Nuremburg Code/ Declaration of Helsinki
How many "codes" are listed in the Nuremburg Code?
What is 10
What are the 3 principles underlying conduct of research?
What is Beneficence, Respect for Persons and Justice.
What year was ICH initiated internationally?
What is 1996.
What is the Code of Federal Regulations Title 21?
What is a codification of the general and permanent rules of Food and Drugs.
Protection of Human Subjects is also known as...what?
What is the common rule.
What version of Helsinki do we use today? (Month, Year)
What is October 2013- but will soon be October 2024
Main reason for the creation of the Belmont Report?
What is basic ethical principles/ethics regarding human subject research.
How do you properly "GCP" source documentation?
What is cross out with one line, initial, and date said information.
When is a revised Title 21 issues?
What is every April.
What are the 3 vulnerable populations this section of the CoFR emphasizes?
What is pregnant women, prisoners, and children.
When was the Nuremburg Code officially adopted by thew US?
What is NEVER!!
The Nuremberg Code has never been officially adopted by any country but remains a driving force in the decisions made when conducting human experimentation.
What deliverables did the Belmont Report achieve? (HINT: there are 3)
What is the formation of: Informed Consent, Office for Human Research Protection (OHRP), and Institutional Review Board (IRB).
What is the purpose of expedited reporting?
What is to make investigators and other clinical peoples aware of new, important information on serious reactions.
What does part 56 of the CoFR cover?
What is IRB
What process is responsible for the evaluation of human subjects in applicants?
What is the peer review process?
Per Helsinki, can only conduct research if the ____ outweighs the ____ to human subjects.
Who wrote the Belmont Report?
What is the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (NCPHS).
Regulatory agencies should be notified ASAP, but you have ____ days after FIRST knowledge of fatal or life-threatening ADRs to notify the sponsor.
What is 7 days.
Part ___ focuses on INDs, while part ___ focuses on IDEs.
What is 312, 812.
Who is responsible for ensuring compliance of this aspect of Federal Regulations?
What is the Office for Human Research Protections (OHRP).
What is the reason for the adoption of Helsinki?
What is to prioritize the safety and benefits to research subjects.
**Including the goal of obtaining new medical understanding
What is THE primary change that will be made to Helsinki in the upcoming revision?
What is terminology changing from "human subjects" to "human participants".
Which GCP guideline in conjunction with ICH pertains to clinical safety and data management?
What is section E2A.
What does subpart A in every title within the CoFR contain?
What is the general provisions of said chapter.
What are the 3 sections of Grants regarding human subjects?
What is
1. Risks to Human Subjects
2. Sources of Materials
3. Potential Risks