recombinant DNA) guidelines (Federal Web Site)
Biosafety in Microbiological and Biomedical Laboratories (Federal Web Site)

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R&D Site Map