CITI -SOCIAL&BEHAVIORAL RESEARCH EXAM
ELABORATIONS QUESTIONS AND VERIFIED
ANSWERS 2025 UPDATE | EVERY QUESTION SOLVED |
EVERY SCORE SECURED!
What procedures must be described in an agreement called an "assurance of
compliance" with OHRP? - Answer: 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? - Answer: 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? - Answer: In addition to the
consent of the research subjects, are there other individuals or groups whose
permission must be sought?
Nuremberg Code - Answer: Judged human experimentation conducted by Nazis.
Voluntary consent by human subject is absolutely essential
Declaration of Helsinki - Answer: basis of good clinical practices. Addresses research
protocols, informed consent, risks/benefits, et plus
Belmont Report - Answer: basic ethical principles for research involving human
subjects.
-Respect for person's autonomy
-Beneficence
1
APPHIA - Crafted with Care and Precision for Academic Excellence.
, -Justice
Respect for Person - Answer: individuals treated as autonomous agents, and those with
diminished autonomy are entitled protection
Beneficence - Answer: Make effort to secure well-being.
-Do not harm
-Maximize possible benefits and minimize possible harm/risk
Justice - Answer: 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 - Answer: 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 - Answer: 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 - Answer: research presents no more than minimal risk. Does not
have to be full convened committee.
2
APPHIA - Crafted with Care and Precision for Academic Excellence.
ELABORATIONS QUESTIONS AND VERIFIED
ANSWERS 2025 UPDATE | EVERY QUESTION SOLVED |
EVERY SCORE SECURED!
What procedures must be described in an agreement called an "assurance of
compliance" with OHRP? - Answer: 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? - Answer: 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? - Answer: In addition to the
consent of the research subjects, are there other individuals or groups whose
permission must be sought?
Nuremberg Code - Answer: Judged human experimentation conducted by Nazis.
Voluntary consent by human subject is absolutely essential
Declaration of Helsinki - Answer: basis of good clinical practices. Addresses research
protocols, informed consent, risks/benefits, et plus
Belmont Report - Answer: basic ethical principles for research involving human
subjects.
-Respect for person's autonomy
-Beneficence
1
APPHIA - Crafted with Care and Precision for Academic Excellence.
, -Justice
Respect for Person - Answer: individuals treated as autonomous agents, and those with
diminished autonomy are entitled protection
Beneficence - Answer: Make effort to secure well-being.
-Do not harm
-Maximize possible benefits and minimize possible harm/risk
Justice - Answer: 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 - Answer: 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 - Answer: 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 - Answer: research presents no more than minimal risk. Does not
have to be full convened committee.
2
APPHIA - Crafted with Care and Precision for Academic Excellence.
