NURS FPX 5005 Assessment 1 Protecting Human Research Participants

Student 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 pivotal for advancements in human health and well-being (University of Alaska Fairbanks, n.d.). Safeguarding human research subjects is imperative to ensure their safety during studies and experiments (University of Alaska Fairbanks, n.d.). Ethical guidelines are in place to prevent unethical treatment or abuse of study participants (University of Alaska Fairbanks, n.d.). It is crucial to avoid any abuse of human research subjects in order to maintain the integrity of necessary studies.

History and Importance of Human Subject Protection

Throughout the past century, the approach to protecting human subjects has evolved in response to unethical research practices (White, 2020). Historically, vulnerable groups, such as children and inmates, were often used as research subjects without informed consent or understanding of the studies’ purpose (White, 2020). Two notable instances of research exploitation are the Tuskegee Experiment and experiments conducted in German concentration camps during World War II (White, 2020). The Tuskegee Experiment involved 399 syphilis patients and 201 uninfected controls, who were denied informed consent and treatment (White, 2020). The German concentration camps subjected captives to unethical medical procedures, resulting in harm, disease, and death (White, 2020).

Types of Research Activities Involving Human Subjects

The Health and Human Services Policy for Protection of Human Research Subjects defines human subjects as individuals whose personal data and biological samples are investigated, examined, or evaluated by researchers (National Institute of Dental and Craniofacial Research, 2022). Human subjects also include those whose private information or biospecimens are used in research (National Institute of Dental and Craniofacial Research, 2022). Human subject research comprises two types: observational and interventional (National Institute of Dental and Craniofacial Research, 2022).

Observational studies involve data collection without specific treatments, focusing on potential causes of diseases and their progression (National Institute of Dental and Craniofacial Research, 2022). In contrast, interventional studies alter biological or cognitive systems through participant or environmental changes (National Institute of Dental and Craniofacial Research, 2022).

Strategies to Minimize Risks to Research Participants

Throughout history, human research subjects have faced risks without adequate understanding or choice (White, 2020). To mitigate these risks, strategies have been implemented. The Nuremberg trials, responding to unethical research in German concentration camps, resulted in the establishment of The Nuremberg Code, outlining principles for human subject research (White, 2020). The Belmont Report, released in 1979, introduced principles of respect for persons, beneficence, and justice, focusing on informed consent, risk assessment, and subject selection (CITI Program, n.d.) (White, 2020).

Ethical Standards in Research

Before the Belmont Report, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research produced Institutional Review Boards (IRBs) to oversee and review biomedical research involving humans (White, 2020). IRBs are authorized bodies that ensure compliance with federal and institutional standards, safeguarding participants’ rights and well-being (US 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 protections for vulnerable populations in human research (US Department of Health & Human Services, 2020). These regulations include subparts that protect pregnant women, human fetuses, neonates, prisoners, and children (CITI Program, n.d.) (US Department of Health & Human Services, 2020).

Conclusion

The importance of human research cannot be overstated. By protecting the rights and welfare of human subjects, we enable critical medical advancements while ensuring fair and respectful treatment of study participants. The history of human research ethics highlights the need for robust safeguards to protect the well-being of all individuals involved.

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

US 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

US Food and Drug Administration. (2019, September 11). Institutional review boards (ribs) 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. 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

NURS FPX 5005 Assessment 1 Protecting Human Research Participants