May 21, 2010
The National Institutes of Health (NIH) published in the Federal Register on Friday, May 21, 2010 a Notice of Proposed Rulemaking (NPRM) outlining new Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors – NIH’s Financial Conflict of Interest policy (75FR 28688). The text of Federal Register notice is also available on the NIH conflicts of interest website. Comments are due July 21, 2010. This long anticipated proposed rule is a result of NIH’s consideration of the comments it received on the Advanced NPRM in May 2009. The description of the proposed revisions (Section II of the Supplemental Information in the Register notice) addresses the responses NIH received to the Advanced NPRM.
There are substantive and significant changes being proposed by NIH. Some of those changes have been anticipated by the research community; others have not. Some of the changes will require changes in how many research organizations have designed and implemented the current NIH requirements; others will not. It is important to remember that the proposed policy is NIH’s requirement and sets a minimum set of standards. Organizations can implement policies the meet and exceed these requirements. The reference to “minimum standards” is not to suggest that the current NIH policy is insufficient in achieving the goal of objectivity. Rather, it is to remind organizations of how NIH views the reporting requirements – for purposes of reporting to NIH and – under the proposed rule – posting to public websites, organizations must report on financial conflicts of interest (FCOI) according to the organization’s standards, if they are different. For example, the proposed rule lowers the threshold for a “significant financial interest” from $10,000 or equity interests of 5% to $5,000 total value in remuneration and/or equity in a publically traded company. If the organization sets a $0 value, the organization must report and post interests from $0.
General Outline of Important Changes
Small Business Innovation Research (SBIR) program Phase I projects are no longer exempt.
Definitions: The definitions have been clarified and expanded as necessary to support the proposed changes to the policy. For example, there are new definitions of the investigator’s “Institutional Responsibilities,” “Manage,” and “Financial Interest.” NIH makes a distinction between “Disclosure” – by an investigator to the institution – and “FCOI report” – from the institution to NIH.
The most significant modification to a definition is the meaning afforded “Significant Financial Interest” which describes the changes in thresholds (noted above) and what is and is not included in the definition. With regard to the thresholds, any equity interest in a non-publically traded company is considered significant. There are additional modifications to the exclusions, notably income from for seminars, lectures, etc., from non-profit entities other than higher education institutions are no longer excluded.
Subrecipients: NIH clarifies the responsibility of the prime awardee organization to manage the compliance of its sub-recipients including the requirements to articulate the relationship between prime/sub in the subaward document, a written certification and reports to the prime awardee of any FCOI and the prime awardee’s timely reporting to NIH.
Determining Conflicts: The investigator is required to disclose all significant financial interests to the organization annually, updating their disclosure when the information changes. The organization is given the responsibility to determine whether the disclosed interests are related to the NIH-funded research and whether the disclosed interest is a conflict of interest. NIH has outlined criteria for that determination. The organization must develop a management plan and report on the FCOI to NIH.
Training: The institution must provide training for the investigator prior to engaging in funded research and, thereafter, at least every two years.
Managing, Mitigating and Reporting: There is a new section on management and reporting of financial conflicts of interest. Prior to expending funds, the organization will review disclosures, determine if a conflict exists, and develop and implement a management plan. The proposed rule outlines “examples of conditions or restrictions” that might be a part of the plan. Reduction or elimination of the financial interest is included as an example of such a condition or restriction. The proposed rule describes how the organization should conduct the review of those investigator’s disclosures who join a project after its initiation and when the organization identifies an interest not disclosed by an investigator. In the latter case, in addition to managing the recently identified conflict, the organization must implement a mitigation plan to determine if the research has been biased.
The single most significant addition – not discussed in the Advance Notice – is the requirement for organizations to post to publically accessible web site information concerning the identified financial conflict of interest. This information, to be posted before the expenditure of funds, includes the investigators name, position on the project, nature of the interest, and approximate dollar amount. This information must be updated annually and on the disclosure of new conflicts of interest and must remain on the web site for five years from the most recent update.
The reports to NIH would be more comprehensive and include elements of the management plan and the organization will be required to provide annual FCOI reports addressing the status of the conflict and any changes to the plan as well as other assessments.
Institutional Conflicts of Interest: NIH does not address institutional conflicts of interest in the proposed rule but welcomes further comments. They acknowledge the creation of regulations governing this area is complex based, in part, on the extensive differences in administrative structure among institutions receiving PHS funding.
Costs: In describing the proposed rule, NIH acknowledges that there will be a burden but, in assessing the costs, NIH concludes:
“The cost of implementing the amended regulations is an allowable cost eligible for reimbursement as a Facilities and Administrative cost on PHS supported grants, cooperative agreements, and contracts. This generally offsets the cost burdens of implementation of the regulations to the investigators.”
COGR members are invited to participate in the discussion of this proposed rule at the June 3-4 COGR meeting Thursday, June 3, morning session (10-11:45). We will outline the key elements (as above) and invite a wide-ranging discussion/reaction to the proposal. We look for this discussion to serve as the basis for building COGR’s comments on the new regulation.