21 CFR 50 Flashcards
To which five classes of product do the Informed Consent regulations in 21 CFR 50 apply ?
- Drugs
- Medical devices
- Biological products
- Electronic products
- Food (including dietary supplements & infant formulas) & color additives
With respect to 21 CFR 50, the definition of “family member” includes persons with close association with a
subject who May not be related by blood. TRUE OR FALSE?
true
What is the definition of “investigator”?
An individual who actually conducts a clinical
investigation.
What is the definition of “sponsor”?
A person who initiates a clinical investigation but does
not actually conduct the investigation.
What is the definition of “sponsor”?
A person who initiates a clinical investigation but does
not actually conduct the investigation.
For emergency consent, a family member may be a spouse, parent, child (including an adopted child), brother, sister, and spouse of brother and sister, any individual related by blood or affinity whose close association with the subject is equivalent of a family relationship, provided this person meet what criteria?
The person is legally competent. (21 CFR 50.3)
What is the definition of a “sponsor-investigator “?
An individual who both initiates and actually conducts, alone or with others, a clinical investigation.
What is the definition of a “human subject”?
An individual who is or becomes a participant in research, either as a recipient of the test article, or as
a member of a control group.
Regarding the informed consent regulations the term
“institution” and “facility” are deemed to be synonymous. TRUE OR FALSE?
true
An institutional review board is any board, committee, or other group, formally designated by an institution to perform what duties?
- To review biomedical research involving human subjects.
- To approve the initiation of biomedical trials involving human subjects.
- To conduct periodic reviews of trials which were previously approved.
A human subject may be either a healthy human or a patient. TRUE OR FALSE?
true
For the purpose of informed consent, human food additives, color addictives, medical devices and drugs intended for human use are all considered test article while electronic products are not. TRUE OR FALSE ?
false
What is the definition of “minimal risk” as defined by
21 CFR 50?
A situation in which the probability and magnitude of anticipated harm or discomfort are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or physiological examination or tests.
What is the definition of “legally authorized representative” according to FDA informed consent
regulations?
An individual, judicial body, or other group authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in research procedures.
What is the definition of a “clinical investigation” as it pertains to the FDA’s informed consent regulations?
Clinical investigation means any experiment that involves a test article and one or more human subjects that either subject to FDA requirements or not subject to FDA requirements, but is intended to be submitted to, or held for inspection by FDA, as part of a marketing application.
A sponsor-investigator may be a corporation, such as pharmaceutical company. TRUE OR FALSE?
False
What stipulation is mandated for the length of time a prospective research subject is given to determine whether to participate in a research trial?
Sufficient opportunity to consider whether or not to participate must be allowed, under circumstances which minimize the possibility of coercion or under influence.
An informed consent document may not include any exculpatory language through which the subject or subject’s representative releases or appear to release which parties from liability or negligence?
The investigator, the sponsor, the institution or its agents.
Under what conditions may an investigator enter a human subject into a research study employing the exception from general informed consent requirements?
- Prior to enrolling a subject, both the investigator & an independent physician certify in writing.
- The subject is in a life-threatening situation whichnecessitates use of the test article.
- Is unable to give legally informed consent.
- Time is insufficient to obtain consent from the subject’s legal representative.
- There are no alternative methods or therapies available that provide an equal or greater chances of saving the subject’s life.
If an investigator employs the exception from general
requirements process for obtaining consent, within how many days must a full report of the circumstances be reported to the IRB?
Within five working days after the use of the test article.
Following enrollment of a subject into a study under the exception from general requirements criteria for obtaining consent, a written review by a physician not associated with the investigation must be submitted to the IRB within 10 working days. TRUE OR FALSE?
false - 5 working days
Subject to extensive requirements including documentation and ethical review, the U.S. President may approve the use of investigational drugs for military personnel without first obtaining ICF when the department of Defense is the sponsor of an IND. TRUE
OR FALSE?
true
With emergency research involving waiver of consent, public disclosure of the research within the local
community is required. TRUE OR FALSE?
true
IRBs must ensure special criteria are met prior to approving emergency research that will allow subject
entry without first obtaining ICF. TRUE OR FALSE?
true
Under certain limitations, research may be done for emergency conditions under an ICF waiver, if approved by an IRB. TRUE OR FALSE?
true
The FDA provides no regulatory basis to conduct research if written ICF cannot be obtained from subjects prior to entry into a study. TRUE OR FALSE?
false
If clinical investigations could not normally be completed in patients with emergency conditions, due to inability to obtain ICF, special criteria exist to enable such research to be done . TRUE OR FALSE?
true
What must investigators commit to when conducting research under emergency conditions, relative to obtaining ICF for subjects who are unable to give consent?
Attempting to contact family member or legal authorized representative within a protocol-specified therapeutic window to determine if they object to the subject’s participation in the research.
Prior to approving emergency research ,an IRB must assure that additional protections are in place regarding the rights and welfare of the prospectivesubjects. Name at least two of these additional protections.
- Consultation with community representatives.
- Public disclosure to the community regarding risks, prior to the study.
- Public disclosure of the result.
- Establishment of an independent data monitoring committee.
