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?

Accepted Answer

The Declaration of Helsinki, adopted by the World Medical Association in 1964, was the first substantial effort by a professional body in medicine to self-regulate the ethical conduct of research.

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?

Accepted Answer

The Kefauver-Harris Bill, passed in 1962, was a response to the thalidomide disaster and required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval.

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?

Accepted Answer

The U.S. National Research Act of 1974 was enacted in response to ethical concerns raised by studies like the Tuskegee Syphilis Study. It required the establishment of Institutional Review Boards (IRBs) to oversee research involving human subjects.

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?

Accepted Answer

The Belmont Report, published in 1979, outlines the ethical principles and guidelines for research involving human subjects, developed by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

Question 5

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

Accepted Answer

Beneficence is the ethical principle that obligates researchers to maximize possible benefits and minimize possible harms.

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?

Accepted Answer

The Institutional Review Board (IRB) is responsible for reviewing and approving the informed consent process and documentation to ensure the protection of research participants.

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?

Accepted Answer

The answer of The guidelines from which of the following...

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.

Accepted Answer

The Tuskegee Syphilis Study continued to withhold treatment from participants even after penicillin became the standard treatment for syphilis, prioritizing the study's goals over the health of the subjects.

Question 9

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

Accepted Answer

Using visual aids can help ensure that participants with low literacy understand the information being presented, facilitating informed consent.

Question 10

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

Accepted Answer

The principle of beneficence focuses on maximizing benefits and minimizing harms, while the principle of justice addresses the fair distribution of burdens and benefits in research.

Question 11

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

Accepted Answer

The Nuremberg Code was developed in response to the atrocities committed by Nazi doctors during World War II. It was the first international code of ethics for human experimentation and established 10 principles that must be followed in order to conduct ethical research involving human subjects.

Question 12

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

Accepted Answer

The answer of Which of the following includes "freely given...

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"?

Accepted Answer

The principle of "Respect for persons" is based on the conviction that individuals should be treated as autonomous agents and that those with diminished autonomy are entitled to protection.

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?

Accepted Answer

The Belmont Report provided the ethical principles and guidelines for the protection of human subjects in research, which were used as a basis for the regulations codified by the FDA and DHHS in 1981.

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?

Accepted Answer

The U.S. Federal Policy for the Protection of Human Subjects is commonly known as the "Common Rule," which was adopted by several federal agencies and published in 1991.

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?

Accepted Answer

The U.S. Office for Human Research Protection (OHRP) is responsible for monitoring compliance with 45 CFR 46 and issues assurances to institutions conducting federally funded research with human participants.

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?

Accepted Answer

The International Conference on Harmonization (ICH) provides the guidelines for Good Clinical Practice (GCP), which are internationally recognized standards for conducting clinical trials involving human subjects.

Question 18

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

Accepted Answer

Many historical studies, such as the Tuskegee Syphilis Study, were considered acceptable at the time but are now viewed as unethical due to evolving ethical standards and increased awareness of participants' rights.

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.

Accepted Answer

The Tuskegee Syphilis Study lasted for 40 years, from 1932 to 1972, and involved observing untreated syphilis in African American men, making it one of the longest nontherapeutic experiments on humans.

Question 20

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

Accepted Answer

The answer of The principle of justice also applies to...

Quiz 17: Ethics in Research Involving Human Participants