The process begins with questions on our standard submission forms, and continues with a request for the investigator to submit a “conflict of interest management plan.” Aspire wants to work with investigators to identify COI and make sure that it is appropriately managed, and to facilitate the documentation process.
Conflict of interest (COI) has been defined as “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest” (Steinbrook NEJM 360:2160-2163, 2009). Examples of primary interests are welfare of patients (subjects), research integrity, and advancement of medical education. Examples of secondary interests are financial gain, professional advancement, and favors to others.
COI is usually, but not exclusively, financial. Federal regulation defines financial COI as "...a significant financial interest that could directly and significantly affect the design, conduct, or reporting of...research" (42 CFR 50, revised March 2011). (Investigator might, of course, have non-financial COIs. These can be harder to identify, but are also often properly addressed by a strong informed consent process and document.)
It is clearly a conflict for a researcher to have a financial interest sufficiently large to affect his or her participation in research. Just how much financial interest is too much is not universally agreed upon; Aspire’s practice is to adopt certain thresholds that are stated on our submission forms. If those thresholds are exceeded, then a COI exists by definition, and it is not correct to claim, for example, “I sit on this company’s board of directors but I do not have a COI for this study.”
If a COI exists, it must be "managed" by whatever steps are necessary to remove the risks to human subject protection or avoidance of bias or frank fraud in research. These steps may include measures like requiring the investigator to divest her financial interest or asking her to withdraw from or change the nature of her participation in the study. Depending on the specific study or financial interest, steps short of that may be sufficient.
Other appropriate steps to manage COI may include modification of the research plan, monitoring of the research by independent reviewers, using independent consultants and/or “unconflicted” personnel in the research, or others.
Disclosure in the informed consent process and document is a COI management step that should virtually always be taken when conflict exists. Please note, however, to identify that COI is present is a great start but insufficient by itself to manage it.
What it the “best” COI management plan? It depends on the study. There is not a “one size fits all.” It is Aspire’s policy to ask the investigator to propose a plan. Upon review of this plan, Aspire IRB will make a determination as to whether the plan is sufficient to manage the conflict.
Like everything we do here at Aspire, we aim to be as efficient as possible. That means you may expect us to work with you to resolve issues quickly and judiciously to permit a prompt review.
