The provisions of Subpart D, of the HHS charged with? (There may be more than one
regulations, Additional Protections for Children correct answer. Please be sure to select all
Involved as Subjects in Research apply to: - correct answers.) - ANSWER -- Protecting
ANSWER -All research funded by HHS the rights and welfare of human subjects.
- Assuring that all applicable institutional policies
and federal regulations related to research with
The purpose of the Family Educational Rights human subjects are followed.
and Privacy Act (FERPA) is to: - - Reviewing subject recruitment materials and
ANSWER -Provide parents certain rights strategies.
over their children's educational records.
A master's degree candidate needs to conduct a
If the research is subject to Subpart D, which of research project for her master's thesis. She is
the following research activities with children interested in the types of junk food available to
would qualify for an exemption under Category 2 the public. She plans on going to the local
(research that includes educational tests, convenience stores and asking the owners what
surveys, interviews, observation)? - types of junk food the store normally stocks and
ANSWER -Research about aptitude testing which are the biggest sellers. Identifiers will not
be collected. This study would fall under which of
the following? - ANSWER -Not Human
What procedures must be described in an Subjects
agreement called an "assurance of compliance"
with a U.S. federal agency? - ANSWER -
Procedures in place that ensure that subjects will How can faculty researchers avoid undue
be protected in a manner commensurate with the influence of student subjects? - ANSWER -
Common Rule, including review by an Avoid using their own students in their research
independent committee comparable to an IRB.
Which of the following studies need IRB
Which of the following activities constitutes approval? - ANSWER -Studies collecting
engagement in research - ANSWER - data about living individuals.
Obtaining informed consent and conducting
research interviews.
The HIPAA "minimum necessary" standard
applies... - ANSWER -To all human
A student is conducting a research project that subjects research that uses PHI without an
involves using a survey. The survey asks authorization from the data subject.
subjects about their highest level of education,
political affiliation, and views on various social
issues. No identifiable information will be When a research project includes the collection
collected. This study would be categorized as of biological samples, all planned future uses of
which type of review? - ANSWER -Exempt the samples, identifiers, and the data obtained
Review from the samples, must be fully explained to the
research subject. - ANSWER -True
What is the Institutional Review Board (IRB)
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