SOCRA CERTIFICATION EXAM 2024 ACTUAL EXAM COMPLETE 200
QUESTIONS WITH DETAILED VERIFIED ANSWERS (100% CORRECT
ANSWERS) ALREADY GRADED A+
Name the 8 elements of INFORMED CONSENT - CORRECT
ANSWER >>>>1. statement of research. purpose of
research. duration of participation. procedures involved.
identification of all that is experimental.
2. Risks and discomforts
3. Benefits
4. Disclosure of alternatives
5. Confidentiality
6. Compensation if injury
7. Who to contact
8. Statement of voluntariness
ADDITIONAL:
Costs, pregnancy, termination of participation,
withdrawal consequences, disclosure of findings, number
of subjects in the study.
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Clinicaltrials.gov statement.
Short Form consent - CORRECT ANSWER >>>>In the
context of human subjects research, a written document
stating that the elements of informed consent required
by the Common Rule have been ORALLY presented to
and understood by the subject or the subject's legally
authorized representative
When can children participate in clinical trials ?
(conditions) - CORRECT ANSWER >>>>1. No more than
minimal risk
2. Adequate assent of the child
3. Risk is justified by potential benefit
4. Risk is above minimal, but likely to yield knowledge
about a disorder or condition. Not reasonably different
from their expected medical course. Assent.
Things to consider when soliciting ASSENT - CORRECT
ANSWER >>>>Age, maturity, mental capacity
When is ASSENT NOT REQUIRED? - CORRECT ANSWER
>>>>Children cannot be reasonably consulted in this
case. Benefit is so great. Minimal risk. Could not
practicably be carried out without the waiver.
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When can WARDS be included? - CORRECT ANSWER
>>>>related to their status as wards, conducted in a
setting (school) where most are not wards, advocate has
experience to act in the best interest of the child (cannot
be associated with study team)
Within how many days can emergency use of a test
article be reported to the IRB? - CORRECT ANSWER
>>>>5
Do IRBs need to register with the federal government? -
CORRECT ANSWER >>>>Yes! Every IRB that reviews
clinical investigations must register under HHS
How many members are required to be on an IRB? -
CORRECT ANSWER >>>>5 members, with varying
backgrounds to promote complete and adequate review
of researchj
Do the members of an IRB have to represent adequate
diversity of backgrounds, race, vulnerability? - CORRECT
ANSWER >>>>Yes
Each IRB shall include atleast 1 _________ and atleast
one _______ (3 categories) - CORRECT ANSWER
>>>>Scientific member and non scientific member.
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Institution affiliated and NON institution affiliated
Man and Woman
Do a majority of IRB members need to be present when
reviewing protocols? - CORRECT ANSWER >>>>I think so.
And you definitely need one nonscientific person.
Does an IRB have to write out its reasons for not
approving an IRB? - CORRECT ANSWER >>>>Yes. It must
allow the investigators appropriate response.
Does an IRB have to do a yearly continuing review? -
CORRECT ANSWER >>>>Review of research at intervals
appropriate to the degree of risk, not less than once per
year (I suppose this could mean modifications like CHOP)
When can an IRB use an expedited review method? -
CORRECT ANSWER >>>>Research is no more than
minimal risk OR minor changes to previously approved
research
What criteria must be met for an IRB to approve a study?
- CORRECT ANSWER >>>>-Risks are MINIMIZED
-Risks are reasonable in proportion to benefits
-Selection of subjects is equitable
-Informed consent will be sought
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