Title: VA Research and Development 2002 Animal Research Update
1VA Research and Development2002 Animal Research
Update
Michael T. Fallon, DVM, PhD, dip ACLAM CVMO,
VACO VMO Atlanta
2Introduction of Dale Conaway, DVM, MS
- B.S. (1978) Animal and Poultry Science and D.V.M.
(1979) from Tuskegee Institute, M.S. (1985)
Pathology, CVM, MSU - 1979-81 Positions Clinician with Humane Society
of Missouri Vet epidemiologist at Wash Univ St.
Louis - 1982-84 Graduate Fellow, Dept of Path, CVM, MSU.
- 1985-88 Postdoctoral fellow Wayne State Schl of
Med, Dept. of Immunology - 1988-94 Director, Animal Facility Mich Cancer
Found, WSU - 1994-98 Regulatory Affairs Manager, Mich Dept
Pub Health - 1998-2001 Manager Equine Drug Testing Animal
Disease Surveillance Sections Michigan Dept Of
Agriculture - 2000 Assumed position of Deputy Regional
Director, Southern Region Chief Veterinary
Medical Officer, VA Office of Research Compliance
Assurance (ORCA)
3Outline
- Brief overview Where do I fit in at the VA?
- ORCA and ORD relationship and role delineation
- VA Research Budget Outlook for FY2003
- JIT ACORP Reviews
- Hosting non-VA projects in the VMU new guidance
- Highlights New Handbook 1200.7, Use of Animals
in Research - New semi-annual forms and minutes template
- ShEEP New procedures for requesting animal
equipment funds - Update Web-based training at www.researchtraining
.org, and AALAS CRADA - Questions, hopefully answers
4Office of Research and Development (ORD)
Dir, HSRD
Chief RD Officer (CRDO) James Burris, MD
Dir, Coop Stud.
Dir, Rehab RD
Dir, Med Res Svc
Deputy Under Secretary for Health, Robert H.
Roswell, M.D.,
Med Center
RD Svc
VISN
The Field
Dir, South Ofc
Dir, NE Ofc
Chief Officer , John Mather, MD
Dir, Midwest Ofc
Dir, Western Ofc
Office of Research Compliance and Assessment
(ORCA)
Dir, Mid-Atlantic Ofc
5ORCA and ORD- Brief Role Delineation
- ORCA
- Develops, implements, evaluates policies and
procedures to assess VA research - Conducts for cause and courtesy site visits of
research programs - Holds FWAs for stations conducting human research
- Interacts with other regulatory agencies for
compliance issues
- ORD
- Develops policy and standards for conduct of VA
research (e.g. Handbooks) - Provides research guidance and support to
stations - Administers peer-review system of funding,
manages research portfolio - Administers research infrastructure evaluation
visits and ShEEP program
6Outline
- Brief overview Where do I fit in at the VA?
- ORCA and ORD relationship and role delineation
- VA Research Budget Outlook for FY2003
- JIT ACORP Reviews
- Hosting non-VA projects in the VMU new guidance
- Highlights New Handbook 1200.7, Use of Animals
in Research - New semi-annual forms and minutes template
- ShEEP New procedures for requesting animal
equipment funds - Update Web-based training at www.researchtraining
.org, and AALAS CRADA - Questions, hopefully answers
7Past and Projected VA RD Budget and cc105 Budgets
9
1.9
2.5
1.8
8
2.0
2.0
7
2.0
6
5
4
Total VA RD Bud in millions
Cost Center 105 in millions
3
2
1
0
8How Does My VMU Get Its Share of cc105 Money in
FY03 from VACO?
- The Variables
- D The yearly average of the competitive station
funding for FY 2000, FY 2001, and FY 2002 for
programs which indicated animal use. - F Veterinarians salary or contract amount. Not
linked to actual salary or contract cost (amount
received may be lower than actual).
9How Does My VMU Get Its Share of cc105 Money in
FY03 from VACO?
- The FY2003 cc105 formula
- CC105
- 0.09 x (D between 175K and 1million)
- 0.04 x (D between 1 and 2 million)
- 0.02 x (D greater than 2 million)
- F
10How Does My VMU Get Its Share of cc105 Money in
FY03 from VACO?
