Conflicto de interés financiero en la investigación científica

Los intereses financieros relacionados con la investigación son comunes y los estudios muestran que pueden influenciar la capacidad de las personas para realizar investigaciones precisas y objetivas. Es importante identificar cuándo podría existir un conflicto, de modo que pueda gestionarse para proteger la integridad de la investigación. Este video lo introducirá a los conflictos de intereses comunes en la investigación para que aprenda a evitar estos sesgos reales o percibidos mientras realiza su investigación y difunde los resultados.

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Entonces, le han dicho que complete una declaración de interés financiero antes de participar en un proyecto de investigación, y se pregunta qué tiene que ver este proceso con su investigación. Bueno, tener una relación o interés, ya sea financiero, profesional, personal, político o de otro tipo, relacionado con su investigación puede crear un conflicto de intereses.[1] Los intereses financieros relacionados con la investigación son comunes y los estudios muestran que pueden socavar la capacidad de las personas para realizar investigaciones precisas y objetivas.[2] Es importante identificar cuándo podría existir un conflicto, de modo que pueda gestionarse para proteger la integridad de la investigación. Este video lo introducirá a la investigación de conflictos de intereses para que aprenda a evitar sesgos reales o percibidos mientras realiza su investigación y difunde los resultados.

Desafortunadamente, algunas personas eligen conscientemente explotar los conflictos de intereses, por ejemplo, llenándose los bolsillos o beneficiándose a expensas de su obligación de realizar investigaciones con integridad.[3] Los investigadores pueden sentir la presión de generar datos piloto sólidos para asegurar la financiación o publicar en revistas de primer nivel para ganar la permanencia. Esto podría tentar a los investigadores a exagerar sus hallazgos, aunque esto obviamente violaría el código de ética de la universidad.

Aunque la mayoría de los investigadores no harán algo mal intencionalmente, algunos lo hacen. Más comúnmente, sin darse cuenta completamente de lo que están haciendo y por qué, los investigadores pueden apartarse inconscientemente de las mejores prácticas para avanzar en sus carreras. Las investigaciones muestran que todas las personas están influenciadas por el sesgo egoísta, que es la tendencia a recopilar, procesar e incluso recordar información inconscientemente de manera que sirva a nuestro propio interés.[4]

Una complicación adicional es el hecho de que porcentajes sustanciales de académicos que publican en revistas científicas y médicas tienen intereses financieros, como propiedad de acciones, contratos de consultoría, propiedad intelectual y similares, que pueden verse afectados por los resultados informados.[5] Naturalmente, es difícil para los investigadores evitar verse influenciados por su bienestar financiero al tomar decisiones de investigación.

De manera similar, mientras que la investigación financiada por la industria privada aumenta la productividad de la investigación y ayuda a facilitar la transferencia de nuevas tecnologías y descubrimientos científicos a aplicaciones del mundo real, esta financiación también puede crear relaciones plagadas de conflictos de interés.[6]

Por ejemplo, en artículos de revistas médicas de los que es coautor, el Dr. José Baselga, oncólogo líder en el Centro de Cáncer Memorial Sloan Kettering, repetidamente no reveló completamente los extensos vínculos financieros que tenía con las compañías farmacéuticas cuyos medicamentos estaba probando.[7 ] No en vano, más de una vez Baselga se mostró injustificadamente optimista[8] al informar sobre los resultados de sus estudios de fármacos que estaban siendo desarrollados por Roche, una empresa que le pagaba buenos honorarios de consultoría y más. Baselga estaba convencido de que no había hecho nada materialmente malo, pero otros científicos vieron el hecho de que Baselga no revelara completamente los conflictos de intereses de su investigación como «perturbador y decepcionante». [9] Sloan Kettering forzó su renuncia en 2018. [10]

Como investigador, incluso si logra evitar ser influenciado por sus intereses financieros personales, debe tener en cuenta que la simple apariencia de incorrección puede socavar tanto su reputación como la reputación de investigación honesta de su universidad.[11]

Afortunadamente, la apariencia de sesgo causado por intereses financieros o no financieros puede mitigarse practicando una divulgación completa y justa. No obstante, todavía puede haber una preocupación justificada sobre el posible sesgo causado por tales intereses en conflicto. Por ejemplo, un estudio de 162 ensayos de medicamentos encontró que si los investigadores tenían conflictos de intereses, tenían casi cinco veces más probabilidades de informar resultados positivos en comparación con los estudios realizados por investigadores sin conflictos.[12] Es poco probable que muchos de estos investigadores estuvieran conscientemente sesgados, pero su interés propio influyó claramente en sus conclusiones.[13]

Ahora puede creer firmemente que no se ve afectado por los conflictos de intereses porque las normas de la investigación científica le impiden hacer otra cosa que no sea buscar la verdad. Pero esta percepción errónea común es el sesgo de exceso de confianza en acción.[14] Las investigaciones muestran que la mayoría de las personas asumen erróneamente que son morales, competentes y merecedores, y por lo tanto invulnerables a los conflictos de intereses.[15] Sin embargo, existe evidencia empírica abrumadora de que esto simplemente no es así. [16]

Entonces, ¿cómo debe manejar los conflictos de intereses? En primer lugar, estar alerta a su existencia. No tropieces con los conflictos sin darte cuenta. En segundo lugar, como se señaló, la divulgación completa es fundamental. La mayoría de las universidades,[17] revistas académicas,[18] y agencias gubernamentales de financiación[19] requieren la divulgación de conflictos de intereses financieros y, a veces, no financieros.

Tenga cuidado de evitar las licencias morales, que es la tendencia que todos tienen de darse permiso para ser un poco más egoístas en una determinada situación si también han actuado éticamente.[20] En otras palabras, los investigadores que han revelado sus intereses financieros pueden inconscientemente darse permiso para actuar de una manera más egoísta que aquellos investigadores que no han revelado sus conflictos financieros. [21]

Además, esté atento a la exageración estratégica, que es la tendencia de algunos investigadores a exagerar sus hallazgos reales para contrarrestar cualquier disminución de su credibilidad que pueda resultar de la revelación de sus conflictos.[22]

Finalmente, comprométase con la franqueza y la transparencia al comunicar posibles conflictos a los colaboradores de la investigación, y sea diligente en el uso de métodos y estrategias sólidos para reducir el potencial de sesgo en la investigación. La oficina de cumplimiento de la universidad y, a veces, un comité de conflictos de intereses, pueden ayudarlo a cumplir con las normas legales y éticas relacionadas con los conflictos de intereses financieros y de otro tipo. Si los conflictos se manejan adecuadamente, a menudo no tendrá que perder los lazos financieros u otros intereses externos.

La verdad es que es poco probable que evite por completo los conflictos de intereses en su investigación (son normales y esperables), pero puede divulgar y manejar estos conflictos para mantener la integridad en su investigación y proteger su reputación y su carrera.

Notas a pie de página

[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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