2026 EXAMINATION TEST
◉ A study proposing to involve pregnant adolescents who are
detained in a juvenile detention center would only be allowed if.
Answer: The requirements of Subparts A, B, C, and D are met.
◉ An "autonomous person" is someone who:. Answer: Understands
the risks and benefits of his or her participation and is able to make
a voluntary decision if adequate information is provided.
◉ 45 CFR 46 requires Federal Departments and Agencies to rely
solely on IRBs to evaluate risks to subjects, protection against these
risks, potential benefits of the research and the importance of the
knowledge to be gained.. Answer: False
◉ What are the three ethical principles that constitute the basis for
the HHS Human Subjects Regulations (45 CFR 46)?. Answer: Respect
for Persons, Beneficence, Justice
◉ An institutionally designated authority, other than the
investigator, should determine that proposed studies are exempt
from regulatory requirements.. Answer: True
, ◉ Communities may grant emergency waivers of informed consent
for research involving pregnant women in the community who are in
active labor and call Emergency Medical Services.. Answer: False
◉ Research involving prisoners requires both specific IRB
membership and approval by OHRP to signify that the proposed
research falls within the permissible research categories.. Answer:
True
◉ When might human subjects research require investigators to
obtain informed consent?. Answer: A. Investigators must obtain
informed consent if the study involves interactions with research
participants.
B. Investigators must obtain informed consent if the study involves
interventions with research participants.
C. Investigators must obtain informed consent if the study involves
collection of private information from or about research
participants.
◉ After informed consent for a research study is given, a research
participant must complete the study.. Answer: False
◉ In general, informed consent should be a process rather than a
one-time event.. Answer: True