Avoids Unnecessary Injuryexperiments Must This Is

10 PointsThe 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

10 PointsThe Nuremberg Code emphasized each of the following except:

1. Studies must be conducted in a manner that avoids unnecessary injury
2. Experiments must benefit society
3. Monetary compensation is a right of any research subject
4. Voluntary consent must be obtained from every research subject
5. Subjects have the right to withdraw at any time.

10 PointsThe 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

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

1. Autonomy, beneficence, appropriate compensation
2. Appropriate compensation, autonomy, justice
3. Autonomy, beneficence, informed consent
4. Autonomy, beneficence, justice

10 PointsThe 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

10 PointsIn 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

10 PointsThe 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

10 PointsThe 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

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

1. True
2. False

10 PointsIf 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

10 PointsAn 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

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

1. True
2. False

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

1. The risk/benefit ratio for the subjects involved in the project
2. The means you will use to protect the confidentiality of subjects’ data
3. The source of funding you have obtained for the project
4. The information provided in your informed consent document
5. The information presented in any subject recruitment flyers of advertisements.

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

1. The proposed research protocol
2. The amount of compensation for the research staff
3. The informed consent document
4. The amount of compensation to the subjects, if any

10 PointsIf 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. High risk
2. No more than minimal risk
3. Moderate risk
4. Minor increase over minimal risk