The Research Compliance Services Office and Institutional Review Board (IRB) have created this information in order to affirm our commitment to diversity, equity, and inclusion through adhering to the highest ethical principles in the conduct of research with human subjects.
Purpose & Commitment
The mission of an IRB and HRPP is to ensure the protection of human participants who choose to participate in research conducted by personnel or affiliates on behalf of UNL. While we are required to carry out these obligations from federal regulations (45CFR46) that govern IRBs and human subjects research, the UNL IRB also voluntarily maintains accreditation through the Association for Accreditation of Human Research Protection Programs (AAHRPP). 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 the importance in recognizing that each member of the research community (from the PI, to the full board IRB, research personnel, administration, research participants, and applicable community) all play an integral role in carrying out these principles and protections.
Further, the IRB recognizes protections may need to be in place for projects conducted that are not under the purview of the IRB. The IRB A-Z Guidance on Classroom and Clinical Practica addresses the need for faculty and students to ensure protections for involving vulnerable populations, and managing and mitigating sensitive questions or topics; even when there is no requirement for IRB review and approval.
Diversity, Equity, and Inclusion
Through research, UNL personnel interact with colleagues and research participants around the world and are part of the network of knowledge and information that influences our society. As such, the IRB maintains up to date policies, procedures, guidance, and best practices in order to ensure we are cognizant and able to understand the depth of research and the impact of interactions that could be occurring either locally, nationally, or internationally.
The regulations and ethical principles that comprise the building blocks of IRBs and the conduct of human subjects research includes concerns that potential research participants should neither be excluded based on irrelevant characteristics (that may include socially devalued identities) nor coerced to participate (a risk with economically poor people and members of socially devalued or politically oppressed groups). The IRB application, training requirements, consent documents, and approval processes address both of these concepts directly and research personnel are required to recognize and plan for carrying out the research while not inappropriately excluding or coercing research participants. IRB staff, expedited reviewers, and full board members are trained to identify and work with research personnel in order to mitigate the possibility of inequitable inclusion or coercion of research participants.
IRBs must also consider if a research project runs the risk of burdening members of a devalued group while a privileged group reaps the benefits of the research findings. The IRB application includes questions that address these types of situations and, if such a situation were to be proposed, the IRB works directly with the researcher(s) to minimize burdens on participants as well as, where possible, increasing benefits to the participants in appropriate ways.
The IRB also ensures, where appropriate, that research personnel have and maintain applicable training, licensure, or certification depending on the types of research participants they may be proposing to interact with. For example, the IRB recognizes situations where a research participant may speak English as a second language or may have diminished capacity to provide consent. In those cases, the IRB requires translation certification of consent forms, a translator, or the involvement of a legally authorized representative in order to ensure the research participant can understand their rights and not be excluded from participation unnecessarily.
In addition, the IRB recommends, that in some cases, research personnel consider the need to include certain elements that would make their research more inclusive for the subject population and/or community they are in. While this would not apply to every case, one good example of how this may be accomplished, is the Community Based Participatory Research (CBPR) paradigm. In CBPR, human research protections are not just about individuals but also the respect, beneficence and justice for the community. Some unique elements of CBPR include: 1) active engagement and shared decision-making of community members and academic researchers, 2) involvement of community approval and representation in the research approval, design, and implementation, 3) integration of community social action, social change, and priorities with the scientific objectives of the academic researchers, and 4) consideration and respect for the rights of the community in all aspects of the research.
The IRB staff and Chair also regularly provide training opportunities and outreach to the campus in order to address topics of concern or to discuss emerging issues within human subjects research. These in-person and video training opportunities allow for connection and dialogue with faculty, staff, and students in order to educate about IRB policies, submission processes, and the history/regulatory requirements associated with such protocols. When requested, they also respond to invitations to assist with discussing challenging projects or questions relating to a variety of topics.
The IRB is comprised of UNL faculty, staff and unaffiliated community members from differing backgrounds, disciplines, and expertise based on UNL’s research portfolio. While the IRB maintains a diverse roster of members, we also recognize that it is not possible to have expertise or appropriate representation for all areas that could be involved in a research protocol. In order to address this, the IRB actively reaches out and includes subject matter experts in the review and approval of research protocols. Either before or during review of a protocol, the IRB will determine if there is a need for the services of an expert consultant (scientist or non-scientist) and, depending on the magnitude of the concern or topic, the IRB may seek more than one consultant either within UNL or from outside the Institution. Whether the research is going to be conducted locally or internationally, the IRB seeks out advice and appropriate expertise in order to ensure understanding and the opportunity for diverse opinions to be heard and addressed.
Applicable IRB Policies
All policies listed below can be found on our Policies & Procedures webpage.
- 1.001: The Institution and its Commitment to the HRPP
- 1.003: Vision, Mission and Values Statement for the HRPP
- 2.001: IRB Membership, Requirements, and Responsibilities
- 2.003: IRB Consultants
- 3.002: Ethical Principles Governing Research Under the Jurisdiction of the IRB
- 5.001: Additional Protections for Vulnerable Populations