100% satisfaction guarantee Immediately available after payment Both online and in PDF No strings attached
logo-home
CRA EXAM PRACTICE (Institutional Committees) QUESTIONS & ANSWERS $7.99   Add to cart

Exam (elaborations)

CRA EXAM PRACTICE (Institutional Committees) QUESTIONS & ANSWERS

 6 views  0 purchase
  • Course
  • CRA
  • Institution
  • CRA

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 ...

[Show more]

Preview 2 out of 5  pages

  • September 18, 2024
  • 5
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers
  • CRA
  • CRA
avatar-seller
Bensuda
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

The benefits of buying summaries with Stuvia:

Guaranteed quality through customer reviews

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

Quick and easy check-out

You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.

Focus on what matters

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 $7.99. You're not tied to anything after your purchase.

Can Stuvia be trusted?

4.6 stars on Google & Trustpilot (+1000 reviews)

67866 documents were sold in the last 30 days

Founded in 2010, the go-to place to buy study notes for 14 years now

Start selling
$7.99
  • (0)
  Add to cart