NURS FPX 5005 Assessment 1 Protecting Human Research Participants

NURS FPX 5005 Assessment 1 Protecting Human Research Participants

Name

Capella University

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

Prof. Name

Date

Protecting Human Research Participants

Introduction

Human research has been instrumental in advancing human health and overall well-being (University of Alaska Fairbanks, n.d.). Ensuring the protection of human research participants is crucial to safeguard their safety during experiments and studies (University of Alaska Fairbanks, n.d.). Ethical guidelines exist to prevent mistreatment and abuse of research subjects (University of Alaska Fairbanks, n.d.). These guidelines are vital for maintaining the integrity and ethics of human research, emphasizing the avoidance of abuse in research studies.

History and Importance of Human Subject Protection

Over the past century, the protection of human subjects has evolved in response to historical cases of unethical research (White, 2020). Vulnerable populations, such as children and prisoners, were often exploited as research subjects without proper informed consent or understanding of the research’s aims (White, 2020). Two notorious examples include the Tuskegee Syphilis Study and the experiments carried out in Nazi concentration camps during World War II (White, 2020). In the Tuskegee study, 399 men with syphilis were left untreated, while 201 uninfected individuals were also denied consent (White, 2020). Similarly, Nazi camps saw captives subjected to harmful and often fatal experiments (White, 2020).

Types of Research Activities Involving Human Subjects

According to the Health and Human Services (HHS) Policy for the Protection of Human Research Subjects, human subjects are defined as individuals whose personal data or biological specimens are used for research purposes (National Institute of Dental and Craniofacial Research, 2022). These subjects also include those whose private information is used in research. Human research generally falls into two categories: observational and interventional (National Institute of Dental and Craniofacial Research, 2022).

Strategies to Minimize Risks to Research Participants
Historically, human subjects faced risks without informed consent or adequate protection (White, 2020). To address these concerns, several strategies have been implemented. One such strategy is the Nuremberg Code, established after the Nuremberg Trials, which outlined ethical principles for human research (White, 2020). The Belmont Report (1979) further emphasized principles of respect for individuals, beneficence, and justice, focusing on informed consent, risk assessment, and subject selection (CITI Program, n.d.; White, 2020).

Ethical Standards in Research

Before the publication of the Belmont Report, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research introduced Institutional Review Boards (IRBs) (White, 2020). IRBs are responsible for overseeing research involving human subjects and ensuring adherence to federal and institutional standards, thereby protecting participants’ rights and well-being (U.S. Food and Drug Administration, 2019).

Protections for Vulnerable Populations

Federal regulations, including the Common Rule, issued by the Department of Health and Human Services, provide additional protections for vulnerable populations such as pregnant women, neonates, children, and prisoners (U.S. Department of Health & Human Services, 2020). These regulations ensure that extra precautions are taken to safeguard the rights and welfare of these groups (CITI Program, n.d.; U.S. Department of Health & Human Services, 2020).

Conclusion

Human research plays a vital role in advancing medical knowledge and improving health outcomes. By protecting the rights and well-being of research participants, society can continue to benefit from scientific discoveries while maintaining ethical integrity. The history of unethical human research underscores the importance of robust ethical standards and safeguards.

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

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1978). The Belmont report: Ethical principles and guidelines for the commission for the protection of human subjects of biomedical and behavioral research. http://www.videocast.nih.gov/pdf/ohrp_belmont_report.pdf

U.S. Department of Health & Human Services. (2020, January 28). Principal regulations. Office for Human Research Protections. Retrieved November 28, 2022, from https://www.hhs.gov/ohrp/education-and-outreach/about-research-participation/protecting-research-volunteers/principal-regulations/index.html

U.S. Food and Drug Administration. (2019, September 11). Institutional review boards (IRBs) and protection of human subjects. Center for Drug Evaluation and Research. Retrieved November 27, 2022, from https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials

NURS FPX 5005 Assessment 1 Protecting Human Research Participants

University of Alaska Fairbanks. (n.d.). Human subjects in research. Office of Research Integrity. Retrieved November 28, 2022, from https://uaf.edu/ori/responsible-conduct/human-research-subjects/index.php

Waisel, D. B. (2013). Vulnerable populations in healthcare. Current Opinion in Anaesthesiology, 26(2), 186–192. https://doi.org/10.1097/aco.0b013e32835e8c17

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

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. HeinOnline. https://heinonline.org