NURS FPX 5005 Assessment 1 Protecting Human Research Participants

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Capella university

NURS-FPX 5005 Introduction to Nursing Research, Ethics, and Technology

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Protecting Human Research Participants

Human subject protection entails the ethical and regulatory measures brought into practice to ensure that safety, rights, and welfare are assured in research studies involving human subjects (White, 2020). This paper consists of a discussion on the history and evolution of safeguarding the rights, dignity, and welfare of people to be involved in research activities. The paper identifies relevant events that are responsible for the standards and guidelines followed today, particularly the activities and roles of Institutional Review Boards (IRBs) and informed consent. The evaluation encompasses safeguards for at-risk populations as well as the requirements for ethical review. It aligns science with humanity and respect for human dignity.

History and Importance

Over the last century, human rights protection has greatly evolved to safeguard the participant’s safety, dignity, and rights. This is basically because of harmful studies that resulted from unethical research; early research exploited vulnerable subjects, such as children and inmates, who seldom received informed consent and awareness of research studies. One of the early landmark achievements in the field of ethics in research is probably the Nuremberg Code of 1947, written as a response to the atrocious experiments carried out by Nazi physicians during World War II. These experiments conducted at concentration camps included unethical medical practices that caused impairment, disease, and death.

The Nuremberg Code focused on voluntary participation, informed consent, and the development of making sure that there would be minimal suffering done unnecessarily (White, 2020).One of the most significant cases in the record of human subject protection was the Tuskegee Syphilis Study performed from 1932 to 1972. In this study, syphilis was deliberately not treated in 399 African American men with syphilis. At the time when penicillin became available in the 1940s, the disease was allowed to progress without treatment for studying its full span.

NURS FPX 5005 Assessment 1 Protecting Human Research Participants

These participants were forbidden to give their own informed consent and were paid only for free checkups, food, and funeral coverage. What was expected to last for six months actually lasted for forty years, which demonstrated an ugly disregard for the well-being of the subjects (Spellecy & Busse, 2021). Public outcry about ethical misconduct led to the National Research Act of 1974. It mandates that IRBs lead and give permission to oversee human subject research.

The Stanford Prison Experiment of 1971 exemplified psychological harm as the participants lacked adequate protection, illustrating how lapses in regulation lead to enormous damage. This highlights the significance of protecting human subjects in light of ethical research practices. The key concepts of such frameworks are, however, respecting persons, beneficence, and justice, which, starting from the Belmont Report, continue to guide their design in balancing scientific progress against the welfare of participants (White, 2020).

Research Activities

From time to time, the art of researching human subjects has evolved, and with this evolution comes the need to protect participants’ safety as well as their rights. A human subject is defined as the Health and Human Services Policy for the Protection of Human Research Subjects in 45 CFR Part 46, which is a living individual who may be involved in an investigation where a person’s identifiable private information or biological material will be gathered.

The National Institutes of Health also distinguishes between interventional and observational study approaches. Observational studies follow subjects without applying specific treatments and are based on potential causes of illness and disease progression changes. For instance, cohort studies track smoking behavior to assess the impact on lung cancer rates (National Institute of Dental and Craniofacial Research, 2022).

NURS FPX 5005 Assessment 1 Protecting Human Research Participants

On the other hand, interventional studies involve the manipulation of one or more natural or psychological variables. For instance, clinical trials have been used to test the safety and efficacy of new treatments or drugs. Under this category fall the Phase III clinical trials assessing the effectiveness of a new cancer drug when compared to the conventional therapies of volunteer patients. Interventional studies also fall under behavioral research, whereby researchers study human behaviors, cognition, and emotions under controlled conditions.

For instance, studies on mindfulness techniques for measuring anxiety level changes, surveys or interviews gathered and surveyed for attitude and social trends of various communities, such as studies on public health in relation to vaccine hesitancy. Such examples present the issue of protecting human subjects and ensuring ethical research practice, which is important since such studies signify that all forms of research activities call for informed consent and participant welfare (White, 2020).

Minimizing Risk Potential

Over the years, human beings have been put at great risk in various studies without fully understanding the outcome. Several were not briefed on various dangers that were in these studies, and many ended up being hurt in different studies. Systems are established to play down these risks. This marked a point in the Nuremberg trials, culminating in the Nuremberg Code that provided ethical guidelines after unethical experiments that were carried out in German concentration camps during World War II. However, that was not enough for the complexities of contemporaneous research (White, 2020).

In 1979, the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research issued the Belmont Report with the purpose of extending protection to human subjects. It mentioned three ethical principles: respect for persons, beneficence, and justice. The principle of respect for persons provides protection for individual autonomy and persons who are most vulnerable. Beneficence considers the principle of non-maleficence and beneficence, whereby maximum benefits are ensured without excessive burden to participants. Justice deals with the fair sharing of research benefits and burdens (CITI Program, n.d).

