ACRP CP EXAM 2026/2027 | ACCURATE 2 CURRENTLY
TESTING EXAMS WITH A STUDY GUIDE AND
KNOWLEDGE CHECK FLASHCARDS WITH SUMMARIZED
INSTRUCTOR NOTES AT THE END FOR A GUARANTED
PASS
A 46 year-old man is currently enrolled in a Phase 2 study of a drug for
severe diabetic neuropathy. While the study is on-going, a new drug
becomes commercially available that may have equal or greater benefit
to the subject. The investigator should do which of the following?
......ANSWER......Give the subject comprehensive information about
the new drug, including its side effects. Discuss the pros and cons of
both the investigational drug and the commercially available drug and
then allow the subject to decide whether to withdraw from the
research to take the new drug.
A general requirement for the informed consent form is that it may not
include any exculpatory language. Exculpatory language is that which
waives or appears to waive any of the subject's legal rights or releases
or appears to release those conducting the research from liability for
negligence. Which of the following statements in a consent form is an
example of exculpatory language? ......ANSWER......I waive any
possibility of compensation for injuries that I may receive as a result
of participation in this research
pg. 1
,An investigator is confronted with a life-threatening situation that
necessitates using a test article in a human subject who is unable to
provide informed consent and there is no time to obtain consent from
the individual's LAR and no alternative method or recognized therapy is
available. Under the FDA regulations for using test articles, which of the
following describes the best course of action for the investigator:
......ANSWER......The investigator and an independent physician agree
that the situation necessitates the use of the test article. An exception
or waiver for informed consent can be made under these
circumstances. The IRB will be notified later.
The ethics of genetic and genomic research have received a great deal
of attention due to several factors: ......ANSWER......1) Genetic testing
can reveal a strong predisposition to future disease, making the
information psychologically powerful and raising concerns about stigma
or discrimination
2) Related individuals share many of the same gene sequences in their
DNA, meaning that genetic information about one individual provides
information about other individuals who may or may not have
consented to genetic testing
3) Genetic testing can reveal characteristics of recent and distant
ancestry that may conflict with peoples' family history, with their social
history, or with their religious beliefs
4) Historically, genetic concepts and information have sometimes been
misused to affect social and political ends
genetic determinism ......ANSWER......The concept that the control of
genes confers great power than can be used or misused
pg. 2
,As of January 2015, the NIH expects investigators to obtain the
informed (valid) consent of research participants in NIH -funded genetic
research for broad research use of data and data sharing, even if the
cell lines or specimens are: ......ANSWER......deidentified
When conducting research that involves collecting biological specimens
for genetic testing, which of the following issues are the most important
for the IRB to consider? ......ANSWER......Effects of findings on other
family memebers
Under which of the following conditions is it appropriate to re-contact
the individuals who provided biological specimens?
......ANSWER......Original signed consent documents include provisions
for recontacting subjects
Which choice best describes the purpose of most pharmacogenomic
research? ......ANSWER......To evaluate the association between
individual genotypes and the safety and efficacy of a particular drug or
class of drugs
Identify which type of discrimination the Genetic Information Non-
Discrimination Act protects individuals from: ......ANSWER......Health
insurance and employment discrimination
pg. 3
, The Common Rule (45 CFR 46, Subpart A) found at 46.108(a)(4): An IRB
shall establish and follow written procedures for ensuring prompt
reporting to the IRB; appropriate institutional officials; the department
or agency head; and the Office for Human Research Protections, HHS,
or any successor office, or the equivalent office within the appropriate
Federal department or agency of: ......ANSWER......1) Any unanticipated
problems involving risks to subjects or others or any serious or
continuing noncompliance with this policy or the requirements or
determinations of the IRB; and
2) Any suspension or termination of IRB approval.
According to OHRP, it considers unanticipated problems, in general, to
include any incident, experience, or outcome that meets ALL OF THE
FOLLOWING criteria: ......ANSWER......1) Unexpected given the research
procedures that are described in the research plan-related documents,
such as the IRB-approved research plan and informed consent
documents and the characteristics of the subject population being
studied;
2) Related or possibly related to participation in the research; and
3) Suggests that the research places subjects or others at a greater risk
of harm than was previously known or recognized
21 CFR 312.50 (Investigational New Drug Application 2014) requires
sponsors to ensure that FDA and all participating investigators are
promptly informed of: ......ANSWER......significant new adverse effects
or risks with respect to the drug
pg. 4
TESTING EXAMS WITH A STUDY GUIDE AND
KNOWLEDGE CHECK FLASHCARDS WITH SUMMARIZED
INSTRUCTOR NOTES AT THE END FOR A GUARANTED
PASS
A 46 year-old man is currently enrolled in a Phase 2 study of a drug for
severe diabetic neuropathy. While the study is on-going, a new drug
becomes commercially available that may have equal or greater benefit
to the subject. The investigator should do which of the following?
