Biomed Refresher 1 CITI Exam
Questions with Correct Verified
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In order to grant a waiver or alteration of the requirements of informed
consent, an IRB must find which of the following: - ANS ✓The research could
not practicably be carried out without the waiver of consent. -
In order for an IRB to grant a waiver of consent, it must ensure the
following federal criteria at 45 CFR 46.116 (Protection of Human Subjects
2017) are met:
•The research involves no more than minimal risk.
•The research could not practicably be carried out without the waiver of
consent.
•If the research involves using identifiable private information, the
research could not practicably be carried out without using such
information in an identifiable format.
•The waiver will not affect the rights and welfare of the subjects.
•Whenever appropriate, the subjects (or legally authorized
representatives) will be provided with pertinent information after
participation.
Which of the following statements is accurate in determining subject risk
involved in a genetic study: - ANS ✓Understanding the purpose and context of a
specific study is critical in determining the risk involved - Genetic research covers
a broad spectrum of research from surveys and chart reviews to gene transfer
studies. Therefore, no assumptions should be made about risk in genetic research
- each study must be evaluated on its own merits.
Biomed refresher 1 CITI
, 2
Biomed
Risks associated with genetics research are best described as: - ANS
✓Physical, social and psychological risks -
The physical risks associated with genetic testing are usually no more than
minimal, such as the risks of a blood draw. The more substantial risks are
social and psychological, depending on the type of genetic information
being sought. Pre- and post-test anxiety will be a concern if testing will
reveal information about disease risk and the results will be communicated
to subjects. Subjects are also frequently concerned about risks to
employment and insurability.
Additional information associated with genetics research that should be
disclosed to subjects during the consent process includes: - ANS ✓Plans and
options for re-contacting the subjects with results. -
It is important for researchers to discuss any plans or options for re-
contacting the subjects with genetic results. The IRB may also require a
description of whether the samples are linked or anonymous, how they will
be stored and who will have access to them or the information they contain,
and whether the research will be used to develop proprietary products or
assays along with any plans for sharing financial rewards from the project.
Genetic privacy and confidentiality are sometimes thought to be more
important than privacy and confidentiality in other kinds of research for a
number of reasons, including: - ANS ✓Genetic information is shared among
"blood" relatives, including the subject's parents, siblings, and children. - Privacy
and confidentiality are complicated issues. Genetic research can be difficult for
research subjects to understand. Privacy and confidentiality issues arise because
genetic information is shared among "blood" relatives, including the subject's
parents, siblings, and children. It may extend to social groups with a shared
heritage, including members who are unaware of the research. Therefore, these
individuals can lose privacy even if they are not the source of the specimen or
information being studied.
A research project is designed to test a new treatment for eclampsia (a life-
threatening condition in pregnant women). Which of the following
conditions must be satisfied for the research to be potentially approvable
Biomed refresher 1 CITI
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