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CRA EXAM PRACTICE (Institutional Committees) QUESTIONS & ANSWERS
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CRA EXAM PRACTICE (Institutional Committees) QUESTIONS & ANSWERS IRB - ANSWERSInstitutional Review Board IACUC - ANSWERSInstitutional Animal Care and Use Committee RSC - ANSWERSRadiation Safety Committee IBC - ANSWERSInstitutional Biosafety Committee RESEARCH - ANSWERSA systematic ...

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  • September 18, 2024
  • 5
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

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  • cra exam practice institutional committees quest

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  • CRA
  • CRA

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CRA EXAM PRACTICE (Institutional
Committees) QUESTIONS & ANSWERS

IRB - ANSWERSInstitutional Review Board



IACUC - ANSWERSInstitutional Animal Care and Use Committee



RSC - ANSWERSRadiation Safety Committee



IBC - ANSWERSInstitutional Biosafety Committee



RESEARCH - ANSWERSA systematic investigation, including research development, testing and
evaluation, designed to develop or contribute to generalizable knowledge.



HUMAN SUBJECT - ANSWERSLiving individual about whom an investigator (whether professional or
student) conducting research obtains 1) data or 2) identifiable private information through intervention
or interaction with the individual (45 CFR 46 102f)



Ensuring that the human experimentation is conducted according to ethical principles - ANSWERSWhat
is the IRB purpose?



1) Reviews, approves/disapproves protocols; 2) Reviews institutional policy; 3) Makes sure that the
Belmont principles are protected and implemented. - ANSWERSMain functions of IRB



45 CFR 46 For research funded by HHS; 21 CFR 50 & 56 for research involving products regulated by the
FDA - ANSWERSHuman subjects protection: Relevant Regulation



1) Respect for person; 2) Beneficence 3) Justice - ANSWERSBelmont Report (1979) Ethical principles:

, 1) Informed consent; 2) Notion of privacy 3) Notion of Confidentiality 4) Notion of risk vs. benefit 5)
Equitable selection of subjects - ANSWERSSummary of Belmont Report



1) IRB must register with Office of Human Research Protections (OHRP-HHS) and obtain a FWA number.
2) must register with FDA when reviewing clinical investigation regulated by FDA. - ANSWERSHuman
Subject Protection: Registrations and Assurances



- Must have at least 5 members

- At least one whose primary concerns are scientific

- At least one whose primary concerns are non-scientific

- At least one who is not affiliated with the institution. - ANSWERSIRB membership requirements



- Equitable selection of subjects

- Privacy and confidentiality

- Additional safeguards

- Incentives for participation

- Continuing review (annually)

- Records have to be kept for 3 years from the date of FFR. - ANSWERSFunctions of IRB Review



- Full

- Expedited

- Exempt

- Initial

- Continuation

- Amendment/Modification

- Unanticipated problems (including adverse reaction)

- Non-compliance - ANSWERSTypes of IRB Review



Research that cannot meet the criteria for exempt or expedited review must be submitted for full review
and be approved at a convened meeting. - ANSWERSIRB Full Review

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