- The bottom line If your investigators do not
propose animal use in their VA grants when
appropriate to do so, you lose from 2 to 9 cents
on every non-salary dollar they receive.
11Outline
- Brief overview Where do I fit in at the VA?
- ORCA and ORD relationship and role delineation
- VA Research Budget Outlook for FY2003
- JIT ACORP Reviews
- Hosting non-VA projects in the VMU new guidance
- Highlights New Handbook 1200.7, Use of Animals
in Research - New semi-annual forms and minutes template
- ShEEP New procedures for requesting animal
equipment funds - Update Web-based training at www.researchtraining
.org, and AALAS CRADA - Questions, hopefully answers
12Just in Time (JIT) Reviews
- Original NIH Concept- because only 20-25 of
applications actually receive funding, why not
reduce local administrative work loads and
require detailed data only on those projects
selected for funding after scientific peer
review? - In 1996 NIH implemented JIT for some budget
information - In June 2000 JIT was extended to IRB verification
letters. - September 2002- JIT extended to IACUC
verification letters.
13Just in Time (JIT) Reviews- VA
- Acknowledging intense field interest, and in the
interest of harmonizing with NIH policies, ORD
has now adopted mandatory JIT procedures for
documentation of committee approval for human
subjects (IRB), animal subjects (IACUC), and
biosafety issues (SRS). - Language covering most medical research is found
in Handbook 1202.1, Appendix A, paragraphs p(1)
through (3), page A-17, at http//www.va.gov/resde
v/directive/ 1202_Merit_Review_Handbook_JIT.doc.
14Old System
VACO funding decision and funds release
Scientific Section
RD Com.
DEADLINE 1
Complete Application
ACORP
IACUC
JIT System
DEADLINE 1
Scientific Section
RD Com.
VACO funding decision
ACORP
VACO funds release
IACUC
DEADLINE 2
15Old System
Investigator Angst
VACO funding decision and funds release
Scientific Section
RD Com.
DEADLINE 1
Complete Application
ACORP
IACUC
JIT System
DEADLINE 1
Scientific Section
RD Com.
VACO funding decision
ACORP
VACO funds release
IACUC
DEADLINE 2
16Old System
IACUC Angst
VACO funding decision and funds release
Scientific Section
RD Com.
DEADLINE 1
Complete Application
ACORP
IACUC
JIT System
DEADLINE 1
Scientific Section
RD Com.
VACO funding decision
ACORP
VACO funds release
IACUC
DEADLINE 2
17Possible Timeline- JIT System
T0 station notified
DEADLINE 1
Scientific Section
RD Com.
VACO funding decision
ACORP
T0 12 wks approved ACORP due in VACO
T0 16 wks 2 review completed
IACUC
2 vet review of ACORPs
VACO funds release
DEADLINE 2
18JIT- A Few Important Points
- Stations may continue to require ACORP review
prior to application submission, but ACORPs may
not be put into the application. - Secondary veterinary review will continue as
before, but only on those ACORPs from projects
targeted for funding. - IACUCs will have to maintain high standards, even
when confronted with investigators who lose
funding if their ACORP is not approved in time to
meet the ACORP submission deadline.
19How Will VA Scientific Review Committees Evaluate
Animal Research?
- Answer- in the absence of an ACORP in the
application, a new section of the Merit Review
application must be filled out to give a brief
description of proposed animal use (questions
were taken from Section f in NIH Form 398
application for RO1 applications).
20How Will VA Scientific Review Committees Evaluate
Animal Research?
- The five questions (abbreviated)
- (1) Provide a detailed description of the
proposed use of the animals Identify species,
strains, ages, sex, and numbers of animals to be
used in the proposed work. - (2) Justify the use of animals, the choice of
species, and the numbers to be used - (3) Provide information on the veterinary care of
the animals involved. - (4) Describe the procedures for ensuring that
discomfort, distress, pain, and injury will be
limited - (5) Describe any method of euthanasia
21Outline
- Brief overview Where do I fit in at the VA?
