Saint Joseph’s University IRB Frequently Asked Questions (FAQs)

The Institutional Review Board (IRB) is a federally mandated committee responsible for reviewing research involving human participants to ensure their rights, safety, and welfare are protected. The IRB’s primary role is to evaluate ethical considerations, ensuring participants are fully informed of study procedures, risks, and alternatives (if applicable) through the informed consent process. Additionally, the IRB protects researchers (faculty, staff, and students) by ensuring compliance with federal regulations and minimizing risks in research activities.

The IRB is guided by three core ethical principles from the Belmont Report:

• Respect for Persons: Recognizing the dignity and autonomy of individuals, with special protections for those with diminished autonomy (e.g., children or individuals with decision-making impairments).
• Beneficence: Maximizing benefits and minimizing potential harms to participants.

Justice: Ensuring fairness in the distribution of research benefits and burdens across participants.

• Research: Defined by 45 CFR 46.102(l) as "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge."
• Human Subject: Defined by 45 CFR 46.102(e)(1) 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."

The SJU IRB reviews research involving human subjects if:

• The research is sponsored by SJU, regardless of location.
• It is conducted by or under the direction of SJU faculty, staff, students, or agents in connection with institutional responsibilities.

It uses SJU property, facilities, or non-public information to identify or contact participants.
Special considerations apply to research involving vulnerable populations (e.g., fetuses, pregnant women, prisoners, children, or individuals with decision-making impairments). Refer to SJU IRB Standard Operating Policies and Procedures (SOPPs) 1 and 2 for details.

All SJU faculty, staff, and students (undergraduate and graduate) conducting research involving human subjects or their data must obtain IRB approval before beginning their study. Failure to secure approval may result in legal or disciplinary consequences. If unsure whether your project requires IRB review, contact the Research Compliance Manager at irb@sju.edu or (610) 660-1298.

All projects involving human subjects—whether through direct participation (e.g., surveys, interviews, physical/mental tasks, audio/video recordings) or indirect use of their data—must be submitted to the IRB for review. This includes studies like educational comparisons or biomedical procedures. For clarification, consult SOPP 1 or contact the Research Compliance Manager.

The IRB evaluates:

• Risks to participants.
• Anticipated benefits to participants and others.
• The significance of the knowledge expected to result from the research.
• The informed consent process ensures that participants are fully informed and that consent is voluntary.

• Exempt Review: For research posing no more than minimal risk (comparable to daily life) and fitting specific exemption categories (45 CFR 46.104). Reviewed by the Research Compliance Manager within 2 business days of complete submission via IRBNet.
• Expedited Review: For minimal-risk research fitting specific categories (45 CFR 46.110). Reviewed by two IRB members, with a determination within 14 business days.
• Full Board Review: For research with greater than minimal risk or not qualifying for exempt/expedited categories. Reviewed at a convened IRB meeting, with a determination typically taking 4–8 weeks.

Refer to SOPP 4 for details on review categories.

No, some research qualifies for exempt or expedited review based on risk level and category. However, all projects must be submitted via IRBNet for the Research Compliance Manager to determine the appropriate review level (SOPP 1 and 2).

Yes, even exempt research requires IRB review. Submit all materials via IRBNet, and the Research Compliance Manager will confirm the exempt status. Self-determination of exemption is not permitted.

• IRB Research Protocol Application.
• Study instruments (e.g., surveys, recruitment materials, consent forms).
• CITI Training certificates (valid for 3 years) for all investigators.
• CVs for faculty and graduate students (may be waived for undergraduates).
• Letters of support (if recruiting from external institutions).
  Refer to the SJU IRB New Project Submission Checklist. A determination letter will be issued via IRBNet upon review.

Research involving human subjects may not start until you receive an official exemption or approval letter from the IRB via IRBNet.

All individuals involved in human subjects research (e.g., investigators, faculty advisors, research assistants) must complete CITI Training (valid for 3 years) before final approval. Access the training via the CITI Training Requirements Guide.

• Exempt Review: Typically within 2 business days of a complete IRBNet submission.
• Expedited Review: Typically within 14 business days.
  To expedite the process, ensure all materials are complete and clear. Contact the Research Compliance Manager(irbadministrator@sju.edu) for pre-submission review if needed. Plan to submit at least one month before your intended start date.

Full board reviews may take 4–8 weeks, depending on the protocol’s complexity, clarity, and need for revisions. Submit materials by the 1st business day of the month for consideration at that month’s meeting.

The IRB meets on the third Thursday of each month, except in January, June, July, and August. Contact irb@sju.edu for urgent reviews during these months.

Protocols requiring full board review must be submitted via IRBNet by the 1st business day of the month to be reviewed at that month’s meeting.

Use IRBNet, SJU’s electronic submission system. Follow the SJU IRB New Project Submission Guide and Checklist for detailed instructions.

If your research involves SJU affiliation (e.g., conducted by SJU personnel or using SJU resources), it typically requires SJU IRB review in addition to the site’s IRB. Contact the Research Compliance Manager (irb@sju.edu) to determine the appropriate process.

Submit amendments or modifications via IRBNet, following the Amendment/Modification Submission Guide and Checklist.

All forms and templates, including applications, consent forms, and checklists, are available on IRBNet. You must have an IRBNet account to access these documents.