Deck 14: Ensuring Ethical Research

Question 1

In both the Tuskegee Experiments and Nazi Doctors Trials, examples of ethical misconduct included the following: informed consent was not being obtained, known harm was inflicted to subjects without regard to pain and suffering, and the potential benefits did not outweigh the associated risks of the studies.

Answer 1

True

Question 2

Research policies required by the Health Insurance Portability and Accountability Act (HIPAA) only pertain to studies where public or private insurance (or other reimbursement sources) are billed for experimental services.

Answer 2

False

Question 3

The impetus for contemporary ethical standards for the protection of human research subjects is grounded in previous abuses of humans under the guise of research, such as the Nazi Doctors Trials and the Tuskegee Experiments.

Answer 3

True

Question 4

The World Medical Association adopted the principles set forth in the Declaration of Helsinki regarding the ethical conduct of human research.

Question 5

Ownership rights of data collected during a study belong to the principal investigator, regardless of who collected the data or funded the study.

Question 6

When researchers receiving federal funding are investigated and judged to have engaged in research misconduct, there is the potential for significant penalties and consequences, including imprisonment.

Question 7

Once the research is initiated, the institutional review board (IRB) is responsible for a substantive re-review of the research no less often than once every 365 days.

Question 8

The principal investigator is ultimately responsible for ensuring that human subject protections are followed, reporting any unanticipated problems involving risks to subjects or others, and for abiding by the institutional review board (IRB) approved protocol and consent document/process.

Question 9

Following multiple instances of unethical research practices, regulations were put into place to protect subjects and ensure ethical research practices. Which of the following is not an example of a regulatory code put into place toward this effort?

A) The Nuremberg Code
B) The Declaration of Helsinki
C) The Treaty of Versailles
D) The Principles of Belmont

Question 10

What is the role of the institutional review board (IRB) in protecting human subjects?

A) An IRB exists within a university, medical center, or other industry solely to outweigh the financial risks associated with research for the institution.
B) An IRB exists within a university, medical center, or other institution to review research proposals and ensure that the study is safe and ethical for all participants.
C) An IRB exists within a university, medical center, or other institution to ensure all documentation related to research is adequate and correct.
D) An IRB exists within a university, medical center, or other industry to protect only individuals on whom research is being conducted.

Question 11

Within an institutional review board (IRB), committee members must be:

A) Comprised of individuals who have advanced academic qualifications, diverse life experiences, and seniority within the institution
B) Comprised of individuals who are diverse, representing different research experiences, professional statuses, and demographics
C) Comprised of individuals who were recommended due to having demonstrated professional integrity and possessing advanced knowledge within their fields
D) Comprised of individuals who have advanced knowledge specific to the research problem and the population of sampling

Question 12

When submitting a research proposal application to an institutional review board (IRB), the application will typically address some major topics. Which of the following would not likely be included among these?

A) A section regarding how informed consent would be obtained
B) A discussion of the philosophical argument of the nature of knowledge to be gained
C) Identification and analysis of any associated risks and benefits of the study
D) Any special considerations given to vulnerable populations

Question 13

The Office of Research Integrity defines misconduct for purposes of research. Which of the following characteristics is not part of their description?

A) Examples include fabrication, falsification, and plagiarism.
B) Research practices must represent a significant deviation from commonly accepted practices.
C) Research behaviors must be intentional, knowing, or reckless.
D) Misconduct includes honestly made errors, if these could have been foreseen or prevented.

Question 14

Which of the following is not one of the Principles of Belmont?

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

Question 15

Regarding the training of key personnel as required by typical institutional review board (IRB) guidelines, which of the following statements is correct?

A) It is not necessary for personnel to be trained.
B) Key personnel must undergo rigorous training in order to be effective, accurate, and unbiased.
C) Key personnel must be professionally certified if involved in a medical study.
D) Key personnel must have adequate training and knowledge about the protection of human subjects and have annual continuing education.