Humanities assignment essay on: 

Human Subjects Research Misconduct

Introduction

          Best practices are learnt by researchers in numerous ways and that too in varied kinds of settings. That is why the norms for responsible research conduct may be different for different fields of research. How should the research be conducted?  What ethical practices should be followed by the researcher? These are very tough questions to be answered. The responsible conduct in research is considered to be one which follows certain rules and norms while advancing in knowledge.

           As the interest and the field of research started expanding after World War II, the general public started taking deep interest in the way research is practiced through the elected officials. Over the time major concerns started energising regarding some of the practices which were used for research and the main focus was on initial use of animals and human beings in research and then later the focus shifted to misconduct in rese[MSOffice1] arches. After finding that research community was not doing much to address these concerns, government started framing regulations. It is common that government regulations usually start in Congress (Institute of Medicine, 1989).

           Whenever any potential problem arises like in the case of using animals and human subjects for research, Congress calls for a hearing to know more about the problem and then legislation is being passed to fix the problem (National Institutes of Health, 1997). The regulations which cover the use of animals and humans during research as well as research misconduct have been created from the three acts which have been passed by Congress and they are listed below (Barnbaum & Byron, 2001):

• The 1966 Animal Welfare Act ( PL  89-544)
• The 1974  National Research Act ( PL 93-348)
•  The  1985 Health  Research  Extension Act ( PL 99-158)

Research Misconduct

           The definition of research misconduct and the policies and regulations along with the guidelines which govern the handling of the research misconduct allegations which inculcate the researchers at PHS-funded institutions. The various kinds of research misconducts cover:

• Fabrication
•  Falsification
• Plagiarism
• Error VS. Intentional misconduct
•  Identification of misconduct
• Institutional misconduct policies
• Procedures used for reporting misconduct
•  Protection of whistle-blowers
•  Conducting misconduct  investigations and inquiries
• Federal and institutional responses to  the findings of misconduct (Kulakowski & Chronister, 2006)

Reasons for Scientific Misconduct

          Many literatures have revealed that the organizational themes and the common individuals are the main cause behind scientific misconduct with animals or human subjects. There are wide variety of reasons and motivations which have been put forth by authors (Altman & Melcher, 1986; Kohn, 1986; Caplan, 2007;Wells, et al., 2001). Few [MSOffice2] individual motives which lead to committing scientific misconduct are found to be ambition, greed, laziness, boredom, pride, vanity, and desire for recognition, fame, power or prestige

           Another major contributing factor towards scientific misconduct has been found to be the inability to differentiate between right and wrong and disturbances between the individuals psychological and emotional balance. Some of the common examples of organizational motives due to which the researchers engage in scientific misconduct are:

• Focus on financial success
•  Poor relationship with mentor
•  Susceptibility to  competition and career pressures
• Bad and poor construction of reward systems
•  Innate desire for promotion or tenure
•  Desire  for earning respect from others
• Pressure to publish or to generate grants
• Misplaced loyalty towards the employer
•  Advancement of medical sciences
• Lack of effective supervision

          A famous and very well-known bioethicist tried to articulate the organizational and individual view and stated that: “honesty and integrity are partly individual traits, but they are also reflection of institutional culture. If we create a system where there is overwhelming pressure to succeed at all costs, we should not be surprised when corners are cut” (Caplan, 2007[MSOffice3] , p. 106-107).

Few Cases of Scientific Misconduct

          It has been seen that misconducts are witnessed amongst the professionals and in the universities and it exists almost in every field of science and practice.  Many researchers worked towards scientific misconduct and at that time compiled a list of 34 suspected or well-known cases of scientific misconduct and in this list many of the very well-known scientists appeared who have been highly acclaimed in the recent past (Broad & Wade, 1982).

          Before 1970’s there were hardly any cases of scientific misconduct which were documented , but after that the visibility of scientific misconduct has grown some of the widely publicised cases of scientific misconduct on either animal or human subjects are listed below:

A well-known cancer researcher at the   Sloan Kettering centre called William Summerlin, produced the appearance of successful transplanted skin grafts using felt-pen tip on the laboratory mice (Wells, et al., 2001).

