The continued use of aspirin by individuals who have been diagnosed with the cancers of the colon or the rectum has been linked with better clinical responses to the treatment of these types of cancer. Indeed, the existing experimental evidence advances the inhibition of aspirin consumption for the patients who continually use it after the diagnosis. This research paper is therefore interested in the impact of aspirin poisonous effects, which are analogous to cultured colorectal cancer cells. The research proposal investigates the toxicity of aspirin analogous to cultured colorectal cancer cells and how the patient will respond. Consequently, the research is interested in finding out if the response to aspirin of patients who have mutated cancer cells will vary from those who have normal cancer cells in the body. Similarly, the research will also look at how the body responds to the toxicity of aspirin. The methodology in the research will involve the collection of data from 20 patients believed to have cultured cancer cells and another group of 20 who have normal cancer cells. This research provides an interesting area of study as it looks into an issue that not many other studies have delved into before, thereby providing a new opinion how aspirin can be used in the treatment of colorectal cancer.
The ability of aspirin to inhibit the growth and spread of colorectal cancer has led to increased investigation on further development of this discovery. Nowadays, colorectal cancer, having become one of the leading cancers in developed and developing countries, is associated with significant morbidity and mortality. The treatment has proved to be ineffective while population screening with help of regular colonoscopy is expensive and, thus, most patients cannot afford it. Indeed, the research on aspirin’s ability to inhibit colon cancer has recently begun. There has been long-standing interest in the possibility of aspirin to reduce the risk associated with colorectal cancer. The first randomized trials of aspirin were conducted in the late 1970s and early 1980s, in which randomization to over 300mg aspirin daily prevented up to 75% of colorectal cancers after latency of approximately 10 years (as shown in appendix one).
The common aspect in all the previous experimental methods concerning the use of aspirin has been directed towards establishing the viability of acetylsalicylic acid in the treatment of colorectal cancers. While this is the most important overall goal, all research studies involved have failed to acknowledge the critical aspect of how the body may respond to poisonous aspirin in cases where the cancer cells are cultured. Whereas this research shares the same ambition as those previous research studies, the methodology is significantly different from the previously mentioned investigations. In order to arrive at conclusive results in the study, the use of human cells is critical. However, this research proposal employs the use of the culture in the process of its fulfillment in order to have more accurate results (Ranjit 2005). Therefore, great emphasis has to be put on the accuracy of the results obtained, as well as the use of culture in the study. Cultured cells are important as they help in analyzing basic cell biology, the interaction between disease-causing agents and cells. This is important in studying the response of the cells to new treatment drugs.
Goals and Aims
The goal of this research proposal is to conclusively establish and confirm the use of aspirin in the treatment of colorectal cancers beyond the experimental stages in which such analysis still remains important. The research has three main aims. The first purpose is to establish the link between colorectal cancerous cells and the genetic composition of aspirin that makes it possible for the drug to inhibit the spread of this disease and at the same time not respond to other types of cancer. Secondly, the research also aims at finding the negative effects of taking aspirin daily by patients diagnosed with colorectal cancers (Larrie 2003). Thirdly, the research also aims at establishing the viability of aspirin in the treatment of other cancer types.
The research will involve the collection of cells from two groups of patients. One group will be made up of forty people who are supposedly healthy and not suffering from any cancers, while the second group will be made up of forty people, twenty among which have been diagnosed with colorectal cancer while the other twenty have different types of cancer. Sample cells will be collected from these two groups. These cells will then be cultured and aspirin added to each of them in equal measure (James 2011). After that, the cells will be incubated for 48-72 hours in order to determine which cells will die and which cells will survive. For this determination, the use of the Western blot gel will be crucial.
