Significant Financial Interest Policy for NIH Funded Research

Diamond is committed to ensuring that it complies with the United States of America’s Department of Health and Human Services requirements in respect of disclosing Significant Financial Interest in relation to research projects that are funded by the PHS/NIH.

The purpose of this policy is to provide Investigators with information and guidance on Significant Financial Interests, the DHHS requirements for reporting such interests and Diamond’s internal process for dealing with the same.

This policy will apply in relation to NIH Funded Research and applies to any Diamond Employee or Diamond Personnel that is an Investigator. Diamond Employees and Diamond Personnel should ensure that they adhere to the terms of this policy.

Diamond’s directors have overall responsibility for this policy. Any queries or suggestions relating to this policy should be sent to: policies@diamond.ac.uk.

The NIH is the primary agency of the United States government, responsible for biomedical and public health research. It is part of the DHHS, which is responsible for regulating the disclosure and reporting of financial conflicts of interest in relation to research projects that are funded by its PHS (which includes the NIH). A link to the NIH website can be found here.

Where research is funded by the NIH, the DHHS’ regulations will apply, which aim to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct or reporting of research funded under PHS grants or cooperative agreements will be free from bias resulting from any conflicting financial interest of an Investigator. These set out certain conditions that Investigators must adhere to. In particular, institutions and Investigators are required to comply with the PHS’ Financial Conflict of Interest regulation.

Investigators are required to:

• complete NIH training in relation to financial conflicts of interest (which can be accessed here) before engaging in any NIH Funded Research. Investigators must complete this training again on a four-yearly basis. Two copies of the completion certificate should be printed and retained; one for the Investigator and one should be sent to Diamond’s Research Support team at RESEARCHSUPPORT@diamond.ac.uk who will keep a copy on the relevant project file;
• disclose any Significant Financial Interest related to their Institutional Responsibilities to Diamond promptly after acquiring it and with any event, within 30 days of acquiring such interest (complete as many forms as necessary);
• make an annual Significant Financial Interests declaration to Diamond in relation to their Institutional Responsibilities. Such declaration does not need to be made in the absence of a Significant Financial Interest (complete as many forms as necessary);
• comply with Diamond’s Conflict of Interest Guidelines, which can be found here; and
• complete Diamond’s Conflict of Interest form where a conflict arises, which can be accessed here.

The full text of the NIH’s regulations (entitled Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors) is available here.

The NIH’s grants and funding information page is accessible here and frequently asked questions about the NIH’s regulations on Financial Conflicts of Interest are available here.

Significant Financial Interests relate to payments of over US$5,000 and include (but are not limited to):

• consultancy payments;
• honoraria;
• paid authorship; and
• equity interests (including any stock, stock options or other ownership interest) and reimbursed travel).

Significant Financial Interests do not include:

• payments made by Diamond to an Investigator (e.g. salaries, expense reimbursement);
• income received by an Investigator from delivering any lectures, seminars or teaching engagements sponsored by a federal, state or local government agency, an institution of higher education, an academic teaching hospital, medical centre or a research institute that is affiliated with an institution of higher education; or
• an investment by a mutual fund or pension fund or other investment fund over which the Investigator or their immediate family does not exercise management of fund investment.

A declaration of Significant Financial Interest may not necessarily represent a financial conflict of interest, but it must be disclosed by the Investigator to the Research Support team at Diamond at RESEARCHSUPPORT@diamond.ac.uk.

All declarations should be made using the Declaration Form, which is accessible here.

Once a declaration has been made, the Research Support team at Diamond will discuss with the Finance and Legal teams to determine whether there is a conflict of interest that will need to be reported to the NIH within 30 days of the declaration being made.

If there is determined to be a potential conflict, the team will ask the Investigator to submit a plan for how the financial conflict will be managed. The Investigator will need to submit this plan within five days of the request.

The Research Support team will then consider whether the plan is capable of managing, reducing or eliminating the conflict.

Where the Research Support team deems the plan to be capable of managing, reducing or eliminating the conflict, it will need to send a copy of the proposed plan to the NIH via their electronic Research Administration Commons Financial Conflict of Interest module. The Research Support team will notify the relevant Investigator of their findings. The Investigator will need to provide annual updates to the Research Support team as to how the conflict is being managed. The Research Support team will then share these updates with the NIH.

If the Research Support team determine that the plan is not capable of managing, reducing or eliminating the conflict, the Research Support team will need to notify the NIH of the conflict via their electronic Research Administration Conflicts of Interest module. The Research Support team will notify the Investigator of their findings and submission to the NIH.

The Research Support team will keep a record of any Significant Financial Interests for up to three years from the date that the final expenditures report is submitted in relation to the project.

This policy may be amended by Diamond from time-to-time and Diamond Employees and Diamond Personnel shall be fully responsibility for ensuring compliance with the terms of this policy at all times.

This policy was last updated and published on our website on 5 March 2021.

DHHS: United States of America’s Department of Health and Human Services.

Diamond: Diamond Light Source Limited, a company incorporated and registered in England and Wales, with company number 4375679 and with registered office at Diamond House, Harwell Science & Innovation Campus, Didcot, Oxfordshire, OX11 0DE, United Kingdom.

Diamond Employee: Any person working for Diamond under a contract of employment.

Diamond Personnel: Any person that works for Diamond, or that is an agent, agency worker, intern, contractor, subcontractor, appointee, secondee, student, third-party representative, volunteer, external consultant, business partner, sponsor, director or office holder of Diamond and who is not a Diamond Employee.

Institutional Responsibilities: Professional responsibilities on behalf of Diamond, including, but is not limited to: research, analysis, engagement, outreach, training, professional practice, evaluating, membership of committees, conducting or supporting experiments, investigating or similar activities on behalf of Diamond.

Investigator: Project director or principal investigator of NIH Funded Research, or other person that is responsible (regardless of title or position) for the design, conduct or reporting of NIH Funded Research, in respect of which Diamond applies for or receives NIH funding.

NIH: National Institutes of Health.

NIH Funded Research: Current or proposed research that is, or will be funded by the NIH.

PHS: The Public Health Service of the DHHS.

Significant Financial Interests: Financial interests of an Investigator as set out above that reasonably appear to be related to the Investigator’s Institutional Responsibilities.