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 correctly. ===================================================================== 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 (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 studies. * 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 respectively. * 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.
