Session 1 Flashcards
For emergency consent, a family member may be a spouse, parent, child, or any individual related by blood or affinity whose close association with the research participant is equivalent, provided this person meet what criteria?
The person is legally competent
What is the definition of a “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 subjects participation in research procedures
An informed consent document may not include any exculpatory language through which the subject or subjects representative releases or appear to release which parties from liability or negligence?
The investigator, sponsor, the institution or its agents
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
IRB must ensure special criteria are met prior to approving emergency research that will allow subject entry without first obtaining ICF
True (21.CFR.56)
a federal department or agency head may restrict, suspend, terminate or choose not to authorize an institution’s IRB’s use of the expedited review procedure
True (21.CFR.56)
When appropriate, an IRB is required to determine whether, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects
True (21.CFR.56)
The IRB must pay particular attention to ensure additional safeguards to have been taken for vulnerable subjects in federally supported research. Which groups are considered vulnerable subjects of concern?
- Children, prisoners, pregnant women
- economically or educationally disadvantaged persons, mentally disabled persons
(21.CFR.56)
an IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with IRB’s requirements or that has been associated with unexpected serious harm for subjects.
True
Additionally, any suspensions/termination of approval shall include a statement of the reasons for the IRB’s actions and shall be reported promptly to the investigator, appropriate institution officials, and the department of agency
An institution participating in a cooperative project may enter into a joint review of another qualified IRB, or make similar arrangements for avoiding duplication of effort.
False
Approval of the department or agency head is required prior to entering such agreements
(21.CFR.56)
The IRB is not responsible for ensuring that legal ICF will be obtained for all clinical trials subjects.
False
(21.CFR.56)
IRB’s reviewing federally funded supported research are required to maintain records of continuing review activities, only if the research is approved to continue.
False
Records of ALL continuing reviews must be retained.
(21.CFR.56)
How long must an IRB retain its records for each research project?
3 years after the completion of research
(21.CFR.56)
The only legal action that the FDA can take against an IRB is disqualification
False
(21.CFR.56)
the following statement contains exculpatory language T or F:
“Because of hospital policy, the hospital is not able to offer
financial compensation should you be injured as a result of
participating in this research. However, you are not precluded from seeking to collect compensation for injury related to malpractice, fault, or blame on the part of those involved in the research, including the hospital.”
False
T/F the following statement contains exculpatory language:
“In the event that you suffer a research‐related injury, your medical expenses will be your responsibility or that of your third party payer.”
True
What are the three principles discussed on the Belmont Report?
Respect for Persons
Beneficence
Justice
Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects?
a. Insuring that confidentiality is maintained
b. Determining that the study has maximized benefits and minimized risks
c. Insuring that the selection of subjects includes people from all segments of the population
d. Providing detailed information about the study and obtaining the subject’s consent to participate
b. Determining that the study has maximized benefits and minimized risks
Which of the following best describes the principle of informed consent as described in the Belmont Report?
a. Comprehension, conflicts of interest, risk/benefit ratio
b. Voluntariness, risk/benefit assessment, selection of subjects
c. Risk/benefit assessment, justification of research, comprehension
d. Information, comprehension, voluntariness
d. Information, comprehension, voluntariness
Subject MAB #8469 is scheduled for her study visit 6 on 3/20/2014. Her window for this visit is 3/18-3/22. She calls the morning of her appointment to cancel her appointment .
What do you do?
There are still two days left in the study window to reschedule, ask if she can come in on 3/21 or 3/22 to complete visit 6.
