The SRA Symposium - College of Medicine

Papers
Changes to 5 C.F.R. §5501.109 made clear that not even the requirements set forth by the OGE (at
5 C.F.R. part 2635, subpart H) and the HHS supplemental standards of employee ethical conduct
(at 5 C.F.R. §5501.106) satisfied HHS that Congress and the public would find the actions of NIH
employees sufficiently ethical. Thus, in addition to prohibiting:
* * *
. . . employees of the NIH and other employees of HHS from providing certain services,
for compensation, in the preparation of grant applications, contract proposals or other
documents to be submitted to HHS, and from compensated outside employment with
respect to a particular activity funded by an HHS grant, contract, cooperative agreement,
or other funding mechanism authorized by statute, or conducted under a cooperative
research and development agreement (CRADA)
* * *
[under Interim Final Rule Sec. §5501.109(c)(1)] all NIH employees are also prohibited
from engaging in employment (which includes serving as an officer, director, or other
fiduciary board member, serving on a scientific advisory board or committee, and consulting
or providing professional services) and compensated teaching, speaking, writing,
or editing with a substantially affected organization; a hospital, clinic, health maintenance
organization, or other health care provider (defined comprehensively to include the
types of entities that are eligible to receive payments under the Medicare program for the
provision of health care items or services); a health insurer; a health, science, or health
research-related trade, professional, consumer, or advocacy association; or a supported
research institution. (70 FR 22 (2005), at 5546.)
A “Substantially affected organization” was defined at paragraph (b)(8) to include those entities,
irrespective of corporate form, that are engaged in the research, development, or manufacture
of biotechnological, biostatistical, pharmaceutical, or medical devices, equipment, preparations,
treatments, or products. The term includes those organizations a majority of whose members are
engaged in such activities. (70 FR 22 (2005), at 5546.)
After first quoting and then generally disregarding the National Academy of Sciences observation
in On Being Scientist, that:
Science is inherently a social enterprise . . . .
* * *
The social mechanisms of science do more than validate what comes to be known as
scientific knowledge. They also help generate and sustain the body of experimental
techniques, social conventions, and other ``methods’’ that scientists use in doing and
reporting research. * * * Because they reflect socially accepted standards in science, their
application is a key element of responsible scientific practice. (NAP 1994.) (Cited at 70 FR
22 (2005), at 5549.) the HHS Federal Register Notice set forth examples of myriad exceptions
to the newly-imposed rules, which exceptions would free the NIH employee to enjoy
“[t]he social mechanisms of science” in the face of the 5 C.F.R. §5501.106(d)(3)-imposed
requirement for vetting of those social mechanisms the employee’s supervisor and then
the designated agency ethics officer. (70 FR 22 (2005), at 5549 - 5550.)
The February 2005 Interim Final Rule created at new provision at 5 C.F.R. §5501.110, which
prohibited NIH employees who filed public or confidential financial disclosure reports (as well as
their spouses and dependent children) from owning any financial interest—stock or otherwise—in
“substantially affected organizations,” while those who did not have to file such reports were al-
82 2005 Symposium Proceedings Book