CH2Human Subjects Protection
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Human Subject Protection
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Human Subject Protection
MSN 563 - Evidence-Based Inquiry for Scholarship and Practice
Dr. Katie Bull
February 13, 2023
Human Subject Protection
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Human Subject Protection
Historical Background of Human Subjects Protection
The Nuremberg Code, which was created to try Nazi war criminals, is where the
fundamentals of doing human research initially emerged. The Nuremberg Code's three key
provisions—voluntary informed consent, a positive risk/benefit analysis, and the freedom to
leave a study without penalty—became the model for later ethical standards and research
legislation (Rice, 2008). This served as the catalyst and first step in establishing higher safety
standards for human participation.
Historical Incident of Human Subjects Abuse in Research and Human Rights Violated
The notorious Tuskegee Experiment is a historical episode that is well-known for the
mistreatment of study participants. The informed consent was broken by this experiment. The
U.S. Public Health Service carried out this research on more than 300 patients without informing
the participants of their illnesses or curing them even after the invention of penicillin. The study
includes tracking the development of the illness and conducting autopsies on the deceased (Park,
2017).
Human Subject Protection
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Steps to Take to Minimize Risks on Human Subjects
By employing consistent, acceptable study designs and suggested processes for
upholding the rights and welfare of human subjects, risks are reduced. Additionally, by reading
up on related studies and concentrating on matters of safety and ethics for the study's human
participants. According to UNM (2021), "Even when they are inevitable, risks may be minimized
or controlled. Incorporating precautions, protections, and alternatives into the study project can
lower the likelihood of injury or minimize its severity or duration."
Vulnerable Populations
"In research, there are individuals who are susceptible; when the human subject fails to
fend for themselves in terms of safeguarding themselves, they, therefore, have a heightened
possibility for being purposely and maliciously damaged," says the statement (Gonzalez-Duarte
et al, 2019). Populations with low literacy rates or low economic levels are seen as susceptible
because their involvement may be influenced by simple terms and incentives. The incapacity to
comprehend and offer informed consent, as well as uneven power relations that restrict
fundamental rights, can both contribute to vulnerability (Gonzalez-Duarte et al, 2019).
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Human Subject Protection
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Appropriate Ways to Recruit Subjects
In order to identify and enroll human volunteers for the research project, there has to be
reasonable and equitable recruitment method. They employ strategies including targeting,
screening, and maintaining. They must target the right population for participation by adequately
screening using an unbiased and discriminating method in order to gather the right individuals
for the study. Ensuring that the research is long-term and ongoing because the costs and rewards
of the study must be equally allocated.
How to Properly Obtain Consent
The informed consent form should be prepared in plain language that the subjects can
understand. It must reduce the likelihood of coercion or improper influence. It is necessary to
give the topic enough time to contemplate participating. Informed consent, however, is a
procedure in which the person is made aware of the research and its dangers and goes beyond
just signing a form. It is carefully outlined in the ethical standards and guidelines for using
human subjects in research (Manti & Licari, 2018).
Elements of a Properly Executed Consent
People must be told about what will be performed to them, how the procedure (the study
plan) works, what dangers or discomforts they may encounter, and that participation in the
Human Subject Protection
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clinical trial is optional in order to make an informed decision about whether to join or not to join
(FDA, 2021).
Committees Responsible for Monitoring the Protection of Human Subjects
An Institutional Examine Board is a committee that has been explicitly established to
review and oversee biomedical research involving human beings. The IRB is one of the most
crucial committees. It has the power to endorse, reject, or call for changes to research in order to
achieve endorsement. To safeguard the rights and welfare of human research participants, this
group review is essential (FDA, 2021).
REFERENCES
González-Duarte et al. (2019). II. The Research Ethics Involving Vulnerable Gtoups.Revista de
investigacion clinica; organo del Hospital deEnfermedades de la Nutricion,71(4), 217-
225.
https://doi.org/10.24875/RIC.19002812
Manti, S., & Licari, A. (2018). How to Obtain Informed Consent for Research.Breathe
(Sheffield,England), 14(2), 145-152.
https://doi.org/10.1183/20734735.001918
Park J. (2017). Historical Origins of the Tuskegee Experiment: The Dilemma of Public Health in
the United States.Ui sahak,26(3), 545-578.https://doi.org/10.13081/kjmh.2017.26.54
Human Subject Protection
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Rice, T. W. (2008). The Historical, Ethical, and Legal Background of Human-Subjects
Research.Respiratory care,53(10), 1325-1329.
University of New Mexico [UNM]. (2021).Guidance on Assessing and Minimizing Risk on
Human Subjects.irb.unm.edu.https://irb.unm.edu/library/documents/guidance/assessing-
and-minimizing-risk-in-human-research.pdf
U.S. Food & Drug Administration [FDA]. (2021).Institutional review boards (IRB) and
protection of human subjects in clinical trials.FDA.gov. https://www.fda.gov/about-
fda/center-drug-evaluation-and-research-cder/institutional-review-boards-irbs-and-
protection-human-subjects-clinical-trials
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