NURS FPX 5005 Protecting Human Research Participants Essay Example

NURS FPX 5005 Assessment 1 Protecting Human Research ParticipantsNURS FPX 5005 Assessment 1 Protecting Human Research Participants

Assignment Brief: NURS FPX 5005 Protecting Human Research Participants Assessment 1

Course: NURS FPX 5005 Introduction to Nursing Research, Ethics, and Technology

Assignment Title: Assessment 1 Protecting Human Research Participants

Overview:

In this assessment, students will look into the critical importance of protecting human research participants in the field of healthcare. They will explore historical contexts, ethical principles, the role of Institutional Review Boards (IRBs), effective risk mitigation strategies, and specific protections for vulnerable populations. By analyzing key concepts and guidelines, students will gain a comprehensive understanding of the ethical considerations and regulatory frameworks that govern human research activities.

The Student’s Role:

As a student, your role is to conduct a thorough investigation into the multifaceted aspects of protecting human research participants. You will critically analyze historical events, ethical principles, regulatory frameworks, and practical strategies aimed at safeguarding the rights and welfare of research participants. Through rigorous research and thoughtful reflection, you will develop a comprehensive understanding of the ethical considerations inherent in human research activities and the importance of upholding participants’ dignity and rights throughout the research process.

NURS FPX 5005 Protecting Human Research Participants Essay Example

Introduction

Human research, pivotal for medical advancements and healthcare outcomes, relies on the participation of individuals, necessitating stringent protection measures to ensure their safety and well-being throughout studies and experiments (University of Alaska Fairbanks, n.d.; Miracle, 2016). The historical context, including instances of abuse during World War II, underscores the urgency for international standards, exemplified by the Nuremberg code, to safeguard human subjects, emphasizing respect, benefit, and justice (Miracle, 2016). This essay explores into the historical significance of protecting research participants, the ethical principles guiding research conduct, the critical role of Institutional Review Boards (IRBs), and effective strategies to mitigate risks to participants, highlighting the indispensable importance of conducting research responsibly and ethically to maximize benefits while upholding participants’ dignity and rights.

Historical Context and Importance

The history of protecting human research subjects reflects a transformative journey shaped by responses to unethical conduct and exploitation in research practices over the past century (White, 2020). Throughout this period, vulnerable groups, including children and inmates, were frequently used as subjects without adequate informed consent or understanding of the studies they participated in (White, 2020). Notable examples of egregious exploitation include the Tuskegee Experiment and the criminal experiments conducted in German concentration camps during World War II (White, 2020). The Tuskegee experiment, for instance, involved 399 syphilis patients and 201 uninfected controls from the African American population, who were denied informed consent and appropriate medical interventions (White, 2020). Despite the proven efficacy of penicillin, the study continued for four decades, leading to severe health consequences for the participants (White, 2020). Similarly, physicians in German concentration camps subjected captives to barbaric medical procedures resulting in profound suffering and loss of life (White, 2020). These historical atrocities underscore the imperative of implementing robust protections for research participants to prevent exploitation and ensure ethical conduct in human research endeavors.

Ethical Principles and Guidelines

The Belmont Report, issued in 1979, serves as a cornerstone for ethical conduct in research involving human subjects, delineating three fundamental principles: respect for persons, beneficence, and justice (White, 2020). Respect for persons emphasizes the autonomy of individuals and the necessity of obtaining informed consent, ensuring participants comprehend the aims and risks of the study before consenting to participate (Taraban, 2016; Resnik, 2018). Beneficence mandates researchers to maximize benefits and minimize harms to participants, prioritizing their well-being throughout the research process (White, 2020). Justice necessitates fair participant selection and equitable distribution of research burdens and benefits, ensuring no group or individual is unfairly burdened or excluded (White, 2020). These ethical principles underscore the importance of protecting the rights and welfare of research participants, fostering trust, and upholding integrity in research endeavors.

The ethical standards applied in research are upheld through the oversight of Institutional Review Boards (IRBs), which were established to ensure compliance with federal and institutional regulations (US Food and Drug Administration, 2019; White, 2020). IRBs play a crucial role in safeguarding the rights and well-being of research participants by reviewing and overseeing biomedical research involving human subjects, demanding necessary changes to protect participants’ rights, and ensuring unbiased participant selection and informed consent procedures (US Food and Drug Administration, 2019; White, 2020). By adhering to these ethical standards and oversight mechanisms, researchers can uphold the principles of respect, beneficence, and justice, ensuring the ethical conduct of research and the protection of human subjects’ rights and welfare.

Institutional Review Boards (IRBs)

Institutional Review Boards (IRBs) serve as essential guardians of human research participants, ensuring their protection and welfare throughout the research process. These administrative bodies are tasked with reviewing research proposals to verify compliance with ethical standards and regulatory requirements (Qiao, 2018). IRBs meticulously assess the risks and benefits associated with research studies, evaluate the adequacy of informed consent procedures, and actively monitor ongoing studies to uphold participants’ rights and well-being (US Food and Drug Administration, 2019). By analyzing scientific, legal, and institutional frameworks, IRBs play a pivotal role in safeguarding the ethical conduct of research and mitigating potential risks to human subjects (Qiao, 2018). Through their rigorous oversight and review processes, IRBs ensure that research endeavors prioritize the protection, dignity, and rights of participants, thus upholding the principles of respect, beneficence, and justice in human research.

