With the continuous expansion of the scale of science, while the funds required for research have increased sharply, the distance between scientific results and practical applications has become shorter and shorter, and the boundaries between pure science and applied science have become increasingly blurred. This makes science an investment with potentially huge economic benefits. The "Bayh-Dole 1980 Patent and Trademark Amendment" in the United States is a wise move to follow this trend. Because before the passage of this amendment, federal government departments had two ways to deal with inventions they funded (and were made in projects for which they signed contracts): or the patent rights were vested in the department. (commonly known as the "power-taking policy"), or the power is granted to the unit that signed the contract, but when the government wants to use these inventions, it is exempt from paying "license" royalties. The Bayh-Dole Act of 1980 fully affirmed the "licensing policy." The 1986 "Federal Government Transfer Act" went a step further on this basis: it stipulated that universities have the right to obtain patent rights for their research results, while sponsoring companies are exempt from paying patent licensing fees. Under this circumstance, the enthusiasm of enterprises to fund university R&D has been unprecedentedly high. According to statistics from the National Science Board of the United States, the federal government accounted for 70.5% of university research funding in 1970, while enterprises only accounted for 2.6%. By 1997, the proportion changed to 59.6% for the government and 7.1% for enterprises.
At the same time, universities and scientists are increasingly paying attention to issues such as the commercial prospects of research results and the ownership of intellectual property rights. Figures from the U.S. Patent and Trademark Office (PTO) show that between 1969 and 1997, the number of patents owned by American universities and colleges showed an upward trend, and increased significantly after 1980. It doubled from 1984 to 1989 and doubled again from 1989 to 1997. Not only that, with the increasing penetration of knowledge into the economy, it has become common practice for scientists to create companies based on their own discoveries and inventions, and high-tech companies have sprung up everywhere. This is as Tinker Ready said: "If you still think that science only happens in university laboratories and is an independent activity that has nothing to do with corporate profits, your concept is at least 20 years behind."
It is against this background that the scientific community in developed countries, especially the American scientific community, has heard from time to time that business owners and scientists have excessively pursued commercial interests, eroding the objectivity of scientific research and corrupting science. Image, negative events that damage public interests, thus making "conflict of interest" in scientific research an important issue of concern to the sociology of science and ethics.
Conflict of interest and its main forms
There are many opinions about conflict of interest. T. Carson’s definition points out that when an individual I (individual) is unable to perform due to the following reasons A conflict of interest will arise when performing professional responsibilities: ① When there is (or the individual believes there is) an actual or potential conflict between the personal interests and the interests of the organization P to which he belongs; ② The individual I has an attempt to promote or hinder the interests of X (X refers to an interest subject other than I), and there is (or individual I believes there is) an actual or potential conflict between the interests of X and the interests of P that promote or hinder. In other words, a conflict of interest may arise when an individual's economic or other interests conflict with the professional norms or corresponding obligations to which he or she should abide.
It is worth noting that although the term "conflict of interest" is almost derogatory, the existence of a conflict of interest does not necessarily mean that the interest subject will make mistakes - it only indicates: There are factors that influence people's judgment and behavior. Despite this, the existence of conflict of interest situations does easily lead to unethical behavior. Therefore, "conflict of interest" in ethics often refers to a behavior that undermines and affects professional judgment because an individual puts economic interests or other interests above his or her professional norms or corresponding obligations. In terms of research ethics, there are at least three types of criteria that can be used to determine whether a conflict of interest exists. First, it is judged based on whether it violates professional codes and norms; second, when a certain behavior has foreseeable consequences, it is judged based on whether it produces harmful consequences (such as affecting scientific judgment, distorting research results, or causing relevant individuals or institutions to interests are harmed). Third, judge based on whether the behavior itself violates general moral principles.
In the minds of ordinary people, scientists’ exploration of nature is a “value free” process that is free from all prejudice. However, theoretical research on the philosophy of science and sociology of science in the past thirty years, as well as scientific historical facts over a longer period of time, have all raised challenges to this. Nowadays, most people admit that the existence of interest factors often affects the judgment of researchers - whether intentionally or unintentionally. Ted Weiss, referring to the 1987 U.S. Congressional conflict of interest investigation into a drug produced by a company called Genentech, pointed out: "The most worrying thing is that the researchers who received financial support were not aware of the tendency themselves. Sexuality may affect clinical research and even patient treatment." This worry is not undue. Since the 1970s, research by Hansen, Kuhn and others has fully shown that observation has "theory laden", and one of the "paradigm" factors that determine scientists' observation and thinking about problems is "value". Although the sociology of scientific knowledge school that emerged later seemed a little too extreme, it was not completely ignorant of the idea of ??attaching importance to "interest factors" in scientific debates and theoretical selections "as an intermediary between political and social factors". reason. The process of science also reminds people from time to time: the desire for success and the pursuit of economic interests may often make "people who are honest and passionate about their work be fooled by themselves." As stated in the book "How to Be a Scientist" co-authored by several authoritative organizations including the National Academy of Sciences: "In a certain scientific field, several different explanations may be equally applicable to existing data. And different explanations have different avenues for further research. How should researchers choose? ... The desire to believe in a new phenomenon sometimes even outweighs the requirement for positive and well-controlled evidence."
