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Last reviewed October 9, 2008

**Date:** June 27, 2001

**To:** EPMC Members

CMOC Members

RPC Members

**From:** Director, Office of Federal Advisory Committee Policy, OD, NIH

**Subject:** OFACP Policy Announcement 2001-04: Conflict of Interest for
Special

> Government Employees (SGEs) from State Multi-campus Systems and
> Private
>
> Institutions and Affiliates

**[Background]{.underline}:** For many years, NIH has adhered to
guidance provided by the Secretary, DHHS, contained in the issuance
titled, "Institutions that are Separate Organizations Under 18 U.S.C.
208(a) and Multi-campus Institutions Where Conflict of Interest
Prohibitions Do Not Apply (HHS Standards of Conduct Regulations, 45 CFR
Part 73, Subpart J)." This document contained 22 separate State
organizations and multi-campus institutions where conflict of interest
prohibitions did not apply to matters involving campuses other than
those where a particular NIH advisory committee member held employment
or other professional association. These institutions were not
considered in conflict with the member's institution and did not require
a waiver. All other multi-campus institutions were, however, not exempt
from conflict of interest prohibitions.

The Office of Government Ethics (OGE) has issued new guidelines for
State multi-campus institutions. The guidelines, described below,
supercede the long-standing issuance cited above. In addition, OGE has
provided guidance that under certain conditions, similar allowances can
be extended to private institutions and affiliates. OGE's guidance has
now been incorporated into NIH Manual Chapter 1810-1.

**[Applicability]{.underline}:** This policy applies to Special
Government Employees (SGEs) serving on NIH Federal advisory committees.
Guidance related to this matter for scientific and technical peer review
group members who are not SGEs can be found in OER Policy Announcement -
1999-02: "Blanket Waiver of Conflict of Interest for Peer Review
Consultants - Multi-Component Institutions."

**[Policy for State Multi-campus Institutions]{.underline}:** The Office
of Government Ethics (OGE) has provided a regulatory waiver under 5 CFR
2640.203(c), for SGE Federal advisory committee members employed in one
university of a State multi-university system to review applications
from a separate university of the same system, provided the member has
no multi-institutional responsibilities.

Page 2 OFACP Policy 2001-04: Conflict of Interest for SGEs from State
Multi-campus Systems and Private Institutions and Affiliates

> *Example 1:* An SGE member of an NIH advisory council is from
> California (Cal) State Fullerton. The SGE **may** participate in
> formulating the committee's recommendation to award a grant to a
> researcher at another university of the California State University
> system, so long as the SGE's employment at Cal State Fullerton entails
> no responsibilities at the other university.
>
> Therefore, with this recent OGE guidance and contrary to previous
> regulations, the separate universities of the California State system
> are now considered separate entities in the same way as the separate
> universities of the University of California system had been, under 45
> CFR Part 73, Subpart J. However, the separate campuses **within**, for
> example, Cal State Fullerton are not considered separate entities for
> purposes of this policy.
>
> *Example 2:* A member of the Board of Regents at a State university is
> asked to serve on an advisory committee established by the Department
> of Health and Human Services to consider applications for grants for
> human genome research projects. An application from another university
> that is part of the same State system will be reviewed by the
> committee. Unless the member receives an individual waiver under
> section 208(b)(1) \[for Federal employees\] or (b)(3), \[for SGEs\],
> the advisory committee member **may not** participate in matters
> affecting the second university that is part of the State system
> because as a member of the Board of Regents, he/she has duties and
> responsibilities that affect the entire State educational system.

**[Policy for Private Institutions and Affiliates]{.underline}:** In
addition, an SGE member of an advisory committee who is employed by a
private institution may participate in the review of a grant application
submitted by an affiliate of the private institution if the SGE:

\(1\) does not hold a joint appointment with that affiliate,

\(2\) does not have affiliate-wide responsibilities, and

\(3\) has a waiver to do so.

> *Example*: A professor at Harvard may review a grant application from
> Beth Israel, a Harvard affiliate, if that professor does not hold a
> joint appointment with Beth Israel, does not have affiliate-wide
> responsibilities, and has a waiver which states the following:
>
> Additionally, I recommend that you grant \[name of individual\] a
> waiver that would allow this individual to participate in specific
> matters that may affect any of the affiliates of \[name of
> institution\]. I believe that such a waiver is appropriate because
> \[name of individual\] does not hold any joint appointments with the
> affiliates and has no affiliate-wide responsibilities.

Page 3 OFACP Policy 2001-04: Conflict of Interest for SGEs from State
Multi-campus Systems and Private Institutions and Affiliates

> An SGE who holds a joint appointment at a private institution and at
> one of its affiliates may participate in a review of a grant
> application submitted by another affiliate if the SGE:
>
> \(1\) does not hold an appointment with the affiliate that has
> submitted the grant application,
>
> \(2\) does not have affiliate-wide responsibilities, and
>
> \(3\) has a waiver to do so.
>
> *Example:* A doctor at Harvard Medical School who also holds an
> appointment at Massachusetts General Hospital, a Harvard affiliate,
> may review a grant application submitted by Beth Israel if the doctor
> does not hold an appointment with Beth Israel, does not have
> affiliate-wide responsibilities, and has a waiver which states the
> following:
>
> Additionally, I recommend that you grant \[name of individual\] a
> waiver that would allow this individual to participate in specific
> matters that may affect any affiliates of \[name of institution\]
> other than \[name of affiliate in which the SGE holds an
> appointment\]. I believe that such a waiver is appropriate because
> \[name of individual\] does not hold any joint appointments with any
> other affiliate and has no affiliate-wide responsibilities.

For further information about this policy, please call the Office of
Federal Advisory Committee Policy at 496-2123.

/s/

LaVerne Stringfield

Issuing Office: OFACP (496-2123)

cc: Dr. Kirschstein

Dr. Maddox

Dr. Baldwin

IC Directors

OD Senior Staff