SOCRA EXAM CERTIFICATION 2023-2024 ACTUAL
EXAM 300 EXAM QUESTIOS AND CORRECT
DETAILED ANSWERS (100% VERIFIED ANSWERS)
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What is the definition of a clinical investigation as it pertains to the
FDA’s informed consent regulations? – ANSWER- Clinical investigation
means any experiment that involves a test article and one or more human
subjects that is either subject to FDA requirements, or not subject to
FDA requirements, but is intended to be submitted to, or held for
inspection by the FDA, as part of a marketing application.
A sponsor-investigator may be a corporation, such as a pharmaceutical
company. T or F? – ANSWER- False.
A sponsor-investigator must be an individual.
What stipulation is mandated for the length of time a prospective
research subject is given to determine whether or not to participate in a
research trial? – ANSWER- Sufficient opportunity to consider whether
or not to participate must be allowed, under circumstances which
minimize the possibility of coercion or undue influence.
Under what conditions may an investigator enter a human subject into a
research study employing the exception from general informed consent
requirements? – ANSWER- a. Prior to enrolling a subject, both the
investigator and an independent physician certify in writing:
i. The subject is in a life-threatening situation which necessitates use of
the test article, is unable to give legally informed consent,
ii. Time is insufficient to obtain consent from the subject’s legal
representative,
iii. And there are no alternative methods or therapies available that
provide an equal or greater chance of saving the subject’s life.
An informed consent document may not include any exculpatory
language through which the subject or subject’s representative releases
or appears to release which parties from liability or negligence? –
ANSWER- The investigator, the sponsor, the institution or its agents.
If an investigator employs the exception from general requirements
process for obtaining consent, within how many days must a full report
of the circumstances be reported to the IRB? – ANSWER- Within five
working days after use of the test article
Following enrollment of a subject into a study under the exception from
general requirements criteria for obtaining consent, a written review by a
physician not associated with the investigation must be submitted to the
IRB within 10 working days. T or F? – ANSWER- False.
Within 5 working days after use of the test article.
Subject to extensive requirements including documentation and ethical
reviews, the U. S. President may approve the use of investigational
drugs for military personnel without first obtaining informed consent
when the DoD is the sponsor of an IND. T or F? – ANSWER- True
With emergency research involving waiver of consent, public disclosure
of the research before and after the research within the local community
is required. T or F? – ANSWER- True.
IRBS must ensure special criteria are met prior to approving emergency
research that will allow subject entry without first obtaining informed
consent. T or F? – ANSWER- True
Under certain limitations, research may be done for emergency
conditions under an informed consent waiver, if approved by an IRB. T
or F? – ANSWER- True
The FDA provides no regulatory basis to conduct research if written
informed consent cannot be obtained from subjects prior to entry into a
study. T or F? – ANSWER- False.
Research may be conducted with waived consent for emergency
conditions, or under the general exception from informed consent
criteria.
If clini vestigations could not normally be completed in patients with
emergency conditions, due to inability to obtain informed consent,
special criteria exist to enable such research to be done. T or F? –
ANSWER- True
What must investigators commit to when conducting research under
emergency conditions, relative to obtaining informed consent for
subjects who are unable to give consent? – ANSWER- Attempting to
contact a family member or legally authorized representative within a
protocol-specified therapeutic window to determine if they object to the
subject’s participation in the research.
Prior to approving emergency research, an IRB must assure that
additional protections are in place regarding the rights and welfare of
prospective subjects. Name at least two of these additional protections. –
ANSWER- a. Consultation with community representatives
b. Public disclosure to the community regarding risks, prior to the study.
c. Public disclosure of the results
d. Establishment of an independent data monitoring committee
e. Attempting to contact a family member, if feasible, to ask whether he
or she objects
What role do family members have regarding consent for participation
in emergency research studies? – ANSWER- Family members are to be
consulted with by investigators to determine if the object to subject’s
participation, or continuation in a research study, and are to be fully
informed of the investigation, if feasible, even if the subject dies.
If a subject enrolled in an emergency research study without informed
consent remains incapacitated, how soon must a legally authorized
representative or family member be made aware of the content of the
informed consent document? – ANSWER- At the earliest feasible
opportunity
If a subject entered into a research study under waived consent criteria
dies before legally authorized representatives or family members can be
contacted, these affiliates must be informed about the investigation. T or
F? – ANSWER- True
If an IRB makes a decision not to approve research under waived
consent criteria due to perceived non-complianc regulatio or ethical
concerns, whom must the IRB notify? – ANSWER- The clinical
investigator and the sponsor.
Subjects enrolled in emergency research with waived consent, must be
informed about the study if their condition improves, even if a legally
authorized representative or family eno member consented on their
behalf, or did not object to their participation. T or F? – ANSWER- True
If a sponsor is notified by an IRB that a research investigation intended
to be conducted under the waived consent emergency research
regulations cannot be approved, whom must the sponsor notify of this
decision? – ANSWER- a. The FDA