Essay: Nicole Regna

Conflict of Interest in Academic Peer-Review

According to the U.S. Institute of Medicine, a conflict of interest occurs when circumstances create a risk that a person's professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest (Lo and Field, 2009). These secondary interests may be a result of financial gains, prestige, or career advancement. In the world of academic scientific research these conflicts of interest are ever present. However, the presence of competing interests does not imply that wrongdoing will occur; it simply shows that there is potential for wrongdoing to occur. This wrongdoing may be the result of conscious or unconscious decisions. Academic scientific research could benefit from minimizing the instances in which researchers have conflicting interests forced upon them due to the standards of current research.

Peer-review is a tool used by both journals for publication and funding agencies for distribution of grant awards. Established experts in a field are asked to review either research findings (for publication) or research projects (for grant funding) for significance, novelty, and appropriate methods. Peer-review has been a useful tool in the scientific community since the 18th century, and its role has expanded over time into a requirement for publication for the vast majority of all scientific journals. Researchers are able to gather feed-back from knowledgeable scientists working in the same or a similar field. Peer-review allows for collaboration of ideas and methods as well as acts as a check for proper experimental design and methods. Inaccuracies and faulty logic that may exist in an investigator’s manuscript can be contested and suggestions for correction may be offered. Peer-review helps to eliminate fraudulent data, which is more likely to be detected by a journal requiring the peer-review process than by one that does not.

Every academic researcher wants first to be published and second to have their published work cited. The amount of money one makes and the career track that one is on are entirely dependent upon these two factors. When a researcher decides his/her work is ready to be submitted for publication, a manuscript is sent to the journal of the researcher’s choice. The researcher must choose whether to submit his paper to a more prestigious journal with more stringent requirements or one with fewer requirements, but where work is more likely to be accepted without changes. The editor of the journal then usually chooses 2-3 other researchers to the send the paper to for peer-review. The fate of an investigator’s publication usually rests solely in the hands of 3-4 people: the editor of a journal and 2-3 reviewers. Peer-review is a norm of academic research with the ultimate goal of filtering out work that is incomplete, incorrect or insignificant. However, peer-review is one of the major flaws in the publishing process because of the competing interests that arise during this process. This is not to say that peer-review is unnecessary, but a comment on the inherent conflict of interest present in the peer-review process.

One of the problems that may arise is the researchers selected as reviewers are often studying a similar area of science and will have personal biases to preferred methods and results. Every reviewer is also a researcher whose academic livelihood is dependent upon validation of their work. This need for all researchers to have their work validated can result in bias in the peer-review process. The researchers performing the peer-review are more likely to act positively towards papers that are in agreement with their own research. Whether this means a similar result or the use of a method developed by the researcher does not seem to matter. A paper may be rejected solely because one reviewer did not like what the data showed and the implications that it has for the reviewer’s own research. On the opposite side of the spectrum, a reviewer may choose to accept a paper that cites his own work or that uses a method commonly used in his lab because of personal gains that come from these actions. Researchers are often put into situations where they are asked to sacrifice personal gains for the advancement of science. However, not all researchers are able to make this sacrifice.

Financial motivations tend to be the most prominent of all conflicts of interest. Financial gains may result from a variety of sources including stock ownership, career advancement, funding, or employment. As academia-industry relationships have expanded in recent years so have the number of conflict of interests. Reviewers who own stock in a certain industry are going to be more likely to reject research that reflects negatively on the company for which they have invested their money.

While many conflict of interests, such as financial motivations, may be made apparent through an author’s disclosure, there are many others, which are more difficult to tease out. All researchers have academic commitments. These commitments can include preferred methods or even preferred results. It is natural for a reviewer to question work that challenges popular beliefs especially if that reviewer has played a role in establishing those beliefs. It is unlikely that a researcher would be willing to accept a paper for publication, no matter how sound the methods, if the results contradict the reviewer’s prior work. Furthermore, a reviewer is at risk of ruining his reputation if he accepts the contradicting results for publication. Conflict of interest for reviewers can also arise from researchers who have found similar results that would like to delay the publication of research from other universities. Unpopular results are often rejected without regard for scientific accuracy. In multiple instances have papers been rejected by premier journals and their findings gone on to win the Nobel Prize. Some of the most novel findings in science are often rejected at first. Not only is it difficult to determine if these types of conflict of interest will be present, but it is also difficult to prove once scientific misconduct has occurred.

Personal biases can stem from factors other than an investigator’s professional advancement. Other factors such as religious or political beliefs may also come into play. If a researcher is asked to review a paper for publication on stem cell biotechnology, but as part of his religion he is morally obligated to reject research of this nature, are his interests not conflicted? In this particular situation, as a scientist he is ethically obligated to remove himself from the peer-review, but he also has religious obligations to consider. It would be difficult to use something such as religion or political beliefs as a vetting process for reviewers, but a better job could be done to make sure that reviewers are open to a particular field of study.

