Biomedical Ethics
Research Ethics Board Debate
The REB should not approve the study. The relationship between St X University and GHI pharmaceutical industry should be such that, the university provides a check on the hasty interests of the industry. Though Universities have been playing a major role in the creation of new products for pharmaceutical companies, this study is not ethical. Company funded research are more likely to support the therapy than those funded by a private group. Data is also likely to be falsified. Questions as well as the study may be designed in such a way that the probability of getting positive results is increased.
Rules should be put in place to govern the pharmaceutical industries-university relationship. The responsibility of all research should be placed in the hands of the association of universities and colleges. Health research should be taken as a subset of all research with the university being the institution of record rather than an affiliate. Health sciences should not be allowed to develop ethical standards in segregation. St X Universities should set up rules that do not allow it to bend its responsibility to control practices in its well financially supported peripheries. St X Universities should not be allowed to defend its interest with consistent complexity and dynamism. It is for the best interest of the public if a committee was set up to oversee all the research that involves human subjects (Lewis, Baird, Evans, et al, (2001).
All rules should be designed in such a way that they protect the intellectual integrity of not only St X universities, but also all other universities. If these rules culminate to positive effects, the industry habits would improve enlightened companies would take up moral policies that may in time eliminate the suspicion and distrust that current antagonism have without doubt produced.
To minimize cases of bias during research of this drug, a double blind trial should be employed. In double blind trials, neither the researcher nor the subject knows who is on control and who is receiving the real treatment. Double blind trials are the gold standards for medical studies. They eliminate bias on the part of the researchers and the subjects. Use of double blind trials is very important in research as it culminates to higher principles of scientific strictness. It also eliminates influence of the bias as well as unintentional physical signs on the outcome. The key that identifies the group to which subjects are assigned to should be given to a third party and not to the researchers, the university or the GHI pharmaceutical company. Double blind method would be very helpful in our case because there are chances that the results of the research may be tampered with. Subjects in the study should be numbered and assigned randomly to either the experiment group or the control group and then given drugs marked with matching random numbers (Thurnell-Read, 2007).
It would be unethical to withhold the drug to the control group if the drug is realized to be effective. It would also be unethical to continue with the research if the side effects of the drug are so severe that the researchers and the subjects predict the side of the experiment they were assigned to.
It is not in line with the ethical standards for the GHI Company to give funds to St X University. As per the moral standards, all research funds are supposed to be given to the Association of Universities and Colleges rather than to the University directly. The pharmaceutical company should also not give funds directly to the researchers. If it were to do so, it would manipulate the researchers forcing them to develop results that only favor their financial gains. Chances would also be high that the pharmaceutical company would give incentives to the researchers in order to make sure that they only come up with results in favor of the drug (Smith, 1992).
As noted by Smith (1992), scientists and researchers are charged with the responsibility of ensuring the ethical and scientific validity of all research they conduct. Researchers and scientists in academic institutions work under the guidance of the research ethical board which assists by providing them with guidelines and policies to be followed during the experiments. Scientists have specialized, fiduciary, and moral interests in the accountable performance of research. All scientists are under large scientific bodies which deal with their financial issues. Funds are not given directly to the researchers and therefore they cannot be manipulated by the organizations that fund them.
Scientists however, cannot be assumed to be a hundred percent free of bias. If scientists put their focus in financial interest, they are more likely to produce biased results. Non-financial interests of scientists could also compromise the accountable conducts of the study.
It is ethically unacceptable for GHI pharmaceutical industry to give funds directly to the research team. This would provide a base for manipulation of the research team. They would be forced to declare their results positive though they may be negative. GHI pharmaceutical industry would also control the release of results to the public. The GHI pharmaceutical industry would only release results that favor its financial gains.
The key threat to the scientific transparency currently is the corporate money and tricks directed towards co-opting the good name of studies for the pursuit of profit. Pharmaceutical scandals whereby companies withhold all data that does not favor their products and conceal financial interests of the drug have revealed this.
The GHI pharmaceutical company does not have the mandate of restricting the publication of the results of the drug whether they are positive or negative. Even if the drug proves ineffective, the results should be published for the interest of the public. Researchers should be free from any coercion either from St X University or the GHI Company to produce results that only proves the drug to be effective. The research team should be free to make publication of the outcome whether the drug is affective or ineffective.
The main purpose of ethical principles as illustrated by Lewis, Baird, Evans, et al, (2001) is to direct and induce considerate actions founded on principles. These ethics have been widely utilized in various research disciplines. They put across general standards, ideals and objectives of the research society. One of the ethical issues is the reverence for human dignity. Diverse interests of a person ranging from bodily to psychological to cultural honor should be safeguarded. The principle of respect for human dignity forms the foundations of the moral obligation in study.
Respect for free will and informed consent is the other ethical consideration in research. A person is commonly assumed to have the capability and right to make free as well as informed decisions. Exercise of individuals consent should be respected in the process of research.
All vulnerable individuals are supposed to be respected. Vulnerable individuals are people who have reduced competence and ability to make decisions. Among the vulnerable group of people who should be protected from exploitation and abuse on the foundation of human dignity, fairness and unity are children and institutionalized people. Ethical obligations to vulnerable groups require that special measures for safeguarding their interests be put in place.