Types of IRB Reviews

In overseeing research studies, IRBs conduct three distinct types of reviews: exempt, expedited, and full. Exempt reviews are applicable to studies presenting minimal risks to human participants, thereby exempting them from certain regulatory requirements and protocols. These studies typically involve non-invasive methods and pose negligible harm to participants, warranting less extensive review by the board (Whitney, 2015). Expedited reviews, on the other hand, are reserved for studies with a low probability of causing discomfort or harm to participants, akin to routine medical examinations. Such studies, which do not involve vulnerable populations like the elderly or children, qualify for expedited review to streamline the approval process while ensuring participant safety (Whitney, 2015). Conversely, studies incorporating high-risk procedures and methods necessitate full review by the IRB due to the potential dangers posed to participants. By subjecting these studies to comprehensive evaluation, IRBs prioritize the protection and welfare of participants, ensuring that risks are thoroughly analyzed and mitigated before research commencement.

Purpose of the Institutional Review Board

In the realm of human research, adherence to protocols and regulations is paramount to safeguarding participant rights and welfare. Institutional Review Boards serve as gatekeepers, ensuring that research studies comply with established standards and receive requisite approvals (Grady, 2015). By scrutinizing research proposals and overseeing the research process, IRBs promote responsible conduct among researchers, fostering adherence to ethical principles and professional standards (Grady, 2015). Moreover, IRBs play a pivotal role in minimizing risks to participants by evaluating research protocols and ensuring researchers possess the necessary ethical training and competence to conduct the study (Grady, 2015). Through their oversight and regulatory functions, IRBs contribute to the professional acceptability and ethical integrity of research endeavors, thereby upholding the credibility and trustworthiness of the medical field.

Types of Research Activities Involving Human Subjects and Quality Improvement

Human subject research encompasses various activities that involve the participation of individuals, as outlined by the Health and Human Services Policy for Protection of Human Research Subjects in 45 CFR Part 46. According to this policy, a human subject is defined as a living person whom a researcher investigates by gathering personal data and biological samples for utilization, examination, and evaluation. Additionally, individuals whose private information or biospecimens are utilized, examined, and evaluated by a researcher also fall under this category.

In adherence to the Health and Human Services Policy for Protection of Human Research Subjects outlined in 45 CFR Part 46, human subject research encompasses two primary categories: observational and interventional studies (National Institute of Dental and Craniofacial Research, 2022). Observational studies involve the passive monitoring of subjects and data collection without intervention, focusing on understanding disease etiology, manifestations, and progression (National Institute of Dental and Craniofacial Research, 2022). Conversely, interventional studies actively modify biological or cognitive systems, aiming to evaluate the effects of interventions on health outcomes (National Institute of Dental and Craniofacial Research, 2022).

Moreover, a thorough analysis of proposed research activities is essential to assess the potential benefits and risks to participants and the field of medicine. Evaluating the risk-to-benefit ratio ensures that the chosen research model is justifiable, necessary, and minimally intrusive to participants. Preferably, non-invasive procedures, smaller participant groups, and alternative species are considered to mitigate risks to human subjects (Grady, 2015). Research activities must demonstrate a high quality improvement ratio, indicating substantial value to healthcare and human welfare, before implementation.

Strategies to Minimize Risks to Research Participants

Efforts to minimize risks to research participants have evolved over time, driven by historical injustices and ethical imperatives. The Nuremberg trials, held in the aftermath of World War II, marked a pivotal moment in establishing limits for research involving humans, catalyzing the formulation of The Nuremberg Code (White, 2020). Although this code laid down fundamental principles for ethical research conduct, its scope was limited, necessitating further refinement (The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978). Subsequently, the Belmont Report, released in 1979, emerged as a cornerstone document, advocating for respect for persons, beneficence, and justice in research endeavors (CITI Program, n.d.).

The Belmont Report emphasizes the importance of informed consent, risk assessment, and subject selection to safeguard participants’ rights and welfare (CITI Program, n.d.). Informed consent ensures that prospective participants receive comprehensive information about the research, enabling them to make voluntary and informed decisions (CITI Program, n.d.). Risk assessment aims to balance potential benefits with foreseeable harms, guiding researchers in minimizing risks to participants (CITI Program, n.d.). Additionally, subject selection underscores the principle of justice, advocating for fair distribution of research burdens and benefits among diverse populations (CITI Program, n.d.).

Furthermore, the Belmont Report’s principles of beneficence, respect for persons, and justice serve as guiding beacons for researchers and institutional review boards, ensuring the ethical conduct of research activities (Miracle, 2016). Beneficence emphasizes the obligation to maximize benefits and minimize harms to participants, prioritizing their well-being (Miracle, 2016). Respect for persons mandates equitable treatment and protection of participants’ autonomy, regardless of their decision-making capacity (Miracle, 2016). Finally, justice underscores the need for fair selection of participants and equitable distribution of research burdens and benefits, fostering inclusivity and fairness in research endeavors (Miracle, 2016). These principles collectively contribute to the ethical conduct of research activities, promoting the welfare and rights of human subjects.

