QUESTIONS WITH CORRECT SOLUTIONS.
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1. Identify the example of when situation and time are key to assessing risk of
harm in a research study: - ANSWER ✓ Asking women if they have had an
abortion
2. The FDA regulations governing disclosure of individual COIs require: -
ANSWER ✓ Applicants submitting marketing applications to disclose
financial COIs of researchers who conducted clinical studies
3. An example of an institutional COI is: - ANSWER ✓ An industry sponsor
pays for the construction of a new research laboratory at the organization
4. A researcher's membership on an advisory board with an organization
sponsoring research can create a COI because: - ANSWER ✓ It may be
difficult for the researcher to appear neutral, as the researcher may have an
interest in the research's success
5. During an Institutional Review Board (IRB) meeting, any IRB member who
may have a potential COI with a study under review should: - ANSWER ✓
Disclose their potential COI and may answer questions, but recuse
themselves from voting
6. The COI management plan aims to: - ANSWER ✓ Provide procedures or
extras steps to be taken to minimize the risk of bias when a COI is disclosed
7. 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. - 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.
8. 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? - ANSWER ✓ Determination for Exemption
9. In the U.S., the first federal regulations for human subjects research began in
1981 with the codification of the ________. - ANSWER ✓ Common Rule
10.Identify one way faculty researchers can possibly avoid undue influence of
student subjects? - ANSWER ✓ Avoid recruiting their own students in the
research
11.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? - ANSWER ✓ Not Human Subjects
12.A research project is designed to evaluate a new experimental type of fetal
surgery to correct diaphragmatic hernia in the fetus (a potentially life-
threatening condition for the baby) prior to delivery. This research is
directed toward the fetus as subject to meet the health needs of the fetus. The
pregnant woman is otherwise healthy. The investigator must obtain consent
from whom? - ANSWER ✓ The pregnant woman and the father of the fetus.
13.According to current NIH Guidelines, which of the following is adequate
justification for exclusion of women from NIH-funded research? -
ANSWER ✓ There is compelling evidence that inclusion would be
inappropriate with respect to the health of the subjects.
14.A therapist at a free university clinic treats elementary school children with
behavior problems who are referred by a social service agency. She is also a
, doctoral candidate who proposes using data she has and will collect about
the children for a case-based research project. Which of the following
statements about parental permission is correct? - ANSWER ✓ The parents
of the children might feel pressure to give permission to the therapist to use
their children's data so that she will continue to provide services to their
children.
15.A general requirement for informed consent is that no informed consent may
include any exculpatory language. Exculpatory language is that which
waives or appears to waive any of the subject's legal rights or releases or
appears to release those conducting the research from liability for
negligence. Which of the following statements in a consent form is an
example of exculpatory language? - ANSWER ✓ Taking part in the research
is voluntary, but if you choose to take part, you waive the right to legal
redress for any research-related injuries.
16.A criterion for waiving informed consent is that, when appropriate, subjects
are provided additional pertinent information after the study. In which of the
following studies would it NOT be appropriate to provide subjects with
information about missing elements of consent: - ANSWER ✓ A study in
which subjects were assigned to study activities based on an undesirable or
unflattering physical characteristic as assessed by members of the research
team.
17.A waiver of the requirement for documentation of informed consent may be
granted when: - ANSWER ✓ The only record linking the subject and the
research is the consent document and the principal risk is a breach of
confidentiality.
18.As part of the consent process, the federal regulations require researchers to:
- ANSWER ✓ Provide potential subjects with information at the appropriate
reading comprehension level.
19.Which of the following constitutes both a breach of confidentiality (the
research data have been disclosed, counter to the agreement between
researcher and subjects) and a violation of subjects' privacy (the right of the
individuals to be protected against intrusion into their personal lives or
affairs)? - ANSWER ✓ A faculty member makes identifiable data about