Do I Need IRB?
An Institutional Review Board (IRB) is a federally mandated committee that oversees the ethical conduct of research on human subjects 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.
Am I conducting research that requires IRB review?
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 the project meets the following federal definitions, then the project should be submitted to the IRB.
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.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research:
(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
| Generalizable knowledge | “Not generalizable knowledge” (examples) |
|---|---|
|
Benefits extend beyond the immediate population of study to society, other researchers, scholars, or practitioners in field. Drawing conclusions, testing or generating a hypothesis. Publication or presentation to inform the field of study. Contributing to a theoretical framework or body of knowledge. Test a new device, product, drug or biologic material |
Program evaluation or quality improvement intended only for an institution’s internal assessment and management. Biography or medical case history that is not generalizable beyond that individual. Journalism, Oral History Political poll Classroom or training activities where the only objective is to teach students proficiency on a topic. Disease outbreak investigations and Public Health Surveillance activities conducted, supported, requested, ordered, required, or authorized by a public health authority Innovative medical therapy to improve the health of an individual patient. 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 you are uncertain whether you need IRB review, submit a request for human subjects research determination into the IRBNet system. If you do not have an account, please register as a New User to access IRBNet.
If the project is secondary use research, secondary research, funded, or you need an official letter, Policy 10.3.3 “Human Subjects Research Determination” provides more information on these types of projects.
*Note: If using a de-identified data set or specimen samples, a letter of collaboration from the cooperating institution stating this must be included. A data use agreement (DUA) or Material Transfer Agreement (MTA) may be required. Further guidance is available on the following web pages:
https://www.fau.edu/research-admin/sponsored-programs/files/fau-dua-guidance-02-10-2017.pdf
https://www.fau.edu/research-admin/research-integrity/files/guidance-secondary-data-analyses-v3.pdf
What Are the Steps for IRB Submission?
Step 1: Complete Mandatory Training
- CITI is the required human subjects research training.
- Complete the Biomedical or Social & Behavioral Research Investigators course (Relevant to your research discipline).
- Save your CITI completion certificate as .pdf document to upload into IRBNet system.
- CITI completion is valid for three (3) years and must be renewed by taking the refresher course.
- If you completed the CITI at another institution within the past three (3) years, you can affiliate with FAU. If you forgot your Username or Password, CITI link “Forgot Username or Password?” will assist.
Step 2: Register in IRBNet
- New User Registration is available at www.irbnet.org
- Create your own Username and Password
- Forms and Templates are available in IRBNet (routinely updated)
- Link your CITI Training report to your “User Profile,” located at top right
Step 3: Create and Submit
- Create New Project” and upload required documents (Step 3)
- Upload an IRB Application (Form 1)
- List a faculty member as the Principal Investigator (PI) on the IRB application
- For Greater than Minimal Risk projects, upload a Research Protocol
- Upload Informed Consent Document(s) (choose the consent form/process most appropriate)
- Include additional materials when applicable:
- Recruitment materials (ads, flyers, email, or phone script, etc.)
- Data Collection Instruments / Questionnaires / Surveys / Interview Questions
- Click on “Share the Project” – e-Signatures (electronically) Required
- Principal Investigator, Department Chair, and in some Colleges, the ADR or Dean (check with your college regarding any additional signature requirements). Add the respective names that are required to sign your IRB application, depending on your college requirements.
- Click “Send project mail” and send email to required signatories review and provide their required e-Signatures (electronically) BEFORE you submit your application
Click on “Submit this Package.”
If you have any questions or need more information, please contact the Research Integrity office at researchintegrity@fau.edu or 561.297.1383.