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Proposal Preparation

As with many aspects of research administration, careful proposal preparation is key in managing the ongoing compliance of a project. There are four main questions that should be considered when considering conflict of interest requirements for proposals:

  1. Do conflict of interest requirements apply to this proposal? 
  2. Who will be considered an Investigator on this project? 
  3. Are there external Investigators on this project, either subrecipients or consultants, who will need to follow Northwestern's COI policy?
  4. Are there special terms or requirements that must be met before the proposal can be submitted?

Information on each question is provided below, along with a few common scenarios and other FAQs related to proposals. 

Key Tools for proposal preparation:

Questions for ensuring a proposal's compliance with COI requirements

Does the Conflict of Interest in Research policy apply to this proposal?

To determine whether conflict of interest (COI) requirements apply to a proposal, first look at the sponsor.  If the sponsor is:

  • Federal?  Yes, COI requirements apply
  • An industry partner (e.g., a corporation or LLC)?  Yes, COI requirements apply
  • A foundation, nonprofit, or other organization?  Sometimes.  It depends on whether the organization has COI requirements in the solicitation and/or award.  Foundations and nonprofits handle COI in a variety of ways from very stringent requirements to not mentioning COI at all.  We have a list of sponsors that we know always include COI requirements in grants, but always check the solicitation for language related to COI, or send us an email if you would like us to confirm.
Additionally, if the project will involve human participants, COI requirements apply regardless of the funding source.  We review all studies submitted to the IRB that involve human participants and the corresponding grants or other funding sources.

Who are the Investigators on this proposal?

 Conflict of interest requirements only apply to Investigators on a research project, so it is important to understand who the Investigators are on a project.

Definition of Investigator:  Anyone responsible for the design, conduct, or reporting of research, regardless of title or position.

Note: The interface between InfoEd and eDisclosure assumes that anyone listed by name on the InfoEd record is an Investigator, though this is not always the case.  If someone is listed by name on the proposal record, but does not meet the definition of Investigator, change their Investigator status on the COI Compliance page in eDisclosure to "Not an Investigator" which will exclude them from COI requirements.

Tips:

  • Key Personnel are always considered Investigators by virtue of the definition of Key Personnel
  • Investigators may also include others (internal or external to Northwestern) who are independently responsible for research design, conduct, or reporting (i.e., individual(s) who have the authority to make independent decisions about the direction of the research and the subsequent conclusions about the results and/or are likely to be authors on manuscripts or to present research findings)
  • Investigators are not administrative personnel or individuals who perform routine, pre-defined, or incidental tasks related to the project

 

Are there subrecipients or consultants who need to follow Northwestern's COI policy on the proposal?

To determine whether a subrecipient Investigator needs to follow Northwestern's COI policy, review the information on the subrecipients page.  This will depend on sponsor requirements, and whether the subrecipient has a compliant policy.  In general, proposed subcontracts to U.S. university, other institutions of higher education, and academic medical centers will have their own COI policies and will not need to follow Northwestern's policy.

Consultants who are listed as Key Personnel on a project will often need to follow Northwestern's COI policy for the purpose of the project.

If a subrecipient or consultant Investigator needs to follow Northwestern's COI policy, please email nucoi@northwestern.edu with the following information:

  • Name
  • E-mail address
  • Subrecipient Institution
  • InfoEd proposal number (SP#)
  • Date the proposal submission is due

We will create a profile for that person in eDisclosure, ask them to complete COI requirements, and associate them to the project so they can be viewed on the COI Compliance Page.

Are there special terms in the proposal guidelines that require review, a letter, certification, or other statement with the proposal submission?

While PHS and NSF sponsored projects have COI regulations that apply to all proposals, other sponsors will include COI requirements in each solicitation.  Sometimes this will require review, a certification, and sometimes a request for a waiver at the time of proposal submission, which can take time to prepare.

This guide to identifying COI language in solicitations can help determine whether a solicitation has COI language. 

When in doubt, please feel free to reach out to our office: nucoi@northwestern.edu | 847-467-4515

Example scenarios

NSF proposal with no subcontracts

A faculty member would like to submit a proposal to the NSF.  The proposal has no subcontracts, and lists the following personnel:  Jane Black, Co-PI; Susan Gold, Co-PI; Jim Brown, Postdoc; Mark Green, technician. 

Looking at the personnel justification, it says that Jim Brown will be contributing to experimental design, overseeing work, and participating in team meetings. Mark Green will be keeping the equipment in working order and running samples.

Do COI requirements apply? 

  • Yes; NSF is a federal sponsor.

Who are the Investigators?

  • Drs. Black and Gold are definitely Investigators.  Jim Brown might be - it would be best to ask the PI if he will be making independent decisions about the design, conduct or reporting of the research (for example, will his contribution result in authorship on publications?).  Mark Green is likely not an Investigator

Are there subrecipients or consultants?

  • No. 

Any special terms?

  • No. NSF has standard terms in the PAPPG
To submit:  Confirm that Drs. Black, Gold, and maybe Brown have disclosed in the past year, and have completed training in the past four years.

NIH R01 with a subcontract to University of Virginia

A faculty member would like to submit an R01 to the NIH.  The proposal has a subcontract to the University of Virginia, and lists the following personnel: 

  • Key: James Teal, PI; Susan Gold, Co-I; Mary Rose, PI of subcontract
  • Other Significant Contributor: Sierra Smith
  • Non-Key: TBD, technician. 

Looking at the personnel justification, it says that Sierra Smith will be the project manager, helping to coordinate site visits under the direction of the PI.

Do COI requirements apply? 

  • Yes; NIH is a federal sponsor.

Who are the Investigators?

  • Drs. Teal, Gold, and Rose are definitely Investigators.  Sierra Smith might be - it would be best to ask the PI if she will be making independent decisions about the design, conduct or reporting of the research (for example, will her contribution result in authorship on publications?).  The statement that she will be acting at the direction of the PI may mean she is not an investigator.  The technician is not an investigator.

Are there subrecipients or consultants?

  • Yes
    • University of Virginia has a compliant COI policy and is listed in the FDP FCOI Clearinghouse
    • PHS (NIH) requires that we not only flow-down award terms, but that we also verify that the proposed subrecipient has a compliant policy prior to submitting the proposal.  If not, Investigators from the subrecipient institution need to follow Northwestern's policy.  More information on the Subrecipients and Consultants page.

Any special terms?

  • No. NIH has standard terms.
To submit:  Confirm that Drs. Teal, Gold, and maybe Smith have disclosed in the past year, and have completed training in the past four years.  Confirm that the LOI from UVA includes a statement of compliance with PHS FCOI regulations, or have a completed subrecipient commitment form.