21 CFR Part 50 Flashcards
Define Clinical Investigation
Experiment that involves a test article and 1 or more human subjects and that either is subject to requirements for prior submission to the FDA or the results of which must be submitted to the FDA
Define Investigator
Person who conducts a clinical investigation under whose immediate direction the IMP is administered/dispensed to a subject
The responsible leader of a clinical research team
Define Sponsor
Person who initiates a clinical investigation but does not conduct the investigation - the IMP is administered/dispensed under the immediate direction of someone else
An agency that uses 1 or more of its employees to conduct a clinical investigation
Define Sponsor-Investigator
Someone who initiates and conducts a clinical investigation - the IMP is dispensed/administered under the immediate direction of this person
What is a human subject?
Someone who is or becomes a participant in research either by receiving active study treatment or control study treatment
Can be healthy human or a patient
What is an institution?
Public or private entity or agency
What is an Institutional Review Board (IRB)?
A formerly designated board/committee/group that reviews biomedical research involving humans as subjects to approve the initiation of and conduct periodic review of that research
Define test article
Drug or biologic
Medical device for human u se
Human food additive
Color additive
Electronic product
Or other article subject to regulation under the Public Health Service Act
What is minimal risk?
The probability and magnitude of harm/discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine exams/tests
What is a legally authorized representative?
A person or judicial body who is able to consent on behalf of a participant as to the participant’s participation in the clinical research/procedure
Define assent
a child’s affirmative agreement to participate in clinical research
21 CFR Part 50 Subpart B refers to what?
Informed Consent of Human Subjects
21 CFR Part 50 Subpart A refers to what?
General provisions for clinical trials
The Investigator must obtain ______________ from the subject or the subject’s LAR prior to involving that subject in clinical research
Legally effective informed consent
An Investigator should provide the subject or subject’s LAR with ample ____________ to consider whether or not to participate in clinical research
Time
An Investigator should minimize the possibility of what during the informed consent process?
Coercion or undue influence
The language of the informed consent (document and process) must be _________________ to the subject and subject’s LAR
Understandable and non-technical
Informed consents (oral or written) CANNOT waive what?
Subject’s legal rights
The release of the Investigator, Sponsor, or Institution from liability for negligence
When must informed consent be obtained from the participant?
Before use of the test article
Consent can be forgone prior to administering the test article if the PI and a physician not participating in the clinical investigation can verify in writing all of the following:
a) The subject is confronted by a life-threatening situation that necessitates the use of the test article
b) The subject is unable to communicate
c) There is insufficient time to obtain consent from the subject’s LAR
d) There is no available alternative or generally recognizable methods that will provide an equal or greater likelihood of saving the subject’s life
If immediate use of the test article is recommended by the PI and there is insufficient time to obtain a determination from a physician not involved in the clinical trial, the determinations of the PI must be reviewed by ___________________ within _____ working days after use of the test article.
a) a physician who is not involved in the clinical investigation
b) 5
If consent is not obtained prior to the use of a test article (as in an emergency situation), how soon must the IRB be notified?
Within 5 working days after the use of the test article
True or False: The President can waive the prior consent requirement for the administration of an investigational new drug for a member of the armed forces
True
In order for the President to grant a waiver from informed consent (prior to administering investigational new drug), the President must document what?
a) obtaining consent is not feasible
b) obtaining consent is contrary to the best interests of the military member
c) obtaining consent is not in the best interest of national security
IRBs can approve investigations without requiring informed consent of all research subjects be obtained if
