Social Science Research Mod 3 Lab 1

By Author: Henry Ford
Total Articles: 189
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List and briefly explain (2-3 sentences each) the 4 historical events which lead to the development of procedures to protect human research subjects.
The following are four historical events in development of human research subject protection (U.S Department of Health & Human Services, 2010)
i. Nazi Medical War crimes – Between 1939 and 1945, Nazi government in Germany is said to have conducted research using human subjects. Most of these researches violated ethical principles of human participants.
ii. The Nuremberg code – The Nuremberg code was enacted in August 1947. It included the Permissible Medical Experiments as the first international code of research ethics. It set basic principles that have to be observed to satisfy moral, ethical, and legal concepts in conducting human research.
iii. The Syphilis study at Tuskegee – This was one of the most notorious studies in the United States that violated rights of human subjects. It included 600 African American males in Tuskegee, Alabama. It violated the principle of informed consent for participants.
iv. Cold war human radiation ...
... experiments – These experiments were conducted by United States government between 1944 and 1974, More than 400 experiments were conducted to determine the effect of exposure to radiation without informed consent.
2. List and briefly explain (2-3 sentences each) the 4 sources of codes on the protection of human research subjects.
The following are four source of codes for human research subject protection (U.S Department of Health & Human Services, 2010)
i. Nuremberg Code – These are important basic principles of inclusion of human subject in research that were enacted during Nuremberg Doctors’ trial. It set out ten conditions to be met for inclusion of human subjects in research.
ii. American Psychological Association – APA started developing code of ethical standards for inclusion of human research in 1947. It set out conditions to be met for inclusion of human subjects in research
iii. First U.S Federal Policy for protection of human subjects – set out in 1953, the first U.S Federal policy for protection of human subjects outlined conditions to be met at Clinical Center, NIH. It has mechanism for review of individual research proposition that includes human subjects
iv. Declaration of Helsinki – In 1964, the World Medical Association drafted an international agreement that recommended ethical standards for clinical research. It makes informed consent a central requirement in all ethical research.
3. List and define the 3 guiding principles of ethical research.
The 3 guiding principle of ethical research include (University of Washington School of Medicine, 2010):
i. Justice– Justice Principle demands equitable selection of participants. All research subjects must be treated with equity
ii. Respect of persons - The investigator must respect the participant as a person who is capable of making informed decision regarding their participation in the study through informed consent.
iii. Beneficence – This principle outlines that research must do good and minimal harm. Risks and benefits must be weight before including human subjects in research. Privacy and confidentiality must be maintained.
4. Who is a research subject?
A research subject is individuals who are involved in the research (Sales & Folkman, 2000). These are individuals who undergo research process and gives outcome of the research.
5. When are research subjects protected?
Research subjects are protected when their participation may be exploited by the investigator (Sales & Folkman, 2000). This is when the research process may have adverse effects on them unknowingly or when they have been coerced to participate in research.
6. Why should we protect human research subjects?
Human research subjects should be protected to minimize the negative impact of research process on their life. They should also be protected to maintain integrity of the research process (Sales & Folkman, 2000).
7. Who is responsible for protecting human research subjects?
Although it the duty of all research stakeholders to protect human research subjects, the sole responsibility ultimately lies with the investigator(s) who have direct contact with the research subjects (McNamee, Olivier & Wainwright, 2006).
8. What is equitable selection of subjects & why is it important?
Equitable selection of research subjects entails giving each and ever prospective participant a chance to participate in the study. This is important to avoid bias in the study
9. Who are vulnerable populations and why do they have more extensive protections?
Vulnerable population includes those individuals who are in a position of being coerced to participate in the study because they don’t have a way to resist it. These include prisoners, institutionalized children, and others (Sales & Folkman, 2000). They have more extensive protections because in their position, it is difficult to decline participation in the study.
10. How can research be stigmatizing?
Research can be stigmatizing when the population under study is secluded by the rest of the society or when the impact of the research on the subjects makes them stigmatized by the rest of the society. Research can also be stigmatizing when investigators have preconceived beliefs about research subjects (Wuff, 2004). For example people with hepatitis can be believed to be injection drug users hence making them avoid testing, treatment, and care.
11. Compare privacy and confidentiality. How do we protect each?
Privacy entails having control over the extent, timing, and circumstance for sharing individual’s information with others. To protect privacy, participants have to be ensured of privacy of information (Beauchamp & Childress, 2001). On the other hand, confidentially entails treatment of that information with expectation that it is not divulged to others except for the original intended purpose.

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