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Research and Development Service - Research Committees
Research & Development
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Basic Information on PVAMC R&D Committee Policies and Procedures R&D Committee Roster R&D Committee Meeting Schedule |
With questions regarding the Danielle Beaudry |
Basic Information on the PVAMC R&D Committee
The Research and Development Committee acts as the governing body of the Research Service at the Portland VA Medical Center (PVAMC). 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 Portland VA Medical Center
Responsible Conduct of Research at the PVAMC (MCM 15101) (105KB, PDF)
R&D Committee Roster 2011 (100KB, MSWord)
R&D Committee Meeting Schedule 2013
All meetings start at 4:00 pm and are held in Building 101, Room 433.
January 14, 2013
February 4, 2013
March 4, 2013
April 1, 2013
May 6, 2013
June 3, 2013
July 1, 2013
August 5, 2013
August 26, 2013
September 23, 2013
November 4, 2013
December 2, 2013
HSR&D Research Review Committee
The research review process for HSR&D (Health Services Research) activities at the Portland VA Medical Center (PVAMC) 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 PVAMC 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 PVAMC 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 PVAMC R&D Committee who are responsible for granting final approval.
Submission Process
- The investigator notifies Sandi Long (sondra.long@va.gov, x55315), the Administrative Assistant (AA) of the Portland Center REAP, 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 PVAMC 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)
- The proposal or document is viewed as having minimal chance of eventual funding
- Approve
- 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.
Institutional Animal Care
and Use Committee (IACUC)
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If you have questions regarding the Margaret Doherty |
The Portland Veterans Affairs Medical Center recognizes the vital importance that animals fulfill in research. PVAMC 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.
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.
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.
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 Portland VA Medical
Center'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
(238KB, MSWord)
ACORP
Appendix 1: Use of NonVA Animal Facility (20KB,
MSWord)
ACORP
Appendix 2: Antibody Production (110KB, MSWord)
ACORP
Appendix 3: Test Substances (103KB, MSWord)
ACORP
Appendix 4: Antemortem Specimen Collection (66KB,
MSWord)
ACORP
Appendix 5: Surgery (93KB, MSWord)
ACORP
Appendix 6: Special Husbandry and Procedures (53KB,
MSWord)
ACORP
Appendix 7: Request to Use Patient Care Procedural Areas
for Animal Studies (39KB, MSWord)
ACORP
Appendix 8: Request to Use Explosive Agent (39KB,
MSWord)
ACORP
Appendix 9: Additional Local Information (53KB,
MSWord)
Continuing Reviews
A continuing review is required annually prior to the expiration of the approved ACORP. Notices are generated to investigators one month prior to expiration with the continuing review form. Completed continuing review form (51KB, MSWord) along with abstract should be attached to an email and sent to PVAMC-IACUC@va.gov by the date specified in the email from the IACUC Coordinator and a signed hard copy of the CR form should be delivered to the IACUC mail box in building 101, room 502.
Pilot Study Animal Component of Research Protocol
The ACORP Pilot Study form is intended for use with
small studies that will be performed using animals housed
in the Portland VA Medical Center's VMU to generate preliminary
data for grant preparation. Pilot studies expire 12 months
after IACUC approval.
After completion, all documents should be attached to an email and sent to PVAMC-IACUC@va.gov.
Pilot Study (139 KB, MSWord)
Amendments to ACORP and ACORP Pilot Study
The ACORP and Pilot Study 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 <specific title>
SOP and that you will follow the procedure outlined. 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 Tamara Phillips (phillipt@ohsu.edu)
for additional information.
ThreeDay
Locomotor Activity Test SOP (35KB, MSWord)
Conditioned
Place Preference (or Aversion) Testing SOP (115KB,
MSWord)
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 PVAMC 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)
Deadlines for 2013 January 15, 2013
February 15, 2013
March 15, 2013
April 15, 2013
May 15, 2013
June 14, 2013
July 15, 2013
August 15, 2013
September 16, 2013
October 15, 2013
November 15, 2013
December 16, 2013
Institutional Review Board (IRB)
This link will take you to the IRB and HRPP page of the website. Institutional Review Board
Space Committee
| Space Policy (55KB, MSWord) |
With questions regarding Space, contact: Archie Bouwer, PhD |
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.
Subcommittee on Research Safety (SRS)
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The PVAMC SRS |
With questions regarding the SRS, contact: Anne Dodge-Schwanz |
The PVAMC 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.
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)
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).
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 PI Annual Biosafety Self-Inspection Form to the Research Service Office for SRS review and approval
- Submission of the Annual Update of the PI Annual Biosafety Self-Inspection Form to the Research Service Office for SRS review and approval
- 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 PVAMC 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.
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:
- Annual review of the PI Annual Biosafety Self-Inspection Form
- 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 PVAMC Chemical Hygiene Plan
- Annual review of the Research Service Emergency Preparedness Plan
- Knowledge of emergency phone numbers and injury and spill response procedures
Special Authorization Requirements
BSL3 Facility use and access
The research use of any BSL3 agent at the Portland VAMC 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, Marielle Gold, 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, Charles Meshul, PhD.
SRS Forms
Biosafety Approval of Research Proposals
Submission of all forms is electronic; hard copies are not required. 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 Principle 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)
This form is to be completed by the Principle 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 Principle 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 (VA Web Site, PDF)
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 PVAMC 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 PVAMC 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.
SRS Policies
SRS Standard Operating Procedure (SOP) (154KB, PDF)
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)
