Does My Research Need IRB Review?

Does My Research Need IRB Review?

The federal regulatory agencies that the institution will review and approve all research involving human subjects ( a human subject means a living individual whom an investigator conducting research obtains) before it is initiated. (45 CFR part 46.)

Federal Definition of Research

A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. – from 45 CFR 46.102

Examples of research/projects need IRB review

  • Research that collect data through interventions or interactions with individuals
  • Research that collect identifiable private information

Examples of research/projects do not need IRB review

  • Searches of existing literature or documents
  • Quality assurance activities or evaluation projects designed for marketing purposes or program evaluation, not meant to contribute to generalizable knowledge

If you are not sure if your research/project needs IRB review or not, please contact our office 435-652-7595.