CERTIFICATION FOR IRB PROFESSIONALS
UPDATED ACTUAL QUESTIONS AND
CORRECT ANSWERS
●● The IRB is responsible for conducting its initial and continuing
review and reporting its findings to
Answer: the investigator and the institution
●● The IRB should have written procedures for
Answer: 1. conducting initial and continuing review including projects
for which more frequent than annual review is required
2. determining which projects need verification from sources other than
investigators that no material changes have occurred since the previous
review
3. ensuring prompt reporting of proposed changes in approved research
ALL
●● The Title 45 part 46 common rule refers to
Answer: Part A
●● The common rule is so termed because it is
Answer: subscribed to by multiple federal departments
,●● Departments which subscribed to the common rule include
Answer: DHHS, Department of Education, Defense, Agriculture
●● The IRB shall ensure that its membership is
Answer: not based on one member, not comprised of one profession,
illustrative of every nondiscriminatory efforts to include qualified people
of both sexes
●● Continuing review of research must be conducted at
Answer: intervals appropriate to the risk, at least once annually
●● In considering the risks of research the IRB should ensure that the
study
Answer: 1. ascertain that risks are minimized by using procedures
consistent with sound design
2. avoids procedures which unnecessarily expose subjects to risk
3. use procedures that are already being used in diagnosis and treatment
ALL
●● Guidelines for expedited review are described in the regulations of
Answer: DHHS and FDA
, ●● The IRB considering risk should
Answer: 1. consider risks in relationship to benefits
2. consider the importance of knowledge that may be reasonably
expected but not the long range effects of applying the knowledge
3. consider only the research procedures and not those used in SOC
ALL
●● The number of basic elements of consent is
Answer: 8
●● The number of added elements to informed consent, to be provided
when appropriate, is
Answer: 6
●● An essential element of informed consent affirmed in most ethical
frameworks is
Answer: subjects may discontinue participation at any time without
penalty
●● An essential element of consent that is affirmed in most ethical
frameworks is that
UPDATED ACTUAL QUESTIONS AND
CORRECT ANSWERS
●● The IRB is responsible for conducting its initial and continuing
review and reporting its findings to
Answer: the investigator and the institution
●● The IRB should have written procedures for
Answer: 1. conducting initial and continuing review including projects
for which more frequent than annual review is required
2. determining which projects need verification from sources other than
investigators that no material changes have occurred since the previous
review
3. ensuring prompt reporting of proposed changes in approved research
ALL
●● The Title 45 part 46 common rule refers to
Answer: Part A
●● The common rule is so termed because it is
Answer: subscribed to by multiple federal departments
,●● Departments which subscribed to the common rule include
Answer: DHHS, Department of Education, Defense, Agriculture
●● The IRB shall ensure that its membership is
Answer: not based on one member, not comprised of one profession,
illustrative of every nondiscriminatory efforts to include qualified people
of both sexes
●● Continuing review of research must be conducted at
Answer: intervals appropriate to the risk, at least once annually
●● In considering the risks of research the IRB should ensure that the
study
Answer: 1. ascertain that risks are minimized by using procedures
consistent with sound design
2. avoids procedures which unnecessarily expose subjects to risk
3. use procedures that are already being used in diagnosis and treatment
ALL
●● Guidelines for expedited review are described in the regulations of
Answer: DHHS and FDA
, ●● The IRB considering risk should
Answer: 1. consider risks in relationship to benefits
2. consider the importance of knowledge that may be reasonably
expected but not the long range effects of applying the knowledge
3. consider only the research procedures and not those used in SOC
ALL
●● The number of basic elements of consent is
Answer: 8
●● The number of added elements to informed consent, to be provided
when appropriate, is
Answer: 6
●● An essential element of informed consent affirmed in most ethical
frameworks is
Answer: subjects may discontinue participation at any time without
penalty
●● An essential element of consent that is affirmed in most ethical
frameworks is that