- ORCA and ORD relationship and role delineation
- VA Research Budget Outlook for FY2003
- JIT ACORP Reviews
- Hosting non-VA projects in the VMU new guidance
- Highlights New Handbook 1200.7, Use of Animals
in Research - New semi-annual forms and minutes template
- ShEEP New procedures for requesting animal
equipment funds - Update Web-based training at www.researchtraining
.org, and AALAS CRADA - Questions, hopefully answers
22Hosting Projects From Non-VA Entities in the VMU
- This practice has long been encouraged to utilize
excess VMU space for the mutual benefit of non-VA
entities and local VA research programs. - The emergence of revised VA intellectual property
policy and concern over the potential for unequal
oversight of non-VA vs. VA projects led to a
guidance document, which was released in July
2002.
23(No Transcript)
24(No Transcript)
25(No Transcript)
26VHA Intellectual Property Handbook 1200.18
2. BACKGROUND Under Executive Order 10096, and
Department of Commerce implementing regulations,
37 C.F.R. Part 501, the Government has the right
to assert a right, title, and interest in and to
all inventions made by any Government employee
during working hours with a contribution by the
Government of facilities, equipment, materials,
funds, or information, or of time or services of
other Government employees on official duty or
which bear a direct relation to or are made in
consequence of the official duties of the
inventor.
27VHA Intellectual Property Handbook 1200.18
VA recognizes that not all inventors may be
full-time employees. Some may be part-time VA
employees and part-time employees of another
organization such as a university affiliate.
Inventors may also be full-time employees of
another organization granted access to VA
resources (space, supplies, equipment, patients,
etc.) after executing a VA-WOC Appointee
Intellectual Property Agreement see www.vard.org
for specific instructions and form. As a result
of this unique relationship an invention can be
made while the inventor is acting as an employee
of one or both organizations. It is important to
realize that VA determines ownership rights only
to the extent the invention was made in
connection with the inventors VA employment or
with a substantial VA contribution.
28Outline
- Brief overview Where do I fit in at the VA?
- ORCA and ORD relationship and role delineation
- VA Research Budget Outlook for FY2003
- JIT ACORP Reviews
- Hosting non-VA projects in the VMU new guidance
- Highlights New Handbook 1200.7, Use of Animals
in Research - New semi-annual forms and minutes template
- ShEEP New procedures for requesting animal
equipment funds - Update Web-based training at www.researchtraining
.org, and AALAS CRADA - Questions, hopefully answers
29Handbook 1200.7
- Replaces old VA M-3 Chapter 12 policy animal
research, which was last updated in 1989, and
incorporates Directives issued since then. - Requires compliance with USDA AWA Regs and PHS
Policy. In rare cases, goes beyond both. - Mandates AAALAC accreditation for all VA
facilities, and use of accredited facilities to
house VA animals. - Mandates replacement of all fail-on reheat
boxes in animal facilities as of July 2002. - Mandates use of new ACORP as of October 2002.
301200.7 The Institutional Official
- Requires Medical Center Director to be IO (as
wellas CEO) for USDA/PHS/ AAALAC correspondence.
The ACOS for RD may no longer be designated the
IO.
Except if the VA uses the affiliates PHS
Assurance or is accredited by AAALAC as a
component of the affiliates program, then an
official at the affiliate must be designated the
IO.
31Continuing Education
- 5.c.(5) Continuing education. The USDA Animal
Welfare Act Regulations, PHS Policy and the Guide
for the Care and Use of Laboratory Animals
mandate training for all personnel who work with
laboratory animals. This includes the supervisor
and husbandry care staff. Accordingly, it is
critical that local funds be allocated for
continuing education activities by the VMU
Supervisor and other husbandry staff on an annual
basis. It is an ethical and professional
imperative that the VMU Supervisor and other
caretaker staff continue to learn about advances
in laboratory animal husbandry and care to ensure
the highest standards of care for animals and the
best possible support for animal research
projects.
321200.7 Logistics
- 5.b.(10) Contact with CVMO. If a VMO, VMC, or
clinical veterinarian has not been able to solve
local problems impacting the ethical treatment
and use of animals, he/she may contact the CVMO
directly to discuss concerns, solicit guidance,
or seek information without requesting or
receiving local permission to do so. Â - 5.c.(1) Each facility with an active program of
animal research must assign the responsibility of
overseeing daily husbandry and other care duties
to a single individual No matter what funding
source is used to pay the supervisors salary,
the supervisor is responsible for supervising the
husbandry staff.
