1. A benefit (for a research study) is defined as __________.
a. a valued or desired outcome.
b. the probability of harm or injury from participation in a research study.
c. financial compensation in exchange for participation in a research study.
d. the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
2. Which of the following should NOT be considered when evaluating the potential risk in study participation?
a. Whether the participant will accrue excessive costs from participating in the study.
b. Whether the participant will face social stigma from participation.
c .Considering what could happen to the person if they do not choose to participate in the study.
d. Whether the study intervention will impose physical harm to the participant.
3. Describe the risk to benefit ratio of performing prophylactic double mastectomies.
4. An institutional review board's (IRB's) role in assessing the risk and anticipated benefit of human subject research involves identifying whether the financial compensation (given to study participants) is adequate to mitigate the potential risks of study participation.
True, False
5. Which of the following cases would NOT require special consideration of risk for admission into a research study?
a. A teen with (unmedicated) attention deficit hyperactivity disorder who is asked to consume caffeine for a nootropic dietary intervention study.
b. A woman with type I diabetes who is asked to engage in a high intensity interval (exercise) training study.
c. A (apparently healthy) man of middle age who is asked to engage in a resistance (exercise) training study.
d. A woman who is pregnant and asked to modify her diet in a (gestational) diabetes prevention study.
6. A participant in a research study with a positive history of substance use disorder should have his or her (substance use) status kept confidential, since a breach in confidentiality could trigger psychological harm.
True False
7. Address the risk to benefit ratio of using stem cell therapy to repair cartilage in patients living with osteoarthritis.
8. Which of the following best defines an equipoise?
a. An equipoise ensures that the risks of conducting a therapeutic trial are ethical, provided that there has been assured that the relative safety and efficacy of the new therapy does not supersede the efficacy of a current therapy or placebo.
b. An equipoise ensures that the risks of conducting a therapeutic trial are ethical, provided that there has been a genuine uncertainty about the relative safety or efficacy of current therapy.
c. An equipoise ensures that pharmaceutical companies do not waste their time and money on therapeutic treatments that another company has already developed.
d. None of the above are definitions of an equipoise.

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