Question

1. Question 1

   10 Points

   The Tuskegee Syphilis Study, begun in 1932, led directly to the statement of explicit ethical principles in the Nuremberg Code of 1948 and the Declaration of Helsinki in 1964.

   1. True
   2. False

• Question 2

  10 Points

  The Nuremberg Code emphasized each of the following except:

  1. Monetary compensation is a right of any research subject

  2. Voluntary consent must be obtained from every research subject

  3. Subjects have the right to withdraw at any time.

  4. Studies must be conducted in a manner that avoids unnecessary injury

  5. Experiments must benefit society

Question 3

10 Points

The declaration of Helsinki expanded on the Nuremberg Code by explicitly stating the duty of a physician/researcher to safeguard patients/research subjects, defining the elements of informed consent, and emphasizing proper research design that is ethical and results in an acceptable risk/benefit ratio

1. True
2. False

• Question 4

  10 Points

  The Belmont Report of 1078 first stated our current primary principles of medical and research ethics, which are:

  1. Autonomy, beneficence, appropriate compensation

  2. Autonomy, beneficence, justice

  3. Autonomy, beneficence, informed consent

  4. Appropriate compensation, autonomy, justice

• Question 5

  10 Points

  The researchers in charge of the Tuskegee Study had adequately covered 2 of the 3 ethics principles noted in the Belmont Report, but most of the ethical problems involved issues of autonony

  1. True
  2. False

• Question 6

  10 Points

  In addition to ensuring the subjects understands the normal elements of informed consent, the researcher has an ethical obligation to ensure that subjects have no misconceptions of the research (for instance, a belief that participation will cure them).

  1. True
  2. False

• Question 7

  10 Points

  The IRB is concerned with the protection of human subjects, defined as any individual, living or dead, about whom a researcher obtains data through medical intervention, medical records, or obtaining tissue or blood samples.

  1. True
  2. False

• Question 8

  10 Points

  The IRB requires that each of the human subjects in your study must be completely informed about the study and its procedures and risks, and the consent you obtain must be uncoerced.

  1. True
  2. False

• Question 9

  10 Points

  The Informed Consent Document should be written in lay terms at the level of a high school graduate

  1. True
  2. False

• Question 10

  10 Points

  If you provide payments to your subjects, they should be limited to compensation for time and effort and out-of-pocket expenses, so they are not so high they could be considered coercive

  1. True
  2. False

• Question 11

  10 Points

  An important element of the informed consent document is an explicit statement that participation in research is completely voluntary and that the subject will not be penalized if he or she decides not to participate or withdraws during the study.

  1. True
  2. False

• Question 12

  10 Points

  Only the principal investigator needs to have a copy of the informed consent document.

  1. True
  2. False

• Question 13

  10 Points

  Which of the following would likely be of little or no concern to an IRB?

  1. The information provided in your informed consent document

  2. The risk/benefit ratio for the subjects involved in the project

  3. The source of funding you have obtained for the project

  4. The information presented in any subject recruitment flyers of advertisements.

  5. The means you will use to protect the confidentiality of subjects' data

• Question 14

  10 Points

  Which of the following is not a normal element of the IRB application that must be reviewed by the IRB?

  1. The informed consent document

  2. The proposed research protocol

  3. The amount of compensation to the subjects, if any

  4. The amount of compensation for the research staff

• Question 15

  10 Points

  If you will be doing nothing more to your subjects than would be done in routine physical or psychological evaluations and presents no greater than normal risks of daily living, you should categorize your study as:

  1. Minor increase over minimal risk

  2. Moderate risk

  3. No more than minimal risk

  4. High risk

Answer 1

Answer:

1. True

Reason: The statement is true regarding the Tuskegee syphilis study

2. Monetary compensation is a right of any research subject

Reason: Nuremberg code is not emphasized on the monetary compensation.

3. True

4. Autonomy, beneficence, justice

Reason: Belmont report summarizes the ethical principles and guidelines. These are the 3 core principles were identified.