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Click a question below to view the answer, or download a complete document with all FAQs and answers

For general FAQs regarding the new federal policy, visit NIH's website.

Policy Questions

• What is the Public Health Service (PHS)?

PHS means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).

• I have heard there is a special requirement for clinical research. Is this true?

Yes. Conflicts arising in the clinical environment, whether related to research or not, will be addressed in accordance with the provisions of the Feinberg School of Medicine Conflict of Interest and Professional Integrity Policy. A separate policy governing human subjects research will be developed in the next few months.

• Does the regulation apply to Subrecipients, subgrantees and collaborators (e.g., subcontractors or consortium members)?

Yes. The 2011 revised regulation is applicable to each Institution that applies for or receives PHS funding for research through grants or cooperative agreements and, through the implementation of the regulation by each Institution, to each Investigator planning to participate in, or participating in, such research. A subrecipient relationship is established when federal funds flow down from or through an awardee Institution to another individual or entity and the subrecipient will be conducting a substantive portion of the PHS-funded research project and is accountable to the awardee institution for programmatic outcomes and compliance matters. Accordingly, as a recipient of federal funds from an awardee Institution, the Financial Conflict of Interest regulation applies to Subrecipients (e.g., subcontractors or consortium members). See 42 CFR 50.604 (c).

• I am a collaborator/consultant/subgrantee/subcontractor/subrecipient performing research funded by the PHS but am not employed directly by Northwestern University, which received the award. Does this regulation apply to me?

Yes. If you meet the definition of an "Investigator," the regulation applies to you. The PI of a project ultimately determines the investigators on the project. Please review the policy on Conflict of Interest and Conflict of Commitment as well as the Policy on Conflict of Interest in Research for details at: www.northwestern.edu/coi

• I am a post-doctoral fellow receiving funding from the PHS. Does this regulation apply to me?

Yes. If you meet the definition of an "Investigator," the regulation applies to you. The PI of a project ultimately determines the investigators on the project. In addition, if you receive compensation from a faculty company or have PHS funding in your name (not from a training grant), you will need to complete the financial disclosure form. Please review the policy on Conflict of Interest and Conflict of Commitment as well as the Policy on Conflict of Interest in Research for details at: www.northwestern.edu/coi

• I am a graduate student working on research funded by the PHS. Am I subject to the requirements of the Financial Conflict of Interest regulation?

Yes. If you meet the definition of an "Investigator," the regulation applies to you. The PI of a project ultimately determines the investigators on the project. In addition, if you receive compensation from a faculty company or have PHS funding in your name (not from a training grant), you will need to complete the financial disclosure form. Please review the policy on Conflict of Interest and Conflict of Commitment as well as the Policy on Conflict of Interest in Research for details at: www.northwestern.edu/coi

• What is a "Financial Conflict of Interest?"

A Financial Conflict of Interest (FCOI) exists when a designated official(s) or office, reasonably determines that an Investigator's Significant Financial Interest is related to and could directly and significantly affect the design, conduct or reporting of the research.

• How is a "new" Significant Financial Interest (SFI) defined?

A new SFI is a different type or nature of SFI (e.g., royalty payment versus consulting fees) than what had previously been disclosed from the same source that meets or exceeds the threshold. In addition, a "new" SFI is also considered to be the same type or nature of SFI (e.g., royalty payment) from a different source (e.g., company A versus company B).

• What is an "Entity" as used in the Financial Conflict of Interest regulation?

Entity means any domestic or foreign, public or private, organization (excluding a Federal agency) from which an Investigator (and spouse and dependent children) receives remuneration or in which any person has an ownership or equity interest.

• Who are the "senior/key personnel"?

Senior/Key Personnel means the Project Director/Principal Investigator (PD/PI) and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted. If you are designated as Key Personnel, then you will be deemed an investigator and required to complete the disclosure process.

• Who is considered an "Investigator" for the purpose of this regulation? Is it only the Principal Investigator?

No. "Investigator" means the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research, or proposed for such funding, which may include, for example, collaborators or consultants.

• What information must be obtained from Investigators and when should it be collected?

Under the 2011 revised regulation, Investigators are required to disclose their Significant Financial Interests (and those of the Investigator's spouse and dependent children) that reasonably appear to be related to the Investigator's institutional responsibilities:

  1. no later than at the time of application;
  2. within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest; and
  3. at least annually, in accordance with the specific time period prescribed by the Institution, during the period of award.

• What about financial interests acquired or discovered during the award period?

Investigators have an ongoing obligation to disclose Significant Financial Interests throughout the awarded project period. Under the 2011 revised Financial Conflict of Interest regulation, Investigators must update financial disclosures of Significant Financial Interests Northwestern University within thirty (30) days of acquiring or discovering (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest. As an institution we have sixty (60) days to review the Significant Financial Interest disclosure, determine whether the Significant Financial Interest is related to PHS-funded research, determine whether a Financial Conflict of Interest exists, and if so, implement, on at least an interim basis, a management plan that shall specify the actions that have been, or will be, taken to manage the Financial Conflict of Interest. If a Financial Conflict of Interest exists, the Institution must submit an FCOI report to the PHS within this same 60-day period.

• Do I have to disclose payments to or assets held by my spouse or dependent children related to my institutional responsibilities?

