Risk
Readability
Human Subjects Research Definition
Grab Bag
Chair's Choice
100
The Campus IRB most often deals with studies that are this type of risk.
What is minimal?
100
When reviewing informed consent documents, reviewers should consider whether participants will be able to understand it. This measurement is used to determine readability.
What is grade level (or reading ease score)?
100
What form is used at the ETSU IRB to determine if a study meets the definition of Human Subjects’ Research?
What is the form 129?
100
This person is the rock-star director of the ETSU Institutional Review Board.
Who is Janine Olive?
100
Because of a conflict of interest for the IRB Chair, who reviews studies from PIs in the Department of Psychology?
Who is Brittany Wilkins, the IRB Vice-Chair
200
Two areas of potential risk are privacy and confidentiality. Whereas privacy deals with participation in the study (i.e. the collection of data), confidentiality deals with this.
What is the storage of data once it is collected?
200
This is the recommended grade level for readability (consider a general population)
What is 8th grade? (some sources recommend 7th grade)
200
These are two of the factors that contribute to determining whether a project is HSR and therefore under IRB purview.
What is generalizable, systematic, or involves contact with Human subjects (use of private and identifiable data)?
200
What is the name or acronym for the organization that is investigating the ETSU IRB for re-accreditation this year?
What is Association for the Accreditation of Human Research Protection Programs or AAHRPP?
200
The chair relies on these two board members to review protocols that have children as participants.
Who are Jill Stinson and Flo Weierbach
300
If you are reviewing a new study and you decide that it poses greater than minimal risk what should you recommend?
What is that the protocol be reviewed by the full board?
300
Name 2 things that effect the reading level of a document.
What is vocabulary (complexity of term used), sentence length, frequency of paragraphing, active vs passive voice, outlining, or typeface/font?
300
Are studies falling into the exempt category considered Human Subjects’ Research?
What is yes? Any study that is deemed not Human Subjects’ Research is not purview to IRB review and thus is not placed into a determination category like exempt.
300
Does a researcher have to submit a modification through the IRB if making a change to an exempt study?
What is yes? A modification form must be submitted for any change to any protocol reviewed by the IRB.
300
At our first IRB meeting this academic year the FERPA expert came to speak with us. Based on FERPA, faculty members can use private student data without gaining permission for this purpose.
What is for program evaluation.
400
When reviewing a new study, the considerations you should make to determine risk level include whether the activity is comparable to daily life encounters, the magnitude of risk in the study, and this one:
What is What is the probability of risk, harm, or discomfort?
400
When reviewing an informed consent document, if you are worried that the participants will not understand what the study entails due to the use of jargon, you can request that the PI change the wording and make this type of determination during the approval process.
What is approval pending?
400
CITI training must be updated how often?
What is every 3 years?
400
A researcher is conducting an anonymous survey of high school students in a school system. What category of review would this study likely receive?
What is Expedited? Most studies involving minors cannot be reviewed as exempt.
400
This is the location of the ETSU IRB office.
What is the 4th floor of Ross Hall.
500
When evaluating a study for risk, a reviewer should consider potential risk in multiple areas of a participant’s life, including physical risk (bodily harm) and economic risk (risk to the participant’s employability or insurability). Name two others.
What is psychological risk, social risk, or legal risk?
500
Readability of the study materials, particularly the informed consent document, is important ethically because of this principle derived from the Belmont Report.
What is Respect for Persons.
500
Would a study likely be determined HSR or not HSR if it involves the secondary data analysis of publicly available de-identified data?
What is not HSR? This project would not involve private or identifiable data which composes the definition of 'contact with human subjects'.
500
Name at least 3 types of “advocates” that we have on the board and state which type you are.
What is Child, Community, Participant, Prisoner, Preganant, Neonate or Cognitively Impaired.
500
These are the two members of the campus IRB that represent staff at ETSU.
Who are Janet Keener and Dinah DeFord
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