• John Long ,  a resident of  Massachusetts General Hospital , reported falsely that he had  isolated four line cells from  the Hodgkin’s- disease patients , while just three line cells appeared from the South American Monkey and one was from the  non-diseases patient (Wells, et al., 2001).
•  Anjan Banerjee a research scientist and surgeon at the Royal Hallifax Infirmary indicated that he had used 1200 animals for testing in his experiments, while he had access to only 70.

Historical Cases Detected in Human Subjects Research Misconduct

          Critical reviews of literatures on misconduct in the human clinical trials reveals similar data of misconduct as seen in general science which also involves the elite scientists and the famous institutions. The patterns and the time frames for misconduct on human subjects is similar to general science but the clinical trials arena has witnessed several major reforms prior to 1970’s due to reporting of these misconducts. Before the advent of modern techniques of human clinical trials there were seen earliest cases of scientific misconduct on human subjects, the reason being the researchers used the human experimentation techniques which are now being considered acceptable on moral grounds or the data was fabricated in order to achieve recognition (Rose, Wall, Muchnick, & Shamoo, 2008).

           Even the prominent scientists who have been recognized now have committed misconduct in human-subjects research for example Louis Pasteur, Carl Jonson, Henry Berkley, Robert Bartholomew, Sir Cyril Burt and Sigmund Freud. The public claims of Pasteur are being contradicted by his private notebooks which also include how he arrived at an immunization for the disease like rabies (Broad & Wade, 1982) (Judson, 2004). In a very gruesome example of human –subject’s misconduct in 1874 Bartholomew inserted electrodes into the brain of female patient who was dying of cancer. The electrodes were stimulated for hours by him in order to record the patient’s responses even when it was quite obvious that the patient was undergoing excruciating pain (Shamoo & Resnik, 2003).

           Some of very heinous examples of human subject being forced to scientific misconduct are:

• In 1891, Orphans were being used by Janson for an experiment where they were injected with black smallpox pus, and the reason being the calves for experimentation were very expensive.
• In 1883, syphilis virus was being injected into six female Hawaiian lepers by Fitch in order to find the connection between syphilis and leprosy.
• IN 1897, thyroid extract was being administered by Berkley to such an extent in to the participants that it could have resulted in their death.

          The case studies done by Freud are found to be egregiously fabricated or falsified (Judson, 2004). The originator of field of heredity , Burt and who also  did the twin research and  dominated it for 30 years was accused of fabricating on only the data but also the existence of his subjects and his two assistants.

           The most heinous and infamous cases of human subjects being abused in research are the Nazi experiments which were done on Jews during the World War II (Swazey, Anderson, & Louis, 1993). Even the US Tuskegee syphilis study also falls in the same category (Anderlik & Elster, 2001) (Caplan, 2007). Some of the highly egregious experiments conducted by Nazi involved bone and extremity transplants, glass and shrapnel injections and exposure to extreme radiations and electricity. Whereas the Tuskegee syphilis, the most publicised case of scientific misconduct on human subjects in US started in 1930’s when 400 African American men were enrolled by researchers for observing the progression of syphilis. However the cure for syphilis was found in 1940, but the participants were not informed about penicillin by the researchers and the study was continued for 30 years more.

          In another famous case of scientific misconduct a paediatric mental institute Willow Brooke State School in New York conducted experiments on children from 1956 till 1980 to develop a vaccine for hepatitis. For the research the children were deliberately infected with hepatitis and some kids were fed the excrements from the patients suffering from hepatitis (Aita & Richer, 2005) (Anderlik & Elster, 2001) (Beauchamp & Childress, 2001). In Brooklyn at the Jewish Chronic Disease Hospital patients were knowingly injected with liver cancer cells without taking their consent (Anderlik & Elster, 2001). Human Guinea Pigs, book written by Pappworth (Pappworth, 1990) revealed and exposed the human subjects abuse going on in England. He said that in the zeal to  expand their frontiers of medical knowledge, many British clinicians have forgotten that the subjects of their  experiments are all individual cases who  have common rights  and in most of the cases are just sick people who come for getting cured.

