Page 2 - March ARB Beacon 11-6-15

2 November 6, 2015
BEACON
THE
Volume 80, Number 44
452 AMW Public Affairs
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March ARB, CA 92518-1852
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Col. Russell Muncy
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EDITOR
Ms. Linda Welz
452 AMW EDITORIAL STAFF
Senior Master Sgt. David Smith
Master Sgt. Megan Crusher
Staff Sgt. Tiffany Lindemann
Staff Sgt. Heather Cozad Staley
Senior Airman Russell McMillan
Senior Airman Joseph Dangidang
Senior Airman Kevin Mitterholzer
Senior Airman Callie McNary
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Team March 101: The Veterans Administration
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(This will be an ongoing series to in-
troduce you to individual units or offices
run before each Unit Training Assembly or
twice a month.)
The Veterans Administration Office of Re-
search Oversight (VAORO) has been at March
Air Reserve Base nearly 10 years, according to
John Farley, health science specialist here. But
many, if not most of you, are unaware of its ex-
istence or what its mission is.
The VAORO, in general, is charged with
compliance oversight for VA Research to hu-
man and animal subjects; laboratory safety and
scientific misconducts.
“This office (March location) is focused on
oversight of research program management and
human research subject protection,” Farley said.
“That means that we review VA facilities where
research with human subjects is conducted and
make sure that they’re following all the federal
rules, both the common rule and VA policies.”
The March VAORO team does assessments
in advance that amount to document reviews of
procedures (SOPs) and committee minutes.
Then they visit those facilities, interview people
and review the program on site as well. After
the inspection, the VAORO team gives an as-
sessment of the location’s compliance or non-
compliance so that any issues that need to be
addressed can be in order to make the program
fully compliant, Farley said.
ing to have any particular benefit to them or to
They visit each of their locations on a 3-4
year rotation basis, averaging 7-8 facilities in-
spected each year with the objective to give
oversight by reviewing SOPs (requested and
reviewed prior to the visit) to make sure they
are in line with VA guidance. Their mission is
similar to that of the IG inspection teams who
travel to Air Force locations to conduct Unit
Compliance Inspections.
“In addition (to reviewing SOPs) there are
committees at each location (a safety commit-
tee, R&D {research and development} com-
mittee, institutional review boards) from whom
we request meeting minutes for the past year),”
said, Jeff West, health science specialist here.
“We read the minutes before our visit to see
exactly what they are doing. Then it’s a matter
of, is what you’re doing in line with what your
research at that facility.”
If things don’t line up, the inspection team
will make necessary recommendations to the
medical center director. Findings are given ver-
bally after an on-site inspection. Subsequently,
a written report is compiled, and the inspectors
“We’re in the Veteran’s Health Administra-
will correct non-compliance items.
They also choose research protocols (specif-
ic research plans) to review. These protocols are
not just a one-time thing, according to Carrie
facebook.com/TeamMarch
Pennison, health science specialist.
“The protocols are an ongoing process.
“The majority of large VAs are attached and af-
When reviewing, we will pull a research study
to make sure from the beginning to the end that
all of the steps have been hit, all the records
have been maintained for as long as required,”
Pennison said. “There are administration and
research parts to each protocol.”
The administrative part makes sure that
research is being done in compliance and
on a timely basis. They review the processes
and interview the principal investigators to
make sure that those principals understand
what they are responsible for, and that their
staffs are trained, make sure the medical
center director (ultimately responsible for
everything) knows what his or her responsi-
bilities are and that those have been delegat-
ed accordingly so that everything flows in
a manner that is compliant, Pennison said.
Permission to conduct research
Farley explains that facilities have to get a
federal-wide assurance, which is permission
from the Office of Human Research Protection,
to conduct research at their facilities. By obtain- This included an oversight program to include
the office of research and development plus
guidelines, and all the federal and VA rules.
“They have to establish this institutional re-
view board. That’s a committee of physicians
and non-scientists, community members, lay
people, to review each protocol and either ap-
prove it or not,” Farley said. “During that review
they will be asking, ‘What are you going to be
asking the veteran participant to do? Is this go-
in Loma Linda, said Hammond, who has
people afterward? What are the risks involved?’
Then they make a determination as to whether
to permit it or not.”
He said the studies usually come with a con-
sent form that each participant gets to read and
have his or her questions answered about the
study. It formalizes his or her agreement to par-
ticipate in the study.
“Nobody is involved in research without
their permission. That’s one of these guiding,
ethical principles,” Farley said.
When they go on site, they ask if consent has
been obtained from everyone who is enrolled
in the study, and if the study has been properly
reviewed with experts in the area to help judge
whether it was safe and appropriate, Farley said.
“If program is extremely non-compliant,
where participant veterans in studies were at
risk, we have the authority to actually stop the
TheVA components
The Department of VeteransAffairs is divid-
ed up into three components; the cemetery, the
VA Benefits administration and the VA Health
administration, said Dr. Paul Hammond, direc-
tor of the March VAORO facility.
tion, which has three legs to the stool; patient
care, education and research,” Hammond said.
filiated with a university. So it is thought that in-
stead of being just a mediocre HMO by virtue
of the academic affiliations, that the care that is
provided to veterans is superlative, that it is the
best that can be provided,” he said.
He went on to say that the problem with the
VA is that it is overwhelmed with patients and
the care that they receive, and it is the access to
care, not the care itself that is drawing the ma-
jority of complaints.
“So, the research component is a very,
very important one. That covers animals, wet
labs and human subject research,” Hammond
said. “Veterans, when engaged in that type of
research, really benefit from it, but we have to
make sure they are protected.”
Unlike human subject research, the VA
maintained a number of regulations in place
for animal care that were quite profound, Ham-
mond said. So, in 1999, the VA set up an ac-
crediting program for human subject research.
the office of VA research compliance and as-
surance. This program was divided into five
regions, with the West Coast region responsible
for locations west of the Mississippi River. The
March facility oversees 28 locations, Ham-
mond said.
Originally they were based at the VA
been with the West Coast region office
since its inception.
“They were going to move me to LA and
I heard about this area becoming vacant af-
ter recruiters moved to a larger area,” Ham-
mond said. “We’ve been very fortunate.
Team March has been very gracious to us
from the onset. They made base assets avail-
able to us (lodging and conference space)
for our training sessions.”
The VAORO West Coast is staffed by
six employees. Hammond, the director is a
medical doctor, and the others are health
science specialists.