"We have to be careful that we are not using our Duke non-profit resources to the benefit of a for-profit entity"

Thursday, March 14, 2019

Angie Solomon, Associate Director, Duke Conflict of Interest Office

"Dear DOSI": Questions from the Audience of our Research Town Halls

Before and after each of our monthly town-halls, ASIST collects questions and topics of interest from the audience. Through the rubric “Dear DOSI”, we offer the research community an opportunity to have their questions answered by trusted experts. This month, your questions are answered by Angie Solomon, Associate Director, Conflict of Interest, Duke Office of Scientific Integrity and Sharlini Sankaran, Director, Translational Programs, Duke Innovation & Entrepreneurship.

Q: How to partner with a company that I am not a founder/owner as we develop an SBIR? What would be the logistical steps?

 ​Sharlini Sankaran, Director, Translational Programs, Duke Innovation & Entrepreneurship:

"If you already have a company in mind to partner with, you should work with the Office of Research Contracts to ensure that your subcontract with the company will be compliant with Duke and federal funding requirements. If the project involves any intellectual property (IP) developed at Duke in your role as a researcher, you should ensure that you have first disclosed your invention to the Office of Licensing and Ventures, who will help ensure that your IP is protected. The OLV will assist you in filing provisional patents and/or copyright protection as appropriate, and also help to negotiate the terms of any technology license from Duke to the small business. The invention disclosure form can be found here: https://olv.duke.edu/disclosure-form/

If you do not have a company in mind yet, there are resources available to help you. You could  contact the OLV to list your technology/ innovation in their pipeline https://olv.duke.edu/about/pipeline/ . You can also contact our Translation Team at Duke Innovation & Entrepreneurship by scheduling a phone call through https://calendly.com/duke-i-e , or email me at sharlini.sankaran@duke.edu. We will discuss options with you and be able to help you find potential companies to partner with."

 *Note: Outside relationships should be reported on your Conflict of Interest disclosure form. It is always a good idea to discuss outside relationships with the Conflict of Interest Office: dukecoi@dm.duke.edu if they will in any way overlap with your Duke responsibilities.

 

Q: If our department's grants office cannot help with the administrative details of an SBIR/STTR grant, how are we supposed to obtain information like percent effort and "other support"? (I am presuming this information is necessary in the grant proposal.)

Angie Solomon: As a Duke employee you can absolutely help with the Duke subcontract portion of an SBIR/STTR. These funding mechanisms are made to small businesses. When the funding agency receives these proposals they are assuming that the company has submitted the proposal and it is the company that is responsible for all of the terms associated with the award. As a Duke employee, we have to be careful that we are not using our Duke non-profit resources to the benefit of a for-profit entity. You may be called upon to help with the subcontract portion and that is perfectly acceptable.

 Q: How does Duke manage resolution of Conflict of Interests related to Faculty-associated STTRs?

A.S.: There is no one answer to this question, COI is managed on a case-by-case basis. Oversight of data is one option. Having an un-conflicted PI is another option but there are other options as well. By discussing these potential projects ahead of time, all options for management can be explored prior to crunch time of proposal due dates. The goal is to mitigate the perception of bias for the protection of participants, the institution and investigators.

Q: Could you provide me with some guidance on the roles in which a duke faculty member can participate in a SBIR-STTR.

A.S.: This depends on whether the Duke faculty member has a COI related to the company in question or not. Another consideration is to decide on which side of the project the Duke faculty wants to have effort on. For example, is the project a pre-clinical one or will human subjects be involved? Can the perception of bias be mitigated? These and other questions can help determine the participation of a faculty member. The main thing to keep in mind is that the strategies we review with faculty will only make the science stronger. If you would like to discuss specifics, feel free to give DOSI-COI a call.

Q: As a Grants and Contracts Administrator, should I be referring all PIs that are applying for an STTR to the COI office before they submit their application?

A.S.: We need to remember that an application for an SBIR/STTR comes from a company and not from Duke. If a Duke faculty member wants to be involved with these funding mechanisms and has a relationship with that company, yes, please refer them to DOSI-COI. We are always happy to talk through different scenarios related to these funding mechanisms.