- NURS FPX 5005 Assessment 1 Protecting Human Research Participants.
Protecting Human Research Participants
Because of its antecedent in an era of savagery in conducting research, there is a dire call in matters of ethics to protect the human subjects involved in the study. To avert future wrongful doings and conduct research with the maximum respect for the individuals’ rights and their dignity, it is unconditionally imperative to act ethically and protect participants from harm. Engaging society’s knowledge enhancement towards ethically encouraging research can bear the following ethical standards: consent, privacy, and risk control.
History and Importance of Human Subject Protection
Erich’s research conducts that were said to infringe on human rights and cause great suffering have a worse background that cannot be separated from the history of protecting human subjects (White, 2020). The first example is one of the dark chapters of the medical field; the Tuskegee Syphilis Study conducted from 1932-1972 (Zbar, 2022). From this research, it was discovered that African American male patients with syphilis received minimal access to treatment even with the existence of treatment drugs (White, 2019).
That is why there were numerous ethical violations in these trials: they were risking human lives. The Nuremberg trials after the Second World War are the second historical event that proves that human beings should be protected. Some of the trials were trials of Nazi physicians for torturing tests on prisoners, which would lead to their anguish or death (Zvyagintsev, 2019).
These trials resulted in the formulation of certain moral principles universally accepted as the Nuremberg Code governing the use of human subjects in scientific research. An overview of the research process provided important consideration for informed consent and participant safety (Gallin & Bedzow, 2022).
An exploration of the impact of prison settings on prisoners was undertaken at Stanford University in 1971 by Philip Zimbardo through the study known as the Stanford Prison Experiment. The power dynamics and authority with moral concerns of the participants were shown after only six days when the study was stopped, and one learned about the psychological effects of power relations and authority; other moral issues and concerns about the safety of the participants in the conducted study (Bartels, 2019).
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Significance and Evolution of Protecting Human Subjects
Fundamental principles of protecting people derived from historical fallacies, as presented by the Stanford Prison Experiment, the Tuskegee Study, and the Nuremberg Trials, hold the ethical base about human beings. It is very important to protect the rights and interests of the research participants underpinning such psychological and historical incidents.
The area of ethical research needs to have a high level of standards to address the issue of unlawful access to private data and then protect it. This evolution is due to the combination of research advancement with regulation enhancement, such as social behavioral education (SBE) and the Collaborative Institutional Training Initiative (CITI) (Cascio & Racine, 2019). Due to the plurality of the research methodologies, new ethical issues emerge; for example, the study has ethical implications for incorporating genomics, artificial intelligence, and big data (Rendtorff & Kemp, 2019).
Types of Research
Among the most common studies conducted on individuals, there is one known as clinical research. To determine the advantages and disadvantages of a new cancer therapeutic medicine, scientists perform experiments on people (White, 2020). Psychological research commonly consists of human participants to effectively explain human behavior, thoughts, and feelings. One of the possible approaches when recruiting human trial participants is to determine the impact of stress on mental performance (Pavarini et al., 2021). Research in biology and genetics very often requires participants from among human beings.
An example is research on establishing the biomarkers of a specific genetic disorder involving the solution of DNA samples from contributing human subjects (Palk et al., 2020). Studying behavior is conducted to gain knowledge on how people behave and, in the process, change their behavior. For example, Olson pointed out that it may examine how observational data and behavior modification strategies could help people change their dietary patterns for the better. Using people as participants in their studies, researchers in the social sciences employ a wide range of topics in forms such as surveys, interviews, or observations (Olson, 2021).
Strategies to Minimize Potential Risks
Essentially, any research that involves people has to ensure that certain levels of harm are avoided. Hence, one important strategy is to implement a complex and rigorous informed consent protocol (Shamoo, Khin-Maung-Gyi, 2021). Researchers can inform participants about the study’s procedures and potential benefits and risks of participation in the given study so they may have the capacity to make rational decisions.
