All Correct Answers
Your informed consent form must describe _______. correct answer -All
foreseeable risks and discomforts.
Under the U.S. Department of Health and Human Services (HHS) and U.S. Food
and Drug Administration (FDA) regulations, what is the Institutional Review
Board (IRB) charged with? Select all that apply. correct answer --
Protecting the rights and welfare of human subjects
- Assuring that researchers follow all applicable institutional policies and
federal regulations related to research with human subjects.
- Reviewing subject recruitment materials and strategies.
A student is conducting a research project that involves the use of a survey.
The survey asks subjects about their highest level of education, political
affiliation, and views on various social issues. The student will not collect
identifiable information. This study would be subject to which type of review?
correct answer -Determination for Exemption
A graduate student needs to conduct a research project for her master's
thesis. She is interested in the types of junk food available to the public. She
plans to go to the local convenience stores and ask the owners what types of
junk food the store normally stocks, and which are the biggest sellers. She will
not collect identifiers. This study would be subject to which type of review?
correct answer -Not Human Subjects
Where could student researchers and/or student subjects find additional
resources regarding the IRB approval process? Select all that apply. correct
answer -- Faculty Advisor/Research Mentor- IRB Office
In the U.S., the first federal regulations for human subjects research began in
1981 with the codification of the ________. correct answer -The common
rule
Identify one way faculty researchers can possibly avoid undue influence of
student subjects? correct answer -Avoid recruiting their own students in
the research
, A student plans on interviewing 15 principals in neighboring high schools.
The student plans to collect data about the personal experiences the
principals have had with disruptive students, including the types of
disciplinary actions that were taken (including decisions they may have
personally made) and their feelings or thoughts regarding whether those
actions were appropriate. The research data collected could have an impact
on the principals' careers. The student will collect identifiers. This study
would be subject to which type of review? correct answer -Convened
Review
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? correct answer -Justice
The Belmont principle of beneficence requires that: correct answer -Risks
to subjects are reasonable in relation to anticipated benefits.
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? correct answer -Justice
Which of the following is an example of how the principle of beneficence is
applied to a study involving human subjects? correct answer -Ensuring
that risks are reasonable in relationship to anticipated benefits
Humphreys' collecting data for the Tearoom Trade study under the pretense
that he was a lookout is an example of a violation of the principle of: correct
answer -Respect for persons
A study was submitted to the IRB designed to evaluate the effect of
background noise on an individual's ability to concentrate and answer
questions. The IRB approved the study and consent form. The consent form