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Questions for
Wendy Baldwin, M.D. Deputy
Director for
Extramural Research
National
Institutes of Health
1. What
kind of financial controls and accounting of expenditures does NIH
require from those foreign institutions in which NIH provides funding?
Are any more stringent controls and accounting of expenditures required
from domestic institutions, in particular the VA?
Answer:
Foreign institutions that apply for NIH support are required to abide by
a growing list of regulatory requirements by virtue of receiving US
support. The 8% indirect cost reimbursement is designed to provide some
offset to those special requirements. NIH provides limited indirect
costs to foreign and international organizations to support the costs of
compliance with DHHS and NIH requirements, including the protection of
human subjects, the welfare of animals, invention reporting requirements
and financial conflict of interest. We do not support the acquisition
of, or provide for depreciation on, any capital expenses (facilities),
or normal general operations for either type of recipient.
2.
Given that the argument was made to standardize research controls, and
the composition, procedures, and oversight of IRGs across the
government, would not NIH be the most logical government entity to
spearhead such an initiative across the Federal government, obtaining
input from all Government research institutions involved in human
research?
Answer:
This question is best answered by the Office of Human Research
Protection, Office of the Secretary, Department of Health and Human
Services. We have referred it to them, and a response will be
forthcoming under separate cover.
3. For
some major universities, on-campus Facilities and Administration (F&A)
costs average 64% of the basic NIH grant. There is at least one case
where F&A costs were more than 100% of the original grant. NIH
reimburses non-federal organizations for these “reasonable” add-on
costs. Why has NIH established a policy of not reimbursing the VA for
these costs?
Answer:
The NIH reimburses Facilities and Administrative (F&A) costs at
non-federal institutions to support the indirect costs of doing
research. There is considerable variability in these negotiated rates
because different institutions have varying levels of investment in the
infrastructure required to conduct research. In the case of federal
agencies, the costs of being a research agency are provided through the
agency's appropriation. While there are cases where an agency, such as
the VA, may wish to request additional costs, which are incurred because
they elect to participate in research that is funded by the NIH, it is
necessary that those costs be justified in part to ensure that they do
not constitute an augmentation of appropriation. NIH is taking steps to
meet with representatives of the VA to review documentation necessary to
establish an add-on rate.
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