......ANSWER......Give the subject comprehensive information about
the new drug, including its side effects. Discuss the pros and cons of
both the investigational drug and the commercially available drug and
then allow the subject to decide whether to withdraw from the
research to take the new drug.
A general requirement for the informed consent form is that it may not
include any exculpatory language. Exculpatory language is that which
waives or appears to waive any of the subject's legal rights or releases
or appears to release those conducting the research from liability for
negligence. Which of the following statements in a consent form is an
example of exculpatory language? ......ANSWER......I waive any
possibility of compensation for injuries that I may receive as a result
of participation in this research
pg. 1
,An investigator is confronted with a life-threatening situation that
necessitates using a test article in a human subject who is unable to
provide informed consent and there is no time to obtain consent from
the individual's LAR and no alternative method or recognized therapy is
available. Under the FDA regulations for using test articles, which of the
following describes the best course of action for the investigator:
......ANSWER......The investigator and an independent physician agree
that the situation necessitates the use of the test article. An exception
or waiver for informed consent can be made under these
circumstances. The IRB will be notified later.
The ethics of genetic and genomic research have received a great deal
of attention due to several factors: ......ANSWER......1) Genetic testing
can reveal a strong predisposition to future disease, making the
information psychologically powerful and raising concerns about stigma
or discrimination
2) Related individuals share many of the same gene sequences in their
DNA, meaning that genetic information about one individual provides
information about other individuals who may or may not have
consented to genetic testing
3) Genetic testing can reveal characteristics of recent and distant
ancestry that may conflict with peoples' family history, with their social
history, or with their religious beliefs
4) Historically, genetic concepts and information have sometimes been
misused to affect social and political ends
genetic determinism ......ANSWER......The concept that the control of
genes confers great power than can be used or misused
pg. 2
,As of January 2015, the NIH expects investigators to obtain the
informed (valid) consent of research participants in NIH -funded genetic
research for broad research use of data and data sharing, even if the
cell lines or specimens are: ......ANSWER......deidentified
When conducting research that involves collecting biological specimens
for genetic testing, which of the following issues are the most important
for the IRB to consider? ......ANSWER......Effects of findings on other
family memebers
Under which of the following conditions is it appropriate to re-contact
the individuals who provided biological specimens?
......ANSWER......Original signed consent documents include provisions
for recontacting subjects
Which choice best describes the purpose of most pharmacogenomic
research? ......ANSWER......To evaluate the association between
individual genotypes and the safety and efficacy of a particular drug or
class of drugs
Identify which type of discrimination the Genetic Information Non-
Discrimination Act protects individuals from: ......ANSWER......Health
insurance and employment discrimination
pg. 3
, The Common Rule (45 CFR 46, Subpart A) found at 46.108(a)(4): An IRB
shall establish and follow written procedures for ensuring prompt
reporting to the IRB; appropriate institutional officials; the department
or agency head; and the Office for Human Research Protections, HHS,
or any successor office, or the equivalent office within the appropriate
Federal department or agency of: ......ANSWER......1) Any unanticipated
problems involving risks to subjects or others or any serious or
continuing noncompliance with this policy or the requirements or
determinations of the IRB; and
2) Any suspension or termination of IRB approval.
According to OHRP, it considers unanticipated problems, in general, to
include any incident, experience, or outcome that meets ALL OF THE
FOLLOWING criteria: ......ANSWER......1) Unexpected given the research
procedures that are described in the research plan-related documents,
such as the IRB-approved research plan and informed consent
documents and the characteristics of the subject population being
studied;
2) Related or possibly related to participation in the research; and
3) Suggests that the research places subjects or others at a greater risk
of harm than was previously known or recognized
21 CFR 312.50 (Investigational New Drug Application 2014) requires
sponsors to ensure that FDA and all participating investigators are
promptly informed of: ......ANSWER......significant new adverse effects
or risks with respect to the drug
pg. 4
