Human Subjects Protection

Historical Background

Clinical experiments are necessary in the medical world, but the rights of the participants must be respected. Nazi doctors conducted experiments on the prisoners detained in their concentration camps during World War II (Moreno et al., 2017). These experiments were inhuman and were done in extreme conditions of height and temperature. They did not even seek informed consent from the participants. This led to the establishment of the Nuremberg Code, which was aimed in 1947 (Moreno et al., 2017). It was aimed to protect human participants in experiments.

Historical Incidents of Abuse of Human Subjects in Research

One historical incident was done in Willowbrook School for Mentally Retarded Children in Staten Island. The residents in this school were deliberately injected with the Hepatitis virus (Jamrozik & Selgelid, 2020). There was the administration of experimental vaccines to the residents, and the risks were not fully explained to the parents. All students were required to participate in this study before being admitted to this school.

Steps To Minimize Risks On Human Subjects

I will use ethical principles when conducting research on human subjects to minimize risks. I will apply the principle of informed consent to my research. I will explain all the benefits and risks to my study participants and make voluntary informed consent before participating in my research (Melnyk and Fineout-Overholt, 2019). The participants will also be able to leave the research at any point without explanation

Vulnerable Populations

Vulnerable populations require additional protection and measures against the risks linked with clinical research (Polit & Beck, 2018). They include mentally disabled individuals, terminally ill patients, pregnant women, and children. These individuals are considered vulnerable since they may not have the competency to give informed consent or may disproportionately experience side effects of clinical trials.

Appropriate Ways To Recruit Subjects

Researchers must effectively plan how they will recruit participants for their clinical trials. The researchers can use their existing social networks, collaborate with community gatekeepers, and create recruitment materials (Joseph et al., 2016). Participants can be recruited through soliciting volunteers, brochures, newspapers, and emails. They should also inform the study participants of the aim in a straightforward manner that they can understand.

Proper Way of Obtaining Consent

The researcher has first to ensure that the participants are competent, understand the purpose of the research, and give informed consent. The participants should be given the option of declining to participate in the research process (Melnyk & Fineout-Overholt, 2019). The researcher must inform the participants of the benefits and risks of the trials, duration, and purpose.

Appropriately Executed Consent Components

The components of a properly executed consent include the purpose of the study, the expectation of participation, the voluntary nature of participation, and the potential benefits and risks (Polit & Beck, 2018).  The duration of the study should also be included. The participants should be informed about the components in a language that they can understand. Researchers should avoid using technical terms. Research subjects must understand all aspects of the research before giving their consent . Researchers must also ensure that the participants are fully competent to give their consent.

Committees That Protect Human Subjects

Institutional review boards protect human subjects in medical and behavioral research experiments (Polit & Beck, 2018). These Boards are present in the United States and more than eight countries in the world. Before any research on human subjects can start, researchers apply to the IRBs. The IRB can approve, disapprove, or modify the plan.

References

Jamrozik, E., & Selgelid, M. J. (2020). Ethical issues surrounding controlled human infection challenge studies in endemic low?and middle?income countries. Bioethics, 34(8), 797-808. https://doi.org/10.1111/bioe.12802

Joseph, R. P., Keller, C., & Ainsworth, B. E. (2016). Recruiting participants into pilot trials. Californian Journal of Health Promotion, 14(2), 81-89. https://doi.org/10.32398/cjhp.v14i2.1878

Melnyk, B. M., & Fineout-Overholt, E. (2019). Evidence-based practice in nursing and healthcare: A guide to best practice. (4th ed.). Wolters Kluwer

Moreno, J. D., Schmidt, U., & Joffe, S. (2017). The Nuremberg Code 70 years later. JAMA, 318(9), 795. https://doi.org/10.1001/jama.2017.10265

Polit, D. F., & Beck, C. T. (2018). Essentials of nursing research: Appraising evidence for nursing practice. (9th ed.). Wolters Kluwer.

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This course is designed to prepare investigators involved in the design and/or conduct of research involving human subjects to understand their obligations to protect the rights and welfare of subjects in research. The course material presents basic concepts, principles, and issues related to the protection of research participants.

Human Subjects Protection

Evidence-based research involving human subjects requires that researchers be cognizant of and adhere to the important tenets necessary to protect subjects from abuse, harm, injury, and/or other undesirable outcomes resulting from the research process. Based on this fact, write a minimum of 2 pages (Title page and Reference not included in page count) of an APA formatted paper answering the following questions with a minimum of 3 “short” sentences for each question:

Historical background of human subjects protection? (10 points)
Find and discuss at least one historical incident of human subjects abuse in research and what human right was violated. (10 points)
What steps will you take to minimize risks on human subjects? (10 points)
What populations are considered vulnerable populations and why? (10 points)
What are the appropriate ways to recruit subjects? (10 points)
How would you properly obtain consent? (10 points)
What are the elements of a properly executed consent? (10 points)
What committees are responsible for monitoring the protection of human subjects? (10 points)
Scoring Scheme:

Total points for questions/content: 80 points
Title page and a minimum of 2 References: 10 points
Minimum of 3 “short” sentences to answer each question: 10 points
TOTAL POINTS: 100 (the gradebook will re-weight this total as 50 points or 5% of the course grade)
NOTE: This is a written APA formatted assignment and “NOT” a YES or NO answer assignment. You are expected to answer each question with at least 3 short sentences, points will be deducted for using a single sentence. Title and Reference pages are required.

Expectations

Due: Monday, 11:59 pm PT
Length: a minimum of 2 pages, title page and references not included in page count
Citations: a minimum of 2