Cases of Animal Subject Research

          Although there is justification for using animals for research as the benefits gained from researches are substantial and the displeasure, disease and harm which could be expected from the outcomes after forgoing such investigations would be very grave. Although intact live animals react to research interventions in a way which cannot be simulated through research techniques which rely on non-animal systems? The absence of justification for using human subjects does not on its own justify using animal subjects. If the research goals cannot be conducted on human subjects because of suffering and pain which would be inflicted on them, therefore the justification for inflicting the same pain and suffering on animals is not at all correct. If “harm” can be defined as defaming, thwarting or setting back of nontrivial interests, then there are severe harmful acts which are done on animals in biomedical research.

          The Draize Test is a kind of procedure which is employed by many manufacturers in order to determine whether the proposed new product which is most probably new cosmetic would cause irritation to the human eyes or not (Erwin). The Draize-test recommends that a single large dosage test substance should be placed in the conjunctiva sac of the eye of six albino rabbits. The test substance remains in the eyes of the rabbits for a week and during this period they are not given anaesthetic and observations are recorded periodically. Even the rabbits are immobilised to prevent them from clawing at their eyes in case of irritation. Then on the basis of the damage done to the cornea and iris of the eyes of rabbit the test substance’s irritancy is graded (Regan, 1983).

           There is another debate on the ‘vivisection’ issue where an animal is dissected when it is alive and it is cut. The animals which are placed during experimentation in Noble-Collin drum or are radiated or given shocks are not dissected when they are alive (Hoff, 1980).

Use of Animals in Research

           Animals are very frequently used for research. Just like their human counterparts the animals should be treated with respect. It is found that animals have been used for research for past so many decades, it becomes necessary to examine the researcher’s ethical responsibility when we employ them for research purpose (Singer, Animal Liberation, 1977).

          Firstly the animals should be used for research only when there is no suitable model is available for research, because there are many studies which can be conducted without using animal subjects. Every suitable alternative should be sought before using animal for research subject, the reason being the unnecessary use of animal life without any reason is not ethically justified (Souba & Wilmore, 2001).

           Secondly the animal subjects which are used for research should be given dignified treatment and proper attention should be paid to their suffering while conducting research. Using animals for research can be justified only when the research is conducted in properly controlled environment which ensures that adequate anaesthesia is being administered and there is absence of suffering and pain. They should not be left suffering in gracious manner rather adequate amount of food, water and housing should be provided to the animals too.

           Moreover the animals which depict higher level of consciousness deserve treatment of the level which is commensurate with their level of consciousness. Like chimpanzees possess very high level of awareness so they deserve better treatment than cockroaches and mice. Thus the experiments which are morally licit to be conducted on mice might be ethically wrong ort problematic if conducted on chimpanzees (Rollin, 1981).

           Lastly science carries the responsibility to seek alternative methodologies constantly for experiments which do not use animals for research. Although the use of animals for research is indispensable as of now, but science too has ethical duty to find ways in which the use of animal subjects for research can be minimised (Singer, Ten years of animal liberation, 1985).

          Advances in medicine have come through use of animals in research work. Indeed the word vaccine also means “from cows”.  The devastating effects of anthrax bacterium were studied by Louis Pasteur on animals. The vaccine for smallpox was also based on the serum which is being derived from the cows. The earlier research by pioneering cardiovascular surgeon, Michael DeBakey for coronary bypass surgery was done on animals. Thus there is no doubt that research involving animals has improved the understanding of severe diseases and also helped the researchers in perfecting the medical procedures which benefit humanity.

          But there is huge opposition to the use of animals in medicinal and biological researches. These opponents are concerned about the huge number of animals which  may be millions which will be sued during research every year and most of them die every year , mostly due to result of experiments conducted on them. In some cases the animals are treated unethically by the researchers due to disregard towards the protocols.

