VERIFIED ANSWERS |100% CORRECT | ALREADY GRADED
A
Which of the following is not included as FDA-regulated research
Ans✓✓✓Use of an unapproved method of data collection
If a regulated human-subjects research project is NOT subject to the
FDA human protection regulations and involves incarcerated
individuals, it may qualify for exemption from the Common Rule
Ans✓✓✓False
A research study is going to be conducted on approved drugs in a
manner that does not increase the risk or decrease the acceptability of
the risk associated with the use. This study may be eligible for
Ans✓✓✓Expedited review
Verifying IRB approval before allowing research to begin or before
implementing changes is the responsibility of the Ans✓✓✓Principle
Investigator
Typically, the initial approval for a study when it is first reviewed by the
IRB cannot exceed: Ans✓✓✓One year
1) an investigator requires this is order to continue his study
2) Informed consent requires this basic element
3) An IRB requires this prior to approval of a study
,4) a study may be determines inactivated if all criteria are met including
this Ans✓✓✓1) continuing review
2) Identification of an procedures that are experimental
3) Notice that subject privacy is protected and confidentiality of data is
maintained
4) Participants are no longer being treated under the protocol and there
are no plans for future research treatment
What is the primary tool used to ensure research subject autonomy?
Ans✓✓✓Informed consent
Which of the following would likely qualify as exempt research under
the Code of Federal Regulations? Ans✓✓✓Hospital chart review of de-
identified patient records
How is an IRB formed? Ans✓✓✓Local individuals with varying
expertise are selected from inside and outside the institution
Physicians and other health professionals can only use medications and
medical devices from the labeled conditions approved by the FDA
Ans✓✓✓False
Replication is a good way to determine whether findings are applicable
in a different clinical setting or practice Ans✓✓✓True
, When narrowing the focus of a research question, it is important to take
the problem statement and first convert it into Ans✓✓✓a question
Hypotheses are predictive statements Ans✓✓✓True
Which of the following is NOT a factor in determining the need for
studying a particular problem? Ans✓✓✓Funding available for this
particular research
What is the best source of information about the value of inhaled
corticosteroids in the treatment of chronic obstructive pulmonary disease
Ans✓✓✓Cochrane's database
1)Null hypothesis
2) Research question
3) Hypothesis Ans✓✓✓1) A statement of no relationship or difference
between two variables
2) A question that needs to be answered through systematic
testing/evaluation
3) A statement of prediction/observation that can be evaluated,
measured, or analyzed
Previous studies, personal interest, and workplace environment are all
possible origins of research topics Ans✓✓✓True