If it is tolerable for scientists to make mistakes unintentionally due to the influence of interest factors, then it is the practice of researchers to deliberately distort facts and conceal conflicts of interest in order to adapt to the need to pursue fame and fortune. A gross anomie. Scientists, like ordinary people, have to play different roles. This requires scientists to learn to correctly view various interest relationships, especially economic interest relationships, and not to let them threaten or control their scientific judgment. Otherwise, it will not only endanger the existence and development of scientific undertakings, but may also ruin your career. Here are some typical scenarios.
(1) Conflict of interest in the research process refers to the phenomenon that in scientific exploration, researchers violate professional standards and behavioral norms because they take excessive consideration of their own interests (here mainly refers to economic interests). Famous examples include "The Case of Eye Ointment for Dry Eyes." In the mid-1980s, a researcher named Scheffer C.G. Tseng (hereinafter referred to as Dr. ST) from National University in Taiwan became interested in using vitamin A to treat dry eyes while studying in the United States. He studied this therapeutic effect of vitamin A on rabbits in a series of federally funded studies, and seemed to have some success. So began human trials: first at Johns Hopkins University and later at the Massachusetts Eye and Ear Infirmary at Harvard. The hospital's "Human Experimentation Committee" agreed to Dr. ST's trial on 25 to 50 patients in accordance with the relevant regulations of the federal government. However, according to subsequent investigations, Dr. ST expanded the scope of the trial without authorization, violated the principle of "informed consent", and deceptively tried it on hundreds of patients. Cases were selectively selected, and two research reports were written and published that were beneficial to the treatment of dry eyes with vitamin A. Afterwards, Dr. ST and his mentor established a pharmaceutical company called Spectra to produce the so-called "vitamin A ointment to treat dry eyes." The company issues shares publicly, and Dr. ST and his mentor are the largest shareholders. Later, studies by other researchers who did not own shares in the company showed that the ointment was not only ineffective in treating dry eyes, but also had adverse effects on long-term use. Dr. ST heard the news and quickly sold all his shares in the company before the public knew about it. After the incident was exposed, it aroused great public indignation, and both Dr. ST and the director of his hospital were forced to resign. However, because his practice did not cause serious harm to the patient, he was exempted from prosecution.
(2) Consulting services and conflicts of interest: That is, scientists with a certain interest relationship serve as both "athletes" and "referees" in relevant review and consulting services. The famous case is the "Alzheimer's disease diagnostic reagent case".
Dennis Selkoe of Harvard Medical School is a world-famous scientist. Based on his own research results, he invented a reagent that can detect Alzheimer's disease and founded a company called "Athens Neuroscience, Inc.” Through the combination of science and pharmaceutical industry, he became an intellectual tycoon. On the other hand, because there are many types of reagents for detecting Alzheimer's disease on the US market in recent years, many people hope to get expert guidance. In 1997, Athens Neuroscience provided a $100,000 sponsorship to the Alzheimer's Association, a non-profit organization, to host a research event on Alzheimer's disease diagnostic reagents. The "Alzheimer's Disease Association" persuaded the highly prestigious "National Institutes of Health" to organize this event with its president. At the same time, Selke also participated in the research as a member of the National Institute of Health expert group. In April 1998, in the authoritative journal "Geriatric Neurobiology" in this field, in the name of a specially invited expert group from the National Institute of Health, the results of a comparative study of various Alzheimer's disease diagnostic reagents were published. Among them, the reagents of "Athens Neuro Company" are particularly recommended to people. Although the article states that "Athens NeuroCorp is the sponsor of this research," it does not mention anywhere that Selke, who serves as a judge of the research team, is the founder and major shareholder of the company. In this way, the profit influence of "Athens NeuroCorporation" is hidden from the public by relying on the public's trust in two non-profit organizations, "Alzheimer's Association" and "National Institutes of Health." In October of the same year, the American "Wall Street Journal" exposed the interest relationship between Selke and others and recommended product companies. A week later, Harvard Medical School received an anonymous tip alleging that Selke violated the school's rules on conflicts of interest. However, when Selke was investigated by the "Harvard Review Committee", he claimed that the relationship was already well known and that he had explained it in previous papers. However, some people noticed that the relevant paper he published in Science in 1992 never included an interest statement. Some people randomly checked the eight articles he published in 1996 and 1997, but none of them mentioned this relationship. The "Alzheimer's Disease Diagnostic Reagent Case" shows that the lack of supervision of interest disclosure will allow companies' market attempts to deceive the public in the name of high-level academics. There are many similar examples. For example, some researchers at the University of Toronto found through extensive research that funding from pharmaceutical companies greatly affects the evaluation of drug efficacy, and 96% of recommended articles are written by researchers sponsored by companies. A researcher named Sheldon Krimsky conducted an in-depth investigation into this. In 1997, he analyzed 800 scientific papers and found that 34% of them reported research results related to companies in which they owned stocks or served as consultants. In 1998, he examined 62,000 scientific papers to determine how many scientists stated in their articles that they had an interest in the products they recommended. It was found that only 0.5% of the articles included a statement of interest disclosure.
