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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
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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 • 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
Providing psychiatric research subjects with tokens
Ensuring risks to subjects are reasonable in relation to anticipated benefits
Time frame required for reporting an unanticipated serious adverse event to the IRB
PIs often receive multiple rounds of comments from this type of reviewer
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?
This individual should be brought in if your IRB doesn’t have expertise in a particular area
Daily Double!!! External agencies that require reporting of serious or continuing noncompliance for Investigational drug/device studies
What is an institution that is not engaged in human research?
An institution whose employees or agents obtain informed consent from subjects
It holds an FWA, has a local PI, and its IRB of record has approved the project?
Individuals who act on behalf of an institution, exercise institutional authority or responsibility, and/or perform institutionally designated activities
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
An IRB member must be _______ when she/he has a conflict of interest and cannot vote or be counted toward the quorum.
This is an issue that is highly debated among IRB members, resolved by the IRB, and documented in the minutes
These are included in the study when some or all of the subjects are likely to be vulnerable to coercion or undue influence
A project that is planned in advance and that uses data collection and analysis to answer a question
A living individual about whoman investigator conducting research obtains identifiable private information
Expands the knowledge base of a scientific discipline or other scholarly field of study.
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