The Ethics And Integrity Of Human Subjects Research

2.

A practice in which researchers test new drugs, or new ways of using drugs, on volunteer human participants.

Research Investigation
Clinical Trial
Drug Study
Institutional Review Board
Human Subjects Research

Correct Answer

A. 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.

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3.

Which principles make up the Belmont Report? (Check all that apply)

Respect for persons
Honesty
Beneficence
Justice
Compassion

Correct Answer(s)

A. Respect for persons
A. Beneficence
A. 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.

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4.

A person who conducts research is called a(n)...

Researcher
Investigator
Coordinator
Trial Monitor
Scientist

Correct Answer

A. 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.

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5.

If we learn of a better treatment option during a study we must inform patients about it. This scenario illuminates which Belmont principle?

Undue Influence
Beneficence
Respect for Persons
Justice
Vioxx

Correct Answer

A. 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.

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6.

During recruitment, a patient is convinced that the risks of the study do not apply to her. This is an example of...

Undue Influence
Vulnerable Population
Therapeutic Misconception
Respect for Persons
Disclosure

Correct Answer

A. 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.

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7.

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.

True
False

Correct Answer

A. 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.

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8.

Giving a patient one free year of birth control pills for one urine sample may be an example of...

A Vulnerable Population
Therapeutic Misconception
Compensation
Undue Influence
Benificence

Correct Answer

A. 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.

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9.

The medication VIOXX was developed by which major pharmaceutical company?

Bayer
Pfizer
Merck
Johnson & Johnson
Proctor & Gamble

Correct Answer

A. Merck

Explanation

Merck is the correct answer because it is a major pharmaceutical company that developed the medication VIOXX.

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10.

True or False: No research may involve termination of a pregnancy.

True
False

Correct Answer

A. 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.

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11.

Please give one example of a vulnerable population.

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.

The Ethics And Integrity Of Human Subjects Research

True or False: According to the principle of justice, investigators may exclude Caucasian women from a study about women's attitudes toward Depo Provera.

Quiz Preview

A practice in which researchers test new drugs, or new ways of using drugs, on volunteer human participants.

Which principles make up the Belmont Report? (Check all that apply)

A person who conducts research is called a(n)...

If we learn of a better treatment option during a study we must inform patients about it. This scenario illuminates which Belmont principle?

During recruitment, a patient is convinced that the risks of the study do not apply to her. This is an example of...

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.

Giving a patient one free year of birth control pills for one urine sample may be an example of...

The medication VIOXX was developed by which major pharmaceutical company?

True or False: No research may involve termination of a pregnancy.

Please give one example of a vulnerable population.

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?

You feel the research program coordinator or medical director is behaving unethically during a study. What can you do?