The National Institutes of Health (NIH) proposed new rules to amend its regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service (PHS) Funding is Sought and Responsible Prospective Contractors. This is an update to NIH's 1995 rules.
According to NIH Director Francis Collins, MD partnerships with industry and non profits are essential in developing new therapies. But he made clear that to keep the public trust that research should be conducted without bias.
- The new proposed rules which are an update from the 1995 rules now in place shift the responsibility for managing financial interests from the investigator to the institution;
- The rule will require that reporting of financial conflicts be posted on the institutions website and the creation of financial conflict of interest websites;
- The new rules will put significant burden of paperwork and verification on NIH recipient institutions to report verified conflicts of interest greater than $5,000 and which in many cases may creates a whole office to manage the process;
- Institutions will be required to develop a management plan for every indentified financial conflict of interest either to reduce or eliminate the conflict and “significant” additional paperwork to NIH on identified FCOI’s and their management
- Added to the definition of financial interest any interest with no de minimis in a non-public company;
- For the first time payments “Non Profits” will be included in the definition of significant financial interest;
- Payments for speaking at CME events on behalf of a non-profit and travel expenses for all types of relationships will have to be reported to institutions and NIH;
- Payments for writing and editing have also been added to the definition of payments;
- Adds to those managing Financial Interest recipients of SBIR grants (small business grants);
- This rule would affect 5,000 entities and hundreds of thousands of researchers working on NIH funded projects.
NIH proposed these rules in part because of recent legislation (the Sunshine Act), and because of the growing complexity of interactions among Government, research institutions, and the private sector in biomedical and behavioral research. Accordingly, the proposed rules are an attempt to “strengthen accountability, expand and add transparency to investigator disclosure of significant financial interests, enhance regulatory compliance and effective institutional oversight and management of investigators’ financial conflicts of interests, as well as NIH’s compliance oversight.”
Consequently, the regulations, which affect an estimated 40,500 Investigators participating in PHS-funded research that have Significant Financial Interests (SFI), according to the NIH’s charts this would require an additional 344,215 hours of work and cost approximately $12,047,525 for institutions and NIH/HHS to implement (pages 14 and 17 of the proposed rule). While NIH asserts that “the cost of implementing the proposed regulation is outweighed by the benefits of these changes,” their approach may cost significantly more than it is worth. Specifically, as NIH itself notes:
“expanding the public disclosure requirement could increase the administrative burden on the Institutions in some respects (due to an increase in volume of posted information) and raise privacy concerns among impacted Investigators given the increased scope of financial interest information, not all of which is related to PHS-funded research, that would be made publicly available.”
Challenges for investigators are that the proposed rules and requirements “also risk strengthening the misperception that all SFI constitute Financial Conflict of Interest (FCOI).” Coupled with the fact that NIH believes that public disclosure “does risk strengthening the misperception that any FCOI necessarily causes bias,” their proposed rules have the potential to significantly harm the willingness of investigators to carry out PHS-funded research. This potential damage to PHS-funded research must be carefully maintained, and NIH must create rules that minimize theses risks and misperceptions about bias, especially since numerous institutions sufficiently manage FCOIs.
Rulemaking Process
Back on May 8, 2009, NIH invited comments on the following major regulatory areas:
1. Expanding the scope of the regulation and disclosure of interests;
2. Definition of “significant financial interest;”
3. Identification and management of conflicts by Institutions;
4. Assuring institutional compliance;
5. Requiring Institutions to provide additional information to the PHS; and
6. Institutional conflict of interest
After careful consideration of the comments, NIH made substantial revisions to its current regulations to ensure that existing regulations will not be biased by any Investigator FCOI with regards to the design, conduct, or reporting of PHS-funded research, and that regulations continue to apply once PHS-funded research is underway. Accordingly, NIH proposed to:
– Broaden the applicability of the regulations by eliminating the current exception for SBIR/STTR Phase I applications because Phase I awards increased from $99,000 in 1995 to $182,000 in 2009, and because Phase I awards are often used to leverage Phase II funding or significant outside financial support.
Definitions
The proposed rules then created and revised various definitions:
– Contractor (revised) is “an entity that provides property or services “under contract” for the direct benefit or use of the Federal Government;”
– Disclosure of significant financial interests (new) describes the communication between an Investigator and the Institution requesting SFI information;
– “FCOI report” (new) describes communications from an Institution to the PHS regarding FCOI;
– Financial conflict of interest (new) is a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
– Financial interest (new) is anything of monetary value or potential monetary value. NIH added the potential monetary value to capture financial interests that may not have monetary value currently, but could become valuable in the future, such as an ownership interest that an Investigator may hold in a small start-up company;
– Institutional responsibilities (new) are disclosure obligations for institutions;
– “Investigator” (revised) is the PD/PI as well as any other person who is responsible for the design, conduct, or reporting of research funded by or proposed to the PHS
– Manage (new) is taking action to address a FCOI, which includes reducing or eliminating the FCOI, to ensure that the design, conduct, or reporting of research is free from bias or the appearance of bias.
