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) 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
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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