Common Rule
This is the section in the CFR where you find Exempt research categories.
45 CFR 46.104
An IRB shall have at least how many members
Five
This is a living individual about whom an investigator obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or uses, studies, analyzes, or generates identifiable private information or biospecimens.
Human Subject
This policy covers Criteria for IRB Approval of Research
3.004
An IRB Coordinator would find the Expedited Review Categories where?
OHRP Website
This is the section in the CFR where you find the criteria for approval.
45 CFR 46.111
Each IRB shall include at least one member whose primary concerns are in _____ areas and at least one member whose primary concerns are in _______ areas.
Scientific and nonscientific
This is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge
Research
This policy covers Expedited Research
4.002
True or False: Deception is allowed in exempt research?
True - with Authorized Deception
This is the section in the CFR where you find the general requirements for informed consent
45 CFR 46.116
True or False? Each IRB shall include at least one member who is not otherwise affiliated with the institution.
True
This includes communication or interpersonal contact between investigator and subject.
Interaction
This policy covers Request for Change
12.001
Which two categories of Exempt Research do we not use currently at UNL?
Exempt Category 7: Storage or maintenance for secondary research for which broad consent is required; and Exempt Category 8: Secondary research for which broad consent is required
This is the section in the CFR where you find info on applications and proposals lacking definite plans for involvement of human subjects
45 CFR 46.118
No IRB may have a member participate in the IRB's initial or continuing review of any project if that member has a what?
Conflict of interest
This includes both physical procedures by which information or biospecimens are gathered and manipulations of the subject or their environment that are performed for research purposes
Intervention
This policy covers Required Elements for Informed Consent Documents
9.001
Collection of blood sample by finger stick, heel stick, ear stick, or venipuncture falls under which Expedited Review Category?
Expedited Category 2
This is the subpart that covers Additional Protections for Children Involved as Subjects in Research
Subpart D
An IRB may invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. Do these individuals vote on approval?
No
This is a research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes
Clinical Trial
This policy covers Participant Registries, Subject Pools, and Data Repositories
8.012
UNL RCS requires investigators to complete human subjects research training. What training website do we use, and what groups are accepted?
CITI; Group 1. Biomedical & Group 2. Social Behavioral.