NURS FPX 5005 Assessment 1 Protecting Human Research Participants

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).

NURS FPX 5005 Assessment 1 Protecting Human Research Participants

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).

NURS FPX 5005 Assessment 1 Protecting Human Research Participants

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

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  • Discussion Questions (DQ)
Initial responses to the DQ should address all components of the questions asked, including a minimum of one scholarly source, and be at least 250 words. Successful responses are substantive (i.e., add something new to the discussion, engage others in the discussion, well-developed idea) and include at least one scholarly source. One or two-sentence responses, simple statements of agreement or “good post,” and responses that are off-topic will not count as substantive. Substantive responses should be at least 150 words. I encourage you to incorporate the readings from the week (as applicable) into your responses.
  • Weekly Participation
Your initial responses to the mandatory DQ do not count toward participation and are graded separately. In addition to the DQ responses, you must post at least one reply to peers (or me) on three separate days, for a total of three replies. Participation posts do not require a scholarly source/citation (unless you cite someone else’s work). Part of your weekly participation includes viewing the weekly announcement and attesting to watching it in the comments. These announcements are made to ensure you understand everything that is due during the week.
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Familiarize yourself with the APA format and practice using it correctly. It is used for most writing assignments for your degree. Visit the Writing Center in the Student Success Center, under the Resources tab in Loud-cloud for APA paper templates, citation examples, tips, etc. Points will be deducted for poor use of APA format or absence of APA format (if required). Cite all sources of information! When in doubt, cite the source. Paraphrasing also requires a citation. I highly recommend using the APA Publication Manual, 6th edition.
  • Use of Direct Quotes
I discourage over-utilization of direct quotes in DQs and assignments at the Master’s level and deduct points accordingly. As Masters’ level students, it is important that you be able to critically analyze and interpret information from journal articles and other resources. Simply restating someone else’s words does not demonstrate an understanding of the content or critical analysis of the content. It is best to paraphrase content and cite your source. NURS FPX 5005 Assessment 1 Protecting Human Research Participants
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For assignments that need to be submitted to Lopes Write, please be sure you have received your report and Similarity Index (SI) percentage BEFORE you do a “final submit” to me. Once you have received your report, please review it. This report will show you grammatical, punctuation, and spelling errors that can easily be fixed. Take the extra few minutes to review instead of getting counted off for these mistakes. Review your similarities. Did you forget to cite something? Did you not paraphrase well enough? Is your paper made up of someone else’s thoughts more than your own? Visit the Writing Center in the Student Success Center, under the Resources tab in Loud-cloud for tips on improving your paper and SI score.
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The university’s policy on late assignments is a 10% penalty PER DAY LATE. This also applies to late DQ replies. Please communicate with me if you anticipate having to submit an assignment late. I am happy to be flexible, with advance notice. We may be able to work out an extension based on extenuating circumstances. If you do not communicate with me before submitting an assignment late, the GCU late policy will be in effect. I do not accept assignments that are two or more weeks late unless we have worked out an extension. As per policy, no assignments are accepted after the last day of class. Any assignment submitted after midnight on the last day of class will not be accepted for grading. NURS FPX 5005 Assessment 1 Protecting Human Research Participants
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