NURS FPX 5005 Assessment 1 Protecting Human Research Participants
Protecting Human Research Participants
According to the University of Alaska Fairbanks (n.d.), human research has long been recognized as essential for advancements in human health and welfare. According to the University of Alaska Fairbanks (n.d.), human research subject protection is essential for ensuring the safety of participants in studies and experiments. According to the University of Alaska Fairbanks (n.d.), guidelines are in place to safeguard study participants from unethical treatment or abuse. If we are to continue carrying out essential research in an ethical manner, it is imperative that the abuse of human research subjects be avoided at all costs. Human research has the potential to do a lot of good, but only if it is done in an ethical and responsible way for NURS FPX 5005 Assessment 1 Protecting Human Research Participants .
History and Importance of human subject protection
In response to questionable ethical conduct in research, the current approach to protecting human subjects has evolved over the past century (White, 2020). The early use of children and inmates as study subjects can be traced back to a long history of using what is now considered vulnerable groups as subjects (White, 2020). Participants in the studies rarely gave their informed consent, did not comprehend the study’s purpose, or were frequently provided with no information (White, 2020).
NURS FPX 5005 Assessment 1 Protecting Human Research Participants
The Tuskegee Experiment and criminal experiments carried out in German concentration camps during World War II are two examples of situations in which human participants were exploited while being the subject of research (White, 2020). According to White (2020), the Tuskegee experiment tested a drug on 399 syphilis patients and 201 uninfected controls from the African American community surrounding Tuskegee, Alabama. In exchange for their participation in the study, the men received free checkups, food, and funeral coverage (White, 2020), but they were not permitted to give informed consent. Since the study’s objective was to ascertain how the condition progresses in unmanaged cases, no intervention was provided (White, 2020). The study was supposed to run for just six months, but it has been going on for four decades (White, 2020). By 1945, it was established that penicillin was a safe and effective treatment for syphilis (White, 2020). The US Public Health Service established treatment clinics after the effectiveness of penicillin was demonstrated, but the Tuskegee trials’ data were deemed too important to discard; As a result, the study was extended without treating the subjects (White, 2020). Another example of research subjects suffering harm is the Nazi-occupied German concentration camps (White, 2020). According to White (2020), the so-called physicians of the concentration camps performed unethical medical procedures on prisoners, resulting in impairment, disease, and death.
Types of research activities that require the involvement of human subjects
According to the Health and Human Services Policy for the Protection of Human Research Subjects in 45 CFR Part 46, a human subject is a living individual who is the subject of an investigation by a researcher who collects personal data and biological samples for use, examination, and evaluation (National Institute of Dental and Craniofacial Research, 2022). A person who a researcher uses, examines, and evaluates is also referred to as a human subject (National Institute of Dental and Craniofacial Research, 2022). The National Institutes of Health distinguish between two kinds of human subject research: interventional and observational approaches (National Institute of Dental and Craniofacial Research, 2022). According to the National Institute of Dental and Craniofacial Research, 2022, an observational study involves the researcher monitoring subjects and collecting data without assigning participants to a specific treatment or therapy. These examinations focus on noticing likely reasons for sickness, the sign of ailment, and changes in illness advancement (Public Organization of Dental and Craniofacial Exploration, 2022). In an interventional study, at least one natural or mental frameworks are changed by adjusting the member or the member’s environmental factors (Public Establishment of Dental and Craniofacial Exploration, 2022).
Strategies to minimize potential risks to research participants
Human subjects have frequently been subjected to risks in the early stages of research without being aware of the potential consequences (White, 2020). As a rule, these subjects were not given a decision in whether to partake and were not sufficiently educated regarding the dangers they were taking (White, 2020). Consequently, participants have been harmed in numerous research experiments (White, 2020). Because of this, systems have been executed to limit the dangers to investigate members.
