2025-2026 AND CORRECT DETAILED ANSWERS WITH RATIONALES|ALREADY
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Terms in this set (42)
According to the Belmont Report, enter into research voluntarily & with adequate information
respect for persons usually
demands that subjects...
According to the Belmont Report, Justice
the moral requirement that there
be fair
outcomes in the selection of
research subjects, expresses the
principle of:
A poorly designed protocol is research subjects may be put at risk or inconvenienced for insufficient reason
considered unethical because...
When should an IRB suspend or When it is not being conducted in accordance with the IRB's requirements
terminate approval of research?
A quorum for a convened IRB a nonscientific member
meeting requires the presence of...
What is required in research Adequate provisions are made for assent of the child and permission of parent or
involving no more than minimal risk guardian
with children?
Federal regulations require each IRB initial & continuing review of research and for reporting its findings and actions
to have written procedures for... to the investigator and the institution
What are the 3 ethical principles Respect for Persons, Justice, & Beneficence
discussed in the Belmont Report?
An example of how the Principle of Determining that the study has a maximization of benefits & a minimization of
Beneficence can be applied to a risks.
study employing human subjects?
, The researcher's failure to protect Harvard "Tastes, Ties, and Time (T3)" study (2006-2009)"
research subjects from deductive
disclosure is the
primary ethical violation of which
study?
What is an example of how the Ensuring that risks are reasonable in relationship to anticipated benefits
principle of beneficence is applied
to a study involving
human subjects?
Humphreys collecting data for the Respect for Persons
Tearoom Trade study under the
pretense that he was a lookout is an
example of a violation of the
principle of:
Which study is linked most directly "The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro
to the establishment of the Male"
National Research Act in 1974 and
ultimately to the Belmont
Report and Federal regulations for
human subject protection?
The Belmont Principle of potential benefits justify the risks of harm
beneficence requires that...
A subject in a clinical research trial Report the adverse drug experience in a timely manner, in keeping with the IRB's
experiences a serious, policies and procedures, using the forms or the mechanism provided by the IRB.
unanticipated
adverse drug experience. How
should the investigator proceed,
with respect to the
IRB, after the discovery of the
adverse
event occurrence?
How long is an investigator required For a minimum of three years after completion of the study
to keep consent documents, IRB
correspondence, and research
records?
According to federal regulations, The study involves no more than minimal risk and meets one of the allowable
when can the IRB use expedited categories of expedited review specified in federal regulations
review on a new,
proposed study?
Amendments involving changes to The changes must be immediately implemented for the health and well-being of
IRB the subject.
approved protocols do NOT need
prior IRB approval if: