I’m working on a writing discussion question and need support to help me understand better.
Hi, please answer to each DQ with 200-250 words
Ethical issues that can arise from translational research are diverse and complex. These can be similar to issues faced in biomedical research such as “informed consent, animal bioethics, conflicts of interest, social injustice, and risk analysis ethics” (Mandal et al., 2017). Ethical issues with confidentiality of data and participant information can also arise. Principles of ethics such as beneficence, nonmaleficence, autonomy, and justice should be established as ethical guidelines for the research. The well-being of the participants and the society should be prioritized rather than the advancement of scientific knowledge.
Informed consent should be emphasized to ensure that participants are aware of the risks, benefits, and procedures involved in the research. Participants should also be informed of their right to withdraw from the research. The autonomy or right of the participant to make a decision with complete understanding and without external or internal controlling factors should be respected. Therapeutic misconception or “erroneously attributing therapeutic intention to research procedures or unreasonably judges medical benefit from participation in the research” should be avoided (Mandal et al., 2017). Patient safety should also be prioritized to ensure beneficence and nonmaleficence.
Legal considerations about the patient’s dignity, and privacy. Efforts should be made to ensure confidentiality of the patient’s identity. It is the researcher’s responsibility to ensure that any disclosure of information made by the participant will not cause harm to him/her. Legal consequences can also arise from any fraudulent action done by the researcher in publication or completion of the research study. Appropriate measures to obtain consent should be made for participants who are not legally allowed to give consent such as children.
To ensure safety and proper ethical guidelines are established, I will conduct an extensive risk-benefit analysis. Risk-benefit analysis involves assessing possible risks and burden to participants involved in the research in comparison to the possible benefits (Riva & Petrini, 2019). This step minimizes the potential harm for the research subjects and the populations affected (Mandal et al., 2017). After completing this step, I will strive to create changes that will prevent the foreseeable harm to the participants in the research. I will then provide sessions with the participants to ensure that they truly understand the risks, benefits, and processes of the research. I will also emphasize that they have the right to withdraw at any moment and explain the measures taken by the team to ensure their privacy.
Mandal, J., Ponnambath, D.K., & Parija, S.C. (2017). Ethics of translational medical research. Tropical Parasitology, 7(2), 62-64. https://doi.org/10.4103/tp.TP_47_17
Riva, L., & Petrini, C. (2019). A few ethical issues in translational research for gene and cell therapy. Journal of Translational Medicine, 17(395), 1-6. https://doi.org/10.1186/s12967-019-02154-5
Individuals who participate in research serve as sources of data. Researchers have a responsibility an obligation to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of their personal information of the research subjects. According to the Belmont Report researchers should follow three ethical principles when conducting research. Researchers should show respect to the individuals by acknowledging autonomy and protect those individuals with diminished autonomy. Researchers should provide beneficence by not causing harm, maximize possible benefits and minimize possible harms. Researchers should provide justice to the individuals and societal level. It is important for research individuals not to be mistreated or it is called research misconduct. Researchers must follow an approved protocol, proper informed consent, avoid causing physical or psychological harm, avoid fraud and deception, and maintain individual confidentiality. Researchers also need to avoid bias, inappropriate research methodology, incorrect reporting as well as inappropriate use of the individual’s information. The research must ensure to obtain approval from the various regulatory bodies before conducting any research study.
In 2016 the federal government approved a significant increase in government spending on scientific research. The National Institutes of Health (NIH) was increased from $2 billion to $32 billion for the following year (HuffPost, 2017). The recent increase in research activities has led to concerns regarding ethical and legal issues. Guidelines have been developed by organizations and authorities to ensure that researchers follow a process that promotes integrity, compliance, and ethical standards in research conduct. These guidelines and interventions are set in place and must be followed to avoid having fraud which would discredit the quality of establishing evidence-based medicine. Researchers will follow the general guidelines of ethical and legal principles and will enable them to conduct their research in accordance with the best practices (Yip et al., 2016).
HuffPost. (2017). Scientific research needs more funding, but also smarter spending. https://www.huffpost.com/entry/scientific-research-needs_b_9244102#:~:text=The%202016%20federal%20budget%20approved%20in%20December%20was,billion%2C%20to%20%2432%20billion%20for%20the%20upcoming%20year.
Yip, C., Han, N. R., & Sng, B. L. (2016). Legal and ethical issues in research. Indian journal of anaesthesia, 60(9), 684–688. https://doi.org/10.4103/0019-5049.190627
There are several reasons why it is important to adhere to ethical norms in research. First, norms promote the aims of research, such as knowledge, truth, and avoidance of error. For example, prohibitions against fabricating, falsifying, or misrepresenting research data promote the truth and minimize error.In practice, these ethical principles mean that as a researcher, you need to: (a) obtain informed consent from potential research participants; (b) minimize the risk of harm to participants; (c) protect their anonymity and confidentiality; (d) avoid using deceptive practices; and (e) give participants the right to know the content of the research. There are six broad ethical areas that need to be considered in your research. In this chapter, we will discuss voluntary participation, informed consent, confidentiality and anonymity, the potential for harm, communicating the results, and more specific ethical issues. Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice. These ethical norms include issues such as requirements for honesty, requirements for informed consent, anonymization and storage of data, the right of access to data for participants and duty of confidentiality for all those who undertake research.
Research ethics are important for a number of reasons. They promote the aims of research, such as expanding knowledge. They support the values required for collaborative work, such as mutual respect and fairness. They support important social and moral values, such as the principle of doing no harm to others.
Translational research seeks out the possible human applications of scientific and clinical findings and translates them into strategies for improving healthcare delivery, patient outcomes, and community health. This is a horizontal knowledge role that unites different specialties. One prime example of translational research in human disease is the study of cancer therapy. Extensive cooperation between basic researchers, clinicians, and industry has generated numerous new targeted compounds with enhanced efficacy and decreased toxicity.
Whereas basic research is looking at questions related to how nature works, translational research aims to take what’s learned in basic research and apply that in the development of solutions to medical problems.Phase I and II Clinical Trials is integrate as a basic scientific discovery into a candidate health-care application. Phase III Clinical Trial that assess the value of the application for health-care practice and develop evidence-based guidelines for using the application.In sum, participation in translational research benefits basic scientists by enabling them to contribute to the understanding of human health and disease and to participate in the development of solutions to medical and public health problems, which can be a source of intellectual inspiration and stimulation.
Research can have important influences on policy by providing a scholarly basis for action research, and translation science units within academic health centers are in powerful positions to build bridges between the research and policy making communities to promote the development of evidence based policy. Risk of bias can seriously adulterate the internal and the external validity of a clinical study, and, unless it is identified and systematically evaluated, can seriously hamper the process of comparative effectiveness and efficacy research and analysis for practice.
Translational research involves many scientists and clinicians compiling multiple data types and sources. These may include deidentified patient data, whole genome or exome sequences, specific tumor sequences, specimen records from patient blood draws, biopsies, and more.
Mandal, J., Ponnambath, D. K., & Parija, S. C. (2017). Ethics of translational medical research. Tropical parasitology. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5652056/.
Hostiuc, S., Moldoveanu, A., Dascălu, M.-I., Unnthorsson, R., Jóhannesson, Ó. I., & Marcus, I. (2016, January 15). Translational research-the need of a new bioethics approach. Journal of translational medicine. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4714424/.
Hutton, J. L., Eccles, M. P., & Grimshaw, J. M. (2008, December 17). Ethical issues in implementation research: a discussion of the problems in achieving informed consent. Implementation science : IS. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2639614/.