NIH then revises Significant financial interest (SFI) of an Investigator (including spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities:
– Publicly traded entity: SFI exists if the value twelve months preceding the disclosure and the value as of the date of disclosure, when aggregated, exceeds $5,000.
– Remuneration includes salary and any payment for services (e.g., consulting fees, honoraria, paid authorship, travel reimbursement);
– NIH adds to examples of payment for services, “paid authorship” and “travel reimbursement” as additional examples
– Non-publicly traded entity: SFI exists if the value exceeds $5,000, or the Investigator (or spouse/dependent children) holds any equity interest (e.g. stock, stock option, or other ownership interest) or Intellectual property rights (e.g., patents, copyrights), royalties from such rights, and agreements to share in royalties related to such rights.
A SFI does not include:
– Salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution;
– Any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization;
– Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, or an institution of higher education; or
– Income from service on advisory committees or review panels for a federal, state, or local government agency, or an institution of higher education.
– Income from non-profit entities other than institutions of higher education for the types of activities described above would be subject to the SFI definition (e.g. Professional Societies, Patient Originations, and Foundations including speaker fees).
The revised definition would also makes income in excess of the $5,000 for public and non-publicly traded entities and the activities above a SFI, which would require disclosure by Investigators to Institutions for their review.
NIH anticipates that the revised SFI definition would result in the disclosure by Investigators to Institutions of a wider array of interests on a more frequent basis. How would NIH handle a “wider array of interests more frequently?” How much money and resources would be spent sifting through meaningless interests that have no impact on the subject grant, other than slowing the eventual discovery or research?
Responsibilities of Institutions regarding Investigator financial conflicts of interest
NIH proposes that an institution not only to maintain an up-to-date, written, enforced policy on FCOI that complies with the regulations, but also to make such policy available via a publicly accessible web site. Institutions must then require Investigators to complete training regarding the Institution’s FCOI policy, the Investigator’s responsibilities regarding disclosure of FCOI, and the regulations, prior to engaging in PHS-funded research and, thereafter, at least once every two years.
NIH encouraged each Institution to form a committee to review FCOIs and SFIs, but did not change the current regulation which requires an Institution to designate an institutional official to review financial disclosure statements.
Under the proposed rules, an Institution would have to require that each Investigator participating PHS-funded research submit an updated SFI disclosure:
(1) at least annually during the period of the award, including disclosure of any information that was not disclosed initially to the Institution or in a subsequent SFI disclosure, and disclosure of updated information regarding any previously-disclosed SFI (e.g., the updated value of a previously-disclosed equity interest); and
(2) within thirty days of acquiring a new SFI (e.g., through purchase, marriage, or inheritance).
The rules recognize that an Investigator’s SFI is related to PHS-funded research when the Institution, through its designated officials, reasonably determines that the SFI:
(1) Appears to be affected by the PHS-funded research; or
(2) Is in an entity whose financial interest appears to be affected by the research.
Institutions would have to certify they:
(1) Have an up-to-date, written, and enforced administrative process to identify and manage FCOIs in PHS funding;
(2) Promote and enforce Investigator compliance with NIH regulations’ pertaining to disclosure of SFIs;
(3) Manage FCOI and provide initial and ongoing FCOI reports;
(4) Agree to make information available promptly to the HHS; and
(5) They fully comply.
Prior to the Institution’s expenditure of any PHS-funds, an Institution must review all Investigator disclosures of SFIs; determine whether any SFIs relate to PHS-funded research; determine whether a FCOI exists; and, if so, develop and implement a management plan that specifies the actions that have been, and will be, taken to manage such FCOI. Management of FCOI includes:
– Public disclosure of FCOI;
– For research projects involving human subjects research, disclosure of FCOI directly to participants;
– Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias, or the appearance of bias, resulting from the FCOI;
– Modification of the research plan;
– Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
– Reduction or elimination of a financial interest (e.g., sale of an equity interest); or
– Severance of relationships that create actual or potential financial conflicts.
In addition, prior to the Institution’s expenditure of PHS-funds, the Institution must make available via a publicly accessible web site certain information about SFIs, including:
– The Investigator’s name and position with respect to the research project; and
– The nature and the approximate dollar value of the SFI (ranges permissible)
The Institution would have to update the posted information at least annually, and NIH would also require the Institution to update the web site within sixty days of the Institution’s receipt or identification of information concerning any additional SFI that was not previously disclosed. Information on the website must be accessible for at least five years from the date that the information was most recently updated.
