CCRP SOCRA COMPREHENSIVE EXAM 2026 UPDATED
QUESTIONS AND ANSWERS RATED A+
✔✔Where is the Common Rule? - ✔✔45 CFR Part 46; protects human subjects under
HHS
✔✔45 Code of Federal Regulations part 46 Subpart B - ✔✔additional protections for
pregnant woman, human fetuses, and neonates involved in research conducted or
supported by Department of Health and Human Services (DHHS)
✔✔45 Code of Federal Regulations part 46 Subpart C - ✔✔additional protections
pertaining to research conducted or supported by Department of Health and Human
Services (DHHS) involving prisoners as subjects
✔✔45 Code of Federal Regulations part 46 Subpart D - ✔✔additional protections
pertaining to research conducted or supported by Department of Health and Human
Services (DHHS) involving children as subjects
✔✔fetus - ✔✔product conception from implantation through delivery
✔✔dead fetus - ✔✔no heartbeat, respiratory activity, muscle movement, or pulsation of
umbilical cord
✔✔neonate - ✔✔newborn
✔✔nonviable neonate - ✔✔a neonate after delivery that, although living is not viable
✔✔acceptable risk level for mother and fetus - ✔✔no greater than minimal risk and
consent of both parents required
✔✔viability and research - ✔✔research will have no part in determining viability. viability
must be determined prior to participation
✔✔IRBs when prisoners are involved - ✔✔majority should not be associated with the
prison but one member of the board shall be a prisoner or prisoner rep
✔✔assent - ✔✔child's affirmative agreement to participate in research, parental
permission is still required
✔✔Children - ✔✔Persons who have not attained the legal age for consent to treatment
or procedures involved in clinical investigations, under the applicable law of the
jurisdiction in which the clinical investigation will be conducted
, ✔✔Can wards participate in research? - ✔✔yes but only if they have an advocate
serving as the child's legal guardian
✔✔IRB must register and comply with ________ and ___________ - ✔✔Office of
Human Research Protection; and Health and Human Services
✔✔OHRP - ✔✔Office for Human Research Protections
✔✔HHS - ✔✔Health and Human Services
✔✔How long is IRB registration effective for? - ✔✔3 years
✔✔What is MedWatch? - ✔✔a voluntary FDA adverse event reporting system, should
include reporting person, AE details, product details, affected person demographics,
manufacturer info
✔✔Belmont Report goals - ✔✔to identify basic ethical principles in research with human
subjects
✔✔Who wrote the Belmont Report? - ✔✔National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research
✔✔What is the difference between practice and research in the Belmont report? -
✔✔Practice: interventions that are designed solely to enhance the well-being of an
individual (that have a reasonable expectation of success)
Research: activity designed to test a hypothesis, draw conclusions, and develop
generalizable knowledge
✔✔Belmont Report 3 Basic Ethical Principles - ✔✔1) respect for persons
2) beneficence
3) justice
✔✔respect for persons - ✔✔1) treating persons as autonomous agents (acknowledge)
2) protecting those with diminished autonomy (protect)
✔✔beneficence - ✔✔1) do not harm
2) maximize benefits and minimize harm
✔✔injustice - ✔✔when some benefit to which a person is entitled is denied without good
reason or when burden is imposed unduly
✔✔Belmont Report applications (General Principles of research conduct) - ✔✔1)
Informed consent
2) risk/benefit assessment
QUESTIONS AND ANSWERS RATED A+
✔✔Where is the Common Rule? - ✔✔45 CFR Part 46; protects human subjects under
HHS
✔✔45 Code of Federal Regulations part 46 Subpart B - ✔✔additional protections for
pregnant woman, human fetuses, and neonates involved in research conducted or
supported by Department of Health and Human Services (DHHS)
✔✔45 Code of Federal Regulations part 46 Subpart C - ✔✔additional protections
pertaining to research conducted or supported by Department of Health and Human
Services (DHHS) involving prisoners as subjects
✔✔45 Code of Federal Regulations part 46 Subpart D - ✔✔additional protections
pertaining to research conducted or supported by Department of Health and Human
Services (DHHS) involving children as subjects
✔✔fetus - ✔✔product conception from implantation through delivery
✔✔dead fetus - ✔✔no heartbeat, respiratory activity, muscle movement, or pulsation of
umbilical cord
✔✔neonate - ✔✔newborn
✔✔nonviable neonate - ✔✔a neonate after delivery that, although living is not viable
✔✔acceptable risk level for mother and fetus - ✔✔no greater than minimal risk and
consent of both parents required
✔✔viability and research - ✔✔research will have no part in determining viability. viability
must be determined prior to participation
✔✔IRBs when prisoners are involved - ✔✔majority should not be associated with the
prison but one member of the board shall be a prisoner or prisoner rep
✔✔assent - ✔✔child's affirmative agreement to participate in research, parental
permission is still required
✔✔Children - ✔✔Persons who have not attained the legal age for consent to treatment
or procedures involved in clinical investigations, under the applicable law of the
jurisdiction in which the clinical investigation will be conducted
, ✔✔Can wards participate in research? - ✔✔yes but only if they have an advocate
serving as the child's legal guardian
✔✔IRB must register and comply with ________ and ___________ - ✔✔Office of
Human Research Protection; and Health and Human Services
✔✔OHRP - ✔✔Office for Human Research Protections
✔✔HHS - ✔✔Health and Human Services
✔✔How long is IRB registration effective for? - ✔✔3 years
✔✔What is MedWatch? - ✔✔a voluntary FDA adverse event reporting system, should
include reporting person, AE details, product details, affected person demographics,
manufacturer info
✔✔Belmont Report goals - ✔✔to identify basic ethical principles in research with human
subjects
✔✔Who wrote the Belmont Report? - ✔✔National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research
✔✔What is the difference between practice and research in the Belmont report? -
✔✔Practice: interventions that are designed solely to enhance the well-being of an
individual (that have a reasonable expectation of success)
Research: activity designed to test a hypothesis, draw conclusions, and develop
generalizable knowledge
✔✔Belmont Report 3 Basic Ethical Principles - ✔✔1) respect for persons
2) beneficence
3) justice
✔✔respect for persons - ✔✔1) treating persons as autonomous agents (acknowledge)
2) protecting those with diminished autonomy (protect)
✔✔beneficence - ✔✔1) do not harm
2) maximize benefits and minimize harm
✔✔injustice - ✔✔when some benefit to which a person is entitled is denied without good
reason or when burden is imposed unduly
✔✔Belmont Report applications (General Principles of research conduct) - ✔✔1)
Informed consent
2) risk/benefit assessment