331200.7 SOPs
- 6.h. Standard Operating Procedures (SOP). The
VMU Supervisor, with guidance and assistance of
the VMO or VMC, must develop a manual of standard
operating procedures (SOP) setting forth
schedules and methods of cleaning animal housing
and research areas, feeding and watering
practices, staff training, equipment maintenance
and related activities. The SOP must be reviewed
at least once annually by the VMU supervisor and
the VMO or VMC to determine the need for any
changes in procedures. It must also be submitted
for approval by the IACUC at least once annually.
341200.7 IACUC Support
- 6.n. Institutional Animal Care and Use Committee
Activities - Â
- 6.n.(1) It is the responsibility of the
Medical Center Director to provide adequate
administrative support for the IACUC, including
space sufficient to provide privacy for
conducting sensitive duties related to animal
subjects involved in research, and personnel to
support the review and record-keeping functions
of the IACUC, to include timely preparation of
minutes and timely preparation of investigator
correspondence and other documents.
351200.7 Using Joint IACUCs
- 6.n.(3)(a) The affiliates IACUC must agree to
provide copies of IACUC minutes, semi-annual
IACUC reports, AAALAC correspondence, USDA
correspondence, copies of IACUC files on VA
investigatorsin their entirety  - 6.n.(3)(b) The VMO or VMC and at least one
other VA scientist with animal research
experience must sit on the affiliates IACUC as
voting members - 6.n.(3)(c) The affiliates IACUC must agree to
review the VA animal facility and program - 6.n.(3)(d) The affiliates IACUC must agree to
review the VA ACORP for VA applications -
361200.7 ACOS and AO for RD
- 6.n.(7)(a) The ACOS/RD and AO/RD should not
serve as voting members on the IACUC, and when in
attendance, should be very sensitive to the
occurrence or appearance of conflict of interest
relative to their supervisory, management, and
fiscal authority.
371200.7 Semi-Annual Reviews
- 6.n.(10)(a)2. The semi-annual self-review must
include all facilities and investigator areas
where laboratory animals purchased with local VA
funds are used... If a formal arrangement has
been made between the VA IACUC and a satellite or
affiliates facility, the VA IACUC may review
that facilitys semi-annual self-assessment as an
IACUC business item in lieu of sending a VA IACUC
review team to the facility. If the VA IACUC
does not set up such an agreement, the other
facility and its animal care and use program must
be evaluated, and a report of that facilitys
evaluation included as part of the semi-annual
self-review
381200.7 Semi-Annual Reviews
- Â 6.n.(10)(a)4. A standard VA IACUC Program and
Facility Self-Assessment Form, the OLAW
Semiannual Program and Facility Review checklist,
or a similar form incorporating all the elements
in the standard VA IACUC Program and Facility
Self-Assessment Form should be completed within a
month of the self-review. Whichever form is
used, the following must appear in the report
391200.7 Semi-Annual Reviews
- 6.n.(10)(a)4.e. At least three IACUC members
should conduct the program review, unless
exceptional circumstances prevent such
attendance. All members of the IACUC are
strongly encouraged to participate in the
self-assessment, but the review team must include
at least two voting members of the IACUC.
Attendance by the lay and non-affiliated members
is especially encouraged.
401200.7 Semi-Annual Reviews
- 6.n.(10)(a)5. After a majority of all voting
IACUC members has voted to approve the report and
has indicated their approval by signatures next
to their typed names and roles on the committee,
the report should be discussed with the Medical
Center Director by the VMO/VMC, the IACUC Chair,
and the ACOS/RD. The Medical Center Director
must sign the reporting indicating that he/she
has reviewed it. Once the Medical Center
Director has signed the report, it must be sent
to the CVMO through the Medical Center Director
within 60 days of the self-review date. A copy
should also be sent to the local RD Committee
for review, but RD Committee approval is not
needed before the document is sent to the CVMO
through the Medical Center Director.
41Outline
- Brief overview Where do I fit in at the VA?