The cells taken from the group of participants who are supposedly healthy should not be able to survive for long. This is because the normal human cell usually passes through a limited number of cell divisions before they die. The cells from the group of twenty individuals diagnosed with other cancers should also die as aspirin helps to shorten their lifespan. These cells should, however, outlive the normal human cells. Lastly, the cells from the participants diagnosed with colorectal cancer should be able to survive much longer. The whole methodology will have to be reviewed to define if the real results are different from these ones. However, it is difficult to anticipate if the instructions are precisely followed.
Ethical Issues to be Considered
There are a number of ethical considerations that every research must pay careful attention to while conducting biomedical research. Firstly, there is a question of choosing who will participate in the trial. This research looks at the effect of aspirin in analogous cultured cancer cells; consequently, the determination of research participants is critical in getting accurate results. Data must be collected from patients with rectal or colon cancer, and must include the use of aspirin after the ascertainment of diagnosis. However, the selection of research participants must be carried out in accordance with the principles and rules governing biomedical research involving human subjects. For this reason, participants should not be chosen because they are easily available or because they can be manipulated and compromised (Mukta & Lea, 1985). There are a number of principles, which govern the issues that should be considered in the selection of participants for the human experimentation. These principles are described in the Nuremberg Code and the Declaration of Helsinki (as shown in Appendix Two)
Moreover, there is a requirement for procurement of informed consent. This is the requirement that a participant’s informed consent must be procured before being enrolled in a study. This obligation is derived from the ethical principle of respect for human rights and dignity. Thus, patients who volunteer for clinical trials must adequately understand the unproven nature of the research, knowing whether the treatment is randomized or a placebo will be used. They should also be aware of the possible risks and benefits involved, the alternatives available, as well as their freedom to withdraw from the study without repercussions. It is important to procure informed consent in order to determine that a patient’s right of self-determination is respected (Charles & Mark, 2010). The consent must, therefore, be voluntary and not obtained by coercion or undue influence. The research participants must be informed about every aspect of the experimentation (as shown in Appendix Three)
For another thing, there must be an assessment of potential benefits and risks of research participants. This follows the requirement that risks of participants should be reasonable in relation to the potential benefits of the experimentation, which is an established ethical principal in clinical research. This is concerned with the probabilities and magnitudes of possible harm and anticipated benefits. The assessment of potential benefits and risks is based on the ethical principles that brutal or inhuman treatment of human subjects is never morally justified. In such a way, the research must aim to treat people with respect and dignity. Risks should be reduced to those necessary to achieve the objectives of the research. In cases where a research proposal requires the use of human subjects, there needs to be a careful assessment of the possible risks and benefits. If the risks outweigh the benefits, there must be a clear justification for the need of the research (Mary & George, 1990). If the investigation involves threats of serious impairments, review committees should be extraordinarily insistent on the justification of the risks. Therefore, in a research study involving human beings, the threats associated with the research must be minimized; the risks must be proportionate to the knowledge to be gained (see Appendix Four)
In addition, there is an aspect for the selection of controls. Controls in a biomedical research may range from the standard treatment, applying placebo, or no treatment at all. This deals with the concern of the standard of care to be provided to a control group. The standard of care is more than the comparator drug or other intervention. Thus, research participants must be assured of the best proven diagnostic and therapeutic method in current use. The approach used in the research should be the best current method that is applicable anywhere in the world (James 1991). In the UK, the medical practitioners will submit to the standards established by the Care Quality Commission (CQC), which is the independent regulator for all health and social care services in England (see Appendix Five)
Appendix One: Randomized Trial of Prophylactic Daily Aspirin in British Male Doctors
A randomized experiment was carried out on a group of individuals who were supposedly suffering from colorectal cancer for a period of five years. The purpose of the research was to determine if a constant intake of over 300mg of aspirin by post-diagnosis patients with colorectal cancer would inhibit and possibly save the lives of those people (Home Office, 2011). Though the all-cause mortality was 8% lower in the treated group than the control group, this difference was not statistically noteworthy and primarily involved diseases other than stroke or myocardial infarction. Equally, there was no major difference in the prevalence of non-fatal myocardial infarction or stroke, however disabling strokes were somewhat commoner among these allocated aspirin. The inferior buoyancy limit for the effect of aspirin on non-fatal stroke or myocardial infarction was a substantial 26% reduction (Scally & Donaldson, 1998)
Appendix Two: The Nuremberg Code
This is regarded as the most important document in the history of the ethics of medical research. The document was formulated in August 1947, in Nuremberg, Germany. It was based on the trial for the German doctors who had conducted experiments on human subjects during the Second World War. German doctors were on trial for conducting murderous and torturous experiments on human beings, thus exposing them to conditions that were not fit for people. Experimental subjects suffered from phosphorous burns and hazardous effects from radiation. The Code was formulated to govern all biomedical research involving human subjects. It is made up of ten principles with regard to human experimentation. The Nuremberg Code makes a requirement under principle 1 for the consent of the participant before being involved in the research. Principle 2 states that the experiment can be allowed if it is aimed to bring fruitful results for the good of society. In total, The Nuremberg Code consists of ten principles concerning biomedical research involving human subjects.
