Financial Conflicts of Interest in Research

Financial interests related to research are common, and studies show that they can undermine people’s ability to do accurate, objective research. It’s important to identify when a conflict might exist, so it can be managed to protect research integrity.  This video will introduce you to research conflicts of interest so you learn how to avoid real or perceived bias as you do your research and disseminate the results.

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Transcript of Narration

So, you’ve been told to complete a financial interest disclosure before being involved in a research project, and you’re wondering what this process has to do with your research.  Well, having a relationship or interest – whether financial, professional, personal, political or something else – related to your research can create a conflict of interest.[1]  Financial interests related to research are common, and studies show that they can undermine people’s ability to do accurate, objective research.[2]  It’s important to identify when a conflict might exist, so it can be managed to protect research integrity.  This video will introduce you to research conflicts of interest so you learn how to avoid real or perceived bias as you do your research and disseminate the results.

Unfortunately, some people consciously choose to exploit conflicts of interest—for example by lining their own pockets or otherwise benefitting themselves at the expense of their obligation to conduct research with integrity.[3] Researchers may feel pressure to generate strong pilot data to secure funding or to publish in top tier journals in order to earn tenure. This might tempt investigators to exaggerate their findings, even though this would obviously violate the university’s code of ethics.

Although most researchers won’t intentionally do something wrong, some do. More commonly, without fully realizing what they are doing and why, researchers may unconsciously depart from best practices in order to advance their careers. Research shows that all people are influenced by the self-serving bias, which is the tendency to unconsciously gather, process, and even remember information in ways that serve our self-interest.[4]

A further complication is the fact that substantial percentages of academics who publish in scientific and medical journals have financial interests – such as stock ownership, consulting contracts, intellectual property and the like – that can be affected by their reported results.[5] It is naturally difficult for researchers to avoid being influenced by their financial well-being in making research decisions.

Similarly, while research funded by private industry increases research productivity and helps facilitate the transfer of new technologies and scientific discoveries to real world applications, this funding can also create relationships rife with conflicts of interest.[6]

For example, in medical journal articles that he co-authored, Dr. Jose Baselga, a leading oncologist at Memorial Sloan Kettering Cancer Center, repeatedly failed to fully disclose the extensive financial ties he had to pharma companies whose drugs he was testing.[7] Not surprisingly, more than once Baselga was unjustifiably optimistic[8] when reporting the results of his studies of drugs that were being developed by Roche, a company that paid him healthy consulting fees and more. Baselga was convinced he had done nothing materially wrong, but other scientists saw Baselga’s failure to fully disclose his research conflicts of interest as “disturbing and disappointing.”[9] Sloan Kettering forced his resignation in 2018.[10]

As an investigator, even if you do manage to avoid being influenced by your personal financial interests, you must keep in mind that simply the appearance of impropriety may undermine both your reputation and your university’s reputation for honest research.[11]

Fortunately, the appearance of bias caused by financial or non-financial interests can be mitigated by practicing full and fair disclosure. Nonetheless, there may still be a justifiable concern about potential bias caused by such conflicting interests. For example, a study of 162 drug trials found that if the researchers had conflicts of interest, they were almost five times as likely to report positive results as compared to studies done by unconflicted researchers.[12] It’s unlikely that many of these investigators were consciously biased, but their self-interest clearly impacted their conclusions.[13]

Now you may firmly believe that you are unaffected by conflicts of interest because the norms of scientific inquiry prevent you from doing anything other than pursuing the truth. But this common misperception is the overconfidence bias in action.[14] Research shows that most people erroneously assume themselves to be moral, competent and deserving, and therefore invulnerable to conflicts of interest.[15] However, there is overwhelming empirical evidence that this is simply not the case. [16]

So, how should you handle conflicts of interest? First, be alert to their existence. Do not stumble into conflicts unaware. Second, as noted, full disclosure is critical. Most universities,[17] academic journals,[18] and government funding agencies[19] require disclosure of financial and sometimes non-financial conflicts of interest.

