Scientific Review and IRB Submissions
All IRB submissions, including Protocol Revision and Amendment Forms, must be submitted through the administrative offices of the Helfgott Research Institute. The IRB does not accept forms directly from investigators or researchers.
Investigators may download all the forms necessary for a complete IRB submission on the IRB Documents Page, in the left menu. Please note that a complete protocol must be submitted with these forms.
Student Researchers who are designing a study should be in close contact with Student Research Specialist, Morgan Schafer, firstname.lastname@example.org, well before any IRB submission date.
Special Note to Student Researchers: Once you and your mentor have solidified your research proposal idea, please submit the Student Proposal for Scientific Review form electronically to the SRC Liaison. Once the SRC has received your Student Proposal for Scientific Review form, you and your mentor will be contacted by the SRC to schedule a meeting for discussion about your study design and to address any potential concerns. After the meeting and when all of your study documents have been finalized, all study documents are then resubmitted to the SRC for a formal review process.
Process Flow for IRB Submission: Student Researchers
Process Flow for IRB Submission: Non-Student Researchers
Scientific Review and IRB Submissions
Complete IRB submissions must be sent, in electronic form, to Kendal Kubitz, email@example.com, by the submission due dates listed below (the first Monday of the month, excluding holidays). If at all possible, please do not submit paper forms.
As a matter of procedure, all IRB submissions will be reviewed by the Helfgott Scientific Review Committee (SRC) prior to being sent to the IRB. The study protocol and all necessary forms and addenda should be considered final and complete upon their submission to the SRC. Use of the Document Checklist is strongly encouraged to assist investigators with their document submission preparations. During review, SRC members will work with you to make any appropriate revisions and edits. If the submission passes SRC review, applications are then sent, at the beginning of the following month, to the IRB for review. ALL research, including company-funded and investigator-initiated projects must be reviewed by the SRC prior to IRB submission.
Scientific Review Committee submission due dates–first Monday of the month:
SRC-approved documents are due to the IRB on the first Tuesday of each month. Full IRB Meetings are generally convened on the third Tuesday of the month.
Protocol Revision/Amendment Forms (PRAFs)
PRAFs (modifications to approved studies) must be sent electronically to the IRB Liaison, Kendal Kubitz, firstname.lastname@example.org. The IRB does not accept PRAFs directly from investigators. Typically, a PRAF does not need to go through the full SRC review process. Assuming that it is accurate and complete, Helfgott will gather all PRAFs and forward them on to the IRB every two weeks for immediate consideration. However, if the modification is complex or may substantially affect human subjects, the IRB Chair may not be able to expedite the PRAF and it will need to go to the next scheduled IRB meeting.
PRAF submission dates are every other Thursday as follows:
Please Note: In order for a PRAF to undergo a full IRB review in a given month, it must be submitted by the IRB Liaison to the IRB by the first Tuesday of that month. If you have a concern that your modification may require full review, please be in contact with the IRB Liaison, email@example.com, to assure that your PRAF gets to the IRB in time for the next scheduled IRB meeting or you may need to wait for the following month's full review.