Yes. The financial interests that must be disclosed by the Investigator include the aggregated amounts or values of financial interests held by the Investigator and his/her spouse and dependent children, but only if those interests are related to your institutional responsibilities.

• Do I need to disclose the occurrence of any reimbursed or sponsored travel related to my institutional responsibilities?

Yes. The regulation requires Investigators to disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to the Investigator's institutional responsibilities. However, the disclosure requirement does not apply to travel that is reimbursed or sponsored by the following:

  • a federal, state, or local government agency,
  • an Institution of higher education,
  • an academic teaching hospital,
  • a medical center, or
  • a research institute that is affiliated with an Institution of higher education.

• What happens if my financial interests change during the award period?

The 2011 revised regulation requires each Investigator to submit an updated disclosure of Significant Financial Interest to the Institution's designated official(s) within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest.

• Is income from all non-profit institutions excluded from the definition of Significant Financial Interest?

No. The 2011 revised regulation states that income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education is excluded from the definition of Significant Financial Interest. Such income from all other sources is included in the definition of Significant Financial Interest and, accordingly, must be disclosed.

• What actions will be taken in the event that an Investigator fails to comply with Northwestern's Policy on Conflict of Interest and Conflict of Commitment or management plan?

When an Investigator fails to comply with the policy or the management plan, the Institution shall within 120 days:

  1. complete a retrospective review of the Investigator's activities and the NIH-funded research project to determine any bias in the design, conduct or reporting of research;
  2. document the retrospective review consistent with the regulation; and
  3. document the Institution's determination as to whether any NIH-funded research, or portion thereof, conducted during the period of time of the Investigator's non-compliance with the Institution's Financial Conflict of Interest policy or a Financial Conflict of Interest management plan, was biased in the design, conduct, or reporting of such research.
If bias is found, the Institution shall notify the NIH promptly and submit a mitigation report to the NIH that shall address the following:
  • impact of the bias on the research project and
  • the Institution's plan of action or actions taken to eliminate or mitigate the effect of the bias.
Thereafter, the Institution shall submit FCOI reports annually, in accordance with the regulation. Depending on the nature of the Financial Conflict of Interest, an Institution may determine that additional interim measures are necessary with regard to the Investigator's participation in the NIH-funded research project between the date that the Financial Conflict of Interest is identified and the completion of the Institution's independent retrospective review, in accordance with 42 CFR 50.605(a)(3) and 42 CFR 50.605(b)(3). In addition, if the NIH determines that one of its funded clinical research projects whose purpose is to evaluate the safety or effectiveness of a drug, medical device or treatment has been designed, conducted or reported by an Investigator with a Financial Conflict of Interest that was not managed or reported by the Institution, the Institution shall require the Investigator involved to disclose the Financial Conflict of Interest in each public presentation of the results of the research and to request an addendum to previously published presentations.

• Is it just Northwestern University that has to comply with these regulations?

No. All institutions that accept PHS funding worldwide must comply with the new regulations. It will be a common practice for all institutions to implement the same guidelines and processes. In the future, we expect more agencies and sponsors to be following the new federal regulations, particularly for consistency.

• Does every grant have to complete this disclosure process?

No. Please review the policy to indicate whether or not your grant requires disclosure.

• I hold a position as a journal editor and receive a small stipend for travel, do I have to disclose?

Regulations are broad on what has to be disclosed for travel; however, if it relates to your institutional responsibilities it is important to disclose this information.

• When do we have to include graduate students in this disclosure?

Only occasionally do they fall under the definition of investigator. Unless they are taking individual responsibility in the project that meets the definition of investigator do they need to disclose.

• What date would I use when reporting an honarium?

It depends. If it is from another institution you do not need to disclose; however, the date of the payment is received is the preferred method.

• What are considered extenuating circumstances?

This can vary and must be cleared with the Office for Sponsored Research. For example, if an investigator does not have access to complete the disclosure.

• Which sponsors does this policy cover?

This policy will cover all sponsored research. While some sponsors have adopted the new PHS regulations, many have not. To determine what disclosure requirements exist for a particular sponsor, please check with the central COI office, OSR or the sponsor itself. In any case, the research COI was designed to provide a framework in which the specific requirements of an individual sponsor could be incorporated. If a faculty member is submitting proposals to or is funded by several sponsors, the most stringent requirements of any one sponsor will be applied to all proposals. This occurs because all disclosure information for an individual faculty member is stored in a single file, making the detailed information for one sponsor available for review when later proposals submitted.

• What happens if someone is added to a project and they are an Investigator, how do I add them?

If someone is not in InfoEd at the time of submission and needs to be added after the proposal has been submitted, OSR will enter the information into InfoEd so the individual can disclose. Please contact your OSR Grants Officer.

• For those graduate students who must disclose, who will be approving/ reviewing their disclosure?

The school will approve them based on their home department.

• If a Faculty member transfers into Northwestern with an NIH grant must they disclose?

If they have a SFI, yes. At minimum they will have to go into FASIS to do their training. If their interests or commitments meet or exceed the threshold it must be reported it in the system. If their previous institution determined that an SFI presented a financial conflict, that information must be provided to their NU department.

• How do I calculate the amount that I need to disclose?

Please refer to the policy for disclosure guidelines. If you cannot put a dollar figure on the amount, you must still disclose in the description anything that could possibly be an SFI.