Human Research Ethics

Question: Discuss about theHuman Research Ethics. Answer: The Historical Aspects and Infuence of Three Documents: The Nuremberg Code: According to Nuremberg Code, the voluntary permission of the human subjects is essential to progress the particular process in an effective manner. It indicates that the person participating in the process should have the legal capacity for giving the permission. As per the particular code, the human subjects must have the adequate knowledge on the nature, duration and the purpose of the experiments (Dhai, 2014). Moreover, the effect of the research should not affect the health of the human subject. According to the code, the experiment should be beneficial for the society and the research should not be random in nature. During the mid-century, the participants had to face challenges for undergoing the treatment process, as they might face physical trouble due to the adverse clinical effects. On the contrary, according to the Nuremberg code, the experiment must be conducted through following a particular set of processes so that it could not make any unnecessary physical and mental s uffering and injury (Monroe et al., 2013). This particular guideline has facilitated in enhancing the clinical trial process in the present days, and it has contributed to shaping up the process for engaging the research on the human subjects. Moreover, the experiment conducted in present days is executed under the supervision of scientifically qualified persons. Similarly, clinical trial process has also been described in the Nuremberg code. The Declaration of Helsinki: The declaration of Helsinki suggests the set of ethical principles on the human experimentation developed by the World Medical Association (World Medical Association., 2013). It has been developed for the medical community, and it is regarded as one of the prime document on the human research ethics. According to the particular law, the duty of the physicians is to promote and safeguard the health of the patients. Moreover, the physicians are responsible for protecting those who are involved in the medical research process. Physicians need to consider the ethical, legal and regulatory rules and regulations for the investigation involving the human subjects. The prime duty of the physicians participating in the medical research is to safeguard the life, health, dignity, privacy, integrity, confidentiality of personal information of the investigating subjects (Millum, Wendler Emanuel, 2013). In the present days, these factors are considered into the other field of human research ethic s apart from the medical sector. For instance, without upholding the dignity into the process, the researcher would not be able to obtain enhanced outcome out of it. On the other hand, the medical research involving the human subjects needs to be followed by the scientific principles and the researcher mush have painstaking knowledge of the relevant sources of information and other scientific literature. Without upholding the modern and scientific process, the researcher investigating on the human subjects would not be able to obtain a beneficial outcome. According to the Declaration of Helsinki, human subjects must have the proper scientific training and qualifications so that the research can be executed in an efficient manner (Adams Miles, 2013). Likewise, in the modern day, the researcher involves the trained human subjects into the research process for obtaining high value in the research. The Belmont Report: The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research created the Belmont Report. The particular report is first issued on 30th September 1978, and it was published in the Federal Register on 18th April 1979 (Brakewood Poldrack, 2013). The particular legislation indicates the unifying ethical principles, which develops the basis for the National commissions topic-specific reports. According to the Belmont Report, there are three fundamental ethical principles to utilize the human subjects for investigation. Three fundamentals are respect for the person, beneficence and justice (Sieber Tolich, 2012). The researcher needs to treat the human subjects with proper courtesy, and the human subject needs to be respected in an efficient manner. Besides this, the human subjects should not face any harm during the process. Lastly, the human subjects need to be provided the non-exploitative situation. Moreover, the participants should obtain the fa ir distribution of the costs and benefits so that they could be encouraged for the future research. By analysing the Nuremberg code, it can be assessed that the volunteer permission of any human subjects is needed for involving him into clinical trial process. Likewise, in the human resource management system, the manager needs to accumulate the feedback and suggestions before implementing a process in to the business. On the other hand, the experiment needs to be benefited t the employees. On the other hand, the declaration of Helsinki indicates the ethical approaches for the medical community. According to the declaration of Helsinki, the physicians should be responsible for the protection of health of the patient. Moreover, the physicians need to provide a safeguard to the patients. Similarly, the human resource management team needs to safeguard the employees in the difficult situation. With the involvement of the scientific training and development session, the manager could easily enhance the workability skills of the employees. According to Brakewood Poldrack (2013), the Be lmont report draws the ethical principal for utilising the human subject to investigate. It focuses on three fundamentals including respect for the person, beneficence and justice. Likewise, these fundamentals are also applicable for the human resource team, as these rules could facilitate them in providing respects to the employees. Consequently, these rules can improve the productivity in an effective manner. Role of Human Research Ethics Committees: The human research ethics committee plays an integral role and responsibility in the Australian system for identifying the misunderstanding of the research concerning