Human Subjects Protection
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.
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 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)
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.
Human Subjects Protection
Nuremberg Code was the first law to protect human subjects’ rights in scientific research. Human beings were experimented on by Nazi scientists during World War II without the individuals’ agreement or knowledge of the possible consequences of their actions. Developed in the wake of the Nuremberg trials, the Nuremberg Code was designed to assist scholars in five significant areas. Voluntary consent, favorable outcomes, inherent hazards, and a host of other concepts fall under this umbrella. According to the Helsinki Declaration, written in 1964, biomedical research should be guided by a guiding principle. The Human Subjects Regulations, created by the Health and Human Services, were published in 1974. The National Research Act of 1974, passed in response to the Tuskegee Syphilis Study, was enacted to ensure the safety of research subjects. Because of the National Research Act, the Belmont Report was finally made public in 1978. Ethical research values such as goodwill and regard for humans were outlined in this statement. Justice was also mentioned.
Atrocities perpetrated by the Nazis against their victims during World War II were widely publicized. The Nazis tortured and even killed many prisoners of war during World War II to conduct scientific research or experiments on them. Experiments on human subjects were conducted without their consent, hazards were not disclosed, and substances were used to damage their lives. These are only a few examples of human rights violations.
To minimize the danger to the human subjects, I aim to make as much of the study’s design and scientific justification public as possible. I shall ask my human subjects to freely sign a permission form once they have been informed of the purpose of the research and the potential dangers. The researchers for this study must have substantial experience and a high level of expertise. I will ensure that the sample size is large enough to draw reliable results. Data from standard medical procedures will be gathered to reduce the likelihood of invasive surgeries and other treatments, such as chemotherapy.
As a whole, vulnerable populations must be better protected from the risks of conducting research. There is a high probability that this group will end up in a bad situation. As a result of legal limits, they cannot give their approval (Grady, 2018). In addition to persons who have experienced trauma, those who have been incarcerated or are patients at mental health or nursing home are examples of vulnerable populations.
An initial study panel or database of potential research participants is created at the beginning. They then begin searching for human volunteers to engage in their research. As part of a study, researchers can communicate directly with potential volunteers online or by phone. Those who might be interested in participating in the study mustn’t feel pressured in any way (Resnik, 2018). The recruitment letter must include the name of the organization or clinic that will be conducting the study. A prospective participant with questions about their eligibility will be asked to contact the organization directly. Participants or healthcare providers who are not involved in the study can make a referral. An investigator cannot refer because of the nature of their position.
All relevant study information must be presented to patients to acquire informed consent for a study. All of the participant’s options will be open to them, and they will not be compelled to make a decision. If they are still unsure about anything, students can ask questions after reading the options and considering them for a while. A conversation about the advantages and drawbacks of any opportunity or risk must be held to guarantee that everyone knows the facts (Grady, 2018). The patient must then make an informed decision or voluntary agreement.
The patient’s name and the name of the hospital where the therapy will be provided should appear together in the written agreement between a patient and a medical practitioner. For clarity, the authorization request must provide the procedure’s name. The practitioner’s name is an additional factor to consider. The procedure’s benefits, drawbacks, and side effects must be thoroughly explained to patients and their legal representatives. Another stipulation is that this must be done (Resnik, 2018). Not only must the participant but also their legal representative sign the document.
They do this by following federal regulations, which they then examine objectively, and by implementing those restrictions, which Institutional Review Boards uphold. Whatever the funding source, the Office of Human Study Protections monitors all research to ensure that ethical norms are upheld. In addition, the Committee for the Protection of Human Subjects (CPHS) ensures that research involving human subjects is carried out in compliance with ethical standards and with the least amount of risk possible.
Grady, C. (2018). Ethical principles in clinical research. Principles and Practice of Clinical Research, 19-31. https://doi.org/10.1016/b978-0-12-849905-4.00002-2
Resnik, D. B. (2018). The ethics of research with human subjects. International Library of Ethics, Law, and the New Medicine. https://doi.org/10.1007/978-3-319-68756-8
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