The Thin Silver Line - The Boundary Between Bias and Breakthrough
When the topic of big challenges in academic commercialization comes up, there is a good chance I’ll break into a rant about Conflict of Interest (COI). While I’m not sure it’s the biggest limiting factor, it certainly causes both significant delays and stress among faculty. The disclosure and management process is often opaque, accusatory, and riddled with interpersonal conflicts—a bitter irony.
The ‘silver line’ in COI management is about striking a neutral balance—ensuring research integrity without stifling innovation.
Let’s briefly dive into its origins and importance in upholding research integrity.
Origins of COI
Science is rightly held to a high standard. Rigorous experimental design, blinded trials, and peer review are all part of a system that enables our best shot at finding new knowledge and truth.
COI policies emerged in the 1970s to address a critical concern: the risk that faculty financial interests could compromise research integrity, leading to biased or even fraudulent outcomes.
The 1999 death of Jesse Gelsinger in a gene therapy trial exposed a COI: the lead investigator held financial ties to the biotech company sponsoring the research. This case underscored the risks of financial entanglements, spurring stricter COI policies to enhance transparency and protect human subjects.
It’s not clear of the death of Gelsinger was a direct result of Dr. Wilson’s bias and financial stake in Genovo, but it’s hard to argue against putting policies in place to mitigate faculty being put into that position in the first place. At its best, COI management provides a ‘silver line’ of neutrality, balancing trust in researchers with safeguards to ensure integrity. Though, events like these create step-function shifts in risk management, administration, and regulatory practices.
Just as the Elixir Sulfanilamide disaster of 1937 led to the FDA’s mandate for drug safety testing, the Gelsinger case reshaped COI management by highlighting the ethical and practical risks of unregulated financial conflicts in clinical research.
Mission Creep
COI management captures this principle: trust researchers to act ethically, but use structured oversight to verify that their financial interests do not compromise integrity or transparency.
Though my pronunciation may give you difficulty, the maxim is, doveryai, no proveryai. Trust, but verify.
— Ronald Reagan at signing of the Intermediate-Range Nuclear Forces Treaty on December 8, 1987.
But is there a point where COI becomes over-managed?
Let’s step back from COI and dive into an adjacent space—Human research ethics. Institutional Review Boards are found at every university. These are intended to ensure a high ethical standard in dealing with human subjects. For example, in a clinical trial for a new drug treating a life-threatening disease, an IRB might require that patients in the placebo group still receive the best existing treatment, rather than no treatment at all, to ensure they are not exposed to unnecessary harm. A good thing, we would all agree.
Both science and medicine are conservative disciplines. Harm reduction is central to their code of ethics. But what is in place to prevent scope creep?
Alexander on X argues that IRBs have experienced “mission creep”, requiring approval for even minimal-risk studies, like simple surveys, under broad definitions of “harm.” This can and does lead to significant research delays, no-go research topics, and often little feedback for rejected applications.
Like IRBs, COI management faces scope creep, where broad definitions of harm and conflict create unnecessary delays and barriers, even for low-risk activities. Anecdotally, I know of many cases where COI review and management takes over six months to resolve! This, in and of itself, isn’t the problem though, the problem is that COI is often a bottleneck through which anything meaningful must pass—venture creation, R&D and commercialization.
The Cost of Delay
This hampers commercialization. Many faculty members, aiming to reduce delays, administrative burdens, and perceptions of motivated bias, actively avoid any conflicts. For instance, one faculty member chose to forgo formal industry compensation entirely, offering free consultations instead. While this avoids COI-related delays, it significantly limits the potential depth and impact of academic-industry collaboration.
These individuals understand the critical role key opinion leaders (KOLs) play in industry innovation but opt out of compensation to sidestep institutional hurdles. While a rational response to a disincentivizing system that often frames commercialization negatively, this “pain avoidance” mindset ultimately undermines broader innovation efforts.
For example, I know of a startup team that waited eight months for COI clearance, during which they missed two key funding cycles. Such delays do more than waste time; they erode momentum—a critical resource for any startup trying to reach market.
Solutions
To restore the balance—the thin silver line—COI processes must be streamlined to ensure ethical rigor without unnecessary barriers to innovation. Improving COI management requires addressing transparency, efficiency, and culture to reduce delays and foster innovation while maintaining integrity.
Transparent and Consistent Policies: COI policies must be clear, accessible, and consistently enforced. For example, a clinical trial PI with significant financial stakes in the drug being tested should be required to step aside—no exceptions. Clear, consistent policies establish a neutral standard, ensuring all researchers are treated fairly and equally.
Efficient Review Processes: Delays can be mitigated by setting firm timelines for COI reviews, offering expedited paths for low-risk cases, and incentivizing faster processing. Leveraging technology can streamline disclosures and reduce administrative burdens. Expedited reviews for low-risk cases and firm timelines for decisions would ensure that the COI process doesn’t undermine the pace of innovation.
Collaborative and Fair Culture: COI should not be seen as a liability. Instead, institutions should frame it as a collaborative process, treating faculty with respect and positioning COI as an opportunity to align ethics with innovation. As one faculty member aptly noted, conflicts should be celebrated—they signify that something valuable has been discovered or invented. Framing COI as an opportunity rather than a liability can foster trust and collaboration. By fostering a positive and constructive approach, COI management can become a catalyst for progress rather than a barrier.
By addressing these areas, institutions can support timely, ethical commercialization without sacrificing integrity.
Final Thoughts
Streamlining COI processes while maintaining their integrity ensures we stay on the ‘thin silver line’—balancing ethical rigor with the momentum needed to bring innovation to life.
The challenge I see with every potential startup is time. Time and momentum are essential to launching a new technology and company. Time to focus on what matters most, time to reach key milestones, time to reach market with a device or therapy that can help patients.
A clear focus and the ability to minimize friction are hallmarks of a successful founder’s mindset.
So in many cases, a faculty founder might wait months or years (yes, years) to clear institutional hurdles like COI. Every month spent navigating COI approvals, waiting for feedback, or enduring delays is time lost that could have been used to build, fund, or ultimately address ever present patient needs.
How many ideas, technologies, or products have been lost to time? If academia is serious about fostering innovation, it’s time to streamline COI processes while still maintaining the integrity they were designed to protect.