Email list hosting service & mailing list manager

Re: Conflict of interest regs Randall Legeai 13 Jan 1994 18:36 EST

In Message Thu, 13 Jan 1994 15:59:10 -0500,
 Liz Mazzella <EAM01%xxxxxx@UGA.CC.UGA.EDU> writes:

>We were just discussing this on another list I belong to for
>tech transfer.  No sign of it yet.  Apparently they were supposed to
>have it out in December, but received an extension until January.
>Someone on the other list also mentioned that COGR has received infommation
>that the proposed policy being circulated was going to classify
>"significant" financial interest at $5,000!
COGR (The Council on Governmental Relations) included a couple of pages
about what they expected the policy to include in their October Meeting
Report.  I've attached them as a 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

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,

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.  Oth

The following specifics seem is emerge:

{SYMBOL 183 \f "Symbol" \s 10 \h} Universities will have to address all
 research, including but not limited to clinical trials or product related

{SYMBOL 183 \f "Symbol" \s 10 \h} 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 si

{SYMBOL 183 \f "Symbol" \s 10 \h} 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 a

{SYMBOL 183 \f "Symbol" \s 10 \h} "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 significa

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

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

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 indep

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

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,  i

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.