General Questions Flashcards
minimum number of IRB members
at least five members with varying backgrounds to promote complete and adequate review of the research activities commonly conducted by the institution;
In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval?
In a non-emergency situation, subjects cannot be enrolled until IRB/IEC approval has been obtained
The responsibility for ensuring that the investigator understands a clinical trial lies with:
The Sponsor
CFR
Code of Federal Regulations
21 CFR part 11 covers
Electronic Records and electronic signatures
21 CFR part 50 covers
protection of human subjects
21 CFR part 56 covers
IRB
21 CFR part 312 covers
Investigational New Drug Application (IND)
21 CFR part 812 covers
Investigational Device Exemptions (IDE)
minimal risk
the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
LAR (legally Authorized Representative)
an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research
assent
child’s affirmative agreement to participate in a clinical investigation. Mere failure to object should not, absent affirmative agreement, be construed as assent
The World Medical Association (WMA) ethical principles for medical research involving human subjects is called
The Declaration of Helskinki
The international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects is known as
Good Clinical Practices (GCP)
The Code of Federal Regulations that applies to IRBs
21CFR56
The FDA may waive the requirements contained in the regulations, including the requirements for IRB review (true or false)
True
Emergency use of a test article is exempt from the requirement for IRB review, provided that such emergency use is reported to the IRB in writing within 5 calendar days (true or false)
False (no timeframe is specified)
A clinical hold is an order by FDA to the investigator to suspend or stop ongoing investigations
False (it is an order to the sponsor, not the investigator)
what is covered by 21CFR50 subpart B
Informed consent of human subjects
What is covered by 45CFR45 subpart B
additional protections for pregnant women, human fetuses, and neonates involved in research
per 21 CFR part 312 the sponsor must notify FDA and all participating investigators in an IND safety report within 15 calendar days after the sponsor determines that the information qualifies for reporting (true or false)
True
The clinical investigator will update the financial disclosure information if any relevant changes occur during the investigation’s course and for_____________ following the study’s completion
1 year
FDA Form 3455
disclosure of financial interests
FDA Form 3454
Certification of financial interests
IND Application form 1571
submitted by sponsor to FDA prior to the beginning of a drug trial
FDA Form 3500
Adverse Event Form
FDA Form 3500A
medical device AE/problems form
What are the applications for the Belmont Report
1) Informed Consent, 2) Assessment of Risk and Benefits, 3) Selection of Subjects
Phase 3 clinical drug trials
1000s of subjects, safety and effectiveness, different populations and doses, uses of the drug in combination with other drugs
phase 1 clinical drug trial
20-80 subjects, healthy volunteers, emphasis is safety
phase 2 clinical drug trial
100s of subjects, emphasizes effectiveness
phase 4 clinical trial
post marketing. monitors safety. role is to detect serious unexpected AEs
21 CFR 50 subpart D
additional safeguards for children
FDA Form 3454
certification of the absence of financial interest
45 CFR 46
HSS regulations for the protection of human subjects in research. Includes 5 subparts
45 CFR 46 subpart A
The Common Rule, a robust set of protections for research subjects
45 CFR subpart B
additional protections for research with preganant women and fetuses
45 CFR subpart C
additional protections for research with prisoners
45 CFR subpart D
additional protections for research with children
45 CFR subpart E
requirements for IRB registration
FDA form 482
notice of inspection
FDA form 483
inspection observations
unexpected fatal or life threatening SAE associated with drug must be reported to FDA
no later than 7 calendar days after initial receipt of SAE
unexpected SAEs for IND trials must be reported to FDA
within 15 calendar days after initial receipt
according to ICH guidelines, IRB must retain records for
3 years
Purpose of the Belmont Report (1979)
provide basic ethical principles and boundaries between practice and research
Practice
interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success
Research
an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge
ethical convictions of “respect for persons”
individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection
2 rules that express beneficence
1) do no harm, 2) maximize possible benefits and minimize possible harms
5 formulations of justice (just ways to distribute burdens and benefits)
1) to each person an equal share; 2) to each person according to individual need; 3) to each person according to individual effort; 4) to each person according to societal contribution; and 5) to each person according to merit
applications outlined in the Belmont Report
1) informed consent–relates to respect for persons
2) assessment of risks and benefits–relates to beneficence
3) selection of subjects–relates to justice
