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.
Length: a minimum of 2 pages, title page and references not included in page count
Citations: a minimum of 2 within last 5 years
Historical Background of Human Subject’s Protection
Over the years, human cruelty had been perpetuated through research. The discoveries of human subjects’ abuse in the study were the foundation for the Nuremberg code and Nuremberg trials. The Nuremberg code 1949 was the initial global codification of minimal demands while conducting research that involved human subjects (White, 2020). Some of the code’s main requirements included that research with human participants ought to only happen in the situation of strong scientific basis with participants that have been freely selected.
After a long period of harmful research studies on human subjects unwillingly, the U.S congress established the National Commission for protecting human subjects of behavioral and biomedical research. The commission then issued a Belmont Report with ethical principles that guided the federal regulations to protect human subjects (White, 2020). There were three primary ethical principles in the report that guided research involving human subjects: respect for beneficence, persons, and justice. The National Research Act that was passed by the congress, which led to the Belmont, also demanded Institutional Review Boards, whose main task was to review all research that involved human subjects.
Historical Incident of Human Subject’s Abuse in Research and What Human Right Was Violated.
CIA’s Mind Control Program was the name issued to the program of experiments that involved human participants conducted by the U.S Central Intelligence Agency, some of which were unlawful. The experiments aimed to recognize and establish drugs and processes for interrogations to force confessions and weaken individuals through mind control. The CIA has carried out experiments on unaware and cognizant human participants as part of the wide-ranging program to govern and influence human conduct with psychoactive drugs.
Steps to Minimize Risks on Human Subjects
Human subjects’ risks can be reduced by using procedures that are consistent with a sound research approach that does not expose human subjects to risk. The first thing is to think about responsible conduct, which goes beyond adhering to the approved research protocols. The researcher needs to consider the potential benefits and risks and design a study that will minimize the risk of subjects and protect their interests (Islam, 2014). The second thing is to ensure that human subjects are both necessary and justifiable. The researchers have to examine whether the risks are sensible with the knowledge and benefits gained. The last thing is to ensure that the consent to be involved in the research is given freely and is based on the subject’s understanding of the benefits and risks. The subjects should be offered detailed information on the research protocol linked to the experiment’s design and the outcomes of the research proceedings.
Population are Considered Vulnerable Population
Certain groups of human research subjects are considered vulnerable populations since researchers violate their rights. These include prisoners, children, disadvantaged persons, and ethical minorities. These groups are individuals with questionable capacity to consent or are relatively unable to protect their rights or interests. For instance, since children have not reached an age where they can consent independently, a guardian or parent may offer consent for a child to be involved in the research.
Appropriate Ways to Recruit Subjects
Recruitment of individuals during research involves selecting and attracting appropriate candidates for the research or project. This is conducted through posters, emails, brochures, advertisements in television and radios, social media, or through soliciting volunteers within a public space (Manohar, MacMillan, Steiner, and Arora, 2018). The recruitment materials have to include an accurate description of the research aim, the name and address of the facility or investigator, the eligibility criteria, location of research and time required, and the person to be contacted.
How to Properly Obtain Consent
The whole process of informed consent involves offering adequate information to the subject regarding the study and offering an opportunity for the individual to consider the options, risks, and benefits of the research (Islam, 2014). There is a need to respond to the subject’s questions and ensure that the subject completely understands the information. The process should offer an opportunity for the subject and investigator to ask questions and exchange information. After an effective discussion between the two parties, the subject should be allowed to voluntarily participate in the research. The researcher should then receive a written informed consent to indicate the willingness to participate.
Elements of a Properly Executed Consent
The elements of well-implemented and valid consent entail disclosure of essential and necessary information, subjects’ capacity to offer consent and ask questions, and freedom of participation without coercion. Additionally, informing the subject about their rights, the purpose of the research, potential benefits and risks, procedures to be taken, the extent of confidentiality of their personal information, and a statement indicating that the participation is voluntary are essential for a well-executed consent.
Committees Responsible for Monitoring the Protection of Human Subjects
The research ethics committee and Institutional Review Boards are accountable for checking the protection of human research participants. This is done through periodic and advanced independent review of human research’s ethical conduct (Grady, 2015). The committees are charged with offering independent evaluation that the proposed study is acceptable, checking the potential risks and biases, and ensuring compliance with laws and regulations that have been designed to offer a respectful and adequate protection of human subjects.
Grady, C. (2015). Institutional review boards: purpose and challenges. Chest, 148(5), 1148-1155.
Islam, M. R. (2014). Informed consent of human subjects: a review. Bangladesh Journal of Bioethics, 5(1), 20-35.
Manohar, N., MacMillan, F., Steiner, G. Z., & Arora, A. (2018). Recruitment of research participants. Handbook of Research Methods in Health Social Sciences, 1-28.
White, M. G. (2020). Why human subjects research protection is important. Ochsner Journal, 20(1), 16-33.
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