SOCRA COMPREHENSIVE EXAM STUDY
GUIDE TEST PAPER QUESTIONS AND
SOLUTIONS 2026
◉ _______ may request to review documentation and reports from
________
Answer: FDA request from investigator (who should permit the
request)
◉ ICF should not include _____________
Answer: exculpatory language in which subject waives legal rights or
releases investigator/sponsor/institution from liability of
negligence
◉ When is a waiver or alteration of consent acceptable?
Answer: o Study, evaluated, or examine a public benefit/service
program
o No more than minimal risk
o If research involves using PHI then it was used because it cannot
be avoided
No adverse effects on rights or welfare of subjects
,◉ An IRB may waive the requirement for an investigator to obtain
signed consent for some or all subjects if??
Answer: 1) that the consent would be the only linking document
resulting in potential harm from breach of patient confidentiality
2) research presents no more than minimal risk and involves no
procedures for which consent is normally required outside of
research
◉ Where is the Common Rule?
Answer: 45 CFR Part 46; protects human subjects under HHS
◉ 45 Code of Federal Regulations part 46 Subpart B
Answer: 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
Answer: 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
, Answer: additional protections pertaining to research conducted or
supported by Department of Health and Human Services (DHHS)
involving children as subjects
◉ fetus
Answer: product conception from implantation through delivery
◉ dead fetus
Answer: no heartbeat, respiratory activity, muscle movement, or
pulsation of umbilical cord
◉ neonate
Answer: newborn
◉ nonviable neonate
Answer: a neonate after delivery that, although living is not viable
◉ acceptable risk level for mother and fetus
Answer: no greater than minimal risk and consent of both parents
required
◉ viability and research
GUIDE TEST PAPER QUESTIONS AND
SOLUTIONS 2026
◉ _______ may request to review documentation and reports from
________
Answer: FDA request from investigator (who should permit the
request)
◉ ICF should not include _____________
Answer: exculpatory language in which subject waives legal rights or
releases investigator/sponsor/institution from liability of
negligence
◉ When is a waiver or alteration of consent acceptable?
Answer: o Study, evaluated, or examine a public benefit/service
program
o No more than minimal risk
o If research involves using PHI then it was used because it cannot
be avoided
No adverse effects on rights or welfare of subjects
,◉ An IRB may waive the requirement for an investigator to obtain
signed consent for some or all subjects if??
Answer: 1) that the consent would be the only linking document
resulting in potential harm from breach of patient confidentiality
2) research presents no more than minimal risk and involves no
procedures for which consent is normally required outside of
research
◉ Where is the Common Rule?
Answer: 45 CFR Part 46; protects human subjects under HHS
◉ 45 Code of Federal Regulations part 46 Subpart B
Answer: 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
Answer: 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
, Answer: additional protections pertaining to research conducted or
supported by Department of Health and Human Services (DHHS)
involving children as subjects
◉ fetus
Answer: product conception from implantation through delivery
◉ dead fetus
Answer: no heartbeat, respiratory activity, muscle movement, or
pulsation of umbilical cord
◉ neonate
Answer: newborn
◉ nonviable neonate
Answer: a neonate after delivery that, although living is not viable
◉ acceptable risk level for mother and fetus
Answer: no greater than minimal risk and consent of both parents
required
◉ viability and research
