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 xxxxxx@mailhost.tcs.tulane.edu 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 studies. {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 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 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.