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Pros and cons of human drug trials for pharmacological research

Disucuss about the human drug trials(pharmacological research) in ethics.

Human drug trials have been an issue of concern for a time in history with many arguing for or against the research. The bottom line is the ethical issues that are tied to the practice since the research uses a human being as the subject for the experiments. The purpose of this research is to explore human drug trials (pharmacological research) in ethics. Some of the expected results include pros and cons of the research, ethical issues, risk issues, safety issues and integrity issues. The research also seeks to presents response action on these issues with the solution to these issues as the final aspect of the research. Therefore the research in totality looks into ethical issues within the pharmacological research involving human subject.

Ethics is a broad area that affects nearly every aspect of daily life as it defines the moral and acceptable code or standard of practice in the particular field. Pharmacological research forms an important step in the clinical investigation leading to the production of a drug that treats a specific disease or clinical situation. The research uses the human subject for trials and this may involve taking of drugs, surgery or organ donation. Clinical trials that involve human subject require high caution and ethical considerations. The research may also include data collection and analysis before reporting on the result of the trial. For instance, in Australia, various drug trials have been conducted according to Australian Clinical Trial (2016). Cancer trials, for example, take more than 10years, one such trial is ALTTO (a study comparing Trastuzumab and Lapatinib (a new drug)). The research in ethics that investigate human drug trials serve the purpose of highlighting the pros and cons of pharmacological research, ethical issues, integrity issues, risk issues and response action coupled with a solution to such issues. The expected results include various ethical issues in pharmacological research and the expected solutions to such issues (Nardini 2014, pp 387).

Pros of human clinical trials research

There are many different advantages or benefits of human drug trial research as this gives rise to a new treatment or improve existing treatment. Firstly, the research helps others to get treatment for a particular disease (Howick 2011, pp 18–31). The drug trials though have ethical issues, has a high potential for treatment for the specific clinical condition under investigation. Pharmacological research is helpful for getting treatment for clinical situations that has not be treated or those conditions that need improved treatment. Secondly, the pharmacological research helps in improvement of future treatment for the specific disease. Some biomedical research needs further improvement and this can be done through continuous research. Elements of treatment such as organs that are used in pharmacological research are critical for future research and medical improvement. Thirdly, pharmacological research has the potential of improving prevention and cure of some deadly diseases (Maitland & Schilsky 2011, pp 365-81).

Ethical issues surrounding human drug trials

Cons of pharmacological research

Pharmacological research may be associated with some disadvantages that need serious improvement. Firstly, the research may not lead to actual treatment as this is just an experiment that is still progressive. Some trials may produce a result that is not as expected and therefore discarded as treatment may also not better than the previous treatment (Deng, Hanna, Dalakas & Merkies 2012, pp 348-52). In such case, the client may feel used up without any advantage of treatment. Secondly, the pharmacological research may have side effect or risk that are connected to the experiment. Pharmacological research though of high-risk management strategy may have some negative implication on human life as the risk not always assured. Moreover, the investigators need to prevent such unprecedented events that may also result from body reaction to new drugs or allergic reactions to treatment. Thirdly, the drug may not work as the normal drugs hence wastage of time spend on research. Human experimentation may result in result whose integrity is questioned and therefore not useful (Wistuba, Gelovani, Jacoby, Davis & Herbst 2011, pp 135-41).  

Ethical issues

There are many different issues that touch on the ethics in human drug trials and these issues need proper considerations.

Firstly, human consent is an issue as many research shows that there is need to first seek personal consent before involving human in drug trials. The basis of the human concern is to ensure that those under experimentation are aware and accepted to take part in the pharmacological research (Teira & Reiss 2013, pp. 207–24). Secondly, monitoring of the overlapping responsibility ensures that personal. There are many parties that need to show responsibility in monitoring research and these include institution where the trial takes place, an individual taking the research and the researcher that need to monitor the experiment or data. Thirdly, safety concerns of an individual and data safety in human drug research are another important ethical concern. Finally, researcher’s training plays an important role in a human drug trial that raises many concerns. The research that are conducting trials needs to be well trained to ensure there is no error that may lead to complications (Teira 2011, pp 255–297).

Integrity issues

The integrity of parties involved in the experiment has been a matter of debate since human drug trials need an extra care. One of the reasons for integrity concern is the safety of the data that is obtained in the experiment as there is need to monitor data collection and experimentation in general. This is also touching on the integrity of the client used in the experiment as some may opt out of the experiment before completion of the trials. This is detrimental not only to the client but also to the researcher. Patient willing to participate in trials is good as it improves the integrity of the data obtained from the research. Lastly, the integrity of the data obtained is important as it determines the usefulness of the data and any future improvement of the clinical condition under experimentation (Sharma & Schilsky 2012, pp 208–14).

