Name
Capella University
NURS-FPX5005: Managing Health Information & Technology
Instructor’s Name
September 21st, 2024
Protecting Human Research Participants
As one of the elements, an ethical practice aims to safeguard the rights, welfare, and safety of the subjects engaged in scientific research. Therefore there should be a complete ban as described through other examples including the Tuskegee Syphilis Study or the Nazis’ experiments on Jewish prisoners (Barlow 2020) These premises have gradually been created from those ethical principles such as informed consent, respect for and non-exploitation of participants as stated in the Nuremberg Code; Declaration of Helsinki; Belmont Report. These steps are intended to enhance both accountability and transparency of scientific practices while preserving the paradox of using knowledge for improvement on the one hand and preventing the human race from suffering on the other. However, Sulkowski noted that ethical monitoring is appropriate to new topics even now because it can guarantee the rights and human dignity of the participants in the study regardless of the field.
The history and significance of honoring the rights of a human subject
Most of the ethical violations that led to the development of protective measures have informed the history of human research subject protection. Other real and famous experiments are the Tuskegee Syphilis Study, the Jews in Second World War through medical experimentation by the Nazis and this provided society a bad name for the subject of an experiment and their rights and fury (Ezaias et al., 2021). The code we have had from the Nuremberg code formulated in 1947, the Belmont report formulated in 1979 become even ethically more enhanced as well as even broader in a way to delineate the principle of main ethical values such as the principle of beneficence justice, voluntary informed consent, and respect for the human subject.
What can be memorable is that the concept of shielded human studies continues to develop as new strategies for research and additional groundbreaking technology such as big data, artificial intelligence, and genomics seem to present complicated ethical issues (Ezaias et al., 2021). The situation means that the consent procedures have to be altered regarding the present trends in research in cases with vulnerable persons, privacy and security, as well as multinational research. Similarly, to this, the rights of study participants are also protected considering them for a more professional mode of informed consent apart from better honoring of the IRBs and enhanced methods of data security. It assists in stressing the protection of human subjects in scientific research by not only embracing emerging new ethical issues and experiences but also enriching the vital human subject protection principles and justice respecting human subjects in all the research.
Types of Research Activities with Human Subjects
According to ERM, human subjects research is a wide area of studies mainly involving or using people in efforts to investigate human behavior, health, and effects of actions in several fields. The following are some major categories of human subjects research, along with particular examples:
Clinical Trials
Most of the time, patients participate in experimental studies intending to assess the therapeutic impact of new drugs, gadgets, and therapeutic procedures. Because identifying side effects and dosages as well as evaluating the effectiveness of treatment involves human subjects Beladiya et al., 2024. For example, in trials to treat the COVID-19 disease, many employees needed to determine the safety of vaccines and immunity for various populations.
Public Health Research
For illness patterns and health intercessions and their effectiveness across populations to be understood, human involvement in public health research is requisite. That is why such studies at the epidemiological level contribute to improving the health of the population and reducing the risk of the onset of diseases (Beladiya et al., 2024). Individuals involved in studying the COVID-19 outbreak were asked questions about the effectiveness of immunization, the impacts of lockdown down, and the rate of transmission in different regions.
Social Science Research
People become research subjects of social science when it comes to issues like social etiquette, culture, and academics for instance sociologists, anthropologists, and educators among others (Roberts et al., 2019). For example, research sought to establish the consequences of learners’ remote learning experience involving parents, teachers, and students.
Genomic and Personalized Medicine Research
Many genomic studies require taking individual DNA samples since genetic variables may play differing roles in different health issues. According to the study conducted by Roberts, et al (2019), this finding could inform precision medicine or genetic drug prescriptions. Of the two, patient genetic material could be applied in personalized medicine research to explore the medicine for diseases such as cancer.
Strategies for Ensuring Participant Protection
Such a process affirms ethical accomplishment in a study without compromising participants in a detrimental health crisis; nonetheless, the recommendation of measures towards ethical consideration shouldn’t alter the study plan significantly. One of them is asking them and making sure that the participants understand the goals, activities, risks, and positive outcomes of the particular study well. Ivers et al., (2023) have brought out in this review that the use of essentialist language and questions can assist in eliminating complications and dangers and the process of simplification of consent for the researchers. Another good plan is to make sure that the data collected will not be shared with other parties or other means to avoid extreme risks. This may be useful when trying to realize this goal while still leaving the study credible and minimizing chances of undesired access to the information through ways such as encrypting as well as anonymizing the data. They are called officially Independent Review Boards and their main responsibilities are to provide ethical clearance on all research activities to ensure they are standard.
A type of testing conducted before extensive testing is called pilot testing; such a determination can help in the identification of risk and the correction can be made without changing the plan of large-scale testing. Apart from maintaining low participant burden, other low-priority data collection techniques like Web-based questionnaires and observational data collection ensure the acquisition of vital data (Ivers et al., 2023). Special protection because of factors such as age, pregnancy, or mental status is required for subgroups such as youths, pregnant women, and those having decision-making capacities. Some studies can protect participants with little interference to the method of research by deciding between the issue of ethicality and efficiency.
Additional Protections for Vulnerable Research Populations
Additional protections are required for federally designated vulnerable subjects within research for example pregnant women, children, prisoners, and those with diminished autonomy to protect their interest during a study. That is why these populations are equally susceptible to coercion, exploitation, or harm; and for this reason, the processes of doing research should be exposed to critical ethical analysis and reshuffling, according to Harnett (2021). Many of these protections have implications for the design of the research since; there is a need for constant ethical review, new consent methods, and safety.