Be careful to guard against moral licensing – which is the tendency everyone has to give themselves permission to be a little more self-serving in a certain situation if they’ve also acted ethically.[20] In other words, researchers who have disclosed their financial interests may unconsciously give themselves permission to act in a more self-serving manner than those researchers who have not disclosed their financial conflicts. [21]

Also, be on the lookout for strategic exaggeration, which is the tendency of some researchers to overstate their actual findings in order to counteract any discounting of their credibility that might result from their disclosure of conflicts.[22]

Finally, commit to openness and transparency in communicating potential conflicts to research collaborators, and be diligent in using robust methods and strategies to reduce the potential for research bias. Your university compliance office, and sometimes a conflict of interest committee, can help you comply with legal and ethical rules regarding financial and other conflicts of interest. If conflicts are properly managed, often you will not have to forfeit financial ties or other outside interests.

The truth is that you are unlikely to totally avoid conflicts of interest in your research – they are normal and to be expected – but you can disclose and manage these conflicts to maintain integrity in your research and protect your reputation and career.

 

Footnotes

[1] See Robert J. MacCoun, Conflicts of Interest in Public Policy Research, in Conflicts of Interest: Challenges and Solutions in Business, Law, Medicine, and Public Policy 234 (Don A. Moore et al., eds. 2005) (citing Merriam-Webster’s Collegiate Dictionary to define a conflict of interest as “a conflict between the private interests and the official responsibilities of a person in a position of trust.”).

[2] See Rosa Ahn et al., Financial Ties of Principal Investigators and Randomized Controlled Trial Outcomes: Cross Sectional Study, BMJ 356: 16770 (2017) (“We found that more than half of principal investigators of RCTs of drugs [reported in 190 papers] had financial ties to the pharmaceutical industry and that financial ties were independently associated with positive clinical trial results even after we accounted for industry funding.”); Deborah E. Barnes & Lisa A. Bero, Why Review Articles on the Health Effects of Passive Smoking Reach Different Conclusions, JAMA, 279(10): 1566-1570 (May 20, 1998)(finding that “the only factor [in 106 review studies] associated with concluding that passive smoking is not harmful was whether an author was affiliated with the tobacco industry”); Justin E. Bekelman et al., Scope and Impact of Financial Conflicts of Interest in Biomedical Research, JAMA, 289(4): 454-465 (Jan. 22/29, 2003)(aggregating the results of eight articles evaluating 1140 original studies and finding “a statistically significant association between industry sponsorship and pro-industry conclusions”);  Maria Bes-Rastrollo et al., Financial Conflicts of Interest and Reporting Bias Regarding the Association between Sugar-Sweetened Beverages and Weight Gain: A Systematic Review of Systematic Reviews, PLoS Med 10(12): e1001578 (Dec. 2013) (finding in a systematic review of eighteen systematic reviews of the impact of sugar-sweetened beverages on weight gain that 83.3% of conflict-free researchers found that such consumption was a potential risk factor for weigh gain while 83.3% of conflicted researchers found no such positive association); Jane Levine et al., Authors’ Financial Relationships with the Food and Beverage Industry and Their Published Positions on the Fat Substitute Olestra, JAMA, 93(4):664-669 (Apr. 2003)(finding that “supporting authors were significantly more likely than critical or neutral authors to have financial relationships with [Olestra maker] P&G (80% vs 11% and 21%”));  Joel Lexchin et al., Pharmaceutical Industry Sponsorship and Research Outcome and Quality Systematic Review, BMJ, 326:1167 (2003)(finding in study of 30 drug studies that those “sponsored by pharmaceutical companies were more likely to have outcomes favouring the sponsor than were studies with other sponsors”) ; Andreas Lundh et al., “Industry Sponsorship and Research Outcome,” Cochrane Database of Systematic Reviews 2: MR00003 (2017) (finding in a study of 75 papers that “[s]ponsorship of drug and device studies by the manufacturing company leads to more favorable efficacy results and conclusions than sponsorship by other sources.”); Daniele Mandrioli et al., Relationship between Research Outcomes and Risk of Bias, Study Sponsorship, and Author Financial Conflicts of Interest in Reviews of the Effects of Artificially Sweetened Beverages on Weight Outcomes: A Systematic Review of Reviews, PLoS One 11(9): e0162198 (finding that review sponsorship and authors’ financial conflicts of interest introduced bias affecting outcomes of reviews of artificially sweetened beverage effects on weight that could not be explained by other sources of bias.”); Dariush Mazaffarian, Conflict of Interest and the Role of the Food Industry in Nutrition Research, JAMA, 317(17): 1755-1756 (May 2, 2017) (“noting that “evidence for substantial bias has been identified in conclusions of industry-sponsored systematic reviews regarding the health effects of sugar-sweetened beverages and artificial sweeteners.”); Camilla H. Najstgaard et al., Association between Conflicts of Interest and Favourable Recommendations of Clinical Guidelines, Advisory Committee Reports, Opinion Pieces, and Narrative Reviews: Systematic Review, BMJ 371:m4234 (2020) (“We interpret our findings to indicate that financial conflicts of interest are associated with favourable recommendations of drugs and devices in clinical guidelines, advisory committee reports, opinion pieces, and narrative reviews.”);  Lasse Ostengaard et al., Influence and Management of Conflicts of Interest in Randomised Clinical Trials: Qualitative Interview Study,” BMJ 371: m3764 (2020) (“One of the interviewees used the term ‘rent-a-doc trial’ and explained that a pharmaceutical company picks the steering committee and a principal investigator, writes the protocol, analyses the data, and provides data tables to investigators. Other mechanisms of influence are use of inferior comparators, surrogate outcomes, limited access to data, and constraints on publication rights. Our study corroborates these findings and gives more examples, such as fabrication of data and spin of the results, in research publications.”); Henry Thomas Stelfox et al., Conflict of Interest in the Debate over Calcium-Channel Antagonists, New England Journal of Medicine 338(2): 101-106 (Jan. 8, 1998) (finding in review of 70 studies that “[a]uthors who supported the use of calcium-channel antagonists were significantly more likely than neutral or critical authors to have financial relationships with manufacturers of calcium channel antagonists (96 percent, vs. 60 percent and 37 percent, respectively”)). See also Robert J. MacCoun, Conflicts of Interest in Public Policy Research, in Conflicts of Interest: Challenges and Solutions in Business, Law, Medicine, and Public Policy (Don A. Moore et al., eds. 2005) (citing several other studies showing “researcher allegiance” effects).

