CITI -Social&Behavioral Research, Questions with answers. 2022/2023.
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CITI
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CITI
CITI -Social&Behavioral Research, Questions with answers. 2022/2023.
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 revie...
CITI -Social&Behavioral Research,
Questions with answers. 2022/2023.
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.
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