More often than not, conflicts of interest are not reported. Sadly, and more often than not, investigators (and their institutions) don’t realize why that’s a problem. Here we go into what a COI is and why it’s important to disclose it. Like FDA-regulated research, people would rather pretend it doesn’t exist than deal with it, and like FDA-research, when we ignore it, problems are inevitable.
Let’s dig right in!
How do I know I have a COI?
Researchers are encouraged and typically want to partner with commercial bodies when doing their research. This not only makes it easier to fund research, but it makes you more popular as well. I mean, who doesn’t want their amazing research connected to a big name, or want acknowledgment for the hard work they’ve done when working with anyone (including big corporations)?
Many studies result in the discovery of some novel product which, of course, means having your name on a patent. You can say, “hey, I invented this” and yeah, that feels good…
But that doesn’t mean that as awesome as it is to invent and create life-changing stuff, you shouldn’t report your “conflicts of interest” (or in layman’s terms, your “personal motivations for doing what you do”).
More importantly, sometimes if you work for an institution, the patents and discoveries you make, aren’t necessarily only yours, but shared with the institution that supported your research (i.e., your employer).
I’ve seen tons of commercially funded research in which the investigator owns stock in the company but didn’t believe they had a conflict of interest. The fact is, conflicts of interest (COI) are almost impossible to avoid.
To complicate things, conflicts of interest aren’t always financial. Wait, what?? Yeah… marinate on that one…
Even personal relationships can mean having a conflict of interest. Do you, your wife, or immediate family have stock in the product or sponsor? You could have a conflict of interest.
Why is it important for me to report any potential COIs?
Some federal agencies that fund research actually require you to report any potential COIs (42 CFR 50, Subpart F). And if you lie? That could mean serious consequences if you get caught. My favorite quote is: “Doing the right thing doesn’t automatically bring success. But compromising ethics almost always leads to failure.” (Vivek Wadhwa)
Basically, if you wanna make big name for yourself and all the cool stuff you do, people want to be assured that the work you do is not biased due to your “personal motivations” to get stuff done. But it goes beyond your own personal motivations and extends to the institution you work for as well.
Do I, or My Instituiton, Have a COI?
Sample Scenario: Dr. Super works for Awesome Medical University and enrolled Jane Doe in an experimental therapy for treating her disease. Jane dies as a result. After an investigation, it was found that not only did Jane not meet the eligibility criteria, but Awesome Medical University actually had financial ties to the drug company that sponsored the research and questions were asked about if those financial ties were related to the enrollment of Jane, and if that bias could have affected the way the study was conducted.
Answer: This is an example of both investigator and institutional conflict of interest.
Institutional Conflicts of Interest:
As mentioned above, sometimes institutional research exists because the institution has financial ties to the sponsor. Institutional Conflicts of Interest, however, also exist when their financial interests include receipts of gifts, investments, and/or royalties from their researchers’ inventions.
Ok, Ok. That Said, do I Have a COI?
Only you can determine if you have a COI or not. The gist is basically to clarify if you think you (or the institution you work for) may have a bit of a bias (or an appearance of) the stuff you’re trying to accomplish.
What does that mean?
Do you feel you may have a potential bias that could affect enrollment, who works with/for you, how recruitment and consenting is done, which vendor you chose, and how the data collection, sharing, and analysis is done?
Any appearance of conflict can seriously destroy the integrity of the research, which is why the disclosure is so important. It’s not so much that you “can’t have a COI” but that you have to be transparent about it.
The most common COIs I’ve seen are consulting and advisory relationships with the sponsor. Researchers are experts in their fields, and because of that, they are usually asked to serve on advisory boards or be guest speakers at conferences, etc. But another source of conflict that isn’t as obvious is when intellectual property is involved. When researchers are doing “evaluations” of technology that they’ve developed and patented, this is also a conflict of interest.
In fact, some researchers like to take that technology and develop companies based off what they’ve accomplished. This is what is called a “spin-off” or “start-up” company. This can (but not always) results in an additional conflict of interest because now that researcher is part of the company that sponsors the research.
One of the less known sources of conflict of interest, however, is the conflict of conscience. This is when a researcher is personally invested in the research due to emotional, religious, or other “conscience-related” issues.
What if I don’t report my COIs?
Any study that is funded by PHS (42 CFR 50 (Policies of General Applicability 2011)) must report any potential COI. This includes money received by traded stocks (within the last year, when it exceeds $5k), any intellectual property rights and interests, and any travel that is reimbursed by the sponsor.
Ok. Maaaaaybe I have a COI. Now what?
If your conflict of interest is considered financial, then the institution you work for typically develops a management plan to control and manage the conflict.
If the study is funded by the National Science Foundation, there are specific procedures in place for such management.
If your study is FDA-regulated? FDA requires all applicants to disclose their COIs (21 CFR 54.4(a) (Financial Disclosure 2011) and 21 CFR 54.3(c)). If you get caught, the FDA might refuse to file any future marketing applications.
What does a Conflict of Interest Management Plan look like?
Usually, a management plan will include:
* Ensuring the conflict is disclosed in the consent form and publications/presentations.
* Requiring an independent monitoring and/or data safety monitoring committee.
* Limiting the investigator’s role in the study (such as contact with subjects and no data analysis, etc.)
* Randomization and blinding
* selling the “interests” (stocks, etc.) to eliminate the source of conflict
These are similar in many ways to Institutional Conflicts of Interest, but for lack of time and space, I recommend you speak to your institution about their policies and procedures for managing this.
What about IRB Board Members’ COI?
As mentioned above, sometimes the board members that review your research also have a conflict of interest. For more information on institutional-specific IRB Board Member Conflict of Interest Management Plans, you should consult your institution/IRB. However, in general, most IRB’s require their members to disclose all conflicts to each study prior to their review (and they must recuse themselves before voting on such studies)
Conflicts can occur when one has an immediate family member involved in research. For example, it is often the case that an IRB Board Member reports a COI because their spouse or children are investigators or sponsors of a certain research project.
And that’s a wrap!
If there’s any take-away message, it is that if you’re not sure, disclose anyway. Worst case scenario, the conflict committee will laugh and tell you there’s no conflict.
