Cards to study 2 Flashcards
when can informed consent form requirement be waived for emergency use?
- life-threatening situation
- obtaining consent isn’t feasible
- prospect of direct benefit
- investigator is making every effort to contact an LAR
- additional protections will be provided
- IRB has approved waiver
can someone be an advocate for a ward for multiple children?
yes
can a ward have both an advocate and a guardian/parent acting on their behalf?
yes
Does a consent form need to require the approximate number of subjects involved in the study?
No, this is optional
Is it required to state that findings during the research will be provided to the subject on the informed consent form?
No
Who is an investigator?
person conducting the clinical investigation
Who initiates a clinical investigation but does not actually conduct it?
Sponsor
Who initiates and conducts, alone or with others, an investigation?
Sponsor-investigator
How many days does an IRB have to revise its registration?
within 90 days of the changes
How many days does an IRB have to revise its registration if disbanning?
30 days
how long is an IRB’s registration good for?
3 years
What does 21 CFR 312 cover?
investigational new drug application
When is an investigation exempt from part 312?
- not being submitted to FDA for a new indication or significant change in the label
- no significant change in advertising for prescription drugs
- route or dose level change, or new patient population, doesn’t significantly increase risks
- still complies with IRB and other regulations/requirements
What 4 products are exempt from 312?
blood grouping serum, reagant red blood cells, anti-human globulin, drugs meant solely for in vitro or lab research animal testing
how long does the FDA have to approve or disapprove of an IND application?
30 days
Is a study involving use of a placebo exempt from 312?
Can be, if the study does not otherwise require submission of an IND
Can the FDA provide written notification of a hold to the sponsor?
yes, phone or in writing
Can the sponsor proceed with the study after a hold?
Not until the FDA says they can proceed
Per Nuremberg Code principle 4, experiments should be conducted to void what?
unnecessary physical and mental suffering and injury
Per Nuremberg Code principle 7, what 3 things should subjects be protected against?
injury, disability, death
Per Nuremberg Code principle 8, who should conduct investigations?
scientifically qualified persons
Nuremberg Code principle 9 states a subject can end the experiment when he reaches what?
physical or mental state where continuation of study seems impossible
Nuremberg Code principle 10 states that investigators should be ready to do what at all times?
terminate experiment if there is probable cause to believe it will likely result in injury, disability, or death to a subject
When was the Nuremberg Code written?
1947
What are two publicized examples of ethical abuses in research?
Willowbrook Studies, 1956-70
Jewish Chronic Disease Hospital Study, 1963
What happened in the Willowbrook Studies?
children with intellectual disabilities were deliberately infected with hepatitis
In what study were liver cancer cells injected into cognitively impaired patients?
Jewish Chronic Disease Hospital Study
When was Tuskegee condcuted?
1932-1972
What prompted the National Research Act to be passed?
Tuskegee, prisoner research, Willowbrook, and more
When was the National Research Act passed?
1974
When was the Belmont Report released?
1979
Who wrote the Belmont Report?
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
According to Nuremberg Code principle 2, what should experiments yield?
fruitful results for the good of society
Nuremberg says experiments should not be ___ and ___ (principle 2).
Random
Unnecessary in nature
Nuremberg says the experiment should be ___ by other methods
unprocurable
What does the Nuremberg Code say experiment design should be based on?
result of animal experimentation and a knowledge of the disease or problem under study
how long do phase II studies generally take to complete?
1-3 years
how long do phase III studies generally take to complete?
2-5 years
what phase study studies a drug used by practicing physicians in the same manner as it would be used after marketing?
phase III
what phase study makes comparisons between a new treatment and standard therapy or placebo?
phase III
what phase studies look at short and long-term safety data, respectively?
phase II, phase III
what are 3 characteristics of phase IV studies?
- post-marketing
- continue to assess therapeutic value
- monitor less common AE’s
what phase study is generally performed in animals?
pre-clinical
what is submitted by the sponsor after sufficient pre-clinical data is obtained?
an IND to begin research in human subjects
do phase I studies evaluate efficacy?
no, only determine appropriate dose range with regard to safety and toxicity
what is significant equity interest?
if a PI gets interest or stock, or other financial and equity interest, during the time of the study and 1 year following completion (usually more than $50K to PI and family)
what is considered a significant payment to an investigator in a covered trial?
over $25k during the trial or up to 1 year after trial completion
what does 21 CFR 812 cover?
investigational device exemptions
Name 5 parts of an investigational device plan.
1) purpose
2) protocol
3) risk analysis
4) device description
5) monitoring procedures
6) labeling
7) consent materials
8) IRB info
9) other institutions
10) records and reports
Name 5 parts of an investigational device plan.
1) purpose
2) protocol
3) risk analysis
4) device description
5) monitoring procedures
6) labeling
7) consent materials
8) IRB info
9) other institutions
10) records and reports
What does ICH stand for?
international conference on harmonization
What two institutions recommend SOPs for consistency, efficacy, etc.?
FDA, ICH
according to 21 CFR 812, how long should records be kept at a site after study closure?
2 years
according to 21 CFR 812, a sponsor can select a monitor that is qualified by what two things?
experience and training
Do Health and Human services regulations apply under trials conducted under FDA regulations?
Yes
Which phase is an aftermarket trial?
IV
Which trial phase expands on the safety profile of a compound and further explores efficacy?
III
Annual Reports of the study should be submitted to the FDA within ____ days of the anniversary date of the trial? Which regulation requires this?
60; 312
According to 21 CFR 812, if an investigator uses a device without obtaining consent, they must report such use to the IRB within how many days?
5 working days
what is the primary role of the IRB?
protect the rights and welfare of human subjects participating in clinical trials
does the IB need IRB approval?
no
Can 1 IRB member satisty more than 1 category?
yes
FDA requires that all study records be retained for how long after a marketing application is approved?
2 years
what document is the cornerstone of human research ethics?
declaration of helsinki
what is the date of the declaration of helsinki?
1964
what phase are dose escalation studies?
phase I
what regulation covers both informed consent guidelines and additional protections children?
21 CFR 50
what section of 21 CFR 312 covers disposition of unused study drug?
59
Gaining FDA/IRB approval in advance, choosing investigators and monitors, monitoring investigations, and emergency research are all responsibilities of who? And per what regulation?
the sponsor; 21 CFR 812
Awaiting approval, compliance, supervising device use, financial disclosure, and disposing of device are all responsibilities of who? And per what regulation?
the investigator; 21 CFR 812