Safety issues involved in human drug trials

Safety issues

The safety issue is another ethical issue that has been shaping human drug trials. One of the areas that present safety concerns are the safety of human data gained from the experiment as people fear risk associated with their health data being in the hand of an unsafe person. Moreover, the data need monitoring responsibility to ensure that people used in a drug experiment does not lose data due to negligence and misused. This makes those people that participate in pharmacological research feel used for the wrong purpose when their data fall on the hand of wrong persons.  In addition, some other safety issues are based on the ability of researchers to carry out experiment without error that may interfere with the human body and normal physiological functioning (Fleck 2010, pp16–18).

Risk issues

Another ethical issue in a human drug trial is a risk that the human is subject to. There has been a critical concern about the risk that may be associated with human experimentation that may occur during pharmacological research. The central concern has been the venerability of clients as a human is subjected to conditions that may be dangerous to human life. about, there are concerned about the health insurance as the risk may surpass the cost of insurance allocated for a human subject. Some speculation indicates that human being may be subjected to conditions that may be detrimental to their life in future. This risk needs serious protection depending on the right of a human being used in the experiment. Risk issues determine the willingness of people to take part in clinical trials leading to many people refusing to take part in the experiment (Cartwright & Eileen 2010, pp 260–266).  

There are some measures that have been put in place to deal with safety and risk issues. Firstly, privacy rule is one safety standard put in place to deal with safety concerns that may arise from client’s data safety. There is medical privacy requirement that is observed before human experimentation as this is important to reduce any error that may be associated with the trial.  One of the requirements of this plan indicates that there must be written permission that allows the researcher to use any part of the body or data in research. In addition, the researcher needs to keep personal data and information of clients used in the experiment as safe as possible. The information may be informed of protected health information and this is key to ensure patient’s right are protected at all cost (Ioannidis & Khoury 2013, pp 32). 

Integrity issues in human drug trials


Secondly, obtaining the consent of those concerned in the experimentation is an important response plan to deal with the issue in a human drug trial. There are many elements of consent requirement that include an explanation of the research, research purpose, the risk associated with research, the possibility of compensation and contact person in case of any complication that is associated with research. There is also an institutional requirement that is also connected to the consent and should be complied with before conducting an experiment. Researchers are expected to provide the compliance form to the client that is used in an experiment detailing all the issues that may result in objection of participation in the trial (Petrini 2014, pp 61-3).

Thirdly, client right and client protection is another responses plan that enables a deal with the issues of concerns. Clients have right to information and provide the consent before taking part in drug trials. To protect the patient from any harm, exploitation or their privacy data used for medical research, the researcher is expected to adhere to the set-out legislation that deals with human experimentation. There are also ethical codes of practice when conducting experiments with human subject and this must be observed before any experimentation. One of the requirements is the assurances of protection for human subjects that uphold human rights for those used in the experiment (Giordano 2010, pp 98–603).

Fourthly, regulation of researcher training is another important response plan put in place to help in a drug trial. One of the most important aspects of drug trials includes researchers training that focuses on the qualification of the researcher that enable them to conduct an experiment in the most competence manner. There are strategies put in place to assess the training that researchers have and specific training available to help those involved in the design and conducting the experiment. This implies that under this requirement, personnel must undergo specific training before allowed to conduct experiments with a human subject. Moreover, those directly involved in drug trials must comply with certain requirement before approving experiment to run. This also includes institutional requirement where the experiment is likely to take place. The overall objective of this response plan is to reduce any negligence associated with lack of training (Carpenter 2010).


Adverse medical reporting framework is another response requires that the organization must comply with before conducting human drug trial. This involves reporting any adverse event that may arise from the medical research before escalation. Biomedical research requirement includes compliance with research policies and this includes reporting of medical errors. This adverse event reporting technique should protect the human subject used in an experiment in compliance with privacy rules. Various aspects of research are reported by the researcher, not from any other source as this may complicate the integrity of the data collected an monitoring strategy (Golan, Milella, Ackerstein & Berger 2017, pp 192).

Risk issues associated with human drug trials

Conclusion

In conclusion, pharmacological research in ethics particularly presents various issues that may require an ethical response. The research reveals that pros of pharmacological research include improvement of treatment, finding treatment, and offer material that is used for future biomedical research. Cons of the research include failure to get treatment, the risk associated with the research and result may be no different from normal treatment. Some of the ethical issues that have been concerns are investigator’s training, client right and safety, the integrity of parties involved, obtaining client’s consent and client’s privacy. Response actions and solution for the issues presented include compliance with the right of the client, mandatory investigator training, adverse event reporting framework, compliance with medical privacy requirement and obtain client consent before involving them in trials.

