jeopardy rules

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?