Do I Need IRB?

compass pointing toward integrity

An Institutional Review Board (IRB) is a federally mandated committee that oversees the ethical conduct of human subjects research at an institution. Florida Atlantic University's IRB serves an important role in the protection of the rights and welfare of human subjects involved in research.

The IRB reviews and approves protocols for research involving humans and ensures that appropriate steps are taken to protect their rights and welfare. FAU's IRB is comprised of faculty members representing a variety of backgrounds, training and experience, as well as community members who have no formal connection with the University.

Many researchers wonder if their research requires IRB review. If your research meets the following two definitions then you are involved in research with human subjects:

  • "Research" means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this part, the following activities are deemed not to be research:
  • "Human subject" means a living individual about whom an investigator conducting research obtains: 1.) data through intervention or interaction with the individual, or 2.) identifiable private information.

DETERMINATION OF HUMAN SUBJECTS RESEARCH UNDER DHSS REGULATIONS

NOT HUMAN SUBJECTS RESEARCH UNDER DHSS

Proposed activity is not a systematic investigation and does not intend to contribute to generalizable knowledge.

Research is not obtaining information ABOUT living individuals

UNCERTAIN

Research involves interaction or intervention with individuals

AND

Information is identifiable and private ???

Confirm with Research Integrity Office

HUMAN SUBJECTS RESEARCH

Proposed activity is a systematic investigation, intends to contribute to generalizable knowledge, obtains information ABOUT living individuals, involves interaction or intervention with individuals and information is identifiable and/or private.

IRB PURVIEW

For assistance in determining whether you need to submit an application to the IRB, refer to one of the following resources:

Once it is clear that you need to submit an IRB application, click here to begin the electronic submission process.

Click here for an IRB checklist that assists you in the preparation of your new study application.

Upon completion of the Determination of Human Subjects Research Form 6, please contact the Research Integrity staff to confirm your research is not human subjects under DHHS regulations. The IRB will submit an official letter if your project does not qualify as research that involves human participants.

If you have any questions or need more information, please contact the Research Integrity office at researchintegrity@fau.edu or 561.297.1383.