FDA - Human Subjects Flashcards
What does FDA stand for?
Food and Drug Administration
True or False: FDA regulations apply only to drugs and biologics.
False
Fill in the blank: The FDA regulates devices under the __________ Act.
Federal Food, Drug, and Cosmetic
What is the primary purpose of FDA regulations regarding human subjects?
To protect the rights and welfare of human subjects in clinical trials.
Which part of the Code of Federal Regulations outlines the protection of human subjects?
Title 21, Part 50
What is informed consent?
A process by which a participant voluntarily confirms their willingness to participate in a study after being informed of all relevant aspects.
True or False: Institutional Review Boards (IRBs) are responsible for approving research involving human subjects.
True
What is the role of an Institutional Review Board (IRB)?
To review and monitor research studies to ensure the safety and rights of participants.
What is an Investigational New Drug (IND) application?
A request for FDA authorization to administer an investigational drug to humans.
Multiple Choice: Which of the following is NOT a requirement for informed consent? A) Disclosure B) Comprehension C) Compensation D) Voluntariness
C) Compensation
Fill in the blank: FDA regulations require that the risks of research be minimized and reasonable in relation to the __________.
anticipated benefits
What is the definition of a clinical trial?
A research study that tests how well new medical approaches work in people.
True or False: All clinical trials must be registered in a public database.
True
Which part of the Code of Federal Regulations addresses the responsibilities of sponsors in clinical trials?
Title 21, Part 312
What does the term ‘vulnerable populations’ refer to in the context of FDA regulations?
Groups that may be at increased risk of coercion or undue influence in research.
Multiple Choice: Which of the following is considered a vulnerable population? A) Healthy adults B) Pregnant women C) College students D) Retired individuals
B) Pregnant women
What is the significance of the Belmont Report?
It outlines ethical principles and guidelines for research involving human subjects.
Fill in the blank: The principle of __________ requires that participants be treated fairly and equitably.
justice
What are ‘adverse events’ in clinical trials?
Unintended and harmful outcomes experienced by participants during the study.
True or False: The FDA has the authority to terminate clinical trials at any time.
True
What is the function of a Data Safety Monitoring Board (DSMB)?
To monitor patient safety and treatment efficacy during a clinical trial.
Multiple Choice: Which of the following is NOT a requirement for IRB review? A) Risk assessment B) Informed consent process C) Sponsor’s financial status D) Selection of subjects
C) Sponsor’s financial status
What does the term ‘exempt research’ mean in relation to FDA regulations?
Research that is not subject to the usual regulatory requirements due to low risk.
True or False: FDA regulations are the same for all types of human subject research.
False
What is a ‘clinical investigation’ as defined by the FDA?
Any experiment that involves a test article and one or more human subjects.
