FDU IRB Submission Instructions

About IRB Review

45 CFR 46.111 set forth the criteria that must be satisfied in order for the IRB to approve research. These criteria include, among other things, determinations by the IRB regarding risks, potential benefits, informed consent, and safeguards for human subjects. IRBs must obtain information in sufficient detail to make the determinations required under HHS regulations at 45 CFR 46.111.

The following are definitions of IRB review proposal classifications used for both New and Continuation applications, i.e., Full Boad, Expedited and Exempt reviews. You are encouraged to access the criteria for making such a determination, but are encouraged to contact the IRB Compliance Manager, Kim Diccianni, prior to getting started. You can find the application and instructions on the IRB FORMS page.

Full Board Review

Some types of research must be reviewed at a convened Full Board IRB Review. These may include:

  • Studies where subjects may be identified and their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing,  employability, insurability, reputation, or be stigmatizing
  • Studies that request sensitive information such as drug use, illegal/criminal activity, sexual practices or beliefs, abuse, etc.
  • Studies that request sensitive information such as drug use, illegal/criminal activity, sexual practices or beliefs, abuse, etc.
  • Studies asking employees for his/her perspective on working conditions or supervisory conditions where the supervisor may access the information;
  • Studies that place the subject at greater than minimal risk;
  • Studies involving vulnerable populations where a convened IRB must make required determinations;
  • Research not meeting the specific categories for exempt and/or expedited review of research.
  • Research involving PRISONERS must be reviewed at a Full Board convened meeting except if certain conditions apply. Please contact the Human Research Compliance Manager for guidance.

Expedited Review

Expedited review procedures can be used according to 45 CFR 46.110 for certain kinds of research involving no more than minimal risk, and for minor changes in previously approved research. See the list of categories of research that may be reviewed by the IRB through an expedited review procedure. Under these circumstances, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB.

Exempt Review

Some types of research may be exempt from following the regulations of 45 CFR 46 in addition to certain IRB policies and procedures. The IRB Administration must review and assess the submission to ensure the research activities meet one of six definitions as outlined in Exempt Category under 45 CFR 46.101(b). The Investigator will be requested to provide specific documentation which is identified below. This does NOT mean that the research can proceed without IRB review.

Completion of education in human research protection is required before submitting to the IRB. Requirements may be found here: http://view.fdu.edu/default.aspx?id=5825.

Some types of research may be Exempt from continuing review, such as:

  • Studies conducted for educational evaluation purposes within a class at FDU; and
  • Studies using existing archival data, collected in the course of regular clinical or educational activities, where the subjects have signed a general informed consent, approved by the IRB, giving permission for their data to be used in research;

 

For specific guidance and tips to help you formalize your submission, please click on the type of IRB proposal which are listed to the left.

Work in ProgressProposal Submission (Email) Instructions

All IRB proposals must be submitted via email to the IRB administration at fduirb@fdu.edu.

This will allow for ease of dissemination and timely review of the submission. Whenever possible, supporting documentation should be scanned and sent electronically with your proposal. Documents that cannot be scanned or sent electronically should be mailed to the IRB (see contact information) or hand delivered to the IRB at the Grants and Sponsored Projects Office, Metropolitan Campus, Becton Hall, Room 200 (include appropriate reference to your proposal). Examples of such documents include, questionnaires/tests/measures/scales, copyrighted materials, and/or original signed forms such as PI Agreements, Faculty Agreements, etc.

DOS

-  Allow PLENTY of time for a literature review, proposal preparation, and submission of suggested modifications and sufficient time for IRB review.

-  Provide specific information to the research that you are completing and ensure all requested documentation is supplied in a timely manner.

-  Become familliar with the types of proposal classifications (i.e., Full, Expedited or Exempt). You are encouraged to consult with the Human Research Compliance Manager for clarification and guidance of your specific investigation. It is recommended that you draft a timeline for proposal preparation, IRB review/approval and conduct of your research investigation as a planning strategy.

DON’TS

-  Do NOT send your application to the IRB Chairperson. Sending your application to anyone other than the IRB Coordinator will delay the review of your application.

-  Handwritten applications WILL NOT be accepted. Any handwritten documents will be returned without review.

E-mail requirements

  1. 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.
  2. In the body of your e-mail provide:
    • The Project Title and Project Number (see below, Confirmation of Receipt)
    • A list all of the documents that you will be attaching to your e-mail or sending via regular 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, Dissertation, Thesis, etc.
    • Provide a version date for each document.
    • Make sure all documents are attached before you send the e-mail.
    • Scan, whenever possible, and send any documents with signatures required (see contact information)
    • Documents are accepted in PDF, JPEG or Microsoft Word formats. However, all Consent/Assent Forms are required to be submitted in Microsoft Word format.

Confirmation of Receipt

Once your project has been received, the IRB administrative office will send an e-mail receipt of confirmation. An internal 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 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 the calendar restrictions. Please allow sufficient time as per the IRB schedule 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 are designated as either Expedited or Exempt by the IRB administrative office. These are typically reviewed within 15 business days after receipt of your proposal. Please allow at least 15 business days from the date of receipt for the IRB to respond.

If the IRB needs to receive additional information or revisions to complete the review, the 15 business day 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.

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 additional time may be needed for review of 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.

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.