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NURS FPX 5005 Assessment 1 Protecting Human Research Participants

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    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 played a pivotal role in advancing human health and well-being (University of Alaska Fairbanks, n.d.). Ensuring the safety of human research subjects during studies and experiments is imperative (University of Alaska Fairbanks, n.d.). Ethical guidelines are in place to prevent any unethical treatment or abuse of study participants (University of Alaska Fairbanks, n.d.). Maintaining the integrity of necessary studies requires the avoidance of any abuse of human research subjects.

    History and Importance of Human Subject Protection

    The approach to protecting human subjects has evolved over the past century in response to unethical research practices (White, 2020). Vulnerable groups, historically used as research subjects without informed consent, included children and inmates (White, 2020). Two notorious instances of research exploitation are the Tuskegee Experiment and experiments 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). 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

    NURS FPX 5005 Assessment 1 Protecting Human Research Participants

    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

    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

    NURS FPX 5005 Assessment 1 Protecting Human Research Participants

    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%3

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