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
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller Bensuda. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for £6.52. You're not tied to anything after your purchase.
