A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge
What is research?
This level of review applies to research that falls into six specific exemption categories.
What is Exempt Review?
The process of ensuring participants understand the study before agreeing to participate is known as this.
What is informed consent?
Report describing beneficence, respect and justice as key components of research with human subjects
What is the Belmont Report?
When a researcher stores participant data in an unencrypted cloud drive, this ethical principle is compromised.
What is confidentiality (or data security)?
This type of review requires quorum and a majority vote by IRB members.
What is Full Board Review?
An IRB member’s choice not to take part in a review discussion, vote or be counted toward the quorum due to a conflict of interest
What is recusal?
An Institution Review Board must include one of these.
What is a non-scientist, scientist, and community member?
An individual whose identifiable private information is used for research purposes
What is a human subject?
True or False: Chaminade's IRB allows recruitment of participants before protocol approval if the study is minimal risk.
What is False?
A procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB
What is Expedited Review?
A PI wants to change their study population and add a new consent form. What should they submit?
What is a modification/ amendment?
Documents meeting minutes, creates meeting agendas, monitors federal, state, and institutional policy changes, and acts as a liaison between the IRB, researchers, and Key Solutions support
Who is the IRB Administrator?
This is the minimum number of members required on an IRB committee.
What is 5?
This form is used annually by PIs to update the IRB on study status.
What is Human Subjects Annual/Final Report (Form IV)?
The moral obligation to act for the benefit of others, helping them to further their important and legitimate interests, often by preventing or removing possible harms and making efforts to secure their well-being
What is beneficence?
Institutional agreement with OHRP (Office for Human Research Protections) to protect human subjects in research
What is a Federalwide Assurance (FWA)?
This individual is responsible for ensuring a student submission meets ethical and scientific standards prior to IRB review.
What is the Faculty Mentor?
This is the name of the federal office that oversees the protection of human research subjects.
What is the Office for Human Research Protections (OHRP)?
This term describes a protocol that cannot be reviewed due to insufficient information.
What is tabled?
An agreement by an individual who is not legally capable of giving informed consent (e.g., a minor) to participate in research
What is the assent?
These are the circumstances under which a proposed research project involving human subjects requires an IRB approval.
What is always?