UNL HRPP Policies have been developed to be in alignment with applicable Federal and State regulations along with guidance based on discipline standards and principles.

Federal Regulations

The University of Nebraska-Lincoln (UNL) Human Research Protection Program (HRPP) and the Institutional Review Board (IRB) follow the U.S. Department of Health and Human Services Code of Federal Regulations at 45 CFR § 46 (Subpart A) effective before and after January 21, 2019 under the Pre-2018 Requirements and the 2018 Requirements, respectively, and Subparts B, C and D.  In addition, the UNL IRB also follows regulations set forth by a number of Federal Agencies that have promulgated the regulations at 45 CFR § 46 to include sections in their regulations identical to Subpart A creating the Common Rule.  Federal Regulations under the Common Rule and all its Subparts governing human subjects research are applied to all human subjects research at UNL regardless of funding source specified in Policy #1.006 titled, “Authority Granted by UNL to the IRB Operating in the HRPP.”

Throughout the IRB website two sets of icons are used to distinguish between the Pre-2018 and 2018 Requirements of the Common Rule at 45 CFR 46.

Pre-2018 Requirements

The “Pre-2018 Requirements” is the set of regulations that are effective until January 21, 2019 and continue to apply to ongoing projects approved before January 21, 2019 unless transitioned to the 2018 Requirements.

2018 Requirements

The “2018 Requirements” is the set of regulations that are effective beginning January 21, 2019, and applies to all research that has either transitioned to the “2018 Requirements” or is approved on or after January 21, 2019.

The UNL IRB also looks to the (Federal) Office of Human Research Protections (OHRP) to provide clarification and guidance related to the human subjects protection regulations at 45 CFR §46, development of educational programs and materials, and regulatory oversight.

*Note that any UNL human subjects research regulated by the Food and Drug and Administration or required to follow the International Council for Harmonisation – Good Clinical Practices (ICH-GCP) is referred to the University of Nebraska Medical Center IRB for review under the application FDA regulations as described in policy #1.006 above.


In turn, the Federal regulations at 45 CFR § 46 are based on The Belmont Report and the principles of Respect for Persons, Beneficence and Justice as pillars of human subjects research ethics.

Respect for Persons:  Individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protectionInformed Consent:  Includes the three main elements of information, comprehension and voluntariness
Beneficence:  “Do no harm” and maximize possible benefits and minimize possible harmsAssessment of Risks and Benefits:  The risks and benefits are balanced and shown to be in a “favorable ratio”
Justice:  “Fairness in Distribution” – benefits and risks of the research should be afforded by allSelection of Subjects:  Beneficial research opportunities should not be offered to only some participants in their favor or select only “undesirable” persons for risky research.
The Belmont Report

State Statutes

All applicable state laws, regulations and even administrative codes must be adhered to if they intersect with a project that involves human subjects research.  The following Nebraska laws most commonly intersect with research reviewed by the UNL IRB:

A good example that illustrates how the flow from federal regulations, through state regulations and the principles of the Belmont Report are incorporated through a project review is research hoping to recruit a Nebraska citizen who is 18 years old.