How many days does a sponsor have to report an emergency use of an IP
to the FDA? - Exact answer 5 working days
How many members must sit on an IRB? - Exact answer 5
How long must an IRB retain records per 21 CFR 56? - Exact answer 3
years after completion of research
What are the criteria for IRB approval of research? (7) - Exact answer 1.
Risks to subjects are minimized
2. Risks are reasonable in relation to anticipated benefits
3. Selection of subjects is equitable
4. Informed consent will be sought from subjects or LARs
5. Informed consent will be documented
6. There is adequate provision of monitoring
7. There is adequate provision to protect the privacy of subjects
How many days does an IRB have to report a change in registration
information due to a change in chairperson or contact? - Exact answer 90
days
How many days does an IRB have to inform the FDA that it is reviewing
different types of FDA products? - Exact answer 30 days
How often must an IRB renew it's registration? - Exact answer 3 years
What are the 8 basic elements of informed consent per FDA guidelines? -
Exact answer 1. Statement that the study involves research, purpose and
expected duration, description of experimental procedures
2. Description of reasonably foreseeable risks
3. Benefits
,4. Disclosure of alternative procedures or courses of treatment
5. Confidentiality measures
6. Compensation and treatments available if injury occurs
7. contact information
8. Participation is voluntary and subject may discontinue at any time
What are the criteria for involving children in minimal risk research? (2) -
Exact answer 1. No greater than minimal risk
2. Assent from kid + consent from parent obtained
What are the criteria for involving children in greater than minimal risk
research with prospect of benefit? (3) - Exact answer 1. Risks are justified
by benefits
2. Relation of anticipated benefit is at least as favorable as that presented
by alternative approaches
3. Assent + consent
What are the criteria for involving children in greater than minimal risk
research with no direct benefit? (4) - Exact answer 1. Risks are minor
increase over minimal risk
2. Intervention presents experiences that are reasonable commensurate
with normal medical and living situations
3. Intervention is likely to yield generalizable knowledge that is vital
4. Assent + consent
Sponsors must report SAEs to the FDA within how many days of
discovering the event? - Exact answer 15 calendar days (21 CFR 312.32)
Investigators must report SAEs to a sponsor within how many days of
discovering the event? - Exact answer Immediately (21 CFR 312.64)
Sponsors must report what kind of serious events to the FDA within 15
calendar days? (4) - Exact answer 1) Serious and unexpected suspected
adverse reactions
2) Findings from other studies that suggest a significant risk in humans
3) Findings from animal or in-vitro testing that suggest risks to humans
4) Increased rate of occurrence of serious suspected adverse reactions
Sponsors must submit Unanticipated Adverse Device Effects to the FDA
within how many days? - Exact answer 10 working days (21 CFR 812.15)
,Investigators must submit Unanticipated Adverse Device Effects to the FDA
within how many days? - Exact answer 10 working days (21 CFR 812.15)
When was the Nuremberg Code issued? - Exact answer 1947
What are the 10 points made in the Nuremberg Code? - Exact answer 1)
Voluntary informed consent should be obtained
2) Research should yield benefit to society
3) Research should be based on animal work
4) Avoid unnecessary suffering
5) Don't do research resulting in death or disabling injury
6) Risks should be justified by benefits
7) Proper prep and adequate facilities should be used
8) Conducted by scientifically qualified people
9) Subject can withdraw whenever
10) Researchers can end the study if risks are too great
When was the Declaration of Helsinki released? - Exact answer 1964
Who developed the Declaration of Helsinki? - Exact answer World Medical
Association (WMA)
What is the Declaration of Helsinki? - Exact answer Document that laid out
general principles physicians should follow to conduct research with
humans, based on Nuremberg Code. First effort of medical community to
regulate itself
When was the Belmont Report released? - Exact answer 1979
Who created the Belmont Report? - Exact answer National Commission
for the Protection of Human Subjects of Biomedical and Behavioral
Research (at direction of National Research Act 1974)
What are the 3 principles in the Belmont Report? - Exact answer 1)
Respect for Persons: informed consent required and individuals with
diminished autonomy get special protections
2) Beneficence: maximize benefit to research while minimizing risk to
subjects
, 3) Justice: one group of people shouldn't assume risks for the benefit of
another (equality and diversity of participants)
In what order were historical declarations for human subjects protection
released? - Exact answer Nuremberg Code > Declaration of Helsinki >
Belmont Report
At what reading level should ICFs be written? - Exact answer 6th-8th
grade
What FDA guideline lists the basic elements of informed consent? - Exact
answer 21 CFR 50 (50.25)
What are the additional elements of informed consent per FDA guidelines?
(7) - Exact answer 1) Statement that treatment may involve unforseeable
risks
2) Circumstances in which subject participation may be terminated
3) Additional costs to subject
4) Consequences of subject's decision to withdraw
5) Statement that new findings will be provided to subject
6) # of subjects in study
7) clinicaltrials.gov statement (as applicable)
Who ultimately approves an ICF? - Exact answer IRB - sponsor can
provide sample form
Describe the 2 most important points to consider when consenting patients
(per 21 CFR 50) - Exact answer 1) No person can participate without their
or LAR consent (50.20)
2) Documentation of informed consent is required (50.27)
What are the 4 components of the consent process using a short form? -
Exact answer 1) Short form consent document stating all elements of ICF
have been presented orally to pt/LAR
2) Oral presentation of required elements
3) IRB-approved summary of what is said
4) Witness present during presentation
How do you document short form consent? - Exact answer 1) Subject/LAR
signs short form consent
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