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DNP Handbook

Institutional Review Board

Aspen University established an Institutional Review Board (IRB) in 2013 to protect the interests of human participants in research. The primary role of the IRB is the review of all human subject research conducted at Aspen University to ensure that the research fulfills the requirements of the Department of Health and Human Services, Office of Human Research Protections (OHRP), meeting the requirements of OHRP's Division of Compliance Oversight (DCO) reviews institutional compliance with the federal regulations governing the protection of human subjects in Title 45 Part 46 of the Code of Federal Regulations (45CFR46). Also see IRB Policies, Regulations, and Rules. Aspen University IRB follows the OHRP IRB Guidebook, which provides a basic understanding of the background and purposes of the IRB review system. Aspen University’s DNP faculty and students complete the CITI training, and IRB approval processes to demonstrate compliance with federal regulations.

Federal regulations require that researchers give special consideration to protecting the welfare of certain subjects. Special provisions exist for research involving:

  • Children and Minors
  • Prisoners
  • Pregnant Women and Fetuses
  • Institutionalized Mentally Disabled
  • Elderly
  • Economically or Educationally Disadvantaged

In general, these regulations allow IRBs to approve research with populations that are of minimal risk or that benefit the subjects directly. Review and approval of research involving vulnerable (protected) populations may require additional time if outside expertise is needed for further evaluation of the study.

Before the student may begin to collect and analyze data, the application to the IRB must be submitted and approved by the University’s Institutional Review Board (IRB). Only the IRB has the authority to approve research. The student is responsible to acquire IRB approval to ensure that the research is conducted in the appropriate manner and that the participants meet selection and eligibility requirements. The IRB reviews research proposals based on the following queries:

  • Are the risks to subjects and protected groups minimized?
  • Are the risks reasonable in relation to anticipated benefits?
  • Is the selection of subjects equitable?

The student ensures that the participant’s informed consent is appropriately obtained and that the study is properly designed and scientifically valid. Informed consent is obtained before data is collected. Once data is collected, analyzed, and documented, the student is responsible to provide the participants with a copy of the DNP Project, providing the participants with an opportunity to accept or reject the manner in which their data is applied. Participants reserve the right to retract their data up to the time of formal publication.

The IRB at Aspen University considers that the human participants (subjects) of the study are protected by demonstrating:

  • Respect for persons (volunteers choose whether to participate in the research);
  • Beneficence (doing no harm to research subjects);
  • Justice (human participants have the right to be aware of the potential risks of research) as defined by the National Commission for the Protection of Human Subjects. 

The DNP Project Team in conjunction with the Institutional Review Board (IRB) reviews and approves a student’s DNP Project proposal. The proposal must include IRB approval and the final approval of the Chairperson for the IRB Committee.