Certification for IRB Professionals (CIP) Exam:
Questions & Answers: Latest Updated
What do institutional review boards protect? (2) - ANSWERthe RIGHTS and WELFARE
of human research subjects
What are IRBs primary goal? - ANSWERto assess the risk and benefits of any
proposed research study
Define benefit (2) - ANSWER- a valued or desired outcome
- an advantage
What does "minimal risk" mean? - ANSWERthat the probability and magnitude of
harm or discomfort anticipated in the research are not greater in and of themselves
than those ordinarily encountered in daily life or during the performance of routine
physical or psychological examinations or tets
What is "risk? - ANSWERthe probability of harm or injury occurring as a result of
participation in a research study
What types of injury's are included in risk assessment? (4) - ANSWER- physical
- psychological
- social
- economic
The probability and magnitude of possible harm may vary between what? -
ANSWERminimal to significant
IRBs have the authority to do what with research activities? (3) - ANSWER- aprove
- disapprove
- require modifications
Research is what type of investigation? - ANSWERa systemic one
Research includes what? (2) - ANSWER- research development
- testing and evaluation
research is designed to do what? - ANSWERdevelop or contribute to generalizable
knowledge
Human subjects are defined as what? - ANSWERliving individuals about whom an
investigator conducting research obtains (1) data through intervention or interact
with the individual or (2) identifiable private information
IRB should ONLY be involved when it includes what two things? - ANSWER- research
- human subjects
, What are IRB's responsibilities? (5) - ANSWER- conduct INITIAL review of study
- conduct CONTINUING review of projects
- determine if the study requires review more often than 1 year
- review all changes in research protocol
- ensure prompt reporting
What does IRB ensure prompt reporting of? (3) - ANSWER- unanticipated problems
involving risks
- noncompliance with federal regulations
- suspension or termination of IRB approval
If you suspend or terminate your own project what must you do? - ANSWERnotify
the IRB
Why would you suspend or terminate your own project? (4) - ANSWER- people are
dying
- money
- if you can't find patients
- seeing positive results and they want to take the drug to the market
IRBs must have at least how many members? - ANSWER5 with various backgrounds
IRB must be sufficiently qualified how? - ANSWERthrough the experience and
expertise of its members
can IRB members all be MD's? - ANSWERNO!! they may NOT all be of the same
profession
IRB must have at least one member whose primary concern are? (2) - ANSWER-
scientific area
- nonscientific areas
IRBs must include one member who is not what? - ANSWERaffiliated with the
institution and who is not part of the immediate family of person who is affiliated
with the institution
Can an IRB member participate in the review of a project in which they have
conflicting interest? - ANSWERNO - can sit but can't vote
What are the 3 federally regulated categories of review for research proposals? -
ANSWER- exempt review
- expedited review of non-exempt research
- full committee review
What federally regulated category of review for research proposals will we
experience? - ANSWERfull committee review
Questions & Answers: Latest Updated
What do institutional review boards protect? (2) - ANSWERthe RIGHTS and WELFARE
of human research subjects
What are IRBs primary goal? - ANSWERto assess the risk and benefits of any
proposed research study
Define benefit (2) - ANSWER- a valued or desired outcome
- an advantage
What does "minimal risk" mean? - ANSWERthat the probability and magnitude of
harm or discomfort anticipated in the research are not greater in and of themselves
than those ordinarily encountered in daily life or during the performance of routine
physical or psychological examinations or tets
What is "risk? - ANSWERthe probability of harm or injury occurring as a result of
participation in a research study
What types of injury's are included in risk assessment? (4) - ANSWER- physical
- psychological
- social
- economic
The probability and magnitude of possible harm may vary between what? -
ANSWERminimal to significant
IRBs have the authority to do what with research activities? (3) - ANSWER- aprove
- disapprove
- require modifications
Research is what type of investigation? - ANSWERa systemic one
Research includes what? (2) - ANSWER- research development
- testing and evaluation
research is designed to do what? - ANSWERdevelop or contribute to generalizable
knowledge
Human subjects are defined as what? - ANSWERliving individuals about whom an
investigator conducting research obtains (1) data through intervention or interact
with the individual or (2) identifiable private information
IRB should ONLY be involved when it includes what two things? - ANSWER- research
- human subjects
, What are IRB's responsibilities? (5) - ANSWER- conduct INITIAL review of study
- conduct CONTINUING review of projects
- determine if the study requires review more often than 1 year
- review all changes in research protocol
- ensure prompt reporting
What does IRB ensure prompt reporting of? (3) - ANSWER- unanticipated problems
involving risks
- noncompliance with federal regulations
- suspension or termination of IRB approval
If you suspend or terminate your own project what must you do? - ANSWERnotify
the IRB
Why would you suspend or terminate your own project? (4) - ANSWER- people are
dying
- money
- if you can't find patients
- seeing positive results and they want to take the drug to the market
IRBs must have at least how many members? - ANSWER5 with various backgrounds
IRB must be sufficiently qualified how? - ANSWERthrough the experience and
expertise of its members
can IRB members all be MD's? - ANSWERNO!! they may NOT all be of the same
profession
IRB must have at least one member whose primary concern are? (2) - ANSWER-
scientific area
- nonscientific areas
IRBs must include one member who is not what? - ANSWERaffiliated with the
institution and who is not part of the immediate family of person who is affiliated
with the institution
Can an IRB member participate in the review of a project in which they have
conflicting interest? - ANSWERNO - can sit but can't vote
What are the 3 federally regulated categories of review for research proposals? -
ANSWER- exempt review
- expedited review of non-exempt research
- full committee review
What federally regulated category of review for research proposals will we
experience? - ANSWERfull committee review
