Activities Requiring IRB Review and Approval

To determine if the proposed activity requires review by the Drake IRB, answer the following three questions:

• Is the proposed activity research?
  Research is a systematic investigation that includes research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. However, for the purpose of IRB review, the following activities are deemed not to be research: (1) scholarly and journalistic activities that focus directly on the specific individuals about whom the information is collected; (2) public health surveillance activities when conducted, supported, requested, ordered, required, or authorized by a public health authority; (3) collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes. If, according to this definition, the proposed activity is not research, then IRB review is not required. If the proposed activity is research, continue with the next question. If it is not clear whether the proposed activity is research, seek assistance from the IRB chair.
• Does it involve human subjects?
  Research investigators must determine whether their proposed research will involve human subjects. Regulations define "human subject" as a living individual about whom an investigator (whether professional or student) conducting research 1) obtains information or biospecimens through intervention or interaction with the individual and uses, studies, or analyzes the information or biospecimens or 2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. If you determine that the research does not involve human subjects, then IRB review is not required. If you determine that the research does involve human subjects, IRB review is required. If it is not clear whether the research involves human subjects, seek assistance from the IRB Chair.
• Will it be authorized and conducted under the jurisdiction of Drake University?
  All research involving human subjects conducted by Drake University faculty, staff, or students, regardless of the funding status or the source of any funding, is under the jurisdiction of the University. In cooperative research projects involving one or more institutions in addition to Drake University, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with the individual IRB policies.