- ORCA and ORD relationship and role delineation
- VA Research Budget Outlook for FY2003
- JIT ACORP Reviews
- Hosting non-VA projects in the VMU new guidance
- Highlights New Handbook 1200.7, Use of Animals
in Research - New semi-annual forms and minutes template
- ShEEP New procedures for requesting animal
equipment funds - Update Web-based training at www.researchtraining
.org, and AALAS CRADA - Questions, hopefully answers
42Old VA IACUC Semi-Annual Report Form No Longer
Compliant
- New draft form available for download at
www.researchtraining.org in animal research
documents area. - Form has three parts
43(No Transcript)
44(No Transcript)
45(No Transcript)
46VA IACUC Minutes Template- Helps Comply with
1200.7
47Outline
- Brief overview Where do I fit in at the VA?
- ORCA and ORD relationship and role delineation
- VA Research Budget Outlook for FY2003
- JIT ACORP Reviews
- Hosting non-VA projects in the VMU new guidance
- Highlights New Handbook 1200.7, Use of Animals
in Research - New semi-annual forms and minutes template
- ShEEP New procedures for requesting animal
equipment funds - Update Web-based training at www.researchtraining
.org, and AALAS CRADA - Questions, hopefully answers
48Obtaining VA Animal Facility Equipment
- Replaced Animal Facility Equipment Committee
mechanism of outright equipment grants - ShEEP applications due October 15th each year
- Instructions found in Handbook 1202.6
- Reviewed by the following January 15th
- May involve a site visit to evaluate local
facility and program infrastructure prior to
funding decision
Sh
ared
E
quipment
E
valuation
P
rogram
49(No Transcript)
50FY02 ShEEP Program
51Outline
- Brief overview Where do I fit in at the VA?
- ORCA and ORD relationship and role delineation
- VA Research Budget Outlook for FY2003
- JIT ACORP Reviews
- Hosting non-VA projects in the VMU new guidance
- Highlights New Handbook 1200.7, Use of Animals
in Research - New semi-annual forms and minutes template
- ShEEP New procedures for requesting animal
equipment funds - Update Web-based training at www.researchtraining
.org, and AALAS CRADA - Questions, hopefully answers
52Challenges to Meeting Training Mandates
- Research staff are very busy, and very difficult
to get together in one room for traditional
instructor-led training, even when bribed with
free food. - Exclusive use of instructor-led training is very
expensive.
- Documentation of training is crucial, but very
labor-intensive when done on paper.
53Potential Benefits of Web-Based Training
- Staff can go through courses at their own pace,
and when it is convenient for them- at work or
home. - Trainer expertise can be utilized to construct
courses that cover standard material in an
organized, consistent fashion. This can free
trainers to provide specialized, targeted
training to meet most pressing needs. - Self-administered exams can be used to document
training, and records can be maintained on the
web server to reduce admin burden.
54ResearchTraining.Org
- Continuing funding provided by VA Medical
Research Service to help stations meet research
training mandates. - Philosophy- offer convenient high quality
web-based training to foster compliance with
training mandates. - Administrative goal- shift burden of documenting
training to the web server.
55Process
- Research staff members (users) logs into
course/exam site via internet
- Users take course, then pass exam covering course
material
- Web server stores course name, exam score, and
date exam passed
- Administrators log into administration site to
view exam records or print lists of exam records
for documentation
56Use of Exams to Document Training Participation
- Users shown practice questions at the end of
course lessons that form the exam Q pool. - There is no limit to the number of times a user
may take an exam, but the exam is randomly
generated so that for each course exam - The questions and order of questions change.
- The location of the correct answer and locator
order of responses changes for each question. - Exam questions are written to be difficult enough
so that course material must be retained to pass.
57Web Courses with Exams- Now Available
- Working with the VA IACUC. 26 lessons.
- 1 audience research staff who utilize animals
- 2 audience IACUC members, veterinarians, and
husbandry staff, interested administrators - Essentials for IACUC Members. 24 lessons.
- 1 audience IACUC members (incl.
veterinarians) - 2 audience interested administrators and
husbandry staff - Avoiding Financial Conflict of Interest in
Federal Research. 12 lessons. Authored by Mr.