[3] See Brian Deer, The Doctor Who Fooled the World: Science, Deception, and the War on Vaccines (2020) (telling the story of Dr. Andrew Wakefield who attempted to profit in numerous ways by publishing a bogus study that without basis tied the MMR vaccine to autism).

[4] See Donald Langevoort, Organized Illusions: A Behavioral Theory of Why Corporations Mislead Stock Market Investors and Cause Other Social Harms, University of Pennsylvania Law Review 146(1): 101-172 (1997).

[5] See Adil E. Shamoo & David B. Resnick, Responsible Conduct of Research 107 (3d ed. 2015) (noting a study by Krimsky showing that 34% of lead authors in scientific and medical journals “had financial ties related to their research, such as stock ownership, service on company advisory boards, consulting arrangements, or intellectual property”).

[6] See Adil E. Shamoo & David B. Resnick, Responsible Conduct of Research 107 (3d ed. 2015) (“Collaborations between academia and industry can lead to many different ethical problems and concerns because academic values may conflict with corporate values and interests.”).

[7] Matthew Herper, How to Really Take Medical Conflicts of Interest Seriously, Forbes, Sept. 10, 2018 (“But there’s no question Baselga should have disclosed the payment [from Roche]. It’s baffling that he didn’t…”); Charles Ornstein, Top Cancer Researcher Fails to Disclose Corporate Financial Ties in Major Research Journals, New York Times, Sept. 8, 2018 (“One of the world’s top breast cancer doctors failed to disclose millions of dollars in payments from drug and health companies in recent years, omitting financial ties from dozens of research articles in prestigious publications like The New England Journal of Medicine and the Lancet.”).

[8] Charles Ornstein, Top Cancer Researcher Fails to Disclose Corporate Financial Ties in Major Research Journals, New York Times, Sept. 8, 2018 (“At a conference this year and before analysts in 2017, [Baselga] put a positive spin on the results of two Roche-sponsored clinical trials that many others considered disappointments, without disclosing his relationship to the company. Since 2014, he has received more than $3 million from Roche in consulting fees and for his stake in a company it acquired.”).