Ideally reviewers who have conflicts of interest with the content of a paper should ask to be removed from the peer-review process, but many look at it as an opportunity to advance their own research/career. In this instance, one may see the conflict of interest as being forced upon himself when asked to review a paper. Reviewing papers is something that researchers are expected to do in order to stay in the good graces of journal editors. For this reason, researchers may not want to remove themselves even when a conflict of interest is present. Furthermore, researchers may be unaware of the presence of any competing interests at all. Decisions to reject based on factors such as race/gender may be unconscious decisions.

Another problem with the peer-review process that tends to generate conflict of interest is the amount of power given to a small subset of scientists within the field. The “good ‘ol boy” network is very much alive and well in academic scientific research. Prominent, well-established, highly published scientists are the ones who are selected to review papers for publications and applications for grants. These people are often inclined to accept publications or delve out money to their buddies or to those whose work supports their own. This prestigious group of scientists is given a large amount of power when it comes to deciding which direction research will go. They are able to influence the overall direction both through control of publications as well as through distribution of money. In recent years there have been a number of cases documenting ethical problems with peer-review relating to the favoritism towards well-known, prestigious researchers. Studies have shown that reviewers are more inclined to publish data from well-established investigators at well-known universities than lesser-known researchers regardless of the methods and data presented. Peters and Ceci showed that when reviewers were blinded to the publishing author, those papers were more likely to be rejected.

While every journal and funding agency has conflict of interest policies, they do not do enough to prevent scientific bias from occurring. A number of changes could be made help minimize the inherent biases in scientific research and publication. First of all, reviewer comments need to be edited by others to ensure that reviewers are not acting either favorably or unfavorably toward a particular publication out of their own personal bias. Also, the peer-review process should be expanded to include a larger number of reviewers so that rejection is not based solely off of the opinion of one reviewer. A panel of reviewers from a variety of backgrounds would help to eliminate personal biases of specific reviewers who may have undisclosed competing interests. In order to remove the conflict of interest from the peer-review process reviewers need to be required to disclose their competing interests. The majority of journals require the author to disclose his competing interests; however, less than 15% have any guideline for reviewers or editors. One should not be able to influence his own academic success by accepting or rejecting others work. It is a lot to ask of a researcher to put aside one’s own personal biases for the advancement of science. Even a researcher with strong ethical obligations may be tempted to act unethically when his job is on the line. The way that the current system is set up, the responsibility to report conflict of interest relies solely on the reviewer with no consequences for not doing so. Having a system that requires reviewers to disclose their competing interests could help ameliorate some of the above outlined problem. Peer-review is not going away anytime soon, nor should it. However, it does need to be revamped in order for the advancement of science and knowledge to occur.

Final Essay

Scientific Conflict of Interest and Its Impact on Public Trust and Perception

Conflicts of interest are inherent throughout the scientific and medical communities. In recent years, the go to solution for handling such conflicts has been disclosure. Disclosure operates under the premise that if conflicts of interest are made known and public, people will not behave unethically. However, without the proper legal foundation, researchers are taking advantage of this lenient system. The number of researchers engaged in academic-industry financial relationships has significantly increased over the past 50 years. It is important to understand the impact that these relationships have on the public and their beliefs regarding scientific integrity.

In 1942 Robert Merton introduced 4 scientific norms: communalism, universalism, disinterestedness, and Skepticism. Academic-industry financial relations have essentially thrown disinterestedness out the. Scientists usually have a lot to gain or lose, and therefore interest, in the success of their experiments. Sometimes a person’s financial interests may be on the same side as the greater interests of scientific community, but sometimes personal interests are in direct competition with seeking of universal truths. It is possible for scientists to align their interests or to remain objective in spite of conflicting personal interests. The problem is that this does not always happen, and it seems that more and more researchers are being swayed by personal financial interests. Theoretically it may be possible for researchers to remain objective, but practically is that what they are doing?

Due to high rates of scientific illiteracy outside of the scientific community, the public is very dependent upon scientists to produce reliable and trustworthy results and treatments. The public trusts scientists and their research. There are numerous examples of when scientists have taken advantage of this trust to use and mislead the public. Both drugs and medical technologies are periodically being recalled after causing harm to the public. People trust their doctor when they are prescribed a medication and trust the scientists that are responsible for the manufacturing of the drug. But what happens when scientists and doctors put their own personal interests ahead of public safety? What happens when a doctor decides to prescribe a medicine to receive kickbacks instead of the best treatment option available? Whose job is it to protect the public and prevent these types of conflicts from interfering with public safety? The public trusts the doctors and researchers and the work they produce, but should they?

Every year millions of people put their lives on the line and their trust in researchers in order to participate in clinical trials. Conflict of interest can create serious problems for a trusting public putting their health in the hands of researchers. These conflicts have led to fatal betrayals of trust by researchers. 18-year-old Jesse Gelsinger died in 1999 following a failed gene-therapy clinical trial. Gelsinger had been diagnosed with a non-fatal metabolic disease of the liver and had decided to participate in a clinical trial at the University of Pennsylvania. Gelsinger died four days after his participation in the study. So what went wrong? Gelsinger put his trust in the researchers and the doctors running the clinical trial. The investigators failed to disclose that monkeys receiving the same therapy had died during trials. They also failed to inform Gelsinger and his family that a number of other patients that had already undergone the clinical trial had experienced severe side effects. Not only did researchers fail to disclose all information to Gelsinger, but they also failed to inform him that he should have been excluded from the study due to elevated ammonia levels. So why didn’t researchers exclude him from the study?

