Deck 6: Human Research

Question 1

The use of placebos in control groups is

A) never a moral issue.
B) never permissible.
C) often cause for serious moral concern.
D) unprofessional.

Answer 1

C

Question 2

The first article of the Nuremberg Code concerns

A) placebo-controlled trials.
B) informed consent.
C) scientific credentials.
D) randomization.

Answer 2

B

Question 3

Most official policies assert or assume that properly designed research in children is morally acceptable if

A) the children are ill.
B) it is conducted for their sake.
C) there are zero risks.
D) it is conducted without their knowledge.

Answer 3

B

Question 4

Research on the mentally impaired

A) is unnecessary.
B) is unethical.
C) does not require consent.
D) is scientifically necessary.

Question 5

The heart of the modern doctrine of informed consent is

A) Kantian.
B) utilitarian.
C) Rawlsian.
D) Hippocratic.

Question 6

The experiment to study the natural course of hepatitis in institutionalized children by purposely infecting them is known as the

A) Nazi experiments.
B) Tuskegee study.
C) radiation experiments.
D) Willowbrook study.

Question 7

The _______ is a set of minimal ethical principles meant to govern all scientific experiments involving humans that came out of the trial of Nazi doctors.

A) Nuremberg Code
B) Hippocratic Oath
C) WHO
D) categorical imperative

Question 8

_______ is a common phenomenon in which patients sometimes feel better after receiving treatment even when the treatment is inactive or fake.

A) Blinding
B) Confirmation bias
C) The placebo effect
D) Randomization

Question 9

In a clinical trial, the subjects in a(n) _______ receive the standard treatment that is already proven to work.

A) active control group
B) placebo control group
C) randomized sample
D) experimental group

Question 10

A _______ clinical study is one in which subjects and researchers are unaware of what treatments subjects have received.

A) single-blinded
B) double-blinded
C) randomized
D) controlled

Question 11

_______ is the best way to assign subjects to either control or experiment groups if one wants to generate reliable data.

A) Therapeutic grouping
B) The scientific method
C) Placebo-control grouping
D) Randomization

Question 12

A Phase I trial is said to be _______ because it only tests the drug in a few people for safety, adverse reactions, and to ascertain safe and unsafe doses.

A) therapeutic
B) nontherapeutic
C) randomized
D) unethical

Question 13

A Phase _______ trial might be done after an approved drug is marketed.

A) I
B) II
C) III
D) IV

Question 14

One possible benefit of entering a clinical trial is that

A) health insurance covers all patient care costs in a study.
B) if you are taking a new treatment that works, you will be among the first to benefit.
C) there are rarely as many side effects for new treatments.
D) animal testing has already shown the new treatment is as or more effective than current treatments.

Question 15

According to _______, research efforts should be aimed primarily at helping the neediest and it is impermissible to conduct research on the neediest to provide therapeutic benefits only to those who are better off.

A) act-utilitarians
B) Kantians
C) Rawlsians
D) virtue ethicists

Question 16

Medical research has provided great benefits to humanity and has only rarely been conducted in morally questionable ways.

Question 17

Properly conducted clinical trials provide the strongest and most trustworthy evidence of a treatment's effectiveness.

Question 18

For most clinical trials, randomization is unnecessary.

Question 19

The safety and effectiveness of a treatment can usually be established by a single clinical trial.

Question 20

There is substantial agreement in bioethics on the general moral principles that should apply to human research.

Question 21

A typical clinical trial will consist of two groups of subjects: an experimental group that gets the treatment to be evaluated and a control group that closely resembles the experimental group, but does not get the treatment.

Question 22

The U.S. government never formally apologized for the Tuskegee Study.

Question 23

Double-blinding is the assigning of subjects randomly to both experimental and control groups.

Question 24

Often, a single well-crafted clinical trial can establish the safety and effectiveness of a treatment.

Question 25

Before human studies can begin, a treatment must usually be studied in animals.

Question 26

There is consensus that to be ethically permissible, clinical trials must offer therapeutic benefit of some sort in all phases.

Question 27

Most bioethicists agree that the use of placebos is unethical when effective treatments are available.

Question 28

Women have historically been excluded as subjects from many studies of treatments that could help them.

Question 29

Informed consent for participation in a clinical trial requires that researchers inform the subject whether they will be in the control group or experimental group.

Question 30

Informed consent for participation in a clinical trial requires that researchers inform the subject of the expected duration of the subject's participation.

Question 31

What are the five restrictions official ethical codes on human research agree must be met?

Question 32

Explain why a control group is an important element in a clinical trial.

Question 33

Define "blinding" and explain its role in clinical trials.

Question 34

Describe the three stages of clinical trials.

