The SRA Symposium - College of Medicine

Papers
various ethics rules dependent upon the employee’s status and other circumstances. (70 FR 168
(2005), at 51562.)
HHS revised the rules at 5 C.F.R. §5501.109 “to accommodate a significant number of comments
from professional associations, constituent groups, university observers, employees and their
families regarding the new restriction on employment, including
consultation and board service, with ‘related trade, professional or similar associations.’”
The Department reported that “the comments expressed concern that restrictions imposed on
the ability of NIH employees to participate fully as members of the greater scientific community
would negatively affect the public health because NIH scientists
would become isolated from their counterparts in the private and academic sectors * * *[.]”
HHS acknowledged that “a reduction in recruitment and retention at NIH would result, and returned
to the reference to the National Academy of Sciences commentary (NAP 1994). (70 FR 168
(2005), at 51562 -51563.)
The regulations at 5 C.F.R. §5501.109(c)(3)(iii)—setting an exception to the outside activity prohibition
for clerical or similar services—was amended to correspond with the changes to the FDA
counterpart at 5 C.F.R. §5501.106(c)(3)(ii)(B). And the final rule identifies four additional activities
exceptions:
• 5 C.F.R. §5501.109(c)(3)(i)(B) permits compensation for a single class.
• A new 5 C.F.R. §5501.109(c)(3)(vii) permits an compensation exception not only continuing
professional education but for Grand rounds.
• For service on Data Safety Monitoring Boards (DSMBs). And
• For service on grant and scientific review committees for private foundations and other grantmaking
entities. (70 FR 168 (2005), at 51563 -51564.)
The regulations at 5 C.F.R. §5501.109 addressing prohibited financial interests applicable to
NIH employees was amended to define “senior employee” to include:
• the NIH Director and the NIH Deputy Director;
• members of the senior staff within the Office of the Director who report directly to the NIH
Director;
• the Directors, the Deputy Directors, Scientific Directors, and Clinical Directors of each NIH
institute and center (IC);
• extramural program officials who report directly to an IC Director; and
• any employee of equivalent levels of decision-making responsibility who is designated as a
senior employee by the designated agency ethics official or the NIH Director, in consultation
with the designated agency ethics official.
Moreover, the rules continue to bar senior employees, their spouses, and minor children from
holding financial interests in substantially affected organizations, subject to the exceptions for pensions
and other employee benefits, diversified mutual funds, and the “exceptional circumstances”
that existed under the interim final rule. (70 FR 168 (2005), at 51564 -51566.)
The regulations at 5 C.F.R. §5501.111 were amended to set a uniform rule for employees governed
by whether the award donor has matters pending under the employee’s official responsibility. The
definition of “official responsibility” is that in 18 U.S.C. §202(b), to wit: “the direct administrative
or operating authority, whether intermediate or final, and either exercisable alone or with others,
and either personally or through subordinates, to approve, disapprove, or otherwise direct Government
action.” (70 FR 168 (2005), at 51566 -51567.)
2005 Symposium Proceedings Book 85