IRB Scope and Authority
Regulatory Authority of the IRB
The requirements in the IRB Policies and Procedures apply equally to all research involving human participants conducted under the auspices of the University of Northern Iowa. The conduct of research with human beings raises fundamental ethical and civil rights questions; thus, no distinctions in the monitoring of research are drawn between funded and non-funded research; between research conducted on or off campus or internationally; or between various kinds of individuals associated with the institution. All UNI faculty members, staff, students, and affiliated researchers who anticipate conducting research projects involving human participants are responsible for familiarizing themselves and complying with IRB requirements.
The IRB is formally designated by UNI to review and approve or disapprove the initiation and ongoing conduct of research involving human participants. The primary purpose of this review is to assure the protection of the rights and welfare of human participants, although risks to the researcher and to nonparticipants may be considered as well. The IRB also has the authority to disapprove a proposed research activity if in its judgment, appropriate and reasonable mechanisms are not in place for the protection of the participants and/or the potential benefits of the research do not outweigh the risks. The IRB may request that the investigator modify proposed study procedures in order to receive approval.
Review and approval from the IRB must be secured prior to the initiation of any aspect of the research involving individual human participants. (See Recruitment for a discussion of acceptable methods for making initial contacts with research sites and potential participants).
Definition of UNI Affiliation
This policy applies to all research involving human participants, and all activities which even in part involve such research, if the research:
- is sponsored by this institution, or
- is conducted by or under the direction of University of Northern Iowa faculty, staff, or students.
See Inter-Institutional Research for guidelines regarding research activities that are not sponsored by UNI or conducted by affiliates of UNI, but are performed with or involve the use of University records, students or employees, facilities, or equipment.
Research Conducted in Foreign Countries
Research conducted in a foreign country by a UNI-affiliated researcher must be reviewed by the IRB and adhere to University and federal guidelines as well as the laws of that country. The standards for ethical conduct in research as well as considerations regarding cultural differences must be incorporated into the research design. See the OHRP International Compilation of Human Research Standards (PDF).
Performance Sites
The University is responsible for ensuring that all performance sites cooperating in the conduct of research to which the University’s Federal-Wide Assurance applies do so only under an appropriate Federal assurance and/or satisfaction of UNI IRB requirements.