SOCRA CCRP ACTUAL EXAM
CONCLUDING REVIEW SHEET PRACTICE
SOLUTION BUNDLED FULLY VERIFIED
ONE HUNDRED PERCENT PASS
GUARANTEED
⩥ 45 CFR 46, Subpart D.
Answer: 45 CFR 46, Subpart D - Additional Protections for Children as
Research Subjects.
⩥ 45 CFR 46.404-7.
Answer: Research was to be classified according to the risk and the
direct benefit to the child.
⩥ 45 CFR 46.116(f).
Answer: Waiver or alteration of consent or assent is also allowed for
children where studies involve no more than minimal risk (defined under
45 CFR 46.404)
⩥ 45 CFR 46.404.
Answer: Research on children must present no more than minimal risk
to the subject. (blood work, urine, CXR, psychological tests,
observation)
,Direct benefit is not required.
Requires consent from >=1 parent
⩥ 45 CFR 46.405.
Answer: Research that presents greater than minimal risk to the subject
may be approvable under 45 CFR 46.405 if it holds the potential for
direct personal benefit to the child.
Requires consent from >=1 parent
⩥ 45 CFR 46.406.
Answer: Research involving greater than minimal risk and no prospect
for direct benefit to the child subject.
- Risk is no more than minor increase (catheter, biopsy, MRI, sensitive
survey)
- Risks must be commensurate with those risks inherent in the subject's
actual medical situation, assent if possible. (additional bone marrow
biopsy in)
- Research must be likely to yield knowledge of vital importance about
the child's disease or condition.
,Requires consent from >=2 parent
⩥ 45 CFR 46.407.
Answer: Presents an opportunity to understand, prevent, or alleviate a
serious problem affecting the health and welfare of children.
-Review by HHS by panel of experts
Requires consent from >=2 parent
⩥ 45 CFR 46.409.
Answer: Ward research not permitted if not necessary to include them.
Advocate needs to be appointed to act in best interest of the child.
⩥ Assent.
Answer: The child's assent is not a necessary condition for proceeding
with the research if the IRB determines that:
- capability of some or all of the children is so limited that they cannot
reasonably be consulted
- intervention or procedure involved in the research holds out a prospect
of direct benefit that is important to the health or well-being of the child
(45 CFR 46.405) and is available only in the context of the research
, ⩥ NIH Guidelines - research on children.
Answer: March 1998, the NIH published Guidelines on the Inclusion of
Children as Participants in Research Involving Human Subject
-Children must be included in all human subjects research, conducted or
supported by the NIH, unless there are scientific or ethical reasons not to
include them
Exclusion reasons:
-irrelevant to children
-study results are known in children or from another study ongoing
-separate age-specific study is warranted + preferable
-insufficient data in adults to determine potential risks in children
⩥ 21 CFR 50, Subpart D.
Answer: Additional Protections for Children in Clinical Investigations in
response to Children's Health Act of 2000
-does not allow waiver of consent except in emergency research keeping
with 21 CFR 50.23 & 50.24
-FDA will not object when IRBs approve waiver/alteration of consent in
research with minimal risk if other criteria are met + documented
⩥ Best Pharmaceuticals for Children Act (2002).
CONCLUDING REVIEW SHEET PRACTICE
SOLUTION BUNDLED FULLY VERIFIED
ONE HUNDRED PERCENT PASS
GUARANTEED
⩥ 45 CFR 46, Subpart D.
Answer: 45 CFR 46, Subpart D - Additional Protections for Children as
Research Subjects.
⩥ 45 CFR 46.404-7.
Answer: Research was to be classified according to the risk and the
direct benefit to the child.
⩥ 45 CFR 46.116(f).
Answer: Waiver or alteration of consent or assent is also allowed for
children where studies involve no more than minimal risk (defined under
45 CFR 46.404)
⩥ 45 CFR 46.404.
Answer: Research on children must present no more than minimal risk
to the subject. (blood work, urine, CXR, psychological tests,
observation)
,Direct benefit is not required.
Requires consent from >=1 parent
⩥ 45 CFR 46.405.
Answer: Research that presents greater than minimal risk to the subject
may be approvable under 45 CFR 46.405 if it holds the potential for
direct personal benefit to the child.
Requires consent from >=1 parent
⩥ 45 CFR 46.406.
Answer: Research involving greater than minimal risk and no prospect
for direct benefit to the child subject.
- Risk is no more than minor increase (catheter, biopsy, MRI, sensitive
survey)
- Risks must be commensurate with those risks inherent in the subject's
actual medical situation, assent if possible. (additional bone marrow
biopsy in)
- Research must be likely to yield knowledge of vital importance about
the child's disease or condition.
,Requires consent from >=2 parent
⩥ 45 CFR 46.407.
Answer: Presents an opportunity to understand, prevent, or alleviate a
serious problem affecting the health and welfare of children.
-Review by HHS by panel of experts
Requires consent from >=2 parent
⩥ 45 CFR 46.409.
Answer: Ward research not permitted if not necessary to include them.
Advocate needs to be appointed to act in best interest of the child.
⩥ Assent.
Answer: The child's assent is not a necessary condition for proceeding
with the research if the IRB determines that:
- capability of some or all of the children is so limited that they cannot
reasonably be consulted
- intervention or procedure involved in the research holds out a prospect
of direct benefit that is important to the health or well-being of the child
(45 CFR 46.405) and is available only in the context of the research
, ⩥ NIH Guidelines - research on children.
Answer: March 1998, the NIH published Guidelines on the Inclusion of
Children as Participants in Research Involving Human Subject
-Children must be included in all human subjects research, conducted or
supported by the NIH, unless there are scientific or ethical reasons not to
include them
Exclusion reasons:
-irrelevant to children
-study results are known in children or from another study ongoing
-separate age-specific study is warranted + preferable
-insufficient data in adults to determine potential risks in children
⩥ 21 CFR 50, Subpart D.
Answer: Additional Protections for Children in Clinical Investigations in
response to Children's Health Act of 2000
-does not allow waiver of consent except in emergency research keeping
with 21 CFR 50.23 & 50.24
-FDA will not object when IRBs approve waiver/alteration of consent in
research with minimal risk if other criteria are met + documented
⩥ Best Pharmaceuticals for Children Act (2002).
