Protecting Human Research Participants
NURS FPX 5005 Assessment 1 Protecting Human Research Participants
Protecting Participants in Human Research Human research has long been regarded as crucial to improvements in human health and well-being (University of Alaska Fairbanks, n.d.). According to University of Alaska Fairbanks (n.d.), human research subject protection is essential for ensuring the safety of participants in studies and experiments. According to University of Alaska Fairbanks (n.d.), guidelines are in place to safeguard study participants from unethical treatment or abuse. Maltreatment of human exploration subjects should be stayed away from no matter what in the event that we are to keep leading essential examinations with uprightness. Human research has the potential to do a lot of good, but only if it is done in an ethical and responsible way.
History and importance of human subject protection
NURS FPX 5005 Assessment 1 Protecting Human Research Participants
The current approach to protecting human subjects has evolved over the course of the past century in response to questionable ethical conduct in research (White, 2020). An extended practice of utilizing what is currently perceived as weak gatherings as study subjects might be followed back to the early utilization of kids and prisoners (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).
Types of research activities that require the involvement of human subjects
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). After the viability of penicillin was illustrated, the US General Wellbeing Administration made treatment centers, however the information from the Tuskegee preliminaries were considered too crucial for even think about disposing of; 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.
NURS FPX 5005 Assessment 1 Protecting Human Research Participants
The Health and Human Services Policy for the Protection of Human Research Subjects in 45 CFR Part 46 defines a human subject as a living individual who is the subject of an investigation by a researcher who gathers 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 expected reasons for sickness, the sign of ailment, and changes in illness advancement (Public Establishment 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 elements (Public Foundation of Dental and Craniofacial Exploration, 2022).
Strategies to minimize potential risks to research participants
NURS FPX 5005 Assessment 1 Protecting Human Research Participants
Since the beginning of examination, human subjects have frequently been presented to takes a chance with minimal comprehension of the likely outcomes (White, 2020). According to White (2020), these subjects frequently did not have a choice regarding whether or not to participate in the study and were not adequately informed of the risks they were taking. Consequently, participants have been harmed in numerous research experiments (White, 2020). Strategies have been implemented to reduce the risks to research participants as a result.
The Nuremberg preliminaries were a defining moment ever, drawing certain lines for research that would be directed on people. In response to the criminal experiments carried out in the German concentration camps, this trial was held after World War II (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. Establishing, evaluating, and comprehending specific regulations will be made easier with a wider range of moral guidelines (White, 2020).
NURS FPX 5005 Assessment 1 Protecting Human Research Participants
The Belmont Report was delivered in 1979 by the Public Commission for the Security of Human Subjects in Biomedical and Social Exploration (CITI Program, n.d.) Respect for individuals, beneficence, and justice are the three guiding concepts of this report (CITI Program, n.d.). The Belmont report is perhaps of the most persuasive concentrate on morals and clinical exploration since it shields human members in clinical preliminaries and other logical examinations (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: subject selection, risk assessment, and informed consent (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
NURS FPX 5005 Assessment 1 Protecting Human Research Participants
The National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research published an Institutional Review Boards report prior to the release of the Belmont 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. An Institutional Audit Board can request changes be made for research acknowledgment or dismissal (US Food and Medication Organization, 2019). This gathering audit shields human examination 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
NURS FPX 5005 Assessment 1 Protecting Human Research Participants
The government guidelines for safeguarding human examination subjects gave by the Branch of Wellbeing and Human Administrations incorporate assurances that help weak populaces (US Division of Wellbeing and Human Administrations, 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). The Normal Decide orders that analysts get institutional survey board authorization and informed assent from subjects signed up for human exploration (US Division of Wellbeing and Human Administrations, 2020). Gatherings who are viewed as powerless are safeguarded by three extra subparts (US Branch of Wellbeing and Human Administrations, 2020). Pregnant women, human fetuses, and newborns are protected by the regulations in Subpart B (CITI Program, n.d.). 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) Children are protected by the regulations in Subpart D (CITI Program, n.d.). Youngsters are a weak gathering in light of their immature physical and mental abilities (Waisel, 2013)
Conclusion
NURS FPX 5005 Assessment 1 Protecting Human Research Participants
The significance of human examination couldn’t possibly be more significant. 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.
NURS FPX 5005 Assessment 1 Protecting Human Research Participants
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
NURS FPX 5005 Assessment 1 Protecting Human Research Participants
Universtiy 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
