The Hippocratic Oath was essentially the only statement of medical and research ethical principals for over 2,000 years. True – False
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1) The Hippocratic Oath was essentially the only statement of medical and research ethical principals for over 2,000 years. True – False
2) 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. True – False
3) The Nuremberg Code emphasized each of the following except:
a. Voluntary consent must be obtained from every research subject.
b. Studies must be conducted in a manner that avoids unnecessary injury.
c. Experiments must benefit society.
d. Monetary compensation is a right of any research subject
e. Subjects have the right to withdraw at any time.
4) 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. True – False
5) The Belmont Report of 1978 first stated our current primary principles of medical and research ethics, which are:
a. Autonomy, beneficence, appropriate compensation.
b. Autonomy, beneficence, justice.
c. Appropriate compensation, autonomy, justice.
d. Autonomy, beneficence, informed consent.
6) The conflicts among research ethics principles, and the weights granted to each in decision-making, accounts for most of the ethical problems physicians/researchers face.
True – False
7) The researchers in charge of the Tuskegee Syphilis Study had adequately covered two of the three research ethics principles noted in the Belmont Report, but most of the ethical problems with the study involved issues of autonomy. True – False
8) In addition to ensuring the subject understands the normal elements of informed consent, the researcher has an ethical obligation to ensure that subjects have no misconceptions about the research (for instance, a belief that participation will cure them). True – False
9). Which of the following is not a primary purpose of the IRB?
a. To see that research risks to participants are minimized.
b. To see that subject confidentiality is adequately maintained.
c. To see that informed consent is obtained from each subject.
d. To see that each subject is adequately compensated for participation.
e. To see that the risks of the research are reasonable in relation to the benefits.
10). Each of the primary purposes of the IRB can be directly related to one of the four basic principles of research ethics. True – False
11) . 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, direct interaction, through medical records, or obtaining tissue or blood samples. True – False
12) . As a general rule of thumb, if you intend to publish your results in any way, shape or form, your study involving human subjects will be considered research that comes under the purview of the IRB. True – False
13). 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. True – False
14). IRB approval for a study is given once for the full length of the study. True – False
15). In most cases, if you need to make a substantive change in your research protocol, it is permissible to proceed with the change as soon as necessary and inform the IRB at the next annual review. True – False
16). Which of the following would likely be of little or no concern to an IRB?
a. The information provided in your informed consent document.
b. The source of funding you have obtained for the project.
c. The risk/benefit ratio for the subjects involved in the project.
d. The means you will use to protect the confidentiality of subjects’ data.
e. The information presented in any subject recruitment flyers or advertisements.
17). When it is finally time to put together your IRB application, the first step is to obtain any documentation about applications from your local IRB and read it thoroughly.
True – False
18) . 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:
a. No more than minimal risk.
b. Minor increase over minimal risk.
c. Moderate risk.
d. High risk.
19) . If you will be doing mild exercise testing (walking) of elderly subjects along with a single post-exercise muscle biopsy, you should categorize your study as:
a. No more than minimal risk.
b. Minor increase over minimal risk.
c. Moderate risk.
d. High risk.
20). Which of the following is not a normal element of the IRB application that must be reviewed by the IRB?
a. The Informed Consent Document.
b. The proposed research protocol.
c. The amount of compensation to the subjects, if any.
d. The amount of compensation for the research staff.
21). Only the Principal Investigator needs to have a signed copy of the Informed Consent Document. True – False
22). The Informed Consent Document should be written in lay terms at the level of a high school graduate. True – False
23). If you provide any 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 that they could be considered coercive. True – False
24). An important element of the Informed Consent Document is an explicit statement that participation in the research is completely voluntary, and the subject will not be penalized if he or she decides not to participate or withdraws during the study.
True – False
