Essay on Ethical guidelines in Translational Research

Essay on Ethical guidelines in Translational Research

Translational Research Framework and Legal and Ethical Consideration & Research Appraisal

Ethical guidelines in Translational Research

Translational research entails the transfer of research knowledge into clinical practice to aid in diagnosis, treatment, and prevention of diseases. Humans are the main subjects in translational research, a factor that makes it feasible to mandate the protection of the subjects using laid down ethics and guidelines. The guidelines are meant to reduce risk while enhancing benefits from a proposed research. Thus, the focus of this paper is to explore the legal and ethical consideration in translational research.

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Execution of translational research proceeds in phases as well as laid down process under which the researcher makes several considerations. The phases range from T1 through T5. T1 is the preapproval phase, T2 preclinical, T3 is the human research phase, T4 entails implementation into clinical practice, and T5 entails implementation in public health (Mandal et al., 2017 Essay on Ethical guidelines in Translational Research). All the steps must be followed before putting research into practices. The translational process encompasses phases, gaps, and data transfer. During phase period, various ethical considerations including risk benefit analysis, obtaining informed consent, social injustices, and dealing with conflict of interest are considered. The aim of risk benefit analysis is to minimize harm to research subjects while analyzing the benefits that will arise from the research.

Under informed consent, the researcher has the obligation to provide the research subjects with adequate information about the research, benefits, and risks, allowing them to voluntarily participate or withdraw from research any time. Conversely, funding is always the major obstacle as funding will be done based on the probability of success and commercialization rather than the benefit of the research to public health. Data transfer majorly deals with confidentiality of subjects` information. Patient information must never be shared without their consent. Finally, all the ethical considerations must be put in place to enhance protection of the subjects while eliminating bias.

Institutional Review Board (IRB)

IRB are involved in all stages of researches that involve human subject. The major objective of IRB is to protect the human subjects from harm that may result from research practices. IRB roles entail reviewing, approval, evaluation, and monitoring of research. The roles can further be broken down to include reviewing ethical acceptability of research on human protection, evaluating compliance to regulations, research approval, reviewing the plans of the research before the research is conducted, checking bias, review the process of obtaining consent, and continuous monitoring of research as it develops (Nesom et al., 2019). IRB can stop the research process at any point incase of violation of the rights of human subjects or when the risks outweigh the benefits of the research. all the roles performed by IRB are aimed reducing risks in relation to prevailing benefits to human subjects.

Research carried out in human subject is guided by the principles of respect, justice, and beneficence. The building pillars for the three principles include informed consent, confidentiality, privacy, fair recruitment, privacy, and risk benefit analysis. Data from the patients must be kept under protected measures to avoid illegal access of the information by unauthorized persons. Additionally, members must voluntarily accept to participate and be free to withdraw from research without facing any consequences. The vulnerable population including children, prisoners, children, elderly people, the physically impaired, and refugees must be provided with additional protection. This is aimed at reducing harm to this population while protecting the rights of the people. Informed consent, confidentiality, fait treatment, and privacy must be provided to the vulnerable population just like the normal population. IRB is actively involved in all human researches to enhance fairness and protection of all humans regardless of their position in the community.

Reliability and Validity in Research Design

Reliability in research design is defined as the measure of consistency of research. Reliability can be measured using internal consistency, retest, split halves test, and alternative form test. A low random error is considered reliable. Patel et al. (2019) evaluated the different methods of reducing central line infections, specifically focusing on the role of multimodal approach in reducing central line infections. In the same study, the rate of central line infection and utilization of device was also measured. The result revealed reduced device utilization from 24.5 to 22.07. However, there was observed decreased rate of central infection following interventions given. The random error was low making the study reliable.

Validity on the other hand is the measure of the accuracy of the intended measurement.  It can be measured using content validation, construct validation, and criterion related validation. A low non-random error is considered valid. Noteworthy is that the study by Patel et al. (2019) was carried out in two phases divided as preintervention and post intervention. Monthly data was collected and submitted for review. Cumulative attributable difference was used to provide aggregate on preintervention and post-intervention while sanky bar graph were used to present the same data. The overall result shown reduction in infection, however, the effect of multimodal approach was not appreciated. Accuracy was achieved in the study thus valid.

Data collection

The data collection tool is could use is the use paper-based survey and reviewing medical records. The paper-based survey is aimed at providing basic information about the research from nurses and other health care providers who take care of the patients. Specific parameters will be provided to gather more information (Hanson et al., 2018). Reviewing medical records will provide further information about patient diagnosis, clinical presentation, laboratory tests and other clinical signs and symptoms.

However, there are various barriers anticipated during data collection. These includes missing information from medical records, non-cooperative staff, limited time, insufficiency of funds, uncooperative study participants, and limited regulatory support. Overcoming these challenges requires proper planning, having a working team, budgeting appropriately, finding reliable funding individuals, training staff members, gaining informed consent.

Interventional translation is the chosen type. It will involve testing different interventional methods while assessing outcome. This will help in decision-making concerning effectiveness of one type of intervention to the other. Various barriers are expected during research including uncooperativeness and lack of knowledge about the research (Sun et al., 2017). To overcome the challenges and enhance collaboration, various measures must be put in place. These measures including explaining the objectives of the research clearly, training members, holding conference and webinar meetings to discuss the importance and the steps to be taken during research, developing effective communication skills, and assuring competency and confidentiality.

Essay on Ethical guidelines in Translational Research References

Hanson, H. A., Hay, W. W., Jr, Tobin, J. N., Barkin, S. L., Atkins, M., Karagas, M. R., Dozier, A. M., Wetmore, C., Konstan, M. W., & Heubi, J. E. (2018). Opportunities for life course research through the integration of data across Clinical and Translational Research Institutes. Journal of Clinical and Translational Science2(3), 156–162. https://doi.org/10.1017/cts.2018.29

Mandal, J., Ponnambath, D. K., & Parija, S. C. (2017). Ethics of translational medical research. Tropical Parasitology7(2), 62–64. https://doi.org/10.4103/tp.TP_47_17

Nesom, G. L., Petrof, I., & Moore, T. M. (2019). Operational characteristics of institutional review boards (IRBs) in the United States. AJOB Empirical Bioethics10(4), 276–286. https://doi.org/10.1080/23294515.2019.1670276

Patel, P. K., Greene, M. T., Jones, K., Rolle, A. J., Ratz, D., Snyder, A., Saint, S., & Chopra, V. (2019). Quantitative results of a national intervention to prevent central line-associated bloodstream infection: A pre-post observational study: A pre-post observational study. Annals of Internal Medicine171(7_Suppl), S23–S29. https://doi.org/10.7326/M18-3533

Sun, C., Dlamini, P. S., Maimbolwa, M. C., Changala Lukwesa Mukonka, C., Nyamakura, R., Omoni, G., Seboni, N., & Larson, E. (2017). Success stories: Overcoming barriers to research in southern and eastern African countries. Clinical Nursing Research26(4), 399–418. https://doi.org/10.1177/1054773817718935