Conflicts of interest in translational research
Conflicts of interest in translational research
Conflicts of interest in translational research
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Journal <strong>of</strong> Translational Medic<strong>in</strong>e 2004, 2:28http://www.<strong>translational</strong>-medic<strong>in</strong>e.com/content/2/1/28equity or other ownership <strong><strong>in</strong>terest</strong>s, royalties, and <strong>in</strong>tellectualproperty rights. A <strong>research</strong>er may, for example, receiveconsult<strong>in</strong>g <strong>in</strong>come or equity <strong>in</strong> exchange for service on ascientific advisory board <strong>of</strong> a company that then sponsorscl<strong>in</strong>ical <strong>research</strong> <strong>in</strong> her lab. Another <strong>research</strong>er may bepaid for talks to physician groups about an approvedmedication while simultaneously conduct<strong>in</strong>g <strong>research</strong> onpotential <strong>of</strong>f-label uses <strong>of</strong> the drug. The <strong>in</strong>vestigator or animmediate family member may hold stock <strong>in</strong> the <strong>research</strong>sponsor. These examples are all common cases and most<strong>in</strong>stitutions have relatively standardized ways <strong>of</strong> manag<strong>in</strong>gsuch common conflicts.Greater challenges are created when the f<strong>in</strong>ancial relationshipsbetween commercial <strong><strong>in</strong>terest</strong>s and <strong>in</strong>vestigators areeither ambiguous or complex. Ambiguity can result <strong>in</strong> anumber <strong>of</strong> ways, but one <strong>of</strong> the most frequent occurswhen <strong>in</strong>vestigators approach consult<strong>in</strong>g as an extension <strong>of</strong>discussions among academic colleagues. Th<strong>in</strong>k<strong>in</strong>g thattalk<strong>in</strong>g to a corporate representative is the same as talk<strong>in</strong>gto an academic colleague, for example, may lead the<strong>in</strong>vestigator to make <strong>in</strong>appropriate disclosures that compromise<strong>in</strong>tellectual property rights or contractual obligations.Often it is not any one f<strong>in</strong>ancial <strong><strong>in</strong>terest</strong>, but ratherthe comb<strong>in</strong>ation <strong>of</strong> multiple f<strong>in</strong>ancial <strong><strong>in</strong>terest</strong>s that makesa situation unmanageable. It is extraord<strong>in</strong>arily difficult,for example, to manage situations <strong>in</strong> which an <strong>in</strong>vestigatoris the founder <strong>of</strong> a startup company, an <strong>in</strong>ventor on apatent licensed to the company, a consultant to the company,and the recipient <strong>of</strong> other government and <strong>in</strong>dustrygrants for closely related <strong>research</strong>.How <strong>in</strong>stitutions manage potential conflicts <strong>of</strong>f<strong>in</strong>ancial <strong><strong>in</strong>terest</strong>Spurred by a comb<strong>in</strong>ation <strong>of</strong> bad experiences and newregulations, most <strong>research</strong> <strong>in</strong>stitutions now have policies<strong>in</strong> place for the management <strong>of</strong> some aspects <strong>of</strong> personalf<strong>in</strong>ancial <strong><strong>in</strong>terest</strong>s <strong>in</strong> <strong>research</strong>. One strategy is simply toprohibit personal f<strong>in</strong>ancial <strong><strong>in</strong>terest</strong>s <strong>in</strong> <strong>research</strong>. The Association<strong>of</strong> American Universities, for example, advocatesoutright prohibition <strong>in</strong> cases <strong>in</strong>volv<strong>in</strong>g <strong>research</strong> onhuman subjects unless there are "compell<strong>in</strong>g circumstances"that justify an exception [4]. Prohibition forcesf<strong>in</strong>ancially <strong><strong>in</strong>terest</strong>ed <strong>research</strong>ers to either divest their<strong><strong>in</strong>terest</strong>s or to remove themselves from the <strong>research</strong>.Although effective, prohibitions are blunt tools and <strong>in</strong> ourop<strong>in</strong>ion should be used only as a last resort. We say thisnot only because prohibit<strong>in</strong>g f<strong>in</strong>ancial <strong><strong>in</strong>terest</strong>s may leaveany number <strong>of</strong> other equally bias<strong>in</strong>g <strong><strong>in</strong>terest</strong>s <strong>in</strong> place [5],but also because, when properly managed, f<strong>in</strong>ancial <strong><strong>in</strong>terest</strong>smay play a positive