           Manufacturers of everything ranging from cosmetics to medicines test their products on animals. A pharmaceutical company will administer varied dosage of new drugs on tens of thousands of guinea pigs and then observe their behaviour, signs for negative or positive impact on their mood or appetite. After sometime these guinea pigs are euthanized and dissected to find out nay carcinogenic or toxic or any other harmful effect of the drug on their body.

Recommendations for Protection of Human and Animal Subjects

           The use of human subjects while conducting research’s benefits society in many ways. It helps in contributing in development of new drugs and developing new medical procedures too which help on understanding the method of thinking and acting. But this also imposes and can result in unacceptable risks on the research subjects Thus in order to make sure that these risks do not outweigh the benefits reaped, human subjects research is very minutely and carefully being regulated by the society (Steneck, 2007).

           Therefore the investigators conducting research on human subjects and are subjected to regulations should and must comply to all the Federal regulations along with any other state or local laws and regulations or policies which are applicable and are related to the protection and safety of the human subjects. The investigators are also expected to follow all the relevant codes of conducts which have been formulated by the professional groups. In order to cater to all these responsibilities the researchers require:

• Know what research  is subject to regulation
•  Understanding as well as following  the rules for project to be approved
• Get required and appropriate training
•  Accept continuous responsibility for compliance through all the stages of the project.

           Thus if you expect to study human living beings or use them in your research, no matter how harmless they might seem, and get Federal funding too, it is mandatory that the researcher should familiarise himself with their responsibilities and cross check with someone senior or the one in position of authority before conducting the research or making any contacts (Steneck, 2007).

           There are two sides of debate and varied opinions regarding whether using animals is right or wrong?  These ethical questions like killing thousands of animals are ethical? Have a financial aspect also attached to it. Reduction in the number of animals used for testing will reduce the financial cost of research too. The scientist will be pressurised to find alternative ways to evaluate the potential impact their findings. But we need to know the impact of drug on the whole organism not just on single cell or tissue portion. Thus the scientists will have to test the compounds in short-term on animals before using them on human beings.

            The organization People for the Ethical Treatment of Animals (PETA) has been promoting itself as the largest animal rights organization and is totally dedicated to the animal rights philosophy. PETA completely stands against using the animals for clothing, food, experimentation, entertainment or for any other purpose (Gluck, DiPasquale, & Orlans, 2002). Peta’s impact on general public and its message has been able to create some influence on the science policy. Other groups like the Humane Society of United States has also been striving to decrease and totally eliminate any kind of harm being done to animals while conducting research and its does so by promoting the research methods which have the potential to replace or reduce the usage of animals or simple refinement of usage of animals so that the animals have to undergo least harm and suffering or physical harm (Neal, Smith, & McCormick, 2008).

Welfare of Laboratory Animals

           Animal research has been carefully regulated just like human research, but the reasons are different. From the information acquired the animals might get some benefit through animal experimentation and some research is purposefully done in order to improve the animal health as in case of veterinary science and animal husbandry research. But it has been seen that most of the researches on animals are done for the benefit of human beings and not for animals (Baird & Rosenbaum, 1991). Moreover for better or worse the animals cannot provide their consent to participate in the experiment or comment on the method of their treatment. Therefore special needs should be taken care of while conducting research on animals.

           These special needs of animals have evolved over the time into concrete policies for taking care and using the animals which are used for research, biological testing and research training. The researchers can carry their responsibilities in proper manner by following few guidelines like (Monamy, 2000):

• Knowing which all activities are subjected to regulation
•  Getting right training
•  Understanding as well as following the appropriate rules for the project to be approved
•  Accepting the continuing responsibility for the compliance throughout the whole project in all the stages.

