RCS
This person is the Institutional Official at UNL
Dr. Dan Hoyt
UNL’s HRPP has been accredited since (year).
2008
This is the primary role of the IRB
Protection of human subjects
These people make the determination of "Research".
Often, investigators determine if their projects meet the definition of research. *However, Exempt vs. non-exempt determinations are made by RCS staff and IRB members as needed.
Name some resources available to you regarding Human Subjects Research.
*Website (e.g. A-Z Guidance, Templates, FAQs)
*Video Tutorials
*Requested in-person trainings
Name the organizational official(s) responsible for the day to day management of the UNL HRPP.
Sara Frizzell (Director of RCS) & Rachel Wenzl (Associate Director of RCS)
This is the organization who conducts the process and grants accreditation.
Association for the Accreditation of Human Research Protections Programs (AAHRPP)
Name the federal regulation that governs human subjects research
45 CFR 46 - The Common Rule
Ultimate authority to approve human subjects research is held by...
*Full Board Projects = IRB
*Expedited Project = IRB Expedited Reviewer
*Determination and Certification of Exemption = RCS Staff/IRB Coordinator
A colleague wants to know how long it takes to have an IRB application reviewed and approved. Where might you point them?
IRB Metrics on the IRB/Human Subjects Research webpage
Name the people you would go to for help on issues, be they regulatory or ethical
Dan Hoyt, Sara Frizzell, Rachel Wenzl, Lissette Gilster, Ryan Thompson, Becky Freeman, Jenn Klein, Emily Shultz, Joshua Renner, and other members of the UNL IRB.
Name some components of the HRPP at UNL
Research Compliance Services/IRB
Conflict of Interest Committee
Radiation Safety Committee
Institutional Biosafety Committee
Office of Sponsored Programs
Institutional Animal Care and Use Committee
These are the 3 principles of the Belmont Report
Justice, Beneficence, Respect for Persons
These are places where you would find the required elements of informed consent
*UNL HRPP 2018 Policy #9.001
*45 CFR 46.116
For non-exempt research, investigators need to submit a form (at least) annually via NUgrant to update the status of their research. One is required by the Common Rule and then other is required by the Institution. Name these form types.
Continuing Review & Annual Update
These are the 6 areas of UNL Research Compliance Services
Export Control, Conflict of Interest, Human Research Protection Program, Scientific Research Oversight Committee, Responsible Conduct of Research, and Research Misconduct.
These UNL HRPP polices apply to the "Organizational Commitment to the HRPP"
#1.001 - 1.006
This person authorizes the IRB to independently review and approve all human participant research conducted or supported by UNL.
The Chancellor
These are some ways the CIRC can manage reduction or elimination of conflict of interest or commitment as it relates to human subjects research.
*Add language about conflict to consent form
*Require disclosure to research staff
*Exclude conflicted investigator from certain aspects of the research
Name the disclosure form filled out annually related to conflict(s) of interest. (BONUS Question: Who is the COI Coordinator at UNL?)
Interest and Outside Activity Reporting Form (IOARF); Ryan Thompson
This is the institutional oversight program at UNL that includes multiple areas of compliance (i.e. Biosafety, radiation safety, IRB, etc.) and will be reviewed at the upcoming site visit.
The Human Research Protection Program (HRPP)
This is the mission of the HRPP at UNL
To ensure the protection of human participants who choose to participate in research conducted by investigators at the Institution and affiliates that is part of a broader framework of the responsible conduct of research.
These are 3 requirements of IRB composition
1. (1) Non-scientist & (1) Scientist
2. Community member (unaffiliated w/institution)
3. At least 5 members in total
These are forms that can be submitted for a project after approval.
*Change Request
*Continuing Review/Annual Update
*RNIF
*Final Report
This is the definition of "Research" per 45 CFR 46.102
A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.