Research Framework and Legal and Ethical Translation
Name
Affiliation
Course
Instructor
Due Date
Clinical research should be well structured in an organized way for the findings to be considered authentic. However, this takes time, and ethical questions come up when urgent interventions are required. Issues arise whether to forego some stages and involve human subjects or let the pandemic go on as proper trials continue. This essay will explore legal or ethical guidelines to consider before involving human subjects in a clinical trial, steps to take in translational research, and how to balance the ethical concerns.
Topic 2 DQ 1
All researchers have a role in adhering to the ethical concerns before involving human subjects in trial interventions regardless of the urgency. Some of the ethical aspects of factors include informed consent, transparency, dignity preservation, respect, and confidentiality. The Belmont Report summarizes these in three factors, including beneficence, justice, and respect for persons (Yip et al., 2016). Informed consent ensures that individuals agreeing to participate in research learn about the risks and benefits. Transparency issues see to the disclosure of necessary information while dignity preservation entails issues such as allowing needed freedom. Respect is also vital from the time of approach, selection, and during the research. Researchers also have a role in protecting the identity of participants. All these ethical issues help to maintain human integrity and promote the common good of people. The Fair scenario seems to violate some of the ethics in that it is disorganized, and their approach seems disrespectful. There is also the question of beneficence and transparency.
If I were involved in the Fair trial, I would take various steps to adhere to ethical guidelines. First, there is a need to identify a prospective candidate using the inclusion criteria, approach them with respect, and obtain their voluntary willingness to participate (DeNisco, & Barker, 2016). Another step is to inform the identified candidates on risks and benefits they will gain and see if they voluntarily agree. It is also crucial to give any additional relevant information for the research-centered primary purpose. Such could include, what happens upon withdrawals, the participant’s role in the study, and duration, among others. Informing the candidates on their right to participate, withdraw, or refuse to participate in the research is necessary. Furthermore, a researcher should give all kinds of information or print it in a language the participant can understand. Information obtained also has to be documented, including date, and the participant allowed signing.
Topic 2 DQ 2
During the research, justice, research burdens, potential benefits, and respect for persons should be kept in balance. The U.S. Department of Health & Human Services (2020) gives a recap of the Belmont report on balancing issues. For instance, respect for persons should see that the anonymity of participants is maintained. It is also vital to factor the moral requirement for protecting those with diminished autonomy. By all means, choices and opinions of individuals are not to be obstructed unless they are detrimental. Further, the issue of justice entails fairness distribution. Researchers also ensure balance in justice by giving participants their benefits. There should be no imposing of unduly burdens, and equality is a vital factor. Further, research burdens and potential benefits are balanced through assessment. This means an examination to determine if the research is designed well and evaluate whether the projected risks to the participant are well justified. The evaluation should inform the prospective subjects and enable them to determine if they will participate in the clinical trial or refuse.
Various ways exist in which individuals can ensure balance in the construct of respect, justice, risks, and potential benefits. For example, when balancing the respect aspect, one has to agree to the subject’s judgments and allow the subject to act on their proposed judgment. Availing all the information necessary for individuals to make their judgment is crucial, except when there is a compelling reason to withhold. Another example of balancing the justice factor is to ensure each subject receives their equal share based on their needs, and each participant gave efforts. Other factors, such as societal distribution and merit basis, also play a vital role in determining the share that a person should get (Jharna et al., 2017). Another example of balancing benefits and risks and benefits is identifying the favorable benefit or risk. This works on the principle of beneficence, whereby the research should promote goodness. This means that the probable risk should be “small” and of a lesser magnitude. On the other hand, health positive related values mean a researcher does not cause economic, social, legal, physical, and psychological harm to individuals. For instance, a participant should not incur the financial cost or lose his or her friends due to participating in research.
Conclusion
Clinical trials are vital as they provide interventions that ease health problems. However, researchers should not violate the proposed ethical guidelines. Consequently, it is critical to ensure that prospective individuals give their consent, and the recruitment criteria involve respect, justice, benefits, and risk assessment considerations.-2