21 CFR Part 50 - Exam Questions Flashcards
Which of the following is NOT a required element of informed consent under 21 CFR 50.25?
A) A description of the risks and benefits of the research
B) A statement that the subject may withdraw at any time
C) A description of the statistical methods used in the study
D) An explanation of whom to contact for questions or in the event of a research-related injury
C?
Under what circumstances can informed consent be waived in FDA-regulated research?
A) If the research presents minimal risk and is eligible for expedited review
B) If the IRB determines that obtaining consent is impracticable and the research has social value
C) If the research involves public health surveillance activities
D) FDA regulations do not provide a general waiver of informed consent, except for specific emergency use cases
Which of the following is TRUE regarding the exception from informed consent for emergency use of a test article under 21 CFR 50.23?
A) The IRB must approve the emergency use before the test article is administered
B) The physician must determine that the test article is necessary and that obtaining consent is not feasible
C) The exception applies only if the research sponsor waives the requirement
D) The exception can be used multiple times at the same institution without IRB notification
Research conducted in emergency settings may qualify for an exception from informed consent under 21 CFR 50.24 if which of the following conditions is met?
A) The research involves only minimal risk
B) The research could not practicably be carried out with informed consent
C) The research is intended to study an investigational device only
D) The research does not involve subjects in life-threatening situations
When may an IRB approve a short form consent process under 21 CFR 50.27?
A) When the research subject is a child
B) When the subject’s legal representative is unavailable
C) When informed consent is presented orally and a witness is present
D) When the research involves minimal risk
Which of the following statements is TRUE about the documentation of informed consent?
A) The IRB can waive the requirement for obtaining a signed consent form if the research presents no more than minimal risk
B) FDA regulations allow investigators to obtain consent verbally without documentation
C) The consent form only needs to be signed by the investigator, not the subject
D) A witness signature is required on all written informed consent forms
Under 21 CFR 50.55, when is only one parent’s permission sufficient for research involving children?
A) When the research involves greater than minimal risk with no prospect of direct benefit
B) When the research is minimal risk or presents direct benefit to the child
C) When the IRB determines the research involves a vulnerable population
D) When the research is federally funded
Research involving greater than minimal risk and no prospect of direct benefit to the child subject can only be approved if:
A) The risk is justified by anticipated knowledge that will benefit society and represents a minor increase over minimal risk
B) The research presents a benefit to at least 10% of the subjects
C) The research is approved under expedited review procedures
D) The research involves no greater than minimal risk
Which of the following is an IRB responsibility when reviewing research involving children under 21 CFR 50.50?
A) Ensuring that children are given complete autonomy in deciding whether to participate
B) Determining that adequate provisions are in place for obtaining parental permission and child assent
C) Allowing parental permission to be waived in all cases
D) Requiring that all child subjects sign an assent form regardless of age
An IRB is reviewing an FDA-regulated study involving children. The study presents greater than minimal risk but offers a prospect of direct benefit to subjects. What should the IRB determine to approve the research under 21 CFR 50.52?
A) That the risk is justified by the anticipated benefit and is at least equal to alternative treatments
B) That the research represents a minor increase over minimal risk
C) That a waiver of parental permission is appropriate
D) That all children must be 14 years or older to participate
Which of the following best describes how information should be presented in an informed consent document?
A) In scientific terms to ensure accuracy
B) In language understandable to a person with an advanced medical background
C) In language that is understandable to the subject or the subject’s legally authorized representative
D) In a way that minimizes the description of risks to avoid undue anxiety
Which of the following is NOT a required element of informed consent under 21 CFR 50.25?
A) A statement describing the extent to which confidentiality of records will be maintained
B) A statement about any costs to the subject for participation in the research
C) A statement ensuring that the subject will receive compensation for research-related injuries
D) A statement that participation is voluntary and that subjects may discontinue participation at any time
Under 21 CFR 50.23, the exception from informed consent for emergency use of a test article requires that:
A) The IRB must approve the use before it occurs
B) The emergency use must be reported to the IRB within five working days
C) The physician must obtain consent from a legally authorized representative
D) The exception is available only for investigational drug studies, not devices
Under 21 CFR 50.24, IRB approval of emergency research without prospective informed consent requires:
A) That the research could be conducted elsewhere with consent but is more convenient without it
B) That subjects are informed of the research as soon as feasible after enrollment
C) That subjects are enrolled only if a legally authorized representative is present
D) That the IRB ensures subjects are compensated for participating
Which of the following situations would allow an IRB to waive the requirement for a signed informed consent form?
A) The research is FDA-regulated and presents no more than minimal risk with no procedures requiring written consent outside of the research
B) The subject is unable to sign due to a physical disability
C) The IRB finds that written consent is burdensome for the research team
D) The research is conducted in a foreign country
What is a key requirement when using the short-form informed consent process?
A) The research must be minimal risk
B) The subject must be a non-English speaker
C) A witness must be present during the oral presentation of consent information
D) The research must involve an investigational drug
An IRB may approve research involving children that presents greater than minimal risk but offers no direct benefit if:
A) The research is of national importance and has been approved by another IRB
B) The risk represents only a minor increase over minimal risk and the research provides generalizable knowledge about the child’s condition
C) At least one parent provides permission, regardless of the level of risk
D) The research is conducted under an emergency exception
Under 21 CFR 50.55, when is the assent of a child NOT required for research participation?
A) When the child is under 7 years old and cannot reasonably be expected to provide assent
B) When the research is greater than minimal risk without direct benefit
C) When the child refuses but the parents give permission
D) When the research involves investigational drugs
Under 21 CFR Part 50, an IRB must determine that informed consent is legally effective. Which of the following would NOT be considered legally effective consent?
A) Consent obtained in a private room with minimal pressure or coercion
B) Consent given by a legally authorized representative when the subject is incapacitated
C) Consent obtained from a subject who was informed of the study risks but was not given time to consider participation
D) Consent obtained using an IRB-approved process that follows federal regulations
A clinical trial involving an investigational drug is being conducted under FDA oversight. The IRB must ensure that the informed consent document:
A) Contains a statement that the FDA may inspect the research records
B) Ensures that subjects will be compensated for any study-related injuries
C) Specifies that subjects must complete the study once enrolled
D) Guarantees that the drug will be FDA-approved after the trial
