Regulatory

Question 1

FDA 21 CFR Part 50

Answer 1

Protection of Human Subjects

Question 2

FDA 21 CFR Part 54

Answer 2

Financial Disclosure by Clinical Investigators

Question 3

FDA 21 CFR Part 56

Answer 3

Institutional Review Boards (IRB)

Question 4

FDA 21 CFR Part 312

Answer 4

Investigational New Drug Application (IND)

Question 5

FDA 21 CFR Part 812

Answer 5

Investigational Device Exemption (IDE)

Question 6

What does the OHRP provide ?

multiple answer

Answer 6

• Clarifications and guidance for researchers
• Develops education programs and materials
• Maintains regulatory oversight, provides advice on
  ethical and regulatory issues biomedical and
  behavioral research
• Administers assurance of compliance and IRB
  registration programs

Question 7

Code of Federal Regulations (CFR)

Answer 7

The codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government

Question 8

What does OHRP stand for ?

Answer 8

The Office for Human Research Protections

Question 9

When was OHRP created ?

Answer 9

June 2000

Question 10

Why was OHRP created ?

Answer 10

The Office for Human Research Protections (OHRP) was created to lead the Department of Health and Human Services’ efforts to protect human subjects in biomedical and behavioral research and to provide leadership for all federal agencies that conduct or support human subjects research under the Federal Policy for the Protection of Human Subjects

Question 11

What does the FDA cover ?

multiple answer

Answer 11

• Ensuring the protection of the rights, safety, and welfare of human subjects
• clinical investigations that support applications for research or marketing permits for products regulated by the FDA such as:

Question 12

FDA vs OHRP

Answer 12

FDA’s rules on human subjects protection govern clinical investigations regulated by FDA under the Food, Drug, and Cosmetic Act (FDCA)

OHRP (DHHS) Common Rule covers DHHS federally funded research

Question 13

45 CFR 46

Answer 13

Laws set by the U.S. Department of Health and Human Services (DHHS) to protect a person from risks in research studies that any federal agency or department has a part in. Includes 5 subparts

(https://www.cancer.gov/publications/dictionaries/cancer-terms/def/45-cfr-46)

Question 14

45 CFR 46 Subpart A

Answer 14

The Common Rule.

Provides a robust set of protections for research subjects; includes guidelines for Institutional Review Boards (IRB) and informed consent

Question 15

45 CFR 46 Subpart B

Answer 15

Additional protections for research with pregnant women and fetuses

Question 16

45 CFR 46 Subpart C

Answer 16

Additional protections for research with prisoners

Question 17

45 CFR 46 Subpart D

Answer 17

Additional protections for research with children

Question 18

45 CFR 46 Subpart E

Answer 18

Requirements for IRB registration

Question 19

What are some types of clinical investigations are regulated by the FDA ?

Answer 19

• food and color additives
• drugs for human use
• medical devices for human use
• biological products for human use
• electronic products