Certification for IRB Professionals (CIP) Exam/ 42
Question and Answers/ 100% correct.
According to the Belmont Report, respect for persons usually demands that subjects... -
-enter into research voluntarily & with adequate information
-According to the Belmont Report, the moral requirement that there be fair outcomes in
the selection of research subjects, expresses the principle of: - -Justice
-A poorly designed protocol is considered unethical because... - -research subjects may
be put at risk or inconvenienced for insufficient reason
-When should an IRB suspend or terminate approval of research? - -When it is not
being conducted in accordance with the IRB's requirements
-A quorum for a convened IRB meeting requires the presence of... - -a nonscientific
member
-What is required in research involving no more than minimal risk with children? - -
Adequate provisions are made for assent of the child and permission of parent or
guardian
-Federal regulations require each IRB to have written procedures for... - -initial &
continuing review of research and for reporting its findings and actions to the
investigator and the institution
-What are the 3 ethical principles discussed in the Belmont Report? - -Respect for
Persons, Justice, & Beneficence
, -An example of how the Principle of Beneficence can be applied to a study employing
human subjects? - -Determining that the study has a maximization of benefits & a
minimization of risks.
-The researcher's failure to protect research subjects from deductive disclosure is the
primary ethical violation of which study? - -Harvard "Tastes, Ties, and Time (T3)" study
(2006-2009)"
-What is an example of how the principle of beneficence is applied to a study involving
human subjects? - -Ensuring that risks are reasonable in relationship to anticipated
benefits
-Humphreys collecting data for the Tearoom Trade study under the pretense that he
was a lookout is an example of a violation of the principle of: - -Respect for Persons
-Which study is linked most directly to the establishment of the National Research Act
in 1974 and ultimately to the Belmont Report and Federal regulations for human subject
protection? - -"The Public Health Service Tuskegee Study of Untreated Syphilis in the
Negro Male"
-The Belmont Principle of beneficence requires that... - -potential benefits justify the
risks of harm
-A subject in a clinical research trial experiences a serious, unanticipated adverse drug
experience. How should the investigator proceed, with respect to the IRB, after the
discovery of the adverse event occurrence? - -Report the adverse drug experience in a
timely manner, in keeping with the IRB's policies and procedures, using the forms or the
mechanism provided by the IRB.
-How long is an investigator required to keep consent documents, IRB correspondence,
and research records? - -For a minimum of three years after completion of the study
Question and Answers/ 100% correct.
According to the Belmont Report, respect for persons usually demands that subjects... -
-enter into research voluntarily & with adequate information
-According to the Belmont Report, the moral requirement that there be fair outcomes in
the selection of research subjects, expresses the principle of: - -Justice
-A poorly designed protocol is considered unethical because... - -research subjects may
be put at risk or inconvenienced for insufficient reason
-When should an IRB suspend or terminate approval of research? - -When it is not
being conducted in accordance with the IRB's requirements
-A quorum for a convened IRB meeting requires the presence of... - -a nonscientific
member
-What is required in research involving no more than minimal risk with children? - -
Adequate provisions are made for assent of the child and permission of parent or
guardian
-Federal regulations require each IRB to have written procedures for... - -initial &
continuing review of research and for reporting its findings and actions to the
investigator and the institution
-What are the 3 ethical principles discussed in the Belmont Report? - -Respect for
Persons, Justice, & Beneficence
, -An example of how the Principle of Beneficence can be applied to a study employing
human subjects? - -Determining that the study has a maximization of benefits & a
minimization of risks.
-The researcher's failure to protect research subjects from deductive disclosure is the
primary ethical violation of which study? - -Harvard "Tastes, Ties, and Time (T3)" study
(2006-2009)"
-What is an example of how the principle of beneficence is applied to a study involving
human subjects? - -Ensuring that risks are reasonable in relationship to anticipated
benefits
-Humphreys collecting data for the Tearoom Trade study under the pretense that he
was a lookout is an example of a violation of the principle of: - -Respect for Persons
-Which study is linked most directly to the establishment of the National Research Act
in 1974 and ultimately to the Belmont Report and Federal regulations for human subject
protection? - -"The Public Health Service Tuskegee Study of Untreated Syphilis in the
Negro Male"
-The Belmont Principle of beneficence requires that... - -potential benefits justify the
risks of harm
-A subject in a clinical research trial experiences a serious, unanticipated adverse drug
experience. How should the investigator proceed, with respect to the IRB, after the
discovery of the adverse event occurrence? - -Report the adverse drug experience in a
timely manner, in keeping with the IRB's policies and procedures, using the forms or the
mechanism provided by the IRB.
-How long is an investigator required to keep consent documents, IRB correspondence,
and research records? - -For a minimum of three years after completion of the study
