Concerned About Conflict of Interest?

Addressing possible Conflict of Interest (COI) considerations in the early stages of collaboration with industry offers the higher likelihood of a smooth, successful path for research initiation. When a potential conflict exists, the Medical School Conflict of Interest Board (MEDCOI) works with researchers to manage the possible COI to allow researchers the ability to work creatively with potential external collaborators with the least constraints possible in a given situation.

Below you'll find Frequently Asked Questions regarding COI and collaboration with industry. If you have other specific concerns, check out the MEDCOI website or simply contact the Business Development team or MEDCOI staff at 734-764-6730.

Which Conflict of Interest group oversees possible industry collaboration?
While there are several boards that oversee COI at U-M, MEDCOI has primary oversight for research and technology transfer that involve industry collaboration with Medical School researchers.

I am discussing a possible research collaboration with an outside, for-profit company. Does this mean that an Outside Interest Disclosure via M-Inform is automatically required?
No. If the only association you have with the company relates to funding of your research through DRDA, this is considered the University's interest and not a personal outside interest for you. If you DO have an outside relationship such as a consulting contract or service on a company's advisory board, you must make a disclosure in M-Inform. Some level of conflict management will be required only when you have both an outside relationship and research funding from the same company.

How is "outside relationship" defined?
An outside interest, activity, or relationship is defined as one that is related to your work or position and has the real or perceived potential to result in benefit to you or your spouse, domestic partner, or dependents. 'Related to your work or position' means an interest, activity, or relationship that:

• relies upon your clinical, research, teaching, or other expertise that the University considers part of your work at UMHS, OR
• has the potential to influence your clinical, research, teaching, or other duties that the University considers part of your work at UMHS.

Examples include (but are not limited to):

• equity interest in a company
• stock ownership
• licensed intellectual property for which you could potentially receive royalties
• unpaid or paid consulting with a company
• service on a scientific or advisory board for industries, non-governmental organizations, and other non-profit entities

Some activities that involve a non-UM entity but are considered part of your University employment rather than an Outside Interest include:

• salary and other support for research that is administered by DRDA or a University development office,
• grant reviews for state or federal organizations (e.g. NIH),
• service as an editor for professional journals,
• service on an advisory group for other universities,
• positions on academic societies.

My project may be sponsored by a company with which I do not have an outside relationship. Does that mean there are no COI concerns?

• COI management may still be needed if the U-M has an equity stake in the company and the research involves human subjects. DRDA will usually initiate the needed COI management steps, but when you know U-M has equity, check "Yes" for the COI question on the ePAF (proposal application form).
• COI management may be needed if anyone on the UM study team has an interest in the company. You need to check "Yes" for the COI question on the ePAF whenever anyone on your study team has an outside interest with the sponsor (and indicate potential COI in the IRB application when doing human subjects research).

My mutual funds include stocks in a company that may sponsor my project. Do I need to update my M-Inform Disclosure?
No. You do not have to report any investment over which you do not have direct, individual stock purchase control. If you hold stock shares or options in a healthcare related company, you should make an M-Inform disclosure for that type of interest regardless of whether or not the company may sponsor your research.

Will DRDA be aware of possible Conflict of Interest issues with my project?
Not necessarily. In most cases where U-M holds equity in a company, DRDA will know about the COI. It is your responsibility to assure personal interests that present perceived, potential, or actual COI are reported in the ePAF and Human Subject Application (if applicable).

I have been asked by a company to participate on an advisory board, for which there will be no financial compensation. Do I need to update my M-Inform Disclosure?
Yes.

I have Intellectual Property that the U-M licensed to an outside company. Can I manage trials or studies of that IP that may take place at the U-M?
It depends. For research involving human subjects, the default position is that anyone who could personally benefit financially by the outcome of the research should not be the principal investigator.

• An exception to the rule may be made when the researcher can make a case for "compelling circumstances." For example, if you have invented a device that involves innovative techniques for implantation, you may be the only person with the expertise to be the principal investigator.
• In other cases, you may be allowed to serve as a co-investigator with someone else overseeing selection of subjects or other duties.

For bench or animal research the COI management will not typically prohibit you from serving as principal investigator if MEDCOI sees that the design of the study assures scientific integrity of the data.

Once I have updated my M-Inform Disclosure and have sponsorship for a study that presents a possible Conflict of Interest, what will happen and how long will it take?
MEDCOI will develop a COI Management Plan for your project, which typically takes 2-6 weeks from the time they learn of the COI. If the conflict is such that the convened MEDCOI Board must review the management plan, the Board only meets the last week of each month, so it may depend on when they learn about the COI. Action by MEDCOI is prompted by one or more of the following:

• A 'yes' answer to the COI question on the ePAF and the ePAF is submitted to the sponsor,
• A 'yes' answer to the COI question in the IRB application and the application is in the "Ancillary Review" state,
• Your email or phone call to the MEDCOI Office. Email June Insco of MEDCOI or call 734-764-6730.
  
  

MEDCOI understands that collaboration with outside industry can sometimes require an expedited turnaround. Contact them early in the process!