Deck 17: Ethics in Research Involving Human Participants

Question 1

Which of the following represents the first substantial effort by a professional body in medicine to self-regulate the ethical conduct of research?

A) Belmont Report
B) Nuremburg Code
C) Declaration of Helsinki
D) Kefauver-Harris Bill

Answer 1

Declaration of Helsinki

Question 2

Which of the following was spurred by the European thalidomide disaster, in which safety tests failed to demonstrate the drug's teratogenicity, and it was prescribed to pregnant women for morning sickness?

A) Belmont Report
B) Nuremburg Code
C) Declaration of Helsinki
D) Kefauver-Harris Bill

Answer 2

Kefauver-Harris Bill

Question 3

Which of the following, galvanized in part by publicity from the Tuskegee Syphilis Study, specifically required institutions to establish review boards with at least five members from diverse backgrounds, including one nonscientist?

A) Nuremburg Code
B) Declaration of Helsinki
C) Kefauver-Harris Bill
D) The U.S. National Research Act

Answer 3

The U.S. National Research Act

Question 4

Which of the following, published in 1979, is a summary of the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research over 4 years of deliberations?

A) Belmont Report
B) Nuremburg Code
C) Declaration of Helsinki
D) Kefauver-Harris Bill

Question 5

Through which ethical principle, researchers are obligated to maximize possible benefits and minimize possible harms?

A) Justice
B) Autonomy
C) Beneficence
D) Nonmaleficence

Question 6

Informed consent should usually be documented with a written consent form that must be preapproved by which of the following as signed by research participants or their legally authorized representative?

A) Institutional Review Board (IRB)
B) U.S. Office for Human Research Protection (OHRP)
C) U.S. Food and Drug Administration (FDA)
D) The Department of Health and Human Services (DHHS)

Question 7

The guidelines from which of the following provide a unified standard for conducting human clinical trials in the European Union, Japan, and the United States to facilitate mutual acceptance of resulting data, reduce the need for duplicative studies, and reduce delays in international access to beneficial products and procedures?

A) Institutional Review Board (IRB)
B) U.S. Office for Human Research Protection (OHRP)
C) The International Conference on Harmonization (ICH)
D) The Department of Health and Human Services (DHHS)

Question 8

When penicillin became widely available by 1947 as a standard cure for syphilis, treatment was denied to Tuskegee subjects so as not to interfere with the scientific aims of the study.

Question 9

Special consideration should be given to methods for obtaining informed consent from participants with low literacy, including the use of visual aids.

Question 10

The principle of beneficence helps determine whether the burdens and benefits of research are fairly distributed.

Question 11

The 10 principles outlined in which of the following were among the first rules for experimentation involving human subjects?

A) Belmont Report
B) Nuremburg Code
C) Declaration of Helsinki
D) Kefauver-Harris Bill

Question 12

Which of the following includes "freely given informed consent" as a key requirement of ethical research?

A) Belmont Report
B) Nuremburg Code
C) Declaration of Helsinki
D) Kefauver-Harris Bill

Question 13

Which of the following is based on the conviction that "individuals should be treated as autonomous agents" and that "persons with diminished autonomy are entitled to protection"?

A) Justice
B) Beneficence
C) Nonmaleficence
D) Respect for persons

Question 14

The U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS) codified human subjects regulations based on which of the following in 1981?

A) Belmont Report
B) Nuremburg Code
C) Declaration of Helsinki
D) Kefauver-Harris Bill

Question 15

The U.S. Federal Policy for the Protection of Human Subjects, referred to as which of the following, was adopted by several federal agency and published in 1991?

A) Golden rule
B) Common rule
C) Simple rule
D) Universal rule

Question 16

Which of the following monitors compliance with 45 CFR 46 by issuing a type of permit, termed an assurance, to institutions that receive federal funds to conduct research with human participants?

A) Institutional Review Board (IRB)
B) U.S. Office for Human Research Protection (OHRP)
C) The International Conference on Harmonization (ICH)
D) The Department of Health and Human Services (DHHS)

Question 17

The guidelines for Good Clinical Practice (GCP) from which of the following offer an international ethical and scientific quality standard for the design, conduct, recording, and reporting of trials involving human subjects?

A) Institutional Review Board (IRB)
B) U.S. Office for Human Research Protection (OHRP)
C) The International Conference on Harmonization (ICH)
D) The Department of Health and Human Services (DHHS)

Question 18

Many studies that are deemed unethical today were viewed at the time as acceptable.

Question 19

The Tuskegee Syphilis Study, which was halted in 1972 only when national press reports prompted public outrage, was the longest nontherapeutic experiment on human beings in medical history.

Question 20

The principle of justice also applies to information obtained through research.