Informed Consent
Research Regulation
Unethical Studies
Risk
Chairs' Choice
100
IRBs often require investigators to simply consent form language using this criterion
What is a "reading level"? (6th or 8th)
100
Children, prisoners, ?psychiatric patients
Who are vulnerable populations?
100
Its IRB does not have to approve the research
What is an institution that is not engaged in human research?
100
Documents that must be available within a week of convened IRB meetings
What are draft IRB minutes?
100
A project that is planned in advance and that uses data collection and analysis to answer a question
What is a systematic investigation?
200
Treating individuals as autonomous agents
What is respect for persons?
200
PIs often receive ?multiple rounds of comments from this type of reviewer
Who is the nitpicker?
200
An institution whose employees or agents obtain informed consent ?from subjects
What is an institution that is engaged in human research?
200
An independent committee of scientific and non-scientific members that review research proposals.
What is the Institutional Review Board (IRB)?
200
A living individual about whom an investigator conducting research obtains identifiable private information
What is a human subject?
300
Providing psychiatric research subjects with tokens
What is undue influence?
300
Who is the Institutional Officer or I/O?
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?
300
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?
300
These can never be altered
What are final IRB minutes?
300
Expands the knowledge base of a scientific discipline or other scholarly field of study.?
What is Generalizable Knowledge?? ?
400
Ensuring risks to subjects are reasonable in relation to anticipated benefits
What is one of the ?IRB approval criteria?
400
This individual should be brought in ?if your IRB doesn’t have expertise ?in a particular area
Who is a consultant/adhoc reviewer?
400
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?
400
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?
400
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?
500
What is one of the ?IRB approval criteria?
What is 5 business days?
500
External agencies that require reporting of serious or continuing noncompliance for Investigational drug/device studies
DAILY DOUBLE Who are the FDA and OHRP?
500
Guidance followed by the institution on whether or not a local institution facility is engaged in human research
What is OHRP guidance on engagement of institutions in ?human subjects research?
500
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?
500
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? 
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