SUBJECT:

Conflict of Interest Federal Regulations

The Conflict of Interest (COI) Office received the National Science
Foundation (NSF), the Public Health Services (PHS) and Department of
Health and Human Services announcement of July 11, 1995 formalizing policy
regarding "Objectivity in Research" and "Investigator Financial
Disclosure." This final policy announcement follows more than a year of
activities within PHS and NSF regarding new federal regulations for the
disclosure of significant financial interests by investigators receiving
federal support for research, otherwise known as the Federal Conflict of
Interest Policies.

The regulations establish standards and procedures for institutions
applying for research funding under PHS or NSF grants, contracts,
subcontracts, or cooperative agreements. Principal Investigators,
Co-Principal Investigators and any other individual who is responsible for
the design, conduct or reporting of research or educational activities,
will be required to disclose financial interests related to the research
BEFORE a proposal can be submitted to the Agency. In addition,
institutions will now be required to review and report all existing and
potential financial interests and assure that they will be managed,
reduced or eliminated prior to the Institution's expenditure of any funds
under the award.

Currently, State regulations require COI disclosures of interest in the
sponsor who funds the research project. However, Federal regulations
require disclosure of financial interests in all entities RELATED to the
research project. The COI review process will be expanded to all
federally-funded projects, beginning with PHS and NSF projects in 1995-96,
and expanded to all other federally-sponsored projects in 1997. In
anticipation of these regulations, the Conflict of Interest Office has been
working collaboratively with the Office of Graduate Studies and Research
and the Contract & Grant Administration Office to develop implementation
guidelines for UCSD, which will be distributed to the campus during the
month of September. The implementation date is October 1, 1995.

If you would like to review these new regulations, the following reference
information should assist you:

NIH Guide, Vol. 24, No. 25, July 14, 1995, and Federal Register,
Vol. 60, No. 132, July 11, 1995, ref. 35810 and 35820.

On Internet you may retrieve the information at:
Office of Contract and Grant Administration Home Page through World
Wide Web (WWW): http://ocga.ucsd.edu

An excellent summary of the present status of the University with respect
to COI and the Federal government is to be found in SCIENCE, Vol. 269, 294
(21 July 1995). Please note in order to facilitate the enormous burden of
reporting, and the volume of forms and procedures, the Independent Review
Committee will need your full cooperation and understanding.

Paul Saltman, Chair Independent Review Committee on Conflict of Interest