One more strategy to exclude high possible risks and maintain the study design is the application of careful ethical evaluation and monitoring (Teays & Renteln, 2020). Lawful and ethical issues must be met before research commences, and an institutional review board provides for this.
NURS FPX 5005 Assessment 1 Protecting Human Research Participants
Further, the objective is for ethical advisors to assist in reviewing the study’s method and deem any harm to human participants as a concern without undermining the quality of the research study. Another possible very successful strategy is to use encrypted or de-identified data (Gallin & Bedzow, 2022). Survey research where the data collected is sensitive is well suited for this technique.
There is also the issue of minimizing interference during the process, whereby we use the least invasive approach. Olson, 2021 further opines that risk assessments and procedures ought to be conducted and bolstered for the safety of human subjects. For instance, as identified by Colozzi et al. (2019), some risks may be significantly reduced by clinical trials due to early identification and quick mitigation of adverse events facilitated by comprehensive safety monitoring.
Additional Protections for Federally Identified Research
To a point, it is necessary to note that the federal government further recognizes the necessity for additional precautions to safeguard the ethical usage of vulnerable populations for research (Palk et al., 2020). Special protection is important in the above vulnerable groups, including children, pregnant women, prison inmates, and physically challenged persons. For instance, the consent of the minor and their legal guardian must also be sought when recruiting a minor for research. The dual permission approach helps support human rights in a manner that also preserves a child’s safety and fulfills their best interests.
Using a middleman is one of the ways of ensuring humanity is safeguarded (Olson, 2021). This ensures that principles of beneficence and justice will apply and that the study will be done without exploiting the people the research targets to willingly subject them to its benefits. Gallin & Bedzow (2022) state that an important aim of research with the pregnant woman should be the improvement of the mother’s health and the health of the fetus.
NURS FPX 5005 Assessment 1 Protecting Human Research Participants
In their opinion, based on Gallin and Bedzow (2022), this framework entails the cardinal rules of beneficence and non-maleficence to protect these vulnerable persons. While researching human participants, one has to be very careful because it alters the outcome of the research. We have to be concerned about their moral standards and vulnerability as a community.
Nevertheless, it has to be stated that these measures contribute to the overcomplication of the study and may also pose certain challenges since they are aimed at maintaining ethical standards and ensuring that research is receiver-oriented and respects the rights and well-being of vulnerable groups as per definitions provided by the federal government (Michelson et al., 2022). Especially about the considerations of the specificity of the research relationship, these measures indicate the responsible approach to conducting research as well as respect for human dignity.
Ethical Standards Applied in Research
The set of principles that guarantee that research is carried out with integrity and respect for the people involved is positively called an ethical standard. In their study to address the research question, Rentorff and Kemp (2019) identified one vital model of ethical principles that include the informed consent principle.
This stipulation requires detailed participant information, which is an issue of method but respects participant self-governance. Varkey (2021) defines the beneficence principle as when individuals must produce value and avoid nasty, pernicious things.
As a researcher, you have an ethical responsibility not to harm your subjects in any way in the course of your research, depending on the principle of non-maleficence. The idea for both research opportunities and rewards must be fairly and equitably distributed to ensure there is justice. Some restrictions are put on research involving health-related information by regulatory privacy rules like HIPAA in the US (Michelson et al., 2022).
Ethical principles of research determine the criteria for considering the primary principles in the study procedure. In the job, they have said that the analysis will be conducted ethically and in the participant’s best interest. Bias is eliminated when research complies with these features; it enables the study of participants with the respect they require (Teays & Renteln, 2020).
Conclusion
The ethical guidelines address the participants’ rights in the study. The background of appalling unethical research practices, such as the Tuskegee Syphilis Study and the Nuremberg Trials, draws attention to the importance of strict ethical norms in research. The ethical issue of human research subject protection calls for the provisions for privacy, consent, and risk mitigation.
References
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