The Nuremberg trials marked a turning point in history and established guidelines for human research. This preliminary happened after The Second Great War in response to the lawbreaker tests in the German death camps (White, 2020). The Nuremberg Code was established as a result of these proceedings (White, 2020). The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978) stated that although this code specified ten principles that physicians were required to adhere to when carrying out experiments on human subjects, it was insufficient for dealing with complex situations. A more thorough scope of moral rules will help lay out, examine, and figure out unambiguous guidelines (White, 2020).
NURS FPX 5005 Assessment 1 Protecting Human Research Participants
The National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research released the Belmont Report in 1979 (CITI Program, n.d.). Respect for individuals, beneficence, and justice are the three guiding concepts of this report (CITI Program, n.d.). Because it protects human participants in clinical trials and other scientific investigations, the Belmont report is one of the most influential studies on ethics and medical research (White, 2020). Everyone has the right to autonomy, and those who lack competence must be protected, according to respect for people (White, 2020). The concept of beneficence is governed by two conditions: avoid harm, maximize potential rewards, and minimize potential losses (White, 2020). The question of who ought to bear the burdens of research and reap the benefits is addressed by the justice principle (White, 2020). The final section of the Belmont Report talks about three important aspects of human subject research: informed assent, risk appraisal, and subject determination (White, 2020). • Providing prospective research participants with information, assisting them in comprehending it, and encouraging their voluntary participation in the study are all components of the informed consent procedure (CITI Program, n.d.). The purpose of risk assessment is to carry out research whose expected benefits outweigh the risks that participants face (CITI Program, n.d.). The element of subject selection necessitates a fair distribution of the benefits and disadvantages of research (CITI Program, n.d.). This ensures that no individual or group suffers harm while others benefit (CITI Program, n.d.).
Ethical Standards Applied in Research
Prior to delivering the Belmont Report, the Public Commission for the Assurance of Human Subjects of Biomedical and Conduct Exploration created an Institutional Audit Sheets report (White, 2020). According to White (2020), an Institutional Review Board is a body with explicit authority to review and supervise human biomedical research in accordance with institutional and federal regulations. According to the US Food and Drug Administration (2019), an Institutional Review Board may demand modifications in order to accept or reject research. This gathering audit shields human exploration members’ privileges and prosperity (US Food and Medication Organization, 2019). In addition, the Institutional Review Board ensures that informed consent is obtained and that the participant selection procedure is impartial (US Food and Drug Administration, 2019).
Protections Needed for Federally Identified Vulnerable Populations
Protections for vulnerable populations are included in the Department of Health and Human Services federal regulations for the protection of human research subjects (US Department of Health & Human Services, 2020). Commonly referred to as the Common Rule, subpart A of 45 CFR 46 of the federal guidelines established by the Department of Health and Human Services to safeguard human research participants is its first section (US Department of Health & Human Services, 2020). According to the US Department of Health and Human Services 2020 report, the Common Rule mandates that researchers obtain informed consent and permission from institutional review boards from subjects participating in human research. Three additional subparts provide protection for groups of people considered to be vulnerable (US Department of Health & Human Services, 2020). Pregnant women, human fetuses, and newborns are protected by the regulations in Subpart B (CITI Program, n.d.).
NURS FPX 5005 Assessment 1 Protecting Human Research Participants
It is necessary to provide additional safeguards for pregnant women, human fetuses, and newborns as a result of the possibility of unidentified risks in research (Williams, 2005). The regulations in Subpart C provide protection for inmates. Due to their limited freedom and opportunities, inmates are a particularly vulnerable group, making informed consent difficult for them. (2005 Williams) Subpart D contains guidelines that protect kids (CITI Program, n.d.). Due to their insufficient physical and intellectual development, children are a vulnerable group (Waisel, 2013).
Conclusion
It is impossible to overstate the significance of human research. We ensure that participants in studies are treated fairly and with respect by safeguarding the rights and well-being of human subjects. In doing so, we make it possible for significant advancements in medicine to be made. Those who have taken part in human research owe us a great deal, and it is our duty to continue safeguarding their wellbeing.
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 (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
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