NURS FPX 5005 Assessment 1 Protecting Human Research Participants

Researchers employ numerous strategies to mitigate risks. Among these is informed consent, which involves providing participants with comprehensive information regarding the purpose, procedures, and risks of a study in order for the participant to make an informed decision. Risk-benefit analyses are conducted to substantiate that any foreseen benefits could outweigh possible risks; participants would also be closely followed in clinical trials to avoid adverse incidents. Protocols exist to maintain participant confidentiality by anonymizing and encrypting data to protect privacy CITI Program, n.d).

The use of non-invasive methods, such as remote data collection, minimizes physical and psychological harm. Lastly, the well-monitored state of the participants during the experiment enables researchers to make necessary interference on time in case of unexpected risks, further ensuring safety. These strategies, if implemented, protect the participants and enhance the validity of research studies by establishing trust, hence minimizing dropouts. Ethics must be maintained in the quest for scientific knowledge while preserving the dignity and rights of all individuals involved (White, 2020).

Protections for Vulnerable Populations

The Public Commission for the Assurance of Human Subjects of Biomedical and Behavioral Research was assigning IRBs before the Belmont Report. IRB serves to review and monitor human biomedical research for its conformance with institutional and federal regulations while protecting the rights and welfare of children, prisoners, pregnant women, persons with disabilities, and economically disadvantaged individuals.

The IRB mandates specific modifications to protect these groups from coercion and harm. For those of limited autonomy, like children, permission should be obtained from participants, while consent must be given by legal guardians, which necessitates communication strategies in greater detail. Regarding prisoners and those who are economically disadvantaged, participation is considered to be free from coercion, which calls for equitable models of compensation, thereby necessitating careful monitoring of the recruitment practices employed (Office for Human Research Protections, 2024).

NURS FPX 5005 Assessment 1 Protecting Human Research Participants

Research involving pregnant women and children requires a high level of risk assessment, with benefits assured with minimal risks; many of the methods used are non-invasive. The IRBs may impose additional monitoring, such as periodic reports, which may become an administrative burden. These protections ensure that the rights of vulnerable populations are upheld, even though these often make research more resource-intensive. Researchers must achieve a balance between ethical obligation and feasibility, which entails thoughtful adjustments to the study design, recruitment, and monitoring protocols (Shaw et al., 2020).

Ethical Standards in Research

Protection for human subjects of research involves federal regulations, which are proposed by HHS and commonly referred to as the Common Rule. These regulations include subpart A of 45 CFR 46, protections for informed consent, and IRB review before research can begin. Besides subpart A, three other subparts complement protection for the most vulnerable populations: pregnant women, prisoners, and children. Key ethical considerations from frameworks include the Belmont Report, respect for persons, beneficence, justice, and scientific integrity in the research design process.

Respect for persons focuses on autonomy through informed consent, which in turn impacts timeline factors because there is a need for articulation of risks and benefits in great detail. Beneficence dictates that benefits are to be maximized while harm is minimized. Thus, detailed risk analyses and safety measures are needed. Justice ensures that participant selection is done fairly, which indicates that the distribution of burdens and benefits must be equitably distributed, especially within marginalized groupings (White, 2020).

Subpart B discusses protections related to pregnant women, human fetuses, and neonates with regard to risks that can occur within the study. It includes prisoners whose free consent may already be compromised by the very nature of limited liberty. Subpart D outlines the protection of children, who are considered a vulnerable population due to developmental constraints. These ethical guidelines brought about limitations in the design of research studies, including strict documentation and plans for risk mitigation. However, they practice ethics in research; it develops trust among the participants and the greater community while, at the same time, bringing scientifically valid findings (White 2020).

Conclusion

Protection for human subjects has evolved to center participants’ rights and welfare, to which historical abuses have contributed. Ethical frameworks, such as the Belmont Report, coupled with the work of IRBs, ensure informed consent and protection of vulnerable populations. This enables responsible research that weighs scientific advances against respect for human dignity and safety.

References

CITI Program.  (n.d.).  https://about.citiprogram.org/en/homepage/ 

National Institute of Dental and Craniofacial Research.  (2022, June).  Human subjects research overview.  https://www.nidcr.nih.gov/research/human-subjects-research 

Office for Human Research Protections. (2024). The Belmont Report. U.S. Department of Health and Human Services; U.S. Department of Health and Human Services. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html 

Shaw, R. M., Howe, J., Beazer, J., & Carr, T. (2020). Ethics and positionality in qualitative research with vulnerable and marginal groups. Qualitative Research, 20(3), 146879411984183. https://doi.org/10.1177/1468794119841839 

NURS FPX 5005 Assessment 1 Protecting Human Research Participants

Spellecy, R., & Busse, K. (2021). The history of human subjects research and rationale for institutional board review oversight. Nutrition in Clinical Practice, 36(3), 560–567. https://doi.org/10.1002/ncp.10623 

White, M. G. (2020). Why human subjects research protection is important. The Ochsner Journal, 20(1), 16–33. https://doi.org/10.31486/toj.20.5012