Protocol Submission Guide

Saint Joseph’s University (SJU) utilizes IRBNet, a secure, web-based platform, to manage the submission, review, and oversight of research protocols involving human subjects. This guide outlines the steps and requirements for submitting a research protocol to the SJU Institutional Review Board (IRB), ensuring compliance with federal regulations, the Belmont Report, and SJU’s commitment to ethical research.

Before preparing a research protocol, investigators must determine whether their project meets the criteria for IRB review by answering the following:

• Does the project involve research?
  Research is defined by 45 CFR 46.102 as "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge." This applies regardless of whether the project is conducted under a program explicitly designated as research.
  
   
• Does the project involve human subjects?
  A human subject, as defined by 45 CFR 46.102(e)(1), is "a living individual about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual, or (2) identifiable private information."
   

Investigators should consult the IRB’s Standard Operating Policy and Procedure (SOPP) 1: Determination of Need for IRB Review and Approval for guidance. If you are unsure, please contact the Research Compliance Manager at irb@sju.edu.

Faculty advisors overseeing student research play a critical role in ensuring ethical conduct and compliance with IRB requirements. Responsibilities include:

• Familiarizing themselves with the ethical and regulatory requirements of human subjects research, including 45 CFR 46 and the Belmont Report.
• Determining whether a project requires IRB review and guiding students through the submission process.
• Discussing research ethics with students, emphasizing principles such as informed consent, confidentiality, privacy, voluntary participation, and the right to withdraw.
• Monitoring student projects to ensure compliance with IRB-approved protocols, particularly regarding risk management and participant protections.
• Reporting any adverse events or unanticipated problems to the IRB promptly.

Completing the required CITI Training for human subjects research (valid for 3 years).

All research protocols must be submitted via IRBNet. The following items are required:

• IRB Research Protocol Application: Complete the application form available on IRBNet.
• Research Instruments: Include all relevant materials, such as recruitment flyers, questionnaires, interview guides, or other tools.
• CITI Training Certificates: Provide proof of human subjects research training (valid for 3 years) for all investigators, including principal investigators (PI), faculty advisors (FA), co-investigators, and graduate students. Follow the CITI Training Instructions to complete this requirement.
• Curriculum Vitae or Resume: Submit CVs or resumes for all individuals involved in the protocol (PI, FA, co-investigators, graduate students). This requirement may be waived for undergraduate students in certain cases, at the discretion of the IRB.
• Letters of Support: If recruiting subjects from institutions other than SJU, include a signed letter of support on the institution’s letterhead from an authorized representative.

Additional Documentation: Refer to the SJU IRB New Project Submission Checklist for a comprehensive list of requirements.

IRBNet streamlines the submission, review, and management of research protocols. Key features include:

• Electronic Submission: Investigators submit all materials electronically via IRBNet.
• Collaboration Tools: IRBNet facilitates communication and document sharing among investigators, administrators, and IRB members.
• Resources: Access forms, templates, and submission guides directly within IRBNet.

For detailed instructions, refer to the Investigator Submission Guide. Training sessions (group or individual) are available upon request by contacting irb@sju.edu. The IRB also offers class visits to provide training on research ethics and IRB processes.

IRBNet Training Resources

Access training materials, including videos and guides, at IRBNet Training Resources. Use the following login credentials:

• Username: sju
• Password: training

All forms and templates are available on IRBNet and the SJU IRB Forms Page. Key documents include:

• Application for New Projects
• Consent Form Template
• Web Consent Template
• Consent Template for Exempt Research
• IRB Conflict of Interest Form
• Amendment/Modification Form
• Progress Report Form
• Final Report Form
• Support Letter Template
• New Project Submission Checklist
• Amendment/Modification - Continuing Review - Closure Submission Checklist
• New Project Submission Guide
• Amendment/Modification - Continuing Review - Closure Submission Guide
• Child Assent Form

The IRB operates under Standard Operating Policies and Procedures (SOPPs) to ensure compliance with federal regulations (45 CFR 46) and SJU’s commitment to ethical research. These policies apply to all faculty, staff, and students conducting human subjects research, regardless of funding or location. Key SOPPs include:

• SOPP 1: Determination of Need for IRB Review and Approval
• SOPP 2: Submission Requirements and Procedures
• SOPP 3: Research Personnel Roles and Responsibilities
• SOPP 4: Initial and Continuing Review by the IRB
• SOPP 5: Noncompliance
• SOPP 6: Adverse Events and Unanticipated Problems
• SOPP 7: Informed Consent
• SOPP 8: Research Involving Students
• SOPP 9: International Research
• SOPP 10: Use of the Internet and Social Media
• SOPP 11: Recruitment and Payment of Subjects

For a complete list, refer to the SJU Policy on Research Involving Human Subjects.

Protocols requiring Full Board Review must be submitted by the 1st working day of the month to be considered at that month’s IRB meeting, held on the third Thursday of each month. The IRB does not typically meet in January, June, July, or August. For urgent reviews during these months, contact the Research Compliance Manager at irb@sju.edu.

IRB Membership (as of September 1, 2024)

• Alexandar Skolnick – Psychology
• Aubrey Wang – Education (Chair)
• Bela Peethambaran – Biology
• David Longerstedt – Physical Therapy (Co-Chair)
• David Thomas – Non-Affiliated/External Member
• Josephine Shih – Psychology
• Judith Parker-Kent – Occupational Therapy
• Kim Logio – Sociology
• Michelle Jeon – Pharmacy Practice
• Patrick Davitt – Kinesiology
• Sally Kuykendall – Health Sciences
• Sylvester Carter – Physical Therapy
• Thomas Kaeo – Office of Research Services