Privacy and confidentiality of a person are to be respected. Standards of privacy as stated by the Canadian institute of health research (2005) should be applied for the control and dissemination of persons information. Justice and inclusiveness should also be upheld. Justice ensures that proper research methods are utilized during research and that burdens of research are not subjected to the vulnerable group alone. Ethical principles require for balancing of benefits and harms of the study. A harmsbenefits analysis should be conducted to make sure that harms do not outweigh benefits.
Ethical principles require that human beings should not be subjected to unnecessary dangers of harm. As per ethical principles researches should involve the smallest number of human subjects possible. Beneficence is the other ethical principle related to the benefits as well as harms of study. Moral ethics impose a duty on research to benefit others as well as increase the total number of benefits. Subjects used in research play a very big part to the advancement and guarantee of research in advancing the condition of human being. Subjects collaborate with researchers as participants in the development of a research project. Subjects should therefore not be taken as objects rather their interests should be core to the research. It is not always that subjects and the researchers will see the benefits and the harms of a research in a similar manner. Individual subjects may respond in different ways though they are in the same study. The research ethical board must do all it can to understand the views of the research (Canadian institute of health research, 2005).
St X University as well as other Universities is supposed to look for the truth. GHI and other Pharmaceutical companies on the other hand have a responsibility of making money for their stakeholders. If a pharmaceutical company fails to make money for its stakeholders, it is thrown out of business. A university that does not provide the society with truth on the other hand losses credibility as well as its position. At times, institutional essentials are bound to disagree. If any of the institution abandons its principle mission, it finally fails. Research can serve the interest of the public or be subverted to serve the interest of the company. Subverting the purpose of research corrupts the integrity of researchers as well as the research institutions.
According to Lewis, Baird, Evans, et al. (2001), some relationship between the universities and the industries are unified by an unbiased pursuit of innovation others are unholy associations in which researchers as well as the university becomes helpers of the industry. Such an association places the interests of the industry well above those of the University and the society. Major difference in revelation requirements, inadequate safeguard of the right to publish in a timely fashion, and researchers having monetary interests in the company potentially affected by the results of their research are some of the evidences that illustrate how some associations may be unholy. The main aim of these unholy associations is the publication of positive outcomes of trails of new medicines only. Publications may also be made showing that the new drug is superior to other competitor drugs in the market. As a result, the sales of the company may be increased. Negative outcomes develop unhappy industry partners. It is the mandate of St X University as well as other Universities to safeguard their own culture and orientation. This however, has not been achieved. Money has been put into the scene leading to inadequate oversight as well as insufficient standardization of rules to settle disputes. Universities status is tarnished production of drug therapies that cannot help, and increase in the cost of drugs, emerge as a result.
When the interest of the public and the private sector conflict, some companies have been shown to protect the interests of their shareholders fiercely. If it develops a drug that acts the same way as another drug in the market, it will tend to market that drug at a very high cost in order to get back its expenses. Pharmaceutical companies in such cases are forced to extensively persuade physicians, pharmacists, as well as the public that its drug is actually the best. In addition to threats and lawsuits, results of therapeutic effects of a certain drug are inclined towards the positive results. Funding done by the pharmaceutical company will lead to creation of incentives to support the positive and repress the negative. The pharmaceutical company may either control the publication of the results or hold back the negative results. The truth is incompletely revealed and therefore compromised when pharmaceutical industries control publication of the outcome. As a result if the researchers, laboratories as well as career prospects depend on the renewed industry financial support of their interests may start to go in line with those of their paymasters (Lewis, Baird, Evans, et al., 2001).
The right of the university to reveal the research findings, whether negative or positive, immediately after clinical trials and make the results public freely should be preserved. Guidelines should be laid down and followed to determine if a proposed industry-university project is of adequate academic novelty and imperative to meet the criteria of being an academic activity. Should the project not succeed, it should be regarded as a consulting contract and therefore priced and managed as such. All universityindustry agreements as well as contracts should be filed with the supervision body. All clinical trials should also be registered. A debriefing should be written and signed by all parties at the end of every university-industry agreement. This debriefing should be filed by the supervision body as well as a hearing process to settle disputes. A rating system should be put in place to evaluate the scientific reliability, adherence of contracts as well as obligation to academic liberty, level of intrusion in the conduct of study and suitability of monetary arrangements. Surtax levied on all university-industry contracts should be used to establish a central office as well as its supervision actions and cater for the cost of defending researchers against harassment by industries. An ombudsperson should be appointed to whom all concerns about the joint venture will be referred to by the researchers and the industry. All agencies funding health studies are required to take part in and support the developed set of rules founded on these common values and arrangements (Lewis, Baird, Evans, et al., 2001).
Resolutions
Disputes are bound to arise during development of new drugs. These disputes may involve complex decisions that are commercially and scientifically important. Measures should be put in place so as to encourage open and quick discussion of such disputes leading to their resolution.
Safeguards
Only a limited number of authorized people should have access to the records kept during the process of research. This greatly helps in reducing chances of tampering with the results of the study. The researchers should record any information acquired from the subjects during the process for research as soon as possible. The research ethical board of St X University should ensure that all the research guidelines are implemented and followed to the latter.
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