CRA EXAM PRACTICE-INSTITUTIONAL COMMITTEES
WITH ALL CORRECT & 100% VERIFIED ANSWERS|
ALREADY GRADED A+
Institutional Review Board ✔Correct Answer-IRB
Institutional Animal Care and Use Committee ✔Correct Answer-IACUC
Radiation Safety Committee ✔Correct Answer-RSC
Institutional Biosafety Committee ✔Correct Answer-IBC
A systematic investigation, including research development, testing and evaluation, designed to
develop or contribute to generalizable knowledge. ✔Correct Answer-RESEARCH
Living 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) ✔Correct Answer-HUMAN SUBJECT
What is the IRB purpose? ✔Correct Answer-Ensuring that the human experimentation is
conducted according to ethical principles
Main functions of IRB ✔Correct Answer-1) Reviews, approves/disapproves protocols; 2) Reviews
institutional policy; 3) Makes sure that the Belmont principles are protected and implemented.
Human subjects protection: Relevant Regulation ✔Correct Answer-45 CFR 46 For research funded
by HHS; 21 CFR 50 & 56 for research involving products regulated by the FDA
Belmont Report (1979) Ethical principles: ✔Correct Answer-1) Respect for person; 2) Beneficence
3) Justice
Summary of Belmont Report ✔Correct Answer-1) Informed consent; 2) Notion of privacy 3) Notion
of Confidentiality 4) Notion of risk vs. benefit 5) Equitable selection of subjects
Human Subject Protection: Registrations and Assurances ✔Correct Answer-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.
IRB membership requirements ✔Correct Answer-- 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.
Functions of IRB Review ✔Correct Answer-- Equitable selection of subjects
- Privacy and confidentiality
- Additional safeguards
- Incentives for participation
- Continuing review (annually)
WITH ALL CORRECT & 100% VERIFIED ANSWERS|
ALREADY GRADED A+
Institutional Review Board ✔Correct Answer-IRB
Institutional Animal Care and Use Committee ✔Correct Answer-IACUC
Radiation Safety Committee ✔Correct Answer-RSC
Institutional Biosafety Committee ✔Correct Answer-IBC
A systematic investigation, including research development, testing and evaluation, designed to
develop or contribute to generalizable knowledge. ✔Correct Answer-RESEARCH
Living 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) ✔Correct Answer-HUMAN SUBJECT
What is the IRB purpose? ✔Correct Answer-Ensuring that the human experimentation is
conducted according to ethical principles
Main functions of IRB ✔Correct Answer-1) Reviews, approves/disapproves protocols; 2) Reviews
institutional policy; 3) Makes sure that the Belmont principles are protected and implemented.
Human subjects protection: Relevant Regulation ✔Correct Answer-45 CFR 46 For research funded
by HHS; 21 CFR 50 & 56 for research involving products regulated by the FDA
Belmont Report (1979) Ethical principles: ✔Correct Answer-1) Respect for person; 2) Beneficence
3) Justice
Summary of Belmont Report ✔Correct Answer-1) Informed consent; 2) Notion of privacy 3) Notion
of Confidentiality 4) Notion of risk vs. benefit 5) Equitable selection of subjects
Human Subject Protection: Registrations and Assurances ✔Correct Answer-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.
IRB membership requirements ✔Correct Answer-- 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.
Functions of IRB Review ✔Correct Answer-- Equitable selection of subjects
- Privacy and confidentiality
- Additional safeguards
- Incentives for participation
- Continuing review (annually)