The other set of ethical principles that has provisions on human subjects in biomedical research is the Declaration of Helsinki. This document was adopted by the World Medical Association in 1964 as an international agreement on human experimentation. It is a statement of moral principles for medical research involving people, including research on identifiable human material and date. Under the Declaration, it is the responsibility of the doctor to promote and safeguard the health of the patients. Thus, contemplations related to the welfare of the human subjects should take primacy over the interest of science and society. The prime purpose of medical research involving human subjects is to advance prophylactic, analytical and curative measures, as well as find out the aetiology and pathogenesis of disease. Even the well-established, prophylactic, diagnostic, and curative methods must be continuously challenged for their efficacy, competence, convenience and quality. Consequently, medical research is a matter of ethical standards that endorse respect for human beings and guard their health and rights. Some research populations are susceptible and need special safeguard. Similarly, the economic needs for the disadvantaged must be respected.
Appendix Three: Informed Consent
Participants of the experiment must be aware of each and every detail concerning the purposes of their involvement in the research. The information that should be given to research participants includes aims, methods, sources of funding, as well as any possible conflict of interest, institutional affiliations of the researcher, the anticipated and potential risks of the study and the discomfort it may entail. The participants should also be informed about the right to abstain participation or withdraw consent without repercussions. The underlying rule is that in every scientific experiment involving the use of human beings, the researcher must acquire an agreement of the subject. In situations when the participant is incapable of giving informed consent, the researcher must obtain the consent of the legally recognized guardian.
Appendix Four: Assessment of Potential Benefits and Risks
This entails the balancing of possible risks with the potential long-term benefits associated with the availability of the evaluated product if it proves to be safe and effective. There must be a careful assessment of predictable risks and burdens in comparison to foreseeable benefits for the subjects and other participants in the process. Researchers should focus on the assessment of potential benefits and risks, or desist from engaging in human experimentation unless they are confident that the risks involved have been adequately assessed and can satisfactorily be managed. Therefore, if the possible risks are found to outweigh the potential benefits, such a research should be called off.
Appendix Five: Care Quality Commission
Care Quality Commission is an independent regulator of all health and social care services in England, which began its operations on 1st April 2009. It has a mandate over care provided by hospitals, dentists, ambulances, care homes and services in people’s own homes. Moreover, CQC ensures that the care given by these institutions meets government standards of quality and safety. The commission established a number of standards that should be met by all care providers. The treatment of the diseased should be carried out with respect, and such patients should be involved in their care and support, whatever happens and at every stage. Patients should expect care, treatment and support that meet their needs. Commissioners should guarantee safety of patients and take care of them with the right skills. Care Quality Commission exercises a number of responsibilities in regard to issuing warnings or requirements for service providers to undertake certain duties within a given time frame. It can also limit the number and type of services a given provider can offer to patients, and issue penalties on care providers who do not conform to the requirements of the Commission.