For instance, the consent of the child should be accompanied by the approval of the parents or legal guardians in any study, or identification data of the child will be included in any study. The process of dueling consent serves the best liberal interest of the child in the way it protects the role of the parent as a protector (Friedland et al., 2020). Yet, according to the population group, especially pregnant women in the involved research, there is a need to budget safety for such a participant, which in most cases will mean more observation of this participant and stricter criteria of inclusion and exclusion to the least possible risks to both the woman and the fetus. Because of the power relations in prison research, another vulnerable group of participants, inmates, in this case, steps must be taken to ensure that there was no coercion to participate in research.
Such safeguards can lead to lengthened study durations, elevated costs, and rather complex analysis plans. However, researchers are in between the ethical principles that demand them to protect vulnerable persons and the purpose of the research (Harnett, 2021). It may raise preventive measures for safety concerns, experimentation on some particular groups of less productivity, or the process modification to decrease the incidence rate. All in all, such measures have a protective shield that protects the vulnerable populace from exploitation by research while also improving the image of the study together with principles of ethical research.
Ethical Standards in Research
Therefore, because of the rights of participants, their dignity, safety, and scientific responsibility for further research, the principles of conducting research are most important. Such guidelines are assumed to lower the harm to participants to some degree, as well as make certain that if experimentation is to occur, it does so in one of the most ethical ways. They are the informed consent, the confidentiality, nonmaleficience, beneficience and justice concepts (Friedland et al., 2020). There are certain requirements that the participants of this research should meet, these are; The participants must appreciate the reasons why this research needs to be done as well as the process that will be followed, the anticipated influence, and all the benefits that come with it, before they can be deemed to have agreed to participate in the research. Personal information is kept secret to ensure participant information is safeguarded and disclosed only where necessary. In one respect it promotes the boosting of the benefits of the research for the participants and the rest of the population In the other respect it detests researchers from bringing about harm. Justice requires equitable ways of choosing participants for research work, and the dissemination of risks.
These ethical guidelines has cleary significant to the research methodology. For example, the time that will be taken to complete the informed consent procedure may be longer than estimated because participants need more time and well-written resources to understand the study. Confidentiality measures the distribution, storage, and sharing protocols, all of which affect data collection. Such practices result in data encryption or anonymization, which is generally costly and problematic (Pieper et al., 2020). Possible purification and maximization of non-maleficence and beneficence can lead to limiting participant freedom or improving safety measures; such changes may be possible only if the nature of the methodology or sample size is altered. The subjects participating in the study must not be used in a way that they will be exploited, the sample size chosen for a given study should contain a fairly sufficient number of participants to give a fair representation of the population and finally, participants selected for a study should also be fairly selected.
NURS FPX 5005 Assessment 1 Conclusion
The principle by which human subjects in research are protected is also one of the ethical principles protecting the rights and interests of everyone that is involved. Finally, a brief is given on historical events and how they have shaped the ethical course and ruled that caution is still needed while safeguarding vulnerable populations (Wendler et al., 2020). To minimize risks, and to protect the research, the researcher has to consider the following constituencies; informed consent, assurance of confidentiality, and ethical review. In addition to enhancing the welfare of the participants involved in conducting the research, the above ethical principles assure the validity and generality of the study. In total, compliance with the identified ethical standards helps to enhance the responsibility for people’s relations between the participants and the researchers and to establish a higher degree of moral and humane attitudes to science.
NURS FPX 5005 Assessment 1 References
Beladiya, J., Kumar, A., Vasava, Y., Parmar, K., Patel, D., Patel, S., Dholakia, S., Sheth, D., Boddu, S. H. S., & Patel, C. (2024). Safety and efficacy of COVID-19 vaccines: A systematic review and meta-analysis of controlled and randomized clinical trials. Reviews in Medical Virology, 34(1), e2507. https://onlinelibrary.wiley.com/doi/10.1002/rmv.2507
Barlow, C. (2020). Human subjects protection and federal regulations of clinical trials. Seminars in Oncology Nursing, 36(2), 151001. https://www.sciencedirect.com/science/article/abs/pii/S0749208120300164?via%3Dihub
Ezaias, R. C., Marziale, M. H. P., & Cardoso, J. A. (2021). Health hazard allowance for Nursing professionals: A reflective analysis under the principle of human dignity, 29, e3498.https://www.scielo.br/j/rlae/a/HNrXmvyD6Qn3kcXYczy7Hgb/?lang=en
Friedland, J., & Peter, E. (2020). Recognizing the role of research assistants in the protection of participants in vulnerable circumstances. Journal of Empirical Research on Human Research Ethics, 15(3), 143–152.https://journals.sagepub.com/doi/10.1177/1556264619872366
Harnett, J. D. (2021). Research ethics for clinical researchers. Methods in Molecular Biology, 2249, 53–64. https://link.springer.com/protocol/10.1007/978-1-0716-1138-8_4
Ivers, R., Vuong, K., Rhee, J., & Williams, K. (2023). Demystifying human research ethics committee applications. Australian Journal of General Practice, 52(10), 721–727. https://www1.racgp.org.au/ajgp/2023/october/demystifying-human-research-ethics-committee-appli
Pieper, I. J., & Thomson, C. J. H. (2020). Vulnerability in human research. Monash Bioethics Review, 38(1), 68–82.https://link.springer.com/article/10.1007/s40592-020-00110-4
Wendler, D. (2020). Minimizing risks is not enough: The relevance of benefits to protecting research participants. Perspectives in Biology and Medicine, 63(2), 346–358.https://muse.jhu.edu/article/761748