References

Carpenter, DP 2010, Reputation, and power: Organizational image and pharmaceutical regulation at the FDA. Princeton: Princeton University Press. Viewed at https://scholar.google.com/scholar_lookup?title=Robust%20action%20and%20the%20strategic%20use%20of%20ambiguity%20in%20a%20bureaucratic%20cohort%3A%20FDA%20scientists%20and%20the%20investigational%20new%20drug%20regulations%20of%201963&author=D.%20Carpenter&author=C.%20Moore&pages=340-362&publication_year=2007

Cartwright, N & Eileen M 2010, The limitations of randomized controlled trials in predicting effectiveness. Journal of Evaluation in Clinical Practice, vol.16, no.2, pp 260–266. Viewed at doi.org/10.1111/j.1365-2753.2010.01382.x

Deng, C, Hanna, K, Dalakas, MC & Merkies, IS 2012, Challenges of clinical trial design when there is lack of clinical equipoise: use of a response-conditional crossover design. Journal of Neurology, vol.259, no.2, pp 348-52. doi: 10.1007/s00415-011-6200-0.

Giordano, S 2010, The 2008 Declaration of Helsinki: some reflections. Journal of Medical Ethics, vol.36, pp 98–603. doi: 10.1136/jme.2009.034132.

Golan, T, Milella, M, Ackerstein, A, Berger, R 2017, The changing face of clinical trials in the personalized medicine and immuno-oncology era: report from the international congress on clinical trials in Oncology & Hemato-Oncology (ICTO 2017). Journal of Experimental & Clinical Cancer Research, vo.36, no.1, pp 192. doi: 10.1186/s13046-017-0668-0.

Howick, JH, 2011, The Philosophy of Evidence-Based Medicine. London: Wiley-Blackwell. DOI:10.1002/9781444342673

Ioannidis, JPA & Khoury, MJ 2013, Are randomized trials obsolete or more important than ever in the genomic era? Genome Medicine, vol.5, pp 32. doi: 10.1186/gm436.

Fleck, LM, 2010, Personalized medicine’s ragged edge. Hastings Cent Rep., vol.40, no.5, pp16–18. doi: 10.1353/hcr.2010.0005.

Karin, A 2016, Breast Cancer clinical trial participant: Australian Clinical Trials, St. John of God – Bunbury. Viewed at https://www.australianclinicaltrials.gov.au/consumers/real-stories/karin-ashman-breast-cancer-clinical-trial-participant-st-john-god-bunbury

Maitland, ML, & Schilsky RL, 2011, Clinical trials in the era of personalized oncology. CA Cancer Journal for Clinicians, vol.61, no.6, pp 365-81. doi: 10.3322/caac.20135.

Nardini, C 2014, The ethics of clinical trials. Ecancer Medical Science, vol.8, pp 387. doi:  10.3332/ecancer.2014.387

Petrini, C. (2014) Ethics and law in research with human biological samples: a new approach. Drug Metabolic Drug Interact, vol.29, no.1, pp 61-3, viewed 23 December 2015 https://www.ncbi.nlm.nih.gov/pubmed/24317784

Sharma, MR & Schilsky, RL 2012, Role of randomized phase III trials in an era of effective targeted therapies. National Rev Clinical Oncology, vol.9, no.4, pp 208–14. doi: 10.1038/nrclinonc.2011.190.

Teira, D 2011, Frequentist versus Bayesian clinical trials. In Philosophy of medicine, ed. Fred Gifford, pp 255–297. Amsterdam: Elsevier. Viewed at doi.org/10.1016/B978-0-444-51787-6.50010-6

Teira, D & Reiss, J 2013, In: Causality, Impartiality and Evidence-Based Policy Mechanism and Causality in Biology and Economics. Chao H-K, Cheng S-T, Millstein RL, editors. the Netherlands: Springer; 2013. pp. 207–24. Viewed at https://link.springer.com/chapter/10.1007%2F978-94-007-2454-9_11

Wistuba, II, Gelovani, JG, Jacoby, JJ, Davis, SE, & Herbst, RS, 2011, Methodological and practical challenges for personalized cancer therapies. Nat Rev Clinical Oncology, vol.8, no.3, pp 135-41. doi: 10.1038/nrclinonc.2011.2.

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