IRBNet is the protocol management system that offers secure, web-based collaboration tools to support the design, management, review, and oversight of research involving human subjects.

1. Prior To Submission

Prior to preparing a research application, investigators should determine the following.

• Does the project involve research?
• Will the project involve human subjects?

Definition of Research
Research is defined by the regulations as "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge." The regulations further specify "activities which meet this definition constitute research, whether or not they are conducted or supported under a program which is considered research for other purposes.

Definition of Human Subject
Human Subject is defined by applicable Federal regulations (45 CFR 46.102(f)) “as a living individual about whom an investigator conducting research obtains:

(1) Data through intervention or interaction with the individual, or (2) Identifiable private information.”

2. What is the Role/Expectation of the Faculty Advisor?

The role as the advisor is to guide students through the IRB process by discussing general principles of research ethics with the class/student prior to the initiation of any project involving human subjects.

Faculty members who supervise student research are responsible for the protection of human subjects and are required to:

1. Be familiar with the ethical and regulatory requirements of human subjects research.
2. Consider whether projects require IRB review and assist students with the process.
3. Discuss research ethics with the students.
4. Monitor student projects, paying special attention to maintaining confidentiality, privacy, level of risk, voluntary participation and withdrawal, and informed consent.
5. Assure that any unexpected or adverse events are reported to the IRB.
6. Complete the CITI Training.

3. Items Required for IRB Project Submission:

1. IRB Research Protocol Application submitted through IRBNet.
2. Research Instruments (Recruitment Flyers, Questionnaires, Interview Guides, etc.)
3. Proof of human subjects training (valid for 3 years.) Please follow this link for instructions to complete the required CITI training. Human Subjects Research Training.
4. Curriculum Vitae or Resume for anyone involved with the Research protocol (PI, FA, Co-Investigators, Graduate Students). This may not be practical for most undergraduate student researchers and in some cases may be waived.
5. Letters of support are required when subjects will be recruited from institutions other than Saint Joseph's University. The letter will need to be signed by an authorized person and on the institution's letterhead.

For additional information and guidance please refer to the SJU IRB New Project Submission Checklist.