Protections for Federally Identified Vulnerable Populations

Federal regulations, issued by the Department of Health and Human Services, establish safeguards to protect vulnerable populations involved in research endeavors (US Department of Health & Human Services, 2020). The primary framework, known as the Common Rule, outlined in subpart A of 45 CFR 46, mandates institutional review board approval and informed consent from participants engaged in human research activities (US Department of Health & Human Services, 2020). To address the specific needs of vulnerable populations, three additional subparts offer additional protections (US Department of Health & Human Services, 2020).

Subpart B focuses on safeguarding pregnant women, human fetuses, and neonates due to the potential risks associated with research involving this demographic (CITI Program, n.d.). Given the unique vulnerabilities of pregnant women, fetuses, and newborns, additional protective measures are essential to mitigate any unidentified dangers (Williams, 2005).

Subpart C addresses regulations aimed at protecting prisoners, recognizing their inherent susceptibility due to limited freedom and diminished autonomy (Williams, 2005). The confined environment of correctional facilities poses challenges for inmates to provide fully informed consent, necessitating heightened protections.

Subpart D outlines regulations dedicated to safeguarding children, acknowledging their underdeveloped physical and intellectual capacities (CITI Program, n.d.). Children represent a vulnerable group requiring special consideration and protection in research settings (Waisel, 2013). These regulations aim to ensure that research involving children is conducted ethically and prioritizes their well-being.

By delineating specific protections for pregnant women, prisoners, and children, these subparts of federal regulations strive to uphold ethical standards and safeguard the rights and welfare of vulnerable populations involved in research activities.

Conclusion

In conclusion, the protection of human research participants is of paramount importance to uphold ethical standards, safeguard individual rights, and foster trust in the scientific community. Throughout history, instances of abuse and exploitation have underscored the need for robust protections, leading to the development of international standards and ethical guidelines. The principles outlined in documents such as the Belmont Report serve as foundational pillars, emphasizing respect, beneficence, and justice in research conduct. Institutional Review Boards play a crucial role in ensuring compliance with these principles, overseeing research proposals, and safeguarding participant welfare. By conducting thorough reviews and implementing appropriate safeguards, IRBs contribute to the ethical integrity of research endeavors. Moreover, federal regulations provide additional protections for vulnerable populations, recognizing the unique needs and vulnerabilities of groups such as pregnant women, prisoners, and children. Through comprehensive oversight and adherence to ethical principles, researchers and IRBs can uphold the dignity, rights, and welfare of human research participants, thereby advancing scientific knowledge while prioritizing human well-being.

References

Belmont Report. (1979). The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

CITI Program. (n.d.). Belmont Report. Retrieved from https://about.citiprogram.org/en/resources/belmont-report/

Grady, C. (2015). Institutional review boards: Purpose and challenges. Chest, 148(5), 1148-1155.

Miracle, V. A. (2016). Protecting Human Research Participants: Evolution of the Human Research Ethics Timeline. Nurse Author & Editor, 26(2), 10-13.

National Institute of Dental and Craniofacial Research. (2022). Protection of Human Research Subjects. Retrieved from https://www.nidcr.nih.gov/research/human-subjects-research

Resnik, D. B. (2018). What is ethics in research & why is it important? National Institute of Environmental Health Sciences. Retrieved from https://www.niehs.nih.gov/research/resources/bioethics/whatis/index.cfm

Taraban, B. (2016). Institutional review board review of clinical research. The Southwest Respiratory and Critical Care Chronicles, 4(15), 89-93. Web.

Qiao, Z. (2018). Understanding and improving institutional review board operations: A primer. Journal of Investigative Medicine, 66(5), 789-794.

University of Alaska Fairbanks. (n.d.). Human subjects in research. Office of Research Integrity. Retrieved from https://uaf.edu/ori/responsible-conduct/human-research-subjects/index.php

US Department of Health & Human Services. (2020). Protection of Human Subjects. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html

US Food and Drug Administration. (2019). Institutional Review Boards. Retrieved from https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/institutional-review-boards

Waisel, D. B. (2013). Vulnerable populations in research: The case of the institutionalized elderly. The European Journal of Anaesthesiology, 30(3), 141-144.

Whitney, S. (2015). The Institutional Review Board process: Regulatory and ethical concerns in psychiatric research. Psychiatric Clinics, 38(4), 665-678.

White, B. (2020). Ethical considerations in research with human participants. Journal of Health & Social Sciences, 5(2), 285-297.

Williams, E. D. (2005).  Federal protection for human research subjects: an analysis of the Common Rule and Its interactions with FDA regulations and the HIPAA privacy rule.  https://doi.org/https://heinonline.org/HOL/Welcome?message=Please%20log%20in&url=%2FHOL%2FPage%3Fhandle%3Dhein.crs%2Fcrsuntaaeyd0001%26collection%3Dcongrec%26id%3D1%26startid%3D1%26endid%3D79

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