          To assure proper respect for animals the researchers can utilise the concept of three R’s of alternatives which were given by Russell and Burch in 1959 which were:

• Replacement:  Using the non-animal models for research like microorganisms, computer simulations, and cell culture techniques or using the species which rank lower in the phylogenetic scale.
•  Reduction:  Using such methods which aim towards reducing the number of animals being used for research like appropriate selection of animal model, careful experimental design, minimization of variability and minimization of loss of animals during research.
•  Refinement: Reduction or complete elimination of unnecessary pain and distress to the animals.

          Animal research is supposed to be still controversial although all the care and review is being taken to assure that the use of animal subjects would be done in responsible manner. Still there are concerns like (Paul & Paul, 2001):

• Pain and Suffering:  Without subjecting the animal subjects to pain and suffering certain experimental information cannot be gained. Researchers studying the effects of severe trauma for example in case of child abuse, get to learn about physiological changes by subjecting the animals to varied levels of pain and suffering. This can only be done through administration of mild shocks, forcing the animals like rats to swim till they get exhausted or subjecting them to other traumatic treatments (Russell & Burch, 1959). Thus the limits of pain and suffering which is acceptable for animals cannot be found.
•  Concern for various species: There is very much agreement of the fact that primates and household pets require more protection as compared to other animals. However lesser amount of agreement is found with regard to relative protection which is required for species within general groups of animals like dogs, cats, rabbits, pigs and mice. It is tough to define that what moral considerations are being thought while keeping certain species apart from the other while making such decisions.
•  Unnecessary Experiments: Public members disagree regarding using animals for certain research, teaching and testing. Like animals can be used for testing the safety of experimental drugs however the usage of animals for testing the toxic levels of certain chemicals and cosmetics is not ethical (Rudacille, 2000).

Ethical Issues for Human Subjects in Research

           Although there are several rules which govern the   human subjects but there are some tough choices like:

• Informed Consent:  The human subjects should be correctly and fully informed about the experiments in which they are going to participate and they should give their consent in writing before getting enrolled. However there are few subjects who cannot give their informed consent like some adults who have impaired decision-making capacity, some children and critically ill patients because either they are not old enough to realise the importance of information or they have lost their ability to understand the relevancy of information (Steneck, 2007).
•  Right to Withdraw:  It is agreed that the research subjects should have the right to withdraw if they want to from the experiment anytime they want. But in some cases they cannot do so like in the final stages of development like mechanical hearts are being tested on the patient’s body whose original heart is just about to fail in such cases they can’t withdraw when they want. Because once the mechanical heart replaces the weakened heart the reverse cannot be done or is not possible (Steneck, 2007).
•  Risk without benefits:  In an experiment conducted recently researchers were trying to find out whether a common surgical method which has been used for arthritis pain relief is beneficial or not and in order to gather relevant information related to the benefits derived a clinical trial was being designed in which the patients in the control group had to undergo sham surgery. In this case an operation was being performed but the common surgical procedure was not performed. In this case the researchers complied with all the regulations which also covered thorough IRB review. But not a single patient had adverse effect and the research study gave the conclusion that the common surgical procedure did not provide any major benefits as desired. But surgery always involves risk so the subjects of control groups were put at risk and that too without any expectation that they will receive any benefit (Steneck, 2007).

          Thus the researchers who deal with growing complexities of social, behavioural and biomedical research need to undergo special training. At the same time the researchers who use human subjects for research should also undergo some kind of formal training related to bioethics so that they can actively take part in the critical reasoning process which is required in order to give response to the complex and critical moral issues which are being raised due to use of human subjects for research.

           This particular topic has been chosen because this is a very controversial topic which has two sides of a coin and needs major attention from legislation as well as society. This matter is concerned with both society as well as business, so we need to ponder over the fact that whether using animals and human subjects during research’s is ethical or not and to what extent their use should be limited. It is a very big question, which needs a relevant answer after analysing from moral as well as ethical perspectives. Therefore the society should open their eyes and create awareness about the scientific misconducts going around them in the society and take severe steps to stop it and this can only be done if we are fully aware about these scientific misconducts done to animal and human subjects and if strong regulations are being made to handle such issues.

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