University Times

The U.S. Department of Health and Human Services posted information on the major changes to the financial conflict of interest (COI) rules for federally funded researchers, which take effect next August.

Those changes that apply to individual researchers include:

• The significant financial interests (SFI) threshold has been lowered from $10,000 to $5,000. Such disclosure generally applies to payments for service and/or equity interests, including any equity interest in non-publicly traded entities.

• Once the minimum threshold is reached, all SFIs related to the investigator’s responsibilities must be disclosed; under the 1995 regulations, only those SFIs the investigator reported as related to Public Health Service (PHS)-funded research had to be disclosed.

However, types of significant financial interests excluded under the new final rule include investment vehicles such as mutual funds and retirement accounts, as long as the investigator does not control directly the investment decisions made in these vehicles.

• Income excluded from disclosure requirements under the new guidelines has changed. Payments from nonprofit entities for seminars, lectures, teaching and service on advisory committees or review panels are no longer excluded from the disclosure requirements. However, payments for such services from a federal, state or local agency; an institution of higher learning; an academic teaching hospital; a medical center, and a research institute affiliated with an institution of higher education are excluded from the disclosure requirements.

Also, while the disclosure of any reimbursed travel fees related to institutional responsibilities is required, travel that is reimbursed by any government agency or any of the other categories listed in the previous paragraph is not required. It is the researcher’s home institution that is responsible for determining if any travel expenses require further investigation, including disclosure of the monetary value.

• Also new is the requirement that each investigator complete Financial Conflict of Interest (FCOI) training prior to engaging in any PHS-funded grant, and at least every four years. FCOI training also is required when institutional policies alter investigator requirements; when an investigator is new to an institution, and when an institution determines an investigator is non-compliant with its FCOI policies. If a COI was not properly identified or reported, or a conflict management plan was not followed, a retrospective review must be conducted to ascertain whether there was any bias in the research from the COI.

There are additional requirements as to what an institution must report initially to PHS on any FCOI forms regarding grants or contracts. Those changes that apply to institutions include:

• The institution, not the individual investigator as was the case under the old regulations, makes the determination whether a particular outside interest gives rise to a potential conflict with the research.

The University must monitor an investigator’s compliance with a COI management plan until the completion of the PHS-funded research project.

• In addition to providing the grant or contract number, the name of the project director/principal investigator, the name of the individual investigator involved in the FCOI and whether the FCOI was managed, reduced or eliminated, institutions also must report the name of the entity with which the investigator has an FCOI; the nature of the FCOI (for example, equity, consulting fees, honoraria); the value of the financial interest or a statement that the value cannot be determined; a description of how the financial interest relates to PHS-funded research and the basis for the institution’s determination that the financial interest conflicts with such research, and the key elements of the institution’s FCOI management plan.

Institutions also are required to file a status report of the FCOI annually to PHS as well as to provide any changes to the FCOI management plan.

In addition, the institution must monitor an investigator’s compliance with a COI management plan until the completion of the PHS-funded research project.

• Institutions now must make information available concerning identified FCOIs via a publicly accessible web site or by written response within five business days to any request, at the option of the institution.

The institution also is required to review those cases of non-compliance with the regulation, but is not required to report the review to the PHS, except where bias is found. In that case, the report must show the impact of the bias on the research project and describe the actions the institution has taken or will take to eliminate or mitigate the effect of the bias.