(3) Conflicts of interest when publishing research results mainly refer to what scientists face when they must choose between complying with scientific norms and submitting to commercial requirements due to the influence of interest relationships such as fund raising and patent applications. conflict. We know that the openness and sharing of scientific research results is not only a prerequisite for scientists and their work to be inspected by their peers, ensure the quality of research, and win recognition from their peers, but it is also an important guarantee for avoiding unnecessary duplication and promoting continued scientific progress. R. Merton also regards "public ownership" as the basic norm on which "scientific social structure" depends. In addition to considerations of national interests and military needs, a scientist who is unwilling to share research results with qualified colleagues is tantamount to an untrustworthy alternative in the eyes of traditional scientists. However, some scientists today often keep silent about their best ideas and pursue the so-called "listen more and talk less" principle in order to gain an advantageous position in the competition for funding or apply for patents. What is even more worrying is that with the massive involvement of industrial funding in academic institutions, the contradiction between the disclosure and confidentiality of research results arising from the different value orientations of scientific norms and commercial operations has become increasingly prominent.
A series of studies conducted by David Blumenthal of Harvard Medical School show that 82% of companies require that the academic research results they sponsor must be kept confidential for at least 2-3 months for patent applications. and even longer.
47% of the companies surveyed said they usually require longer confidentiality periods. In the survey of universities, Blumenthal took the 3,394 life sciences colleges of the top 50 universities that have received the most funding from the National Institutes of Health (NIH) since 1993 as the research subjects, and conducted the survey in the form of mailed questionnaires. investigation. Among them, 2167 surveyed units responded to the questionnaire. After analysis, 19.8% of the respondents explicitly admitted that they had delayed publication for more than 6 months in the past three years in order to apply for a patent (the National Institute of Health considers the acceptable delay time to be 60 days). 8.1% of the respondents admitted to refusing to "share results" with researchers from other universities in the past three years. Multivariate correlation analysis also showed that receipt of industry funding and the commercialization of university scientific research were highly correlated with delayed publication. Another researcher, Rahm, surveyed 1,000 company technical managers in the United States and department members of the top 100 universities with the best R&D in universities in the United States. It was found that 39% of sponsoring companies restricted the sponsored departments from other universities. *** Enjoy the results. 70% of technical managers and 53% of department members admitted that there were cases of delayed publication or even no publication of research results at all.
In addition to delaying or refusing to publish results due to intellectual property considerations such as patent applications, sponsored researchers also found that when they made research results that were unfavorable to the sponsoring company, they publicly published their research There is usually greater resistance when it comes to results. For example, according to the American "Science" magazine, an associate professor at Brown University School of Medicine named David Kern was funded by "a certain" textile company to conduct research as a consultant (later verified by "Science" magazine as Microfibres company), and signed an agreement with the company to keep "business secrets". After more than ten years of research from 1986 to 1997, he found that workers at the textile company were susceptible to a lung disease called ILD. When Kern was ready to make the findings public, the company claimed the research was premature and had an agreement prohibiting him from presenting his findings at conferences. Even if the company name is hidden and published in summary form, it will not work. This approach aroused strong response from the scientific community, and "Science" published many controversial articles on this issue in its "Science and Business" column. For another example, the Wall Street Journal published an article in 1996 saying that a large pharmaceutical company sponsored a study conducted by the University of California, San Francisco (UCSF), which showed that the company's best-selling drug for treating thyroid dysfunction was far less effective than other drugs with higher prices. Other drugs that are much cheaper are more effective. However, the company firmly prohibited the publication of the research results, and the researchers finally had to withdraw the paper that had passed the review. Similar confidentiality issues exist in research funded by tobacco companies on the effects of smoking on human health, and in research on global warming sponsored by coal mining and oil companies.
Principles of conflict avoidance
Conflicts of interest are most likely to occur when people may profit or reduce losses from research results. In view of this, some researchers have proposed several principles for resolving conflicts of interest: ① Disclosure of conflicts. ② Deprive researchers of benefits that may affect their scientific judgment. ③ Stakeholders will not participate in the review of relevant results and papers, and will not make tendentious remarks. ④ Turn to laws, rules and policies that regulate conflicts of interest. ⑤ Strengthen professional ethics education. ⑥ Develop and promulgate clear standards and guidelines for identifying conflicts of interest. Among them, disclosure of interests is considered the most effective means to avoid conflicts of interest and their negative effects. Of course, the prerequisite for this is that the relevant personnel must acknowledge the existence of a conflict of interest situation.