Research and Development Service - VA Portland HCS
Research & Development - Committees and Subcommittees
- R&DC
- HSR&D Committee
- IACUC
- IRB
- SRS
Research & Development
Committee (R&DC)
| Basic Information on VAPORHCS 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 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.
TopPolicies and Procedures
Standard Operating Procedures for the Research & Development Committee (112KB, PDF) at the VA Portland Health Care System
R&D Committee Roster (44KB, MSWord)
R&D Committee Meeting
All meetings start at 3:30pm and are being held virtually using WebEx.
The R&DC typically meets the first Monday of the month, with the following exceptions: the Monday is on or close to a holiday, in August when they meet the first and last Monday of the month, September when they meet the last Monday of the month, and October when there is no meeting.
HSR&D Research Review Committee
The research review process for HSR (Health Systems Research) activities at VA Portland Health Care System (VAPORHCS) is designed to provide scientific review of HSR-related proposals and to provide assistance to VA HSR-funded investigators. The goals of the review are to improve the quality of HSR proposals being submitted from VAPORHCS and to increase the likelihood of funding.
HSR Research Review Committee (RRC)
VAPORHCS RRC membership includes:
- HSR Center of Innovation (COIN) Leadership
- HSR-funded investigators
- HSR Career Development awardees
- Selected ad hoc investigators from OHSU and other institutions
Investigators who have not previously served as a PI on an HSR-funded project must submit a draft of their grant proposal materials to the RRC for written feedback. Investigators will also be invited to present at a Friday morning conference (optional). These sessions are open to any member of the VAPORHCS research community. Investigators planning to submit grant applications that use Health Systems Research (HSR) methodologies and/or that address HSR priorities may find the meetings especially helpful
Investigators who have served as a PI on an HSR-funded project may choose to present their proposed study at a Friday morning conference or submit their grant proposal materials to the RRC for written feedback. Submitting a project for written feedback is preferred. Presenting at a Friday morning conference is optional.
Submission Process
- Contacts Avery Laliberte (Avery.Laliberte@va.gov, x51130), Administrative Officer of the Portland COIN, 8 weeks before the grant/LOI “down to the wire” submission date to notify the Portland COIN of the upcoming submission and request review (written review and feedback and/or schedule a Friday research conference time slot, as appropriate).
- Submit written materials at least 6 weeks prior to the grant/LOI “down to the wire” submission date.
- Written materials can include:
- Letter of Intent
- Grant Application Materials: Specific Aims, Research Plan, Abstract, Budget and Budget Justification, Biosketches, and any other proposal materials
RRC Conferences
- Meetings are held on Friday mornings
- The meetings are held in Building 6, Room 214 and virtually through MS Teams
- The Director of Research Education, Director, or Associate Director of the Portland COIN serves as Chair
- Attendance is expected for all VAPORHCS HSR researchers and Career Development awardees
Proposal Written Review Process
- When materials are submitted for review, the Associate Director of the Portland COIN identifies two primary reviewers from the members of the RRC.
- The Associate Director may identify reviewers from outside the RRC when needed.
- Reviewers will provide written feedback on the proposal materials and a written evaluation of significance and scientific merit.
- The investigator may choose to meet with reviewers to discuss feedback; in this case a meeting will be scheduled with the investigator and reviewers to go over key recommendations.
Institutional Animal Care
and Use Committee (IACUC)
|
|
If you have questions regarding the Margaret Doherty, CPIA |
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 1200.07, 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 (29KB, PDF)
Use of Paralytic Agents (17KB, PDF)
Stabilization of Animals After Transport (16KB, PDF)
Survival Rodent Surgery (109KB, PDF)
Tissue Collection for Genotyping (38KB, MSWord)
Tumor Development (15KB, PDF)
IACUC Standard Operating Procedures (SOP) (185KB, PDF)
Principal Investigators: you must report events identified in VHA Directive 1058.01, Research Compliance Reporting Requirements, to the ACOS/R&D and to the IACUC by deadlines specified in VHA Directive 1058.01.
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).
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)
PLEASE NOTE: Effective June 30, 2021, all initial submissions, continuing reviews and amendments must be submitted through VAIRRS. Forms can be found within VAIRRS under Forms and Templates, then from the drop-down menu VA Portland IACUC, Portland, OR - Documents for Researchers as well as under VHA ORPP&E, Washington, DC - Documents for Animal Researchers.
Continuing Reviews
A continuing review is only required for studies involving USDA species. Continuing reviews for those studies are required annually prior to the expiration of the approved ACORP. Notices are generated to investigators at least one month prior to expiration. Continuing reviews will be submitted through VAIRRS beginning June 30, 2021.
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
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 Jennifer Loftis (loftisj@ohsu.edu) for additional information.
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)
Institutional Review Board (IRB)
This link will take you to the IRB and HRPP page of the website. Institutional Review Board
Subcommittee on Research Safety (SRS)
|
The VAPORHCS SRS |
With questions regarding the SRS, contact: Bryan Jensen |
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.
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 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 all events identified in VHA Directive 1058.01, Research Compliane Reporting Requirements, to the SRS by the deadlines defined in the Directive.
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
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.
SRS Forms
Biosafety Approval of Research Proposals
PLEASE NOTE: Effective June 30, 2021, new submissions, continuing reviews and amendments for existing studies will be submitted in VAIRRS. Forms can be found within VAIRRS under Forms and Templates, then from the drop-down menu VA Portland SRS, Portland, OR - Documents for Researchers.
All submissions received by the 15th of each month will be reviewed at the upcoming SRS meeting.
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.
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)
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)
