IRB New Study Submission Instructions

All IRB proposals must be submitted via email to the IRB administration at dicciann@fdu.edu. Please note: The Grants and Sponsored Projects office will be transitioning to an online submission system via JotForm. Please check back. An announcement will also be made when the changes are completed and final.

All documents must be completed and submitted electronically. Whenever possible, supporting documentation should either be scanned or the original document sent electronically with your proposal. All documents must be submitted in ONE email. All documents MUST be final and not in a draft format.

All forms and protocol, consent/assent templates may be found here. (link to IRB Forms and Templates) The following documents are required:

  • IRB Application, Exempt or Full/Expedited Review,
  • Research Protocol,
  • All recruitment language and media materials. Including: scripts of in-person recruitment, flyers, social media posts, TV/Radio scripts, Email language, Listserv postings, SONA postings, any survey generator or specific research recruitment site postings such as Amazon Mechanical Turk, Prolific, etc.; any other type of recruitment for your study.
  • Consent form: A full consent template is needed for projects being submitted for full board and expedited review studies.
  • Exempt Study, Online Survey, Consent Template for exempt determination studies;
  • Assent Form for studies with children along with a Parent Consent From (the consent form language must be written as if you are speaking to the parent(s) about his/her/their child. Ex: Your child is being asked to participate in a research study. Your child will be asked to complete the following procedures: etc.)
  • All FINAL surveys, measures, interview and/or focus group protocols and scripts, educational presentations, videos or scripts of videos, and anything else a participant must see/complete for study procedures,
  • If this is your first submission to the IRB and you are a faculty or staff member, a curriculum vitae (CV) must be submitted with your project.
  • Signed Principal Investigator Agreement. If this is a student project, the student signs this form.
  • CITI certifies the PI, Faculty Mentor, if applicable, and all key research personnel: consenting/interacting with subjects, performing research procedures, and having access to identifiable research data for analysis purposes. The team is required to complete one of the training courses based on the area the research is being completed in: Faculty, Staff & Students Social, Behavioral & Educational Research, or Faculty, Staff & Students-Biomedical Research. Please note, this education must be updated EVERY three years by taking the Refresher Course. Please see the page Education and Workshops (link to page) for more information.

Additional Forms/Information that may be necessary. Please click on any links to access the web page for more information:

  • Waiver/Alteration to the Consent/Waiver of Documentation of Consent (link to page in Forms and Templates Waiver). Guidance on this form and its use.
  • If a student project, a signed Faculty Sponsor Agreement form is required. This is signed by your Faculty Mentor, Dissertation Chair, or other advisor. Please note, if you have an external advisor or adjunct advisor, please have them sign this form. In addition to your external/adjunct advisor, you MUST also have a signed form from an FDU full-time faculty member overseeing the program.
  • Adjunct Faculty who are completing research as Principal Investigator, please click on this link (link to Adjunct Faculty Requirements) for additional forms and requirements.
  • If the project involves a device or a drug, please provide the Investigator’s Brochure, specific drug information, and any additional supporting documentation from the manufacturer to assist the IRB in its review.
  • If your project involves online research, please ensure to review ALL user agreements and what is allowed for your research. This information should also be submitted as evidence, you may complete research via this avenue. Examples: web-based applications, virtual world research (Second Life, Metaverse, World of Warcraft, Roblox, etc.), social media (Facebook, Instagram, TikTok, Snapchat, X, Blue Sky, LinkedIn, etc.), chat rooms, and other web-based platforms.
  • Approval from external locations by the highest authority required by the site where your research is being completed. If the project has been reviewed by an IRB at this site, please submit the IRB review result correspondence.

