Who Must Apply for IRB Approval

Sometimes it may be difficult for you to decide if your project or study qualifies as human subject's research or not and if it needs IRB committee approval. Please use this worksheet to assist you in determining if your project or study needs IRB approval: To IRB or Not to IRB Questionnaire

OHRP defines research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” Any human subjects investigations meeting this definition must undergo IRB review prior to collecting any data.

Research conducted by faculty, students, staff, or others on the premises of any site governed by Northwest Missouri State University, as well as research conducted elsewhere (including online research) by any representative of Northwest Missouri State University in connection with his/her institutional responsibilities require IRB approval before the investigation can be conducted. Northwest Missouri State University students enrolled in graduate programs need IRB approval for thesis projects.

Activities Not Requiring IRB Review

Non-Research Projects

OHRP requires IRB review of some sort for any human subjects research conducted at an institution or using individuals from an institution. However, 45 CFR 46 clarifies that this only applies to those types of investigations that OHRP has deemed “research.” The guidelines specify that the following forms of study are considered “non-research” and thus do not require review by the Northwest IRB:

1. Activities whose focus is on the subjects of the study only; in other words, the investigator does not want to use data gathered to make generalized claims about behavior, cognition, etc. beyond the subjects who actually participated in the study. Types of study specifically mentioned by 45 CFR 46 as non-research under this category are oral history, journalism, biography, literary criticism, legal research, and historical scholarship.

Other non-research categories apply only in rare circumstances and are unlikely to apply to your project. If you believe your project falls under one of the following, please contact the Northwest IRB first before moving forward with the project to ensure that it does not require IRB review.

2. Projects conducted by a public health authority which observe activity or collect and test information or biospecimens.
3. Projects conducted by a criminal justice agency, authorized by court order, where data are collected solely for the purpose of criminal justice or investigative purposes.
4. Authorized operational activities in support of intelligence, homeland security, defense, or other national security missions.

If your project involves human subjects and does not clearly fit under a category listed above, you should submit your project for IRB review. If you are unsure whether your project needs review, contact the Northwest IRB (IRBNWMS@nwmissouri.edu) for assistance.

Non-Human Animal Research

The Northwest IRB reviews human subjects research only. If your project involves non-human animals, you should contact the Northwest Animal Welfare Committee for more information on applications, requirements, and ethical guidelines to be followed.