Department COVID-19 Updates:
COVID-19 Research Planning UNL IRB COVID-19 response

IRB/Human Subjects Research

COVID-19 Human Subjects Research Response and Preparedness Planning

The suspension of in-person human subjects research will be removed as of July 6, 2020; however, research personnel are still strongly encouraged to conduct human subjects research via remote activity whenever possible.

All in-person human subjects research protocols, under the auspices of UNL, will be allowed to resume activities on July 6, 2020. Research personnel are expected to follow all University policies and guidance or relevant federal guidance regarding performance of in-person research protocols during the COVID-19 pandemic.

Please visit the UNL IRB COVID-19 webpage for further details on COVID-19 as it impacts current UNL IRB operations. This webpage will be continuously updated with information as it becomes available. If there are questions specific to your human subjects research, please review the UNL IRB COVID-19 webpage first. If you have remaining questions, contact the UNL IRB at irb@unl.edu, or call Rachel Wenzl, RCS Associate Director at 402-472-8196.

The University of Nebraska-Lincoln (UNL) is committed to maintaining the highest ethical principles in the conduct of research with human subjects through the UNL Human Research Protection Program (HRPP).

UNL’s HRPP earned full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP) in 2008 with ongoing re-accreditation occurring at various intervals since then but not greater than every five years.  AAHRPP is a nonprofit organization that requires maintenance of rigorous standards to achieve this distinction. This voluntary accreditation process is a testament to UNL’s commitment to human subjects protections and how each member of the research community plays a role.

The HRPP is an organizational structure that includes the Institutional Review Board (IRB) and Research Compliance Services. It also includes the Institutional Official who is responsible for the overall program, other compliance committees such as the Radiation Safety Committee and the Conflict of Interest in Research Committee, and the staff who manage the administrative oversight of the programs. Through these programs we all work together to oversee the protection of human subjects participating in research conducted by UNL faculty, staff, students and affiliates.


IRB Metrics

The metrics presented below include both real-time data for the current calendar year, as well as five years-worth of past calendar year data for comparison. Each of our three most insightful metrics are presented within their own tab. Click through to learn more about the work IRB coordinators are managing for all UNL faculty and student investigators. *Note: These metrics include outliers. 


All applications to the IRB are submitted via NUgrant. UNL is AAHRPP accredited and a member of SMART IRB for multi-site research.

NUgrant
AAHRP accreditation seal
Smart IRB Logo

The Institutional Review Board (IRB)

The UNL Institutional Review Board (IRB) is comprised of UNL faculty, staff and unaffiliated community members from differing disciplines with expertise based on UNL’s research portfolio.  The IRB is charged by the Chancellor to “independently review and approve all human participant research conducted or supported by the faculty, students, staff, or other representatives of UNL…through sufficient resources and decisional autonomy,” documented with Policy #1.006: Authority Granted by UNL to the IRB Operating in the HRPP.

In order for a project to require oversight by the IRB it must meet the regulatory definitions of research AND human subjects. Policy #3.001: Investigational Activities Requiring IRB Review and Approval defines activities that must be reviewed and approved by the IRB before the project begins (including recruitment).

The HRPP assists the IRB through several administrative functions while management of the HRPP is administered through Research Compliance Services. The HRPP and IRB work closely together, but both have their own specific functions and responsibilities.

The HRPP and IRB’s most commonly performed processes are:

HRPPIRB
Composed of other review committees, the Institutional Official, and staff supporting the administration of the IRB.Composed of a certain number of members representing the diversity of the University and local community.
Facilitates the review process of all projectsReviews all projects, adverse events, non-compliance, unanticipated problems and votes to approve, disapprove, suspend, terminate, etc.
Facilitates the monitoring process of approved studiesMonitors approved studies or appoints a neutral party to monitor a study
Tracks all IRB-investigator project-specific conflicts of interestReviews all IRB-investigator project-specific conflicts of interest in conjunction with the Conflict of Interest in Research Committee (CIRC)
Performs project audits and reports results to the IRBReviews audits performed by the HRPP
Manages the  accreditation processEnsures UNL is able to maintain accreditation through upholding institutional policies and maintaining high standards of human subjects research requirements
Facilitates communication between the IRB and investigator(s) throughout the life of a project 
Tracks all required human subjects training and conducts investigator education 
Works with other organizational committees, review processes, officials, etc. during the review process of a project 
Provides educational outreach and facilitates communication with research participants 

If you have questions, concerns, complaints, or suggestions about human subjects research at the University of Nebraska-Lincoln, contact the IRB at 402-472-6965 or irb@unl.edu.