jeopardy rules
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Jeopardy Rules. Game show host will divide the room into two teams When you know the answer, raise your hand and wait to be called on Your answer must be in the form of a question You may refer to handouts or notes - PowerPoint PPT PresentationTRANSCRIPT
Jeopardy Rules• Game show host will divide the room into two teams• When you know the answer, raise your hand and wait to be
called on• Your answer must be in the form of a question• You may refer to handouts or notes • Once you have answered one question, you may not answer
another (whether or not your answer was correct)• Scorekeeping
– Correct answers are added to your team’s score.– Incorrect answers are subtracted from your team’s score
• If you answer correctly you choose the next category, but if you answer incorrectly the other team chooses the next category
• A correct answer for Double Jeopardy doubles the dollar value
Do The Right Thing
Guess Who? I Do, I Do, I DoTick Tock, Tick Tock
Step 1,2,3
5 pts 5 pts 5 pts 5 pts 5 pts
10 pts 10 pts 10 pts 10 pts 10 pts
15 pts 15 pts 15 pts 15 pts 15 pts
20 pts 20 pts 20 pts 20 pts 20 pts
25 pts 25 pts 25 pts 25 pts 25 pts
Equal distribution of burdens and benefits
What is justice?
Treating individuals as autonomous agents
What is respect for persons?
Providing psychiatric research subjects
with tokens
What is undue influence?
Ensuring risks to subjects are reasonable in relation to
anticipated benefits
What is one of the IRB approval criteria?
Time frame required for reporting an
unanticipated serious adverse event to the IRB
What is 5 business days?
Children, prisoners, psychiatric patients
Who are vulnerable populations?
PIs often receive multiple rounds of comments
from this type of reviewer
Who is the nitpicker?
This facility official may NOT serve as a voting or non-voting member of research oversight committees,
but may serve as a non-voting consultant to research oversight committees,
and may attend meetings of these committees when requested by the committee or as described in
local committee SOPs?
Who is the RCO?
This individual should be brought in if your IRB doesn’t have expertise
in a particular area
Who is a consultant/adhoc reviewer?
External agencies that require reporting of serious or
continuing noncompliance for Investigational drug/device
studies
Who are the FDA and OHRP?
Its IRB does not have to approve the research
What is an institution that is not engaged in
human research?
An institution whose employees or agents obtain informed consent
from subjects
What is an institution that is engaged in
human research?
It holds an FWA, has a local PI, and its IRB of record has
approved the project?
What is an institution that is engaged in
human research?
Individuals who act on behalf of an institution,
exercise institutional authority or responsibility, and/or perform
institutionally designated activities
Who are an institution’s employees or agents?
Guidance followed by VA on whether or not a local VA facility is engaged in human research
What is OHRP guidance on engagement of institutions in human subjects research?
Documents that must be available within 3 weeks of
convened IRB meetings
What are draft IRB minutes?
These can never be altered
What are final IRB minutes?
An IRB member must be _______ when she/he has a conflict of interest and cannot vote or be counted toward the
quorum.
What is recused?
This is an issue that is highly debated among IRB members,
resolved by the IRB, and documented in the minutes
What is a controverted issue?
These are included in the study when some or all of the subjects
are likely to be vulnerable to coercion or undue influence
What are additional safeguards?
A project that is planned in advance and that uses data
collection and analysis to answer a question
What is a systematic investigation?
A living individual about whom an investigator conducting research
obtains identifiable private information
What is a human subject?
Expands the knowledge base of a scientific discipline or other scholarly
field of study.
What is Generalizable Knowledge?
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 tests
What is minimal risk?
Is it research, is it human subjects research,
is it exempt, can it be expedited
What is the proper sequence when determining the correct
IRB review requirements?