Bert DiBella, VA OGC, Ethics Group - 1 audience principal investigators,
administrators
58Exams for Videotapes/CD-ROM Courses
- Working with the Laboratory Dog (exams covering
basic material via streaming videotape and
advanced material on CD-ROMs available free to VA
stations from CVMOs office). - 1 audience research staff who utilize dogs,
husbandry staff - 2 audience IACUC members, veterinarians
- Working Safely with Laboratory Primates (exam
covering material on streaming videotape
streaming tape provided courtesy of OLAW in PHS) - 1 audience research staff who utilize
primates, husbandry staff - 2 audience IACUC members, veterinarians
59Web Courses Under Development- December 2002
Release
- Annual Laboratory Safety Refresher Course.
Developed by Vivian Avella-Diaz, Atlanta VAMC
Biosafety Officer. Under review by Dr. Robbins
and her staff at VACO before VA-wide release. - Audience all laboratory research staff
- Use of Mice (Rats, Guinea Pigs, Hamsters,
Rabbits, Dogs, Cats, Pigs) in Research. - Audience principal investigators, and research
and husbandry staff who utilize the species
listed in research
60Web Courses Under Development- 2003
- Research Involving Human Subjects
- Blood-Borne Pathogens
- Other- We are looking for volunteers to work on
courses that would be of wide interest to the VA
and greater research community, including courses
on research/budget administration!
61Our Long-Term Training Goal- One Stop Shopping
for Research Training
Laboratory Safety and Biosafety
Animal Subject Research
Research Administration
Human Subject Research
Responsible Conduct of Research
62WWW.RESEARCHTRAINING.ORG How it Works
Content Experts
Research staff and committee members
Research Administrators
Document staff participation
Create or customize courses exams
Take web courses exams
63Site Walk-Through
64For Research Staff/Committee Members
65New users follow directions and click here
66Choose the correct VA Medical Center, then click
button
67Fill in info requested by local administrators,
then click Submit
68The selected username and institution are shown
above the Main Menu
Click to see available web courses and exams
69Click to take a course
70Simple navigation aids are used to move through
the course
As lessons are completed, dots mark progress
through course
71Practice questions appear at end of lessons
Users get feedback to help learning
72Click on exam link take the course exam
73Progress in exam is tracked
Simple navigation aids are used to move through
the exam
74The exam is then tallied for immediate feedback
Answers to incorrect Qs are shown
75Time to print a completion certificate!
76The certificate is printed with the browser print
function, and includes the date, name,
institution, and course number. It can be used
with IACUC or other committee records to document
training in files.
Each certificate has unique control number to
discourage use of a single certificate by
multiple people
77For Administrators Who Need to Document Training
78After logging into Administration area, there are
many options. One option is to view exam records
79Training documentation reports are simple to
create yet very flexible.
80Decide which users, which courses, what time
frame, and what information you want to see.
81Print a certificate for a committee file
Output can be put into a printable format or
downloaded to a spreadsheet.
82Access to courses and exams can be easily set
83Decide what courses and exams you want your staff
to see.
84For Training Coordinators and Other Content
Experts- Customize Existing Courses or Create New
Ones
85For editing, course are displayed in rows. To
edit a page, click first on the lesson link.
Lets look at Essentials for IACUC Members.
86The lessons in the course now display. To edit a
page in lesson 2, choose the pages link for
lesson 2
87The pages in lesson 2 now display. To choose
page 6, Whistleblower Provisions click on the
Edit link.
88The HTML code can then be edited, and pictures or
references added.
89Returning to the Lessons Table, click in the
"Questions" column to edit the exam questions for
Lesson 2.
90To edit a question, click in the appropriate row
in the edit column.
91The stem, key, distractors, and question
difficulty value can be edited, and a graphic or
picture added to the question.
92Questions can be added in 7 different formats
93Cumulative and New Site Registrations
Cumulative User Registrations
Monthly New Registrations
1/2002
1/2001
6/2001
6/2002
94Additional Information
- Due to support of VA MRS, site usage is free to
VA as well as non-VA institutions - A recent CRADA with AALAS gives them use of the
software for their web-based training initiative
in exchange for 400 accounts for VA husbandry and
technician staff on the AALAS website - Licensing options for private companies available
through CRADA. Proceeds will go toward further
site development - A much higher capacity web server will be
utilized shortly to keep page load speeds high
95Questions