1.
A practice in which researchers test new drugs, or new ways of using drugs, on volunteer human participants.
Correct Answer
B. Clinical Trial
Explanation
A clinical trial is a practice where researchers test new drugs or new ways of using drugs on volunteer human participants. This involves conducting experiments and collecting data to determine the safety and effectiveness of the drug or treatment. Clinical trials are an essential part of the drug development process and help in advancing medical knowledge and improving patient care.
2.
A person who conducts research is called a(n)...
Correct Answer
B. Investigator
Explanation
An investigator is the correct answer because a person who conducts research is often referred to as an investigator. This term is commonly used in various fields such as science, law enforcement, and social sciences. Investigators are responsible for gathering data, analyzing information, and drawing conclusions based on their research findings. They play a crucial role in advancing knowledge and understanding in their respective areas of study.
3.
True or False: The Tuskegee
syphilis experiment enrolled 399 African American men and women infected
with syphilis to look at the long term affects of untreated syphilis.
Correct Answer
B. False
Explanation
The Tuskegee syphilis experiment did enroll 399 African American men, but not women, who were infected with syphilis. However, the purpose of the study was not to look at the long-term effects of untreated syphilis, but rather to observe the natural progression of the disease when left untreated. The participants were not informed of their diagnosis and were denied treatment, even when penicillin became the standard treatment for syphilis. This unethical study lasted for 40 years, from 1932 to 1972, and resulted in numerous deaths and health complications for the participants.
4.
The medication VIOXX was developed by which major pharmaceutical company?
Correct Answer
C. Merck
Explanation
Merck is the correct answer because it is a major pharmaceutical company that developed the medication VIOXX.
5.
Which principles make up the Belmont Report? (Check all that apply)
Correct Answer(s)
A. Respect for persons
C. Beneficence
D. Justice
Explanation
The Belmont Report is a foundational document in the field of research ethics. It outlines three principles that should guide research involving human subjects: respect for persons, beneficence, and justice. Respect for persons emphasizes the autonomy and dignity of individuals, ensuring their informed consent and protecting vulnerable populations. Beneficence requires researchers to maximize benefits and minimize harm to participants. Justice demands fairness and equal treatment in the selection of research subjects. The principles of honesty and compassion are not explicitly mentioned in the Belmont Report.
6.
Giving a patient one free year of birth control pills for one urine sample may be an example of...
Correct Answer
D. Undue Influence
Explanation
Undue influence refers to a situation where a person is coerced or manipulated into making a decision that is not in their best interest. In this scenario, giving a patient one free year of birth control pills in exchange for one urine sample may be seen as undue influence because it could potentially pressure the patient into providing the urine sample, even if they may not necessarily need or want the birth control pills.
7.
If we learn of a better treatment option during a study we must inform patients about it. This scenario illuminates which Belmont principle?
Correct Answer
B. Beneficence
Explanation
The scenario described in the question highlights the principle of beneficence. Beneficence refers to the ethical obligation to act in the best interest of others and promote their well-being. In this case, the principle of beneficence is demonstrated by the requirement to inform patients about a better treatment option that has been discovered during a study. By doing so, the researchers are ensuring that the patients receive the best possible care and have access to the most effective treatment available.
8.
True or False: According to the principle of justice, investigators may exclude Caucasian women from a study about women's attitudes toward Depo Provera.
Correct Answer
B. False
Explanation
According to the principle of justice, investigators cannot exclude Caucasian women from a study about women's attitudes toward Depo Provera. The principle of justice emphasizes fairness and equal treatment for all individuals, regardless of their race or ethnicity. Excluding a specific racial group from a study would be discriminatory and unethical. Therefore, the correct answer is false.
9.
Please give one example of a vulnerable population.
10.
True or False: No research may involve termination of a pregnancy.
Correct Answer
B. False
Explanation
Research may involve the termination of a pregnancy in certain cases. For example, medical research may explore the effects of certain drugs or procedures on pregnancy termination. Additionally, research on reproductive health or fetal development may require the termination of a pregnancy for scientific purposes. Therefore, it is not true that no research may involve the termination of a pregnancy.
11.
During recruitment, a patient is convinced that the risks of the study do not apply to her. This is an example of...
Correct Answer
C. Therapeutic Misconception
Explanation
Therapeutic Misconception refers to the situation where a patient participating in a study mistakenly believes that the experimental treatment being offered will directly benefit them, rather than understanding that the primary purpose of the study is to gather scientific knowledge. In this case, the patient's belief that the risks of the study do not apply to her suggests that she has misunderstood the nature of the study and its potential outcomes, indicating a therapeutic misconception.
12.
A patient has been given 10 minutes alone to read the
informed consent document. You enter the room to discuss the risks of the
study, but the patient states she has read everything. She is a middle-aged
woman who seems like she genuinely understands everything. She is becoming
openly agitated as you try to continue, stating she wants to participate, but
is running late to pick up her son from school and doesn’t need to hear the
risks again, she understands, and doesn’t know why you don’t believe her. What can you do?
13.
You have gone through informed consent with a patient;
however she doesn’t seem to be paying
attention. You go over the same point again, and she seems unfazed, as if you
didn’t just repeat yourself. She insists
she understands, but you have a feeling she doesn’t. What can you do?
14.
A patient sends in a survey. She has been a long standing
patient and you know that she has had three ABs. In the survey, when asked how
many ABs she has had, she wrote in “2”. Knowing that she must have made a
mistake, you correct her answer for her and put the survey in her file, because
you want the study to have accurate information. Is this scenario ethically
sound? Why or why not?
15.
You feel the research program coordinator or medical
director is behaving unethically during a study. What can you do?