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Conflict of Interest Policy - NIH Randall Legeai 14 Jan 1994 11:38 EST

The attachment comes from the CORG October Meeting Report.
Sorry about the problem with the file attached to yesterday's
note; I was in a hurry and forgot to re-format the text file
Randall Legeai              
Tulane University                                  (PHN) 504/865-5758
Government/Agency Affairs                          (FAX) 504/865-5274
327 Gibson Hall, 6823 St. Charles Avenue
New Orleans, Louisiana, 70118-5698, USA

Conflict of Interest Rules Taking Shape
(Source:  COGR October 1993 Meeting Report)

PHS has let it be known that proposed rule making for
promoting objectivity in research may be announced in the
Federal  Register in the first week of December.  This rule
making deals with assuring that PHS-funded research is not

compromised by any significant financial interest.  The
rules will require PHS funded applicants to assume full
responsibility to ensure that the financial interests of
their employees do not compromise the objectivity with which
the research is designed, conducted or reported.   in
comments to earlier, more directive PHS rule making,
universities had asked for the freedom to deal with
financial  conflicts and to manage them.   it appears that
PHS will  grant universities this responsibility and expect
full compliance.

At the same time, PHI, NSF and OMB have concurred that there
is merit in the universities' call for a government-wide
policy on this issue.  A federal agency working group has
been formed.   It has met and identified common core
elements of a policy.  Other federal agencies, that
currently have no written policy or regulations are being
invited to participate.  As an immediate next step, however,
PHS expects to publish rule making, being required to do so
by statute, while NSF will issue its guidance in form of a
policy.  Both documents, although using different language,
are said to reflect the same core policy elements.

The following specifics seem is emerge:

*       Universities will have to address all research, including
but not limited to clinical trials or product related

*       Grantee institutions carry full responsibility.  Each
institution that applies for federal funding shall
provide an assurance to the government that: 1) it has
administrative procedures in place to identify and
resolve significant financial conflicts: 2) it will make
information  available  to  the  funding  agency
regarding significant interests and their resolution  and
3) it will comply with federal policyeregulations

*       All significant conflicts attributable to an investigator
must be disclosed to and resolved by the institution
prior to submission of an application.  "Significant"
interests are likely to be defined as interests valued at
greater than is,000 or an equity or ownership interest
of  five  percent  or more.   The definition  should  be
considered in the broad arena of:  1) any financial
investment in the research project, including ownership
of stock. stock options, or any equity, debt, security,
or capital holding in any business enterprise, including
the applicant that owns patents, marketing or
manufacturing rights for any product, or competing
product likely to result from the research: 2) salary or
remuneration, or financial considerations for services as
an employee, consultant, officer or board member of any
such business: and 3) any other significant financial
interest  of  the  investigator  that  the  institution
reasonably determines could affect the research.

*       "Investigator" means the Principal Investigator and any
other person at the institution who has responsibility
for making decisions regarding the design, conduct or
reporting of the PHS-funded project that could
significantly influence the accuracy of the outcome or
research or the timely and accurate dissemination of the
results of the research.  In this context, the term
investigator includes the spouse and each dependent,
according to the IRS definition.  It no longer includes
business partners.

Elements of the institutional policy should include:

1) safeguarding PHS-funded research

2) informing the investigator of institutional compliance:

3) designating an institutional official who will solicit
and review financial disclosure

4) maintaining records of all financial disclosure
statements filed and all  actions taken by the institution,
on an award by award basis, for at least three years beyond
the termination of an award or until resolution of any
action by the DHHS involving the records

5)  establishing  procedures  for  resolving  any
allegations  of undisclosed or misrepresented financial
interest and establishing a range of appropriate sanctions
for noncompliance with institutional policy: and

6) certifying on each funding application regarding
identification and resolution of significant financial
interests and to update PHS within 60 days about newly
arisen conflicts.

The institution must take steps reasonably calculated to
remove or limit any bias in design, conduct or reporting of
research.  The following  steps would meet this  criterion:
1)  provide close oversight and review of the research by an
official independent of the   investigator:   2)
disqualify  the  individual   from  any participation in
those parts of the research that might be affected: and 3)
provide waivers or alternative resolution.

An institution may develop criteria far waivers.  Waivers
might be applied in circumstances such as:  1) the interest
is so remote or inconsequential  that there  is  no
probability  for bias  on  the objectivity of research: 2)
any resolution other than by waiver would be ineffective or
inequitable  and 3) any bias reasonably to be expected is
outweighed by the interests of scientific progress.

In  its  administrative procedures,  an  institution will
have to include  measures  for  sanctioning  noncompliant
employees.   The institutions must promptly notify PHS of
instances at noncompliance, of the corrective action taken,
and the effect,  if any, on the respective project.

We understand that when PHS publishes its rule making, it
will be offered for a 60 day comment period. In the case of
NSF, the policy will be final and effective upon issuance.