- Attempting to contact a family member, if feasible, to ask whether he or she objects.
What role do family members have regarding consent for participation in emergency research studies?
Family members are to be consulted with by investigators to determine if they object to a subject’s participation, or continuation in a research study, and they are to be fully informed of the investigation, if feasible, even if the subject dies.
If a subject enrolled in an emergency research study without ICF remains incapacitated, how soon must a legally authorized representative or family member be made aware of the consent of the informed consent document?
At the earliest feasible opportunity.
If a subject entered into a research study under waived consent criteria dies before legally authorized
representatives or family members can be contacted, these affiliates must be informed about the
investigations. TRUE OR FALSE?
true
If an IRB makes a decision not to approve research under waived consent criteria due to perceived noncompliance with regulations or ethical concerns, whom must the IRB notify.
The Clinical Investigator and the sponsor.
Subjects enrolled in emergency research with waived consent, must be informed about the study, if their
condition improves, even if a legally authorized representative or family member consented on their
behalf. or did not object to their participation. TRUE OR FALSE ?
true
If a sponsor is notified by an IRB that a research investigation intended to be conducted under the waived consent emergency research regulations cannot be approved, whom must the sponsor notify of this decision?
- The FDA.
- Any other investigators conducting or anticipating to conduct the same or similar investigation.
- Other IRBs that have been asked to review & approve the same or substantially equivalent research.
What is the therapeutic window within which an investigator must attempt to contact family members or legally authorized representative, prior to entering a subject without consent is an emergency research study?
The therapeutic window is defined in the investigational plan (protocol ) and is based on scientific evidence.
A basic element of ICF requires a statement that the study involves research. State the items that should be described about the research.
- An explanation of the purpose of the research.
- The expected duration of the subject’s participation.
- A description of procedures to be followed.
- Identification of any procedures which are
experimental.
How much information must an ICF statements include regarding potential risks or discomforts to study
subjects?
Any reasonably foreseeable risks or discomforts must be described.
A statement regarding potential benefits to subjects or others is required element of the ICF. TRUE OR FALSE?
true
If no reasonable alternative procedure or treatment are available to subjects in a research study, the ICF must
state this fact. TRUE OR FALSE?
true
A statement regarding the extent of confidentiality of a subject’s study records must be included in all ICF
documents, including the possibility that the FDA may inspect the records. TRUE OR FALSE?
true
All ICF must contain a statement describing whom the subject may contact for answers to their question
about the research, and whom to contact in the event of a research-related injury. TRUE OR FALSE?
true
According to FDA ICF regulations, a subject may discontinue participation in a study at any time without
sacrificing what?
Without a penalty or loss of benefits to which the subject is otherwise entitled.
ICF has numerous required elements as well as several optional elements. TRUE OR FALSE?
FALSE. In addition to the elements required in all ICF documents, there are additional elements that, if
applicable to the study, must be included.
If a study involves potential risk to an embryo or a fetus, a statement describing the risk must be included in the ICF document. TRUE OR FALSE?
true
If an investigator may terminate a Pt’s participation in
a study without first obtaining consent from the subject, a statement regarding these circumstances should be included in the ICF. TRUE OR FALSE?
true
Any additional costs to study subject’s that may result from participation in a research should be included in
the ICF. TRUE OR FALSE?
true
If a subject-initiated withdrawal from the study would potentially cause harm to a subject, a statement
regarding the procedure for orderly termination must be included in the ICF. TRUE OR FALSE?
true
Other federal, state or local laws may require additional information to be disclosed for ICF to be legally effective. TRUE OR FALSE?
true
A copy of the ICF must be given to the person signing the form. TRUE OR FALSE?
true
Approximate number of study subjects must always be specified in ICF documents. TRUE OR FALSE?
false
Information on new findings developed during the course of the research must be provided to the investigator. He or she may then decide whether to
inform the subject. TRUE OR FALSE?
false
An ICF may be either a written document which includes the required elements or an IRB approved short form stating that the required elements of the ICF have been presented orally to a subject or subject’s legally authorized representative. TRUE OR FALSE?
true
As long as a subject receives a thorough oral explanation of the ICF, the investigator is not required to allow the subject extra time to read the consent
form prior to signing it. TRUE OR FALSE?
false
Obtaining oral Informed consent using the short form always requires a witness. TRUE OR FALSE?
true
Which two items must a study subject or legally authorized representative record on an ICF document at the time ICF is given?
The signature of the person giving consent and date
consent is given.
When a short form consent process is used, the subject, or his /her representative, is required to sign and date only the short form. TRUE OR FALSE?
true
A witness to short form IC process must sign the IRB approved written summary of what was said to the subject, but not the short form itself. TRUE OR FALSE?
false
In the short form consent process the subject or subject’s legally authorized representative must receive
copies of which document?
The subject or subject’s legally authorized representative must receive the short form consent and IRB approved summary of what was presented orally.
A “telephone” consent from a care giver is generally acceptable to enroll a Pt in a subject in clinical trial who
is currently hospitalized. TRUE OR FALSE?
false
When a short form is used for Informed Consent, whomust sign both the short form and a copy of the summary?
The Witness
