CIP CORRECT TEST PAPER QUESTIONS AND
ANSWERS SET A+
✔✔Subpart B - Research Involving Pregnant Women and/or Human Fetuses - ✔✔45
CFR 46.204 Pregnant women or fetuses may be involved in research if all of the
following conditions are met:
(a) preclinical studies, including studies on pregnant animals, and clinical studies,
including studies on nonpregnant women, have been conducted and provide data for
assessing potential risks to pregnant women and fetuses;
(b) The risk to the fetus is caused solely by interventions or procedures that hold out
the prospect of direct benefit for the woman or the fetus; or, if there is no such prospect
of benefit, the risk to the fetus is not greater than minimal and the purpose of the
research is the development of important biomedical knowledge which cannot be
obtained by any other means;
(c) Any risk is the least possible for achieving the objectives of the research;
(d) the pregnant woman's consent is obtained in accord with the informed consent
provisions of subpart A;
(e) If the research holds out the prospect of direct benefit solely to the fetus then the
consent of the pregnant woman and the father is obtained in accord with the informed
consent provisions of subpart A;
(f) Each individual providing consent under paragraph (d) or (e) of this section is fully
informed regarding the reasonably foreseeable impact of the research on the fetus or
neonate;
(g) For children as defined in §46.402(a) who are pregnant, assent and permission are
obtained in accord with the provisions of subpart D of this part;
(h) No inducements, monetary or otherwise, will be offered to terminate a pregnancy;
(i) Individuals engaged in the research will have no part in any decisions as to the
timing, method, or procedures used to terminate a pregnancy; and
(j) Individuals engaged in the research will have no part in determining the viability of a
neonate.
✔✔Subpart B - Research Involving Neonates - ✔✔45 CFR 46. 205 Neonates of
uncertain viability and nonviable neonates may be involved in research if all of the
following conditions are met:
, (1) preclinical and clinical studies have been conducted and provide data for assessing
potential risks to neonates.
(2) Each individual providing consent is fully informed regarding the reasonably
foreseeable impact of the research on the neonate.
(3) Individuals engaged in the research will have no part in determining the viability of a
neonate.
(4) (b) Neonates of uncertain viability. Until it has been ascertained whether or not a
neonate is viable, a neonate may not be involved in research covered by this subpart
unless the following additional conditions have been met:
*The IRB determines that:
(i) The research holds out the prospect of enhancing the probability of survival of the
neonate to the point of viability, and any risk is the least possible for achieving that
objective, or
(ii) The purpose of the research is the development of important biomedical knowledge
which cannot be obtained by other means and there will be no added risk to the
neonate resulting from the research; and
*The legally effective informed consent of either parent of the neonate or, if neither
parent is able to consent because of unavailability, incompetence, or temporary
incapacity, the legally effective informed consent of either parent's legally authorized
representative is obtained , except that the consent of the father or his legally
authorized representative need not be obtained if the pregnancy resulted from rape or
incest.
(4) (c) Nonviable neonates. After delivery nonviable neonate may not be involved in
research covered by this subpart unless all of the following additional conditions are
met:
(1) Vital functions of the neonate will not be artificially maintained;
(2) The resear
✔✔Waivers of Parental Permission/Child Assent - ✔✔45 CFR 46.116 This mainly
applies to research conducted in public schools. IRBs must find and document that:
1. The research involves no more than minimal risk to the subjects.
2. The waiver or alteration will not adversely affect the rights and welfare of the
subjects.
3. The research could not practicably be carried out without the waiver or alteration.
4. Whenever appropriate, the subjects will be provided with additional pertinent
information after participation.
✔✔Passive Consent & Parental Notification - ✔✔Used in school-based research.
Involves notifying parents that research will take place and giving them an opportunity to
state they do not want their child to participate. Not equivalent to informed consent. May
only be used in school-based research if the IRB has waived the requirement for
parental permission.
✔✔Educational Harm - ✔✔The harm caused by diverting instructional time to research
activities. It is the school, not the researcher, that decides when it is appropriate to use
class time for research. However, researchers should build in transitional activities to
ANSWERS SET A+
✔✔Subpart B - Research Involving Pregnant Women and/or Human Fetuses - ✔✔45
CFR 46.204 Pregnant women or fetuses may be involved in research if all of the
following conditions are met:
(a) preclinical studies, including studies on pregnant animals, and clinical studies,
including studies on nonpregnant women, have been conducted and provide data for
assessing potential risks to pregnant women and fetuses;
(b) The risk to the fetus is caused solely by interventions or procedures that hold out
the prospect of direct benefit for the woman or the fetus; or, if there is no such prospect
of benefit, the risk to the fetus is not greater than minimal and the purpose of the
research is the development of important biomedical knowledge which cannot be
obtained by any other means;
(c) Any risk is the least possible for achieving the objectives of the research;
(d) the pregnant woman's consent is obtained in accord with the informed consent
provisions of subpart A;
(e) If the research holds out the prospect of direct benefit solely to the fetus then the
consent of the pregnant woman and the father is obtained in accord with the informed
consent provisions of subpart A;
(f) Each individual providing consent under paragraph (d) or (e) of this section is fully
informed regarding the reasonably foreseeable impact of the research on the fetus or
neonate;
(g) For children as defined in §46.402(a) who are pregnant, assent and permission are
obtained in accord with the provisions of subpart D of this part;
(h) No inducements, monetary or otherwise, will be offered to terminate a pregnancy;
(i) Individuals engaged in the research will have no part in any decisions as to the
timing, method, or procedures used to terminate a pregnancy; and
(j) Individuals engaged in the research will have no part in determining the viability of a
neonate.
✔✔Subpart B - Research Involving Neonates - ✔✔45 CFR 46. 205 Neonates of
uncertain viability and nonviable neonates may be involved in research if all of the
following conditions are met:
, (1) preclinical and clinical studies have been conducted and provide data for assessing
potential risks to neonates.
(2) Each individual providing consent is fully informed regarding the reasonably
foreseeable impact of the research on the neonate.
(3) Individuals engaged in the research will have no part in determining the viability of a
neonate.
(4) (b) Neonates of uncertain viability. Until it has been ascertained whether or not a
neonate is viable, a neonate may not be involved in research covered by this subpart
unless the following additional conditions have been met:
*The IRB determines that:
(i) The research holds out the prospect of enhancing the probability of survival of the
neonate to the point of viability, and any risk is the least possible for achieving that
objective, or
(ii) The purpose of the research is the development of important biomedical knowledge
which cannot be obtained by other means and there will be no added risk to the
neonate resulting from the research; and
*The legally effective informed consent of either parent of the neonate or, if neither
parent is able to consent because of unavailability, incompetence, or temporary
incapacity, the legally effective informed consent of either parent's legally authorized
representative is obtained , except that the consent of the father or his legally
authorized representative need not be obtained if the pregnancy resulted from rape or
incest.
(4) (c) Nonviable neonates. After delivery nonviable neonate may not be involved in
research covered by this subpart unless all of the following additional conditions are
met:
(1) Vital functions of the neonate will not be artificially maintained;
(2) The resear
✔✔Waivers of Parental Permission/Child Assent - ✔✔45 CFR 46.116 This mainly
applies to research conducted in public schools. IRBs must find and document that:
1. The research involves no more than minimal risk to the subjects.
2. The waiver or alteration will not adversely affect the rights and welfare of the
subjects.
3. The research could not practicably be carried out without the waiver or alteration.
4. Whenever appropriate, the subjects will be provided with additional pertinent
information after participation.
✔✔Passive Consent & Parental Notification - ✔✔Used in school-based research.
Involves notifying parents that research will take place and giving them an opportunity to
state they do not want their child to participate. Not equivalent to informed consent. May
only be used in school-based research if the IRB has waived the requirement for
parental permission.
✔✔Educational Harm - ✔✔The harm caused by diverting instructional time to research
activities. It is the school, not the researcher, that decides when it is appropriate to use
class time for research. However, researchers should build in transitional activities to