DO’S and Suggestions

  • Complete a timeline for yourself. Allow PLENTY of time for a literature review, proposal preparation, and submission of suggested modifications and sufficient time for IRB review. Preparing your protocol first will allow you to assist in completing the application and other information. Your protocol is your Instructional Manual on how to complete your project and for others involved in your study or who need to know your study a complete reference on what is required to be done. October, November, March and April receive the highest number of submissions.
  • Provide specific information about the research that you are completing and ensure all requested documentation is supplied.
  • Become familiar with the types of reviews and the categories, if applicable. (i.e., Full, Expedited or Exempt). Become familiar with the definitions in the human subject research policy.
  • You are encouraged to consult with the Human Research Compliance Manager for clarification and guidance on your specific investigation.
  • Be prepared and have back-up plans in case of extenuating circumstances, such as in-person and electronic interviews in your proposal, loss of research site due to administration changes,and  reaching out to experts on how they were requested to provide information to an IRB on a certain sensitive subject.

DON’TS

  • Do NOT send handwritten applications. Handwritten applications WILL NOT be accepted. Any handwritten documents will be returned without review.
  • Do NOT send our application to the IRB Chairperson. Sending your application to anyone other than the HRCM will delay the review of your application.

E-mail Requirements

Include a description of your submission type in the subject heading of your email to the IRB, i.e. New Project; Continuing Review, Amendment, Final Report, Complaint of a Participant, Notification of a Harmed Participant, etc.

In the body of your email, provide:

  • The Project Title
  • List all the documents that you will be attaching to your e-mail, e.g. Application, Consent Document(s), Methods and Procedures, Protocol Summary, Interview script, Questionnaire, Advertisement, TV/Radio Ad Script, PI Agreement, Faculty Agreement, Grant Application, etc.
  • Provide a version date for each document. This will assist you in organizing any amendments.
  • Make sure all documents are attached before you send the e-mail.
  • Send original electronic documents and send/scan any documents with the required signatures. Electronic signatures are also accepted.

Documents are accepted in PDF or Microsoft Word formats. All Consent/Assent Forms are required to be submitted in Microsoft Word format. Recruitment Flyers and all recruitment must have IRB approval and expiration dates, or an exempt determination date placed by the HRCM. Ensure all recruitment is able to be edited and revised by the HRCM or this will delay your project.

If sending documents by OneDrive. Ensure ALL documents are able to be edited by the HRCM, Kim Diccianni.

Confirmation of Receipt

Once your project has been received, you will receive an email confirmation. An internal IRB Project Number will be assigned. Please reference this number in all future correspondence with the IRB regarding your project.

Review Time Frame

The IRB convenes on the third Wednesday of each month with the exception of the Winter Holiday Break and Summer Schedule (see below). Only proposals designated as Full Board are subject to calendar restrictions. Please allow sufficient time to ensure that your proposal is reviewed and approved, to allow adequate time for the conduct of your investigation. Any proposal that is received after the meeting deadline date will be delayed and placed on the next scheduled meeting agenda.

All other proposals designated as either Expedited or Exempt are reviewed all year round. These are typically reviewed within 3-4 weeks after receipt of your proposal. Please note this may be longer based on high submission times, IRB member availability, university/office closure, and holidays.

If the IRB needs to receive additional information or revisions to complete the review, the 3–4-week turnaround time begins at the time the additional information is received.

Please note that a final determination on the submission cannot be made until all required and requested revisions, materials, documents, etc., have been received and reviewed by the IRB Research Compliance Manager and/or IRB member.

Winter (Holiday) and Summer Schedules

Holiday Schedule

The IRB does not convene during the Winter Holiday Break, which begins the first Friday of December. Therefore, any proposal requiring Full Board review will be delayed until the January meeting.

The IRB administrative office will continue to accept applications during the Winter academic break (with the exception of the University’s holiday leave calendar for employees/staff). The review process will be completed as soon as possible. Submissions received one week before holiday leave will be confirmed but processed upon the re-opening of the office. Please note that additional time may be needed for reviewing applications, depending on the availability of committee members during the final exam period.

Summer Break

The IRB will continue to review exempt and expedited projects throughout the summer break. However, the IRB does not convene during the summer months of June, July, or August except on an as-needed basis or for emergency circumstances. Please contact the HRCM for these circumstances.

These schedules are subject to the academic calendar as published by the University, and the IRB reserves the right to adjust its calendar and review practices as necessary.

Applicants are encouraged to check the IRB Announcements section of the website frequently for changes to the calendar.