45 CFR Part 46 Flashcards
Activities Excluded from Research in the 2018 Common Rule
-Scholarly and journalistic Activities
-Public health surveillance activities
-Collection and analysis of information, biospecimens, or records by or fora criminal justice agency for activities authroized by law, court order, or criminal investigation
-Authorized intelligence, homeland security, defense, or national security mission activities
Can INDs/IDEs be utilized for multiple protocols/trials?
Yes
What does 45 CFR 46 subpart B, C, D and E cover?
B-D are additional protections for vulnerable populations. B is for pregnant women and fetuses, C is for prisoners, D is for children. E covers IRB requirements.
What is 45 CFR Part 46? How is this different than 21 CFR 50?
HHS – Protection of Human Subjects How is this different than 21 CFR 50? 45 CFR encompasses Public Welfare, 21 CFR is administered by the FDA and covers regulations of Food and Drugs.
Human subjects, informed consent, research with human subjects, ethical principles
HHS-45 gneral human subjects protection/public welfare, test article vs.
FDA-21, subject protection investigational product
What is the common rule and which regulation does it fall under?
The common rule requires that research involving human subjects be reviewed and approved by an IRB. It also requires researchers obtain informed consent from participants. It falls under 45 CFR 46.
What is the official notification by the institution to the supporting department or agency, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance?
Certification
