Starting with the Scientific Review Committee (SRC)
As a matter of procedure, all human subject research must receive approval from the Helfgott Scientific Review Committee (SRC) prior to being sent to the IRB. Please submit your complete IRB proposal to the SRC for review. 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 for Scientific Review is strongly encouraged to assist investigators with their document submission preparations.
After completing its review, the SRC will provide investigators with a written summary evaluation as well as detailed comments and edits on submitted documents. The committee may request a meeting to discuss substantive questions about the proposal. Depending upon the committee’s findings, one of the following recommendations may be made:
- If only minor changes are recommended, the SRC may require no further review before submission to IRB. In this case, investigators may make suggested edits, to their own satisfaction, and submit to the IRB at the next IRB deadline (first Tuesday of the month).
- If more significant changes are recommended, the committee may request a complete resubmission, with edits, to the SRC. Depending upon the changes that are recommended, the committee will give instructions either to resubmit the proposal as soon as edits have been made, or to resubmit at the usual SRC deadline (first Monday of the month), in a subsequent month. Investigators should submit revised documents to the primary reviewer, addressing all comments from the previous review. Approval from the SRC is still required before documents may be submitted to the IRB for review, and depending upon the quality of the resubmission, this could take longer than anticipated. The primary reviewer may request more than one round of edits.
Please consider that most student submissions involving human subject research require major revisions before receiving SRC approval. Student researchers should therefore budget for a period of 2-3 months between the initial SRC submission and submission to the IRB.
During review, SRC members will work with you to make any appropriate revisions and edits. Instructions and deadlines for resubmissions will be provided by the primary reviewer, after initial review. Please contact your primary reviewer with any questions about the review timeline or SRC requirements. Once the submission passes SRC review, it is the responsibility of the investigator(s) or student(s) to send the complete submission, in electronic form, to Kendal Kubitz (email@example.com), by the due dates listed below (the first Monday of the month, excluding holidays).
Please Note: 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
- September 7
- October 5
- November 2
- December 7
- January 4, 2016
- February 1
Ending with the Institutional Review Board (IRB)
SRC-approved documents are due to the IRB on the first Tuesday of each month by 5 p.m. Complete IRB submissions must be sent with the IRB Submission Checklist, in electronic form, to Kendal Kubitz, firstname.lastname@example.org (by 5 p.m.). IRB Meetings are generally convened on the third Tuesday of the month. It is HIGHLY recommended that students and principal investigators attend the meeting of their study’s review. This helps to clarify any points the study team would like explained and vice versa.
Institutional Review Board Submission Due Dates–first Tuesday of the month
- September 1
- October 6
- November 3
- December 1
- January 5, 2016
- February 2
Process Flow for IRB Submission: Student Researchers
Editing IRB Approved Protocols via Protocol Revision/Amendment Forms (PRAFs)
Protocol Revision and Amendment forms are used when modifications to approved studies are required by the research team. All PRAFs must be sent electronically to the IRB Liaison, Kendal Kubitz, email@example.com. The IRB does not accept PRAFs directly from investigators. Typically, a PRAF does not need to go through the full IRB review process. Assