Regulations

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) 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.”

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 they oversee, 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.

Principles

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.

The Belmont Report
Principle Application
Respect for Persons:  Individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection Informed Consent:  Includes the three main elements of information, comprehension and voluntariness
Beneficence:  “Do no harm” and maximize possible benefits and minimize possible harms Assessment 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 all Selection of Subjects:  Beneficial research opportunities should not be offered to only some participants in their favor or select only “undesirable” persons for risky research.

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:

  • Age of majority – Nebraska’s age of majority is set at 19 years of age meaning that anyone under the age of 19 years is a minor in the State of Nebraska. Specific requirements must be met to obtain IRB approval if including children in research.
  • Mandatory Child Reporting Laws – Research design/procedures that have the possibility of obtaining information that would trigger Nebraska mandatory reporting laws must incorporate a protocol to know when and how to report such information.
  • Electronic signature – For an electronic signature to meet the minimum standards it must be individually identifiable to that person.

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.

  • Federal regulations stipulate that only those who have reached the age of majority may consent on behalf of themselves
  • State regulations stipulate the age at which a Nebraska citizen has reached the age of majority at 19 years of age with exceptions.
  • The Belmont Report guides us in understanding that individuals participating in research should be provided respect and those participating should provide informed consent including legal guardians, as applicable.
  • Institutional policy (and the IRB application) then brings all of these together to ensure we are meeting these standards.