role <strong>in</strong> the development <strong>of</strong> a <strong>translational</strong><strong>research</strong> program. Access to company resourcesand shar<strong>in</strong>g <strong>in</strong>vestigator knowledge are <strong>of</strong>ten critical totimely translations <strong>of</strong> basic science to cl<strong>in</strong>ical practice. Thecomplex <strong>research</strong> enterprise needed to develop cl<strong>in</strong>icalproducts is simply beyond the scope <strong>of</strong> what many <strong>in</strong>vestigatorscan achieve on their own <strong>in</strong> academic <strong>in</strong>stitutions.Fortunately, there are usually less draconian alternativesto outright prohibition. These strategies seek to ensure the<strong>in</strong>tegrity <strong>of</strong> the <strong>research</strong>, guarantee public scrut<strong>in</strong>y andaccess, and, <strong>of</strong> course, to protect human participants [6].One <strong>of</strong> most common is to assign key <strong>research</strong> activitiessuch as recruit<strong>in</strong>g, consent<strong>in</strong>g, and data analysis to teammembers who have no f<strong>in</strong>ancial stake <strong>in</strong> the results.Multi-center designs ensure that the biases <strong>of</strong> any one<strong>in</strong>vestigator are less likely to <strong>in</strong>fluence the f<strong>in</strong>al results.Independent data safety monitor<strong>in</strong>g boards or other oversightcommittees may also check the <strong>in</strong>fluence <strong>of</strong> personalf<strong>in</strong>ancial <strong><strong>in</strong>terest</strong>s. So, too, will requirements to disclosef<strong>in</strong>ancial <strong><strong>in</strong>terest</strong>s to publishers, conference organizers,and <strong>in</strong>stitutional review boards.Research <strong>in</strong>tegrity is further protected by a vigilant stanceregard<strong>in</strong>g publication restrictions. Industry partners havea legitimate <strong><strong>in</strong>terest</strong> <strong>in</strong> protect<strong>in</strong>g proprietary <strong>in</strong>formation,but this can usually be honored by provid<strong>in</strong>g a shortperiod for review prior to submitt<strong>in</strong>g a manuscript forpublication. No contract or agreement, however, shouldgive the sponsor the right to control publication. Workthat requires such control is more appropriately done <strong>in</strong><strong>in</strong>dustry rather than <strong>in</strong> academic laboratories. The closeattention to publication restrictions is particularly importantwhen a <strong>research</strong>er may have a student work<strong>in</strong>g on an<strong>in</strong>dustry sponsored project. Junior and student scientistswork<strong>in</strong>g <strong>in</strong> a <strong>research</strong> program, who may not have anyrelationship with a company, must be able to have freedom<strong>in</strong> pursu<strong>in</strong>g aspects <strong>of</strong> projects outside the bounds <strong>of</strong>the <strong>research</strong> agreement and publish<strong>in</strong>g data <strong>in</strong> a timelyfashion.Translational <strong>research</strong> that results <strong>in</strong> the development <strong>of</strong> anew company presents particular opportunities and challenges.Because <strong>of</strong> the importance <strong>of</strong> small companies toeconomic growth, public <strong>research</strong> universities <strong>of</strong>ten viewthe number <strong>of</strong> university-related startups as an <strong>in</strong>dex <strong>of</strong>their contribution to the state economy. More specific<strong>in</strong>stitutional <strong><strong>in</strong>terest</strong>s are created when universities takeequity <strong>in</strong> startups through licens<strong>in</strong>g agreements. Unlikemore established firms, start-up companies are <strong>of</strong>tenhighly dependent on obta<strong>in</strong><strong>in</strong>g favorable <strong>research</strong> outcomesfrom a particular project. In many cases, prohibitionmay be the only way to manage the tangle <strong>of</strong><strong>in</strong>stitutional and <strong>in</strong>dividual <strong><strong>in</strong>terest</strong>s than can result <strong>in</strong>this situation. Universities may create "firewalls" betweenthe management <strong>of</strong> equity and <strong>research</strong>ers [7]. They mayrequire divestiture or bar <strong>research</strong>ers from receiv<strong>in</strong>g grantsback from companies to which their <strong>in</strong>ventions have beenlicensed. Consult<strong>in</strong>g and other company contacts may bePage 2 <strong>of</strong> 4(page number not for citation purposes)