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CITI -Social&Behavioral Research Exam Questions with Complete Solutions
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CITI -Social&Behavioral Research ExamQuestions with Complete Solutions
What procedures must be described in an agreement called an "assurance of
compliance" with OHRP? - -Procedures in place that ensure that subjects will
be protected in a manner commensurate with the Common Rule, including
review by an independent committee comparable to an IRB.
-A researcher proposes to conduct a study at a foreign site that has been
determined to be exempt from the federal regulations by institutional policy.
According to federal regulations, is review required at the foreign site? - -If a
proposed study qualifies for exemption, federal regulations do not require
review at the foreign site where it will be conducted.
-What are some considerations for a U.S. researcher conducting a study in a
non-U.S. setting when obtaining informed consent from subjects? - -In
addition to the consent of the research subjects, are there other individuals
or groups whose permission must be sought?
-Nuremberg Code - -Judged human experimentation conducted by Nazis.
Voluntary consent by human subject is absolutely essential
-Declaration of Helsinki - -basis of good clinical practices. Addresses
research protocols, informed consent, risks/benefits, et plus
-Belmont Report - -basic ethical principles for research involving human
subjects.
-Respect for person's autonomy
-Beneficence
-Justice
-Respect for Person - -individuals treated as autonomous agents, and those
with diminished autonomy are entitled protection
-Beneficence - -Make effort to secure well-being.
-Do not harm
-Maximize possible benefits and minimize possible harm/risk
-Justice - -Equals be treated equally.
-To each person an equal share.
-To each person according to individual need.
, -To each person according to individual effort.
-To each person according to societal contribution.
-And to each person according to merit.
-IRB Review - -to protect the rights and welfare of human subjects by
ensuring equitable subject selection, assuring adequate informed consent,
assessing and minimizing risks, and maintaining privacy and confidentiality.
-Exempt Review - -research with human subjects that generally involves no
more than minimal risk. Does not require ongoing review, unless amended st
it no longer fulfills the exempt criteria
-Expedited Review - -research presents no more than minimal risk. Does not
have to be full convened committee.
-Full Board (convened) Review - -research that involve more than minimal
risk require full board review at a convened meeting at which a quorum of
IRB members is present.
Must receive approval by majority of members.
-Research - -a systematic investigation, including research development,
testing, and evaluation, designed to develop or contribute to generalizable
knowledge.
To test a hypothesis with conclusions to be drawn
-Human subject - -a living individual ABOUT whom an investigator (whether
professional or student) conducting research obtains (1) data through
intervention or interaction with the individual, or (2) identifiable private
information.
-Which of the following studies need IRB approval? - -Studies collecting data
about living individuals.
-Which type of IRB review does not require an IRB approval but does require
a determination by the IRB or an IRB designee? - -Exempt
-Which of the following on-line research strategies raises the most concerns
regarding the ethical principle of respecting the autonomy of research
subjects and the corresponding federal regulations requiring informed
consent? - -A researcher proposes to join a moderated support group for
cancer survivors posing as a survivor. She plans to insert comments to see
how the members respond.
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