Question 35

A clinical trial of HIV-infected pregnant women in several African countries and Thailand used a placebo-control group to determine whether a lower, cheaper dose of AZT could substantially reduce the transmission of HIV from pregnant women to their fetuses. The results showed the less expensive AZT treatment (that could be more widely used in poorer countries) could indeed significantly reduce vertical transmission. However, many questioned the morality of using a placebo (no-treatment) group, which deprived control subjects of an effective treatment that could have prevented many babies from being infected with HIV. Briefly contrast an act-utilitarian versus Kantian assessment of this clinical trial.

Question 36

The Following Questions For Readings: The Nuremberg Code
-According to the Nuremberg Code, an experiment should be conducted so as to

A) yield fruitful results for the researchers.
B) yield fruitful results that can be obtained by other methods or means.
C) avoid all unnecessary physical and mental suffering and injury.
D) avoid any and all physical and mental suffering and injury.

Question 37

The Following Questions For Readings: The Nuremberg Code
-According to the Nuremberg Code, no experiment should be conducted where there is

A) an a priori reason to believe that the experiment will succeed.
B) an a priori reason to believe that death or disabling injury may occur.
C) reason to expect that the experiment will succeed.
D) an a priori reason to believe that any injury at all may occur.

Question 38

The Following Questions For Readings: The Nuremberg Code
-According to the Nuremberg Code, an experiment should be designed and based on all available information so that the anticipated results will

A) justify the performance of the experiment.
B) be exactly as expected.
C) not justify replication of the experiment.
D) be considered a breakthrough in the field of inquiry.

Question 39

The Following Questions For Readings: Declaration of Helsinki, World Medical Association
-Unlike previous international ethical codes, the code set forth in the Declaration of Helsinki provides guidelines for conducting research on subjects who

A) object to the use of placebos.
B) refuse to give their consent.
C) opposed to the line of research.
D) cannot give their informed consent.

Question 40

The Following Questions For Readings: Declaration of Helsinki, World Medical Association
-The code set forth in the Declaration of Helsinki asserts that medical research is justified only if there is a reasonable likelihood that the populations in which the research is carried out

A) will be compensated.
B) are acknowledged and thanked by the researchers.
C) stand to benefit from the results of the research.
D) stand to benefit from exposure in medical journals.

Question 41

The Following Questions For Readings: Declaration of Helsinki, World Medical Association
-The code set forth in the Declaration of Helsinki declares that at the conclusion of a study, every patient entered into the study should be assured of

A) free medical care for years after the study.
B) the best proven treatments identified by the study.
C) the best medical advice that seems justified by the study.
D) a repeat of the study if necessary.

Question 42

The Following Questions For Readings: "The Belmont Report," National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
-According to the Belmont Report, the three most relevant moral principles are

A) respect for persons, consent, and justice.
B) respect for persons, beneficence, and justice.
C) respect for persons, truth, and beneficence.
D) beneficence, justice, and competence.

Question 43

The Following Questions For Readings: "The Belmont Report," National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
-According to the Belmont Report, an autonomous person is an individual capable of deliberation and of

A) acting under the direction of others.
B) acting without deliberation.
C) acting under the direction of such deliberation.
D) revising their deliberative reflections.

Question 44

The Following Questions For Readings: "The Belmont Report," National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
-According to the Belmont Report, the principle of beneficence demands that efforts be made to

A) see that justice is done.
B) determine what is deserved.
C) maximize benefits to the research project.
D) secure the well-being of persons.

Question 45

The Following Questions For Readings: "Final Report: Human Radiation Experiments," Advisory Committee on Human Radiation Experiments
-"Final Report: Human Radiation Experiments" documents that subjects were

A) exposed to harmful radiation and consented to such exposure.
B) told of the potential dangers of radiation.
C) exposed to harmful radiation without their consent.
D) never exposed to real danger.

Question 46

The Following Questions For Readings: "Final Report: Human Radiation Experiments," Advisory Committee on Human Radiation Experiments
-"Final Report: Human Radiation Experiments" documents that human radiation experiments between 1944 and 1974

A) numbered nearly 4,000.
B) were limited in number and scope.
C) were numerous but mostly benign.
D) numbered less than 400.

Question 47

The Following Questions For Readings: "Final Report: Human Radiation Experiments," Advisory Committee on Human Radiation Experiments
-According to "Final Report: Human Radiation Experiments," for not protecting the rights and interests of human subjects, government officials and investigators are

A) blameworthy.
B) blameless.
C) to be commended for their commitment to science.
D) blameworthy but innocent.

Question 48

The Following Questions For Readings: "Of Mice but Not Men: Problems of the Randomized Clinical Trial," Samuel Hellman and Deborah S. Hellman
-According to the Hellmans, randomized trials often pit the good of patients against the good of

A) researchers.
B) science.
C) society.
D) future generations.

