We strongly recommend that investigators informally consult with the HSRB to confirm exempt status and to ensure human subjects protections are handled appropriately. Research involving more than minimal risk is not exempt, and certain minimal risk projects might not be exempted if, in the opinion of the HSRB, the research contains procedures that should be periodically re-reviewed. Also, if an investigator thinks she or he might want to publish or present their research outside of Metropolitan State University, HSRB review is required.

All human subjects research, whether exempt or not, must be conducted in accordance with Metropolitan State University policies, federal guidelines, and ethical principles set forth in the Belmont Report. An Exempt Research Form must be submitted to the HSRB via IRBNet.org to verify the exempt status. For all other research with human subjects a Research Review Application Form must be submitted to the HSRB via IRBNet.org.

Research may be exempt from the HSRB review if the only involvement of human subjects will be in one or more of the categories below.

A. Research conducted in established or commonly accepted educational settings, involving normal educational practices such as:

  1. research on regular and special education instructional strategies; or
  2. research on the effectiveness of, or the comparison among, instructional techniques, curricula or classroom management methods.

B. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified directly through identifiers linked to the subjects.

C. Research activities, conducted by University personnel and intended for internal use only, that are designed to assess, evaluate or otherwise examine:

  1. University courses, services, and programs;
  2. procedures for obtaining benefits or services at the University;
  3. possible changes in or alternatives to services, programs or procedures; or
  4. possible changes in methods or levels of payment for benefits or services under those programs.

D. Research activities that are conducted within an established University course and are directed solely toward the learning of research methodology and procedures. Exceptions that are subject to review include capstones, thesis, or other research activities that are conducted beyond the boundaries of the supervisory classroom environment and involve human subjects who are not registered members of the course.

It is expected that appropriate measures will be taken to preserve subjects' anonymity and/or confidentiality and that subjects will be informed that their participation is voluntary and no coercive strategies will be used in order to gain subjects' compliance.

NOTE: All non-exempt research is subject to continuing review at least annually. If research involves significant risk to subjects, the HSRB may require more frequent review and may ask to be kept apprised of all research activity.