IRB/Human Subjects Research
IRB/Human Subjects Research
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 not only 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.
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).
- Research is “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”
- Human subject is “a living individual about whom an investigator (whether professional or student) conducting research obtains, 1) data through intervention or interaction with the individual, or 2) identifiable private information (including data or tissues)”
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:
|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 projects||Reviews all projects, adverse events, non-compliance, unanticipated problems and votes to approve, disapprove, suspend, terminate, etc.|
|Facilitates the monitoring process of approved studies||Monitors approved studies or appoints a neutral party to monitor a study|
|Tracks all IRB-investigator project-specific conflicts of interest||Reviews 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 IRB||Reviews audits performed by the HRPP|
|Manages the accreditation process||Ensures 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 firstname.lastname@example.org.