GUIDE WITH SOLUTIONS
◉ A researcher submits a study to the IRB that proposes to evaluate
a new after-school on-line tutoring program for middle-school
students in a local school district examining the effect on student
grades. She proposes to perform this assessment at the school that
her children attend, because she is familiar with the school district.
Students may use either their personal smartphone or computer to
participate in the program. This study might be determined to be
violating which principle of the Belmont Report?
Beneficence
Justice
Respect for persons Answer: Justice
◉ An example cited in the Belmont Report (The National
Commission 1979) stated that "During the 19th and early 20th
centuries the burdens of serving as research subjects fell largely
upon poor ward patients, while the benefits of improved medical
care flowed primarily to private patients." This is an example of a
violation of which Belmont principle?
,Respect for persons
Beneficence
Justice Answer: Justice
◉ Which of the following is an example of how the principle of
beneficence is applied to a study involving human subjects?
Ensuring that risks are reasonable in relationship to anticipated
benefits
Ensuring that the selection of subjects is fair
Providing detailed information about the study to potential subjects
Ensuring that subjects understand that participation is voluntary
Answer: Ensuring that risks are reasonable in relationship to
anticipated benefits
◉ The researcher's failure to protect research subjects from
deductive disclosure of identity (that is, the re-identification of
subjects by other researchers) is the primary ethical violation in
which of the following studies?
,"Tastes, Ties, and Time (T3)" study
Zimbardo's "Stanford Prison Experiment"
PHS Tuskegee study
Milgram's "Obedience to Authority" study Answer: "Tastes, Ties, and
Time (T3)" study
◉ The Belmont principle of beneficence requires that:
Risks are managed so that they are no more than minimal.
Risks to subjects are reasonable in relation to anticipated benefits.
Subjects derive individual benefit from study participation.
The study makes a significant contribution to generalizable
knowledge. Answer: Risks to subjects are reasonable in relation to
anticipated benefits.
◉ According to the federal regulations, research is eligible for
exemption, if:
, The research falls into one of eight categories of research activity
described in the regulations.
All the subjects are adults and the risk is minimal.
Participation in the research will involve ten minutes or less of the
subjects' time.
The researcher is experienced in the field of inquiry. Answer: The
research falls into one of eight categories of research activity
described in the regulations.
◉ In addition to pregnant women, fetuses, and neonates, another
subpart of the HHS regulations provides additional protections for
which of the following vulnerable populations?
Prisoners
Adults with decisional impairments
The elderly
College students Answer: Prisoners
◉ Which of the following statements about the relationship between
an institution and the institution's IRB(s) is correct?