NIH Financial Conflict of Interest Procedures
In order to apply for US National Institutes of Health (NIH) and other US Public Health Services (PHS) research funding. Investigators must appraise themselves of the PHS regulations and procedures relating to Financial Conflicts of Interest (FCOI).
A summary or the requirements is provided below and the procedure which must be followed is outlined in more detail here.
The Following steps must be followed by all investigators in receipt of funding originating from the NIH or other PHS source.
1. Prior to applying for NIH funding applicants must appraise themselves of the Universities Financial Conflict of Interest policy contained in sections 3.4 and 10.24 of the Financial Regulations and sections 10.57 and 10.64 of the Financial Procedures.
2. Each applicant must ensure their Research Integrity training is up to date (this must be completed every 3 years) and for NIH funded investigators this should include completion of the additional module on Conflicts of Interest.
3. Applicants are reminded that they must complete a Register of Interest return each year in line with University policy and any significant financial interests declared through this NIH process must also be declared via the university register of interest process.
4. On award all NIH / PHS funded investigators (PI/CoIs) must complete the online training course at https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html Two copies of the completion certificate should be printed and retained; one for the investigator and one should be held on the on the Research Services grant record either in Pure or local project file.
5. Annually each investigator working or named on an NIH/PHS funded research project must complete an NIH FCOI declaration and return this to their local Research Service team supporting the award. Where no significant financial interests are declared the form should be retained on the project file or on the award record in Pure. Where a significant financial interest is declared. The RS team should notify the Head of Research Services, sending the completed declaration to researchoperations@manchester.ac.uk for review by the Director of Research and Business Engagement.
6. The NIH require a separate annual report on FCOI as part of general project reporting and this will show on the era Commons tool. The FCOI declarations held on the project file or in Pure should reflect what is reported within the annual return to NIH (further details can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-081.html
For further information on the key underlying NIH/PHS regulations in relation to these requirements please consult the following NIH/PHS resources.
Responsibility of Applicants for Promoting Objectivity in Research
Responsibilities of Institutions regarding Investigator financial conflicts of interest
NIH Policy Change for Foreign Subrecipients
From the beginning of 2024, foreign subrecipients of National Institutes of Health (NIH) funding are being asked to provide access to all documents that support research outcomes. As such, UoM subrecipients of NIH funds are required to, “provide access to copies of all lab notebooks, all data, and all documentation that supports the research outcomes as described in the progress report, to the primary recipient with a frequency of no less than once per year, in alignment with the timing requirements for Research Performance Progress Report submission. Such access may be entirely electronic.”
Lead recipients of existing NIH grants (generally the US partner) may need to update their subaward agreements to include this new requirement for foreign subrecipients to provide this access. Any amendment to a subaward agreement should be sent to the Contracts Team for review.
To adhere to this policy change, researchers may find it useful to complete a data management plan for their project(s). Full details on research data management at the University of Manchester can be found here.
Full details of the NIH policy change can be found here.
If you have any queries relating to US federal funding please contact your local Research Services team in the first instance. You can find details of Research Services contacts by Faculty here.