[9] Bruce A. Chabner & Susan E. Bates, Conflict of Interest: An Ethical Firestorm with Consequences for Cancer Research, The Oncologist 23: 1391-1393 (2018).

[10] Katie Thomas & Charles Ornstein, Sloan Kettering Paid $1.5 Million Severance to a Cancer Doctor Forced Out Over Conflicts, New York Times, Dec. 22, 2020 (“In 2018, Memorial Sloan Kettering Cancer Center’s chief medical officer, Dr. Jose Baselga, resigned under fire over his failure to disclose payments from health care companies in dozens of research articles he wrote.”).

[11] See Gary Comstock, Research Ethics: A Philosophical Guide to the Responsible Conduct of Research 233 (2012)(“Unfortunately, the perception of bias that results from having a financial interest can be damaging to the credibility of biomedical research.”).

[12] Roy H. Perlis et al., Industry Sponsorship and Financial Conflicts of Interest in the Reporting of Clinical Trials in Psychiatry, The American Journal of Psychiatry 162: 1957-1960 (2005) (finding in a study of 162 randomized, double-blind, placebo-controlled trials that those involving potential conflicts of interest were 4.9 times more likely to report positive results).

[13] Bioethics expert Sheldon Krimsky argues that “[f]inancial conflicts of interests influence outcomes. Even if the researchers are honorable people, they don’t know how the interests affect their own research. Even honorable people can’t figure out why they have a predilection toward certain views. It’s because they internalize the values of people from whom they are getting funding, even if it’s not on the surface.” (Quoted in Annie Waldman & David Armstrong, We Asked Public Universities for Their Professors’ Conflicts of Interest—and Got the Runaround, Propublica, Dec. 6, 2019.)

[14] David Brooks, The Social Animal: The Hidden Sources of Love, Character, and Achievement 218 (2011) (“…the human mind is an overconfidence machine.”).

[15] Francesca Gino, Sidetracked: How Our Decisions Get Derailed and How We Can Stick to the Plan 203 (2013).

[16] Max Bazerman & Anne Tenbrunsel, Blind Spots: Why We Fail to Do What’s Right and What to Do about It 1 (2011) (“It’s likely that most of us overestimate our ethicality at one point or another. In effect, we are unaware of the gap between how ethical we think we are and how ethical we truly are.”).

[17] See Michael Thompson, Three Initial Considerations for Entrepreneurial Faculty, Researchers, Post-Docs, and Graduate Students, JDSupra (Nov. 17, 2021), at https://www.jdsupra.com/legalnews/three-3-initial-considerations-for-9918300/.

[18] See Susan L. Norris et al., Conflict of Interest in Clinical Practice Guideline Development: A Systematic Review PLoS One 6(10): 1-6 (Oct. 2011) (noting that all journals that are members of the International Committee of Medical Journal Editors had adopted a uniform, detailed disclosure form)

[19] For example, the Public Health Service of the Department of Health and Human Services requires such disclosure by academic applicants for research funding. See 50 C.F.R. 604 (2022).

[20] Chen-Bo Zhong, et al, Moral Self-Regulation: Licensing and Compensation, in Psychological Perspectives on Ethical Behavior and Decision Making 75 (David De Cremer, ed. 2009) (“Individuals who have validated or exceeded their ideal moral selves may experience a respite from moral regulatory forces and take ethical liberties in subsequent situations.”).

[21] See George Loewenstein et al., The Unintended Consequences of Conflict of Interest Disclosure, JAMA, 307(7): 669-670 (Feb. 15, 2012) (“…consistent with strategic exaggeration and moral licensing, a key finding [of the authors’ study] was that the bias was substantially greater when the conflict of interest was disclosed.”). See also Daylian Cain et al., The Dirt on Coming Clean: Perverse Effects of Disclosing Conflicts of Interest, Journal of Legal Studies 34(1): 1-25 (2005).

[22] See George Loewenstein et al., The Unintended Consequences of Conflict of Interest Disclosure, JAMA, 307(7): 669-670 (Feb. 15, 2012) (“[S]trategic exaggeration [is] the tendency to provide more biased advice to counteract anticipated discounting.…[C]onsistent with strategic exaggeration and moral licensing, a key finding [of the authors’ study] was that the bias was substantially greater when the conflict of interest was disclosed.”).

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