21 CFR Part 50

Question 1

What does 21 CFR Part 50 cover?

Answer 1

Protection of Human Subjects

Question 2

What three applications are included in this chapter that are important for you to be aware of?

Answer 2

1) Investigational new drug application, part 312 2) A new drug application, part 314. 3) Application for an Investigational New Device Exemption.

Question 3

Clinical Investigation means..

Answer 3

any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the FDA or is not subject to requirements for prior submission to the FDA but the results of which are intended to be submitted later to or held for inspection by the FDA as part of an application for a research or marketing permit.

Question 4

Investigator

Answer 4

individual who actually conducts a clinical investigation

Question 5

Sponsor

Answer 5

person who initiates a clinical investigation, but who does not actually conduct the investigation.

Question 6

Sponsor-Investigator

Answer 6

individual who both initiates and actually conducts, alone or with others, a clinical investigation.

Question 7

Human Subject

Answer 7

individual who is or becomes a participant in research, either as a recipient of the test article or as a control.

Question 8

Exceptions from informed consent for emergency research

Answer 8

1) subject is in a life-threatening situation and collection of valid scientific evidence is necessary to determine safety and effectiveness of particular interventions. 2) Obtaining consent is not feasible. 3) Participation in the research holds out the prospect of direct benefit. 4) The clinical investigation could not practicably be carried out without the waiver. 5) the tx plan makes sense and the investigator is doing what he/she can to contact a legally authorized rep. 6) IRB has approved 7) additional protections of the rights and welfare of the subjects will be provided

Question 9

Elements of informed consent

Answer 9

1) statement that the study involved research. 2) description of any reasonably foreseeable risks or discomforts to the subject. 3) description of any benefits to the subject or others. 4) disclosure of alternative procedures. 5) statement describing the extent to which confidentiality of records will be maintained 6) statement regarding compensation and medical tx if any injury. 7) who to contact for answers to pertinent questions about research and subjects rights. 8) participation is voluntary.

Question 10

Additional elements of informed consent

Answer 10

1) statement that the particular tx may involve additional risk to the subject.
2) anticipated circumstances under which participation may be terminated.
3) any additional costs.
4) consequences of a subjects decision to withdraw.
5) statement that significant findings during the research will be provided.
6) approximate number of subjects involved in the study.

Question 11

IRB must require appointment of _______ for each child who is a ward.

Answer 11

an advocate

Question 12

And advocate representing a ward must have these attributes:

Answer 12

▪ Will serve in addition to any other individual acting on behalf of the child as guardian etc.
▪ One individual may serve as advocate for more than one child
▪ Must be an individual who has the background and experience to act in, and agrees to act in, the best interest of the child for the duration of the child’s participation in the clinical investigations
▪ Can’t be associated with the investigation, investigators, or guardian organization