Ethical guidelines and Regulations

Question 1

Nuremberg Code and Declaration of Helsinki are

Answer 1

Ethical codes/guidelines

Question 2

Belmont Report is

Answer 2

An ethical guideline

Question 3

45CFR 46 and 21CFR 50, 56, 54, etc. are

Answer 3

Ethical Regulations

Question 4

Title 21

Answer 4

Food and Drugs

Question 5

21 CFR 11

Answer 5

Electronic Records and signatures

Question 6

21 CFR 50

Answer 6

Protection of Human Subjects

Question 7

21 CFR Part 56

Answer 7

Institutional Review Boards

Question 8

21 CFR Part 312

Answer 8

Investigational New Drug Application

Question 9

21 CFR Part 812

Answer 9

Investigational Device Exemptions

Question 10

45CFR 46

Answer 10

HHS regulations for the protection of human subjects in research

Question 11

45CFR 46 Subpart A

Answer 11

Subpart A, also known as the Common Rule, provides a robust set of protections for research subjects

Question 12

45CFR 46 Subpart B

Answer 12

Subpart B Additional protections for research with pregnant women and fetuses

Question 13

45CFR 46 Subpart C

Answer 13

Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects

Question 14

45CFR 46 Subpart D

Answer 14

Additional Protections for Children Involved as Subjects in Research

Question 15

45CFR 46 Subpart E

Answer 15

Registration of Institutional Review Boards