Based off of the current scientific research model, investigators are in direct competition with each other to have successful experiments completed first. The emphasis here is on “first.” Not only do you need to be successful, but you also need to be the first to do it. When researchers are conducting similar experiments, it all comes down to who completes their studies first. The gene-therapy trials were conducted by Dr. James Wilson at the University of Pennsylvania while Wilson held the majority interest of a biotechnology company, Genovo. This biotech company stood to make millions of dollars if Dr. Wilson completed his trials with successful results. Wilson was conflicted in his interests to ethically conduct research and his potential financial gains. When financial conflicts of interest are introduced this further compounds the urgency with which experiments must be performed. So this brings us back to Jesse Gelsinger and why he was even included in the study. Another participant had dropped out of the study and needed to be replaced. Dr. Wilson and his team of researchers were most likely feeling the pressure of finishing the race first and decided to neglect the bioethical concerns of including Gelsinger in the study. This story demonstrates one of the major problems of researchers having some much resting on the success of experiments. It’s one thing to have a publication and prestige resting on the outcome of an experiment, but when you add the potential for millions of dollars in profit, things can get complicated. With the airing of the Gelsinger story along with other similar stories by the media, one must wonder the impact this has on the public’s trust of scientific research.

Due to the scientific illiteracy of the general public it is unreasonable to expect them to even understand what it is that they are consenting to. Can this truly be called “informed consent”? Words can be read (or not read) and papers signed without informed consent actually occurring. This happens so frequently because people put their trust in researchers. The public trusts that they have their best interest at heart, but example after example in recent history shows that this is not the case. Researchers have their own interests to protect, and they do. The problem is that scientists’ own interests can conflict with ethical standards and furthermore public safety.

It is essential for successful scientific research that a trust exists, between researchers and the public, as well as amongst researchers themselves. Blind trust has allowed academic-industry relations to greatly expand during recent history. Scientists have long been regarded as knowledge seekers who are trying to determine universal truths. This false perception of who scientists are has allowed them to evolve these financial relationships without the public questioning the integrity of their work. But how are these relationships going to affect public perceptions. Are researchers at risk of losing the public’s trust?

Conflicts may arise from sources other than academic-industry relations and personal financial gains. Researchers must deal with the problem of bioethics being in conflict with the basic tenets of experimental research. When conducting research, it is important to observe and collect data without influencing the results of a study. Proper controls are needed in order for comparison with experimental variables. A problem arises when you try to bring these standards into human clinical research. According to standard medical ethics and the Hippocratic Oath taken by clinicians, researchers should do no harm and help sick patients improve. It would be impossible to conduct a proper scientific experiment and simultaneously uphold the Hippocratic Oath. Sometimes research method will need to be compromised in order to ensure the public’s safety, however, sometimes scientists choose to compromise bioethics as was done during the Tuskegee syphilis study. These types of conflicts and unethical choices can also lead to public distrust.

Traditionally university researchers have been expected to commit to the objective pursuit of knowledge through research as well as the education of students. When researchers engage in academic-industry relationships, their commitments can change. The academic researchers may become more committed to their external involvements and personal financial gain than their commitments to the university. However sometimes the university may also stand to benefit financially from researcher-industry relations and they may too become conflicted. Let us go back to the Jesse Gelsinger case. It was not only Dr. Wilson who was a stakeholder in Genovo, but also the University of Pennsylvania. They too stood to make millions of dollars off of successful clinical trials. They may help to explain how a study that has since been shown to not be in compliance with many ethical standards was able to get internal approval from review boards at the University of Pennsylvania. Academic-industry relationships do not only create conflicts of interest at the individual researcher level, but also at the level of the university as a whole, which could potentially be a significantly larger problem. If universities were able to remain not conflicted, then they may be able to effectively control researchers who are conflicted through proper disclosures.

Currently there are no laws preventing researchers from having conflicting financial interests. Researchers are still trusted to behave objectively and ethically without any legal ramifications or consequences. Researchers are already under an enormous amount of pressure to publish results without the outcome of experiments mattering. How can researchers remain objective when they have such an extreme vested interest in the outcome of an experiment? It is vital that the public believe in the integrity of scientific research and conflicts of interest pose a problem to this trust.

Even if a researcher is able to remain unbiased and objective despite conflict of interest, there is still a problem with public perception of how these relationships influence scientific research. This creates a problem with public trust, which is something science cannot afford. Research relies on the trust of the public for funding, clinical trial participation, and the acceptance and use of medical treatments and technology. If the public loses its trust in the researchers then who is going to participate in clinical trials? Researchers need to consider the potential negative impact of their academic-industry relationships before they choose to prioritize their financial gains. Scientists must realize the impact their research has on the health and safety of the public. Policies regarding conflict of interest are currently being developed and implemented at both the university level and the government level. As these policies are shaped and molded, it will be important for public perception and trust to be at the forefront of discussions.

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