Question 49

The Following Questions For Readings: "Of Mice but Not Men: Problems of the Randomized Clinical Trial," Samuel Hellman and Deborah S. Hellman
-The Hellmans point out that the purpose of the randomized clinical trial is to avoid

A) disease characteristics.
B) confirmatory trials.
C) double-blind controls.
D) observer bias and patient selection.

Question 50

The Following Questions For Readings: "Of Mice but Not Men: Problems of the Randomized Clinical Trial," Samuel Hellman and Deborah S. Hellman
-The Hellmans say there are dangers in foregoing clinical trials and relying instead on

A) observational studies.
B) physician's intuition and anecdotes.
C) randomized, double-blind studies.
D) other proven experimental methods.

Question 51

The Following Questions For Readings: "A Response to a Purported Ethical Difficulty with Randomized Clinical Trials Involving Cancer Patients," Benjamin Freedman
-Freedman argues that true equipoise (a state of doubt about a treatment's effectiveness) does not depend on

A) uncertainty in society.
B) uncertainty in the physician.
C) certainty in research.
D) uncertainty in research subjects.

Question 52

The Following Questions For Readings: "A Response to a Purported Ethical Difficulty with Randomized Clinical Trials Involving Cancer Patients," Benjamin Freedman
-Freedman says that true equipoise depends on

A) genuine disagreement in the medical community about a treatment's value based on informed intuition.
B) genuine disagreement in the medical community about a treatment's value based on a lack of good evidence from randomized clinical trials.
C) uncertainty in society about effective treatments.
D) disagreements about efficacy among medical journalists.

Question 53

The Following Questions For Readings: "A Response to a Purported Ethical Difficulty with Randomized Clinical Trials Involving Cancer Patients," Benjamin Freedman
-Freedman suggests that the Kantian argument against the morality of clinical trials is

A) powerful.
B) solid.
C) strong.
D) implausible.

Question 54

The Following Questions For Readings: "Racism and Research: The Case of the Tuskegee Syphilis Study," Allan M. Brandt
-Probably the most outrageous and unethical example of unethical research in American history is the

A) human radiation studies from 1944 to 1974.
B) Tuskegee Syphilis Study.
C) Belmont study.
D) Nazi experiments.

Question 55

The Following Questions For Readings: "Racism and Research: The Case of the Tuskegee Syphilis Study," Allan M. Brandt
-In the early twentieth century, Darwinism provided a new (false) rationale for American

A) racism.
B) art and literature.
C) democracy.
D) history.

Question 56

The Following Questions For Readings: "Racism and Research: The Case of the Tuskegee Syphilis Study," Allan M. Brandt
-According to Brandt, the Tuskegee study revealed less about the pathology of syphilis than it did the pathology of

A) science.
B) history.
C) medicine.
D) racism.

Question 57

The Following Questions For Readings: "The Ethics of Clinical Research in the Third World," Marcia Angell
-Angell says that studies comparing a potential new treatment with a placebo are unethical if

A) the placebo is indeed inactive.
B) an effective treatment exists.
C) no effective treatment exists.
D) the placebo is the best known treatment.

Question 58

The Following Questions For Readings: "The Ethics of Clinical Research in the Third World," Marcia Angell
-Angell argues that some trials in developing countries are impermissible because the studies

A) do not use placebo control groups.
B) are conducted by scientists from developed nations.
C) are conducted in poor conditions.
D) use placebo control groups even though a proven treatment exists.

Question 59

The Following Questions For Readings: "The Ethics of Clinical Research in the Third World," Marcia Angell
-According to Angell, in permissible studies, control groups must receive

A) no treatment.
B) the current "local" treatment.
C) the "best" current treatment.
D) the only treatment available.

Question 60

The Following Questions For Readings: "Ethical Issues in Clinical Trials in Developing Countries," Baruch Brody
-Brody argues that in placebo-controlled trials, if no subjects are denied "any treatment that should otherwise be available to him or her in light of the practical realities of health care resources available in the country in question," the trials are

A) unethical.
B) useless.
C) ethical.
D) flawed.

Question 61

The Following Questions For Readings: "Ethical Issues in Clinical Trials in Developing Countries," Baruch Brody
-Brody says some critics have suggested that participants in Third World clinical trials are coerced into participating because of

A) physical threats.
B) desperation.
C) promises of a cure.
D) easily refused offers.

Question 62

The Following Questions For Readings: "Ethical Issues in Clinical Trials in Developing Countries," Baruch Brody
-Brody says clinical trials in developing countries do not exploit developing countries if after the studies, the subjects

A) are not given access to any treatment proven effective.
B) are eligible to enter new trials.
C) have not been harmed in any way.
D) are given access to any treatment proven effective.