The FCOI report, which would be required annually by Institutions, would specify whether a previously reported and identified FCOI is still being managed or explain why the FCOI no longer exists. The report would also include:
– The nature and value of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);
– A description of how the financial interest relates to the PHS-funded research and the basis for the Institution’s determination that the financial interest conflicts with such research;
– A description of the key elements of the Institution’s management plan
Investigators involved in PHS-funded projects must disclose a FCOI in each public presentation of the results of the research, and request an addendum to previously published presentations.
The institutions will collect SFI’s in the following increments on their investigators and staffs:
· $0 – $4,999
· $5000 – $9,999
· $10,000 – 19,000
· Up to $100,000 in $20,000 increments
· Above $100,000 in $50,000 increments
Institutions will report to NIH and the public only if the institution determines the significant financial interest constitutes a conflict of interest.
The institutions will be required to publically disclose conflicts of Interest in the following increments greater than:
> $20,000
> $50,000
>$100,000
>$250,000
Conclusion
NIH noted that “there has been limited study on the effect of the exact monetary value of an Investigator’s financial interests on the integrity of his or her research.” In fact, they cite only one journal article from the social sciences, which showed that behavior can be influenced by gifts of negligible value. Since the study obviously did not focus on the clinical research itself, and because of little evidence, the proposed rules by NIH need further careful consideration before PHS regulations can be formulated, especially in addressing how “institutional conflict of interest” would be defined.
Moreover, since the proposed rules will affect approximately 2000 small business concerns that apply for SBIR/STTR Program Phase I funding, NIH needs to address how these issues will be handled.
By lowering monetary thresholds NIH recognized an increase in administrative burdens on Investigators and Institutions would be seen because more financial interests are likely to be subject to disclosure and review. In addition to this burden, requiring 12 months prior payments because they have already occurred and are likely documented, will hurt investigators who would be willing to manage their SFIs or FCOIs. It would also be a challenge on Investigators and Institutions alike to comply with this provision every time a new, all-but-negligible financial interest was obtained by the Investigator.
Opportunity cost should be considered in this discussion and comments to the agency, the roughly 688,000 hours of compliance time that could have been spent on research is something to consider especially true if the researchers are working on time sensitive issues such as HIV, Cancer and Trauma research.
The Prescription Project lauded these recommendations “The rule lines up with much of Community Catalyst and Pew Prescription Project’s recommendation to the agency in July 2009.”
The Association of Clinical Researchers and Educators commented about these proposed regulations “At a time when the NIH budget is flat and the investment pipeline is seized up due to the recession, why would we divert energy and scarce resources into the minute compilation of who is being paid how much and speculate on what constitutes a “significant” COI – even a FUTURE COI — “that COULD effect the design, conduct or reporting of research?”
These changes fail to address the problems within the current system. Do we want our researchers focused on disclosing financial interests to the last penny (travel expenses meals, payments by non profits….) or do we want them to focus on biomedical research?
To overcome the shortcomings of NIH’s proposed rules, it would be helpful for NIH to recognize that developing new strategies and approaches for translating basic research into clinical application demands researchers to frequently work in multidisciplinary teams to advance human health.
These teams often include SFIs and FCOIs because members the pace “by which new discoveries are translated from the research bench into effective treatment of patients has accelerated significantly and the biomedical and behavioral research enterprise in the United States has grown in size and complexity.”
The fact 57% of biomedical research funding comes from industry, and relationships between individual academic researchers and industry grew from 28% in 1996 to 52.8% in 2007 is good news. It means that more financial resources are going into research from a variety of sources advancing medicine and discovering new ways to help patients.
Comments
Comments must be received on or before July 21, 2010. Comments should be identified by RIN 0925-AA53 and Docket Number [NIH-2010-0001]. Electronic submissions can be sent the Federal eRulemaking Portal: http://www.regulations.gov.
Written Submissions must include the agency name and Regulatory
Information Number (RIN) [0925-AA53] and docket number [NIH-2010-0001], and can be faxed to 301-402-0169 or mailed to:
Jerry Moore, NIH Regulations Officer, Office of Management
Assessment, National Institutes of Health, 6011 Executive Boulevard,
Suite 601, MSC 7669, Rockville, MD 20852-7669
For further Information contact:
Jerry Moore, NIH Regulations Officer,
Office of Management Assessment, National Institutes of Health
6011 Executive Boulevard, Suite 601, MSC 7669, Rockville, MD 20852-7669, Telephone 301-496-4607,
Email jm40z@nih.gov
Questions about the rulemaking process can be sent to Dr. Sally Rockey, NIH Deputy Director for Extramural Research, at FCOI-NPRM@mail.nih.gov.
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