UNL Training Requirement to Conduct Human Subjects Research

UNL affirms its commitment to maintaining the highest ethical principles in the conduct of research with human participants. Consistent with this commitment and our own Federal-Wide Assurance, UNL requires education of key project personnel * including investigators, students, and other project staff who conduct research with human participants, tissue samples, or data. Training of project personnel* must be completed before a protocol can be approved by UNL’s Institutional Review Board (IRB).

Mandatory education of research personnel is consistent with NIH policy, which requires training of key project personnel as a condition of proposal award, and with the recommendations of the AAU Task Force on Research Accountability. UNL’s Human Research Protection Program Policies & Procedures require that all UNL research with human subjects, regardless of funding source, abide by the Belmont principles of respect, beneficence, and justice and the federal regulations at 45 CFR 46. Further, it states that UNL will provide initial and continuing education to personnel conducting research with human subjects to help ensure that these ethical standards are met.

The responsibility for ensuring the rights, safety, and well-being of research participants is shared by the investigator, the Institutional Review Board (IRB), the University, and all research personnel. Education of the research community in the principles and procedures for protecting human research participants is a necessary step towards meeting this joint responsibility. To assist in this process, UNL has subscribed to the Collaborative Institutional Training Initiative (CITI) at the University of Miami, which offers a self-paced, web-based tutorial. To be certified for human subjects research, key project personnel* must complete the CITI tutorial every three years; this training can also be supplemented annually through CITI refresher tutorials or through attendance at one or more educational sessions held by the IRB.

Key Project Personnel:

  1. Investigators (e.g., P.I.s, co-investigators) who are responsible for the project as a whole. (Graduate students collecting their thesis data are considered to be investigators.)
  2. Project staff who have direct contact with human participants (e.g., for subject recruitment, data collection) or who have access to information that links participants’ names with their data.

Exemptions:

  1. Research staff who work with the data (e.g., data entry, data analysis) but who have no contact with participants and no means of identifying participants or linking participants’ names to their data are not required to complete CITI training.
  2. Project personnel who have successfully completed the CITI training within the past 3 years through another university do not need to retake the course at this time. They should provide the IRB office with documentation from the institution showing that they passed either the biomedical or social science course and the date on which they completed the training. Training is valid for 3 years from the date of completion.