the humans. The human research ethics committee accurately reviews the research proposals, which involves the human subjects for ensuring the fact that the participants are ethically acceptable and in accordance with the pertinent standard and guideline (Bell, 2014). More than 200 HRECs have been regulating the particular process in Australia. However, other countries also follow this kind of similar system. The national statement focuses on the participants rather analysing on the subjects. According to the national statement, the values need to be set out for the research process. For instances, the investigator needs to have the respect for the human subjects. Moreover, there should be mutual responsibility, trust and ethical equality in the research process. The national statement includes a series of the guideline for any researcher conducting the investigation with human subjects (National Health and Medical Research Council, 2016). Moreover, the particular guideline consists of regulations for the potential research participants. Finally, it can be assessed that the prime role of the human research ethics committee is to identify the rule highlighting the fact that human being needs to be provided adequate respect for upholding the ethical values in an efficient manner. The entire design of the research must be followed by the particular set of guidelines so that the research outcomes facilitate in conducting the future project (National Statement on Ethical Conduct in Human Research, 2007). The HREC plays an integral role in the governance of research. Moreover, it provides the approval to the new organization conducting the future project. The human research ethics committee accurately reviews the research proposals, which involves the human subjects for ensuring the fact that the participants are ethically acceptable and in accordance with the pertinent standard and guideline. Main Ethical Issues Surrounding RCTs: Randomized controlled trial (RCTs) indicates a particular type of scientific experiment aiming to reduce bias while testing a new treatment or pharmacological agent. The participants of the trial are allocated to the group that receives the treatment under the investigations and a control group who does not have the treatment. Randomization facilitates the analysis to reduce the biases from the experiments. In the clinical trial process, patients are assigned to the groups receiving different treatments. Hence, the method of assigning the patients into group is called randomization. Over the past few decades, the randomized controlled trials have been increasing, as it enhances the outcome of the clinical trial Buchanan (Wordsworth Schuh, 2013). Moreover, the randomized case trial is more powerful than case reports and observational studies. During the same timeline, the randomized controlled trial was an integral part of the regulatory process, as it facilitates the new therapeutic in gaining access to the drug market. Nowadays, the clinical trials have become strict, as new rules and ethical approaches have been implemented to it for obtaining enhanced outcomes in an efficient manner. On the other hand, these days, the organization conducting the clinical trial, needs to abide by a set of ethics so that the human subjects do not face any physical or mental challenges during the execution process (Chaudhry et al., 2013). Without upholding the ethical requirements, the clinical enterprises are no able to execute the particular process in an effective manner. Besides this, the organizations need to uphold the epistemic standards while conducting the clinical trial. It is a legacy to the old treatment for involving the human subjects into the clinical trial. During the World War II, human experimentation was conducted. However, this legacy continues even after World War II. Consequently, this particular process built up negative impression when some identical ca ses of unethical handling of human subjects. During that timeline, prisoners, the mentally challenged, the poor or the ethnic minorities had been involved in the clinical trial process. These groups of people were hired for conducting the ill-famed Tuskegee syphilis study (Sieber Tolich, 2012). The execution of such practices in democratic and civilized countries indicated that the war slaughter were not the only threats for the human subjects. Hence, the conception of such process had to be reformed entirely so that it could not hurt any human subjects (Lewis, Lipworth Kerridge, 2014). Until the 1970s, the medical investigators had sole authority adjudicating the legitimacy of a study protocol. The protection of the participating patients had to be given by the physician. According to Hippocratic Oath, the doctors should provide the safeguard to the patients while conducting research on human subjects. However, the particular research ethics is completely different from the medic al ethics. On the contrary, these ethics emerged when the episodes of the research delinquency uncovered such assurance in all its meagreness. There are some ethical issues surrounding RCTs. The general problem of the clinical trials can be identified through highlighting the fact that the trial participants often are avoided from the benefits of this particular process. In most of the cases, human subject gaining from the trial results and the trial participants bearing the risk and burden are different. On the other hand, participating in the new clinical trial indicates a high-risk factor compared to having an ordinary clinical check-up. There would be the unexpected effects of the new treatments on the participants. However, these risks are not entirely covered by the legislations. Moreover, the potentially beneficial aspects of the clinical process do not properly counterbalance. The particular trial process not only ended by treating the participants but also produce in-depth medical knowledge. During the mid-century, most of the physicians did not provide adequate information to the participants. Consequently, these participants were placed into the process through the disproportional step. On the contrary, nowadays, the participants are guided by all information about the entire process and the probable outcome of the research. Previously, the physicians deceive the participants by promising a cure for their individual disease that they were dealing with it. Hence, the modern system indicates the fact that the physician must allow the patients to accept the entire process of conducting the particular process. The most important ethical consideration of modern biomedical, clinical trial is that the informed permission is now an integral condition for both research and therapy. According to the modern conception, the prime consent of therapy or research protocol includes three basic features for validating the process in an effective manner. These features are such as the process must be voluntarily expressed, it should be the expression of the proficient subject, and the human subject must have adequate information about the particular process (Turner et al., 2012). However, the physicians often face challenges to identify what level of adequate information is needed to be valid for the particular clinical trial process. Without providing the adequate information on the risks and benefits of the treatment to the patients, physicians may not obtain the approval for the continuation of the process. The participants may undergo the process of blinding and randomization for understanding that the research is voluntary (Hebden, Chey Allmanà ¢Ã¢â€š ¬Ã‚ Farinelli, 2012). It indicates the unjustified to the participants, as they are unable to obtain the benefits out of the process. The patients are required to have the in-depth understanding of the diagnostic or the therapeutic process. Moreover, they should have the adequate knowledge on the risks and benefits of the particular process. In the modern medical research process, the prime issues indicate the fact that the aim of the research does not directly benefit the research participants. However, the patients may receive the therapeutic benefits due to the engagement into the clinical trial process. Sometimes the personal expectations of the patients and investigators may play an integral role in the progression of the process. Consequently, the scientific test of new intervention often requires the patients to receive the pla cebo. Although the placebo lacks the active role of the experimental treatment, it is identical with it. The prime issue for using the placebo is that the physicians often face challenges to make them believe that the placebo plays an integral role in the treatment process. Randomization and blinding are both epistemic devices needed in the clinical trial process for ruling out the most palpable perturbations of the trial outcomes due to the interference from the researcher of the participants (Jenkins et al., 2013). Hence, it can be assessed that the particular process includes distinctive issues highlighted in the above discussion. By analysing the above discussion, it can be assessed that the clinical trials have become increasingly complex for evaluating the clinical research progress. The ethical consideration needs to be abreast of new changes for providing adequate guidance for the medical research in the future. There are several advantages of RCTs. The RCTs facilitate in el iminating the bias to assign the treatment properly. Moreover, it contributes in masking of the identity of treatments from the investigators, participants and assessors. References: Adams, D. P., Miles, T. P. (2013). The application of Belmont Report principles to policy development.Journal of gerontological nursing,39(12), 16-21. Bell, J. (2014).Doing Your Research Project: A guide for first-time researchers. McGraw-Hill Education (UK). Brakewood, B., Poldrack, R. A. (2013). The ethics of secondary data analysis: considering the application of Belmont principles to the sharing of neuroimaging data.Neuroimage,82, 671-676. Buchanan, J., Wordsworth, S., Schuh, A. (2013). Issues surrounding the health economic evaluation of genomic technologies.Pharmacogenomics,14(15), 1833-1847. Chaudhry, S. H., Brehaut, J. C., Grimshaw, J. M., Weijer, C., Boruch, R., Donner, A., ... Zwarenstein, M. (2013). Challenges in the research ethics review of cluster randomized trials: International survey of investigators.Clinical Trials,10(2), 257-268. Dhai, A. (2014). The research ethics evolution: From Nuremberg to Helsinki.SAMJ: South African Medical Journal,104(3), 178-180. Hebden, L., Chey, T., Allmanà ¢Ã¢â€š ¬Ã‚ Farinelli, M. (2012). Lifestyle intervention for preventing weight gain in young adults: a systematic review and metaà ¢Ã¢â€š ¬Ã‚ analysis of RCTs.Obesity Reviews,13(8), 692-710. Jenkins, V., Farewell, V., Farewell, D., Darmanin, J., Wagstaff, J., Langridge, C., Fallowfield, L. (2013). Drivers and barriers to patient participation in RCTs.British journal of cancer,108(7), 1402-1407. Lewis, J., Lipworth, W., Kerridge, I. (2014). Ethics, evidence and economics in the pursuit of personalized medicine.Journal of personalized medicine,4(2), 137-146. Millum, J., Wendler, D., Emanuel, E. J. (2013). The 50th anniversary of the Declaration of Helsinki: progress but many remaining challenges.Jama,310(20), 2143-2144. Monroe, T. B., Herr, K. A., Mion, L. C., Cowan, R. L. (2013). Ethical and legal issues in pain research in cognitively impaired older adults.International journal of nursing studies,50(9), 1283-1287. National Health and Medical Research Council. (2016) Human Research Ethics Committees (HRECs) |.Nhmrc.gov.au. Retrieved 20 September 2016, from https://www.nhmrc.gov.au/health-ethics/human-research-ethics-committees-hrecs National Statement on Ethical Conduct in Human Research (2007) - Updated May 2015 | National Health and Medical Research Council. (2015).Nhmrc.gov.au. Retrieved 20 September 2016, from https://www.nhmrc.gov.au/guidelines-publications/e72 Sieber, J. E., Tolich, M. B. (2012).Planning ethically responsible research(Vol. 31). Sage Publications. Turner, L., Shamseer, L., Altman, D. G., Weeks, L., Peters, J., Kober, T., ... Moher, D. (2012). Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals.The Cochrane Library. World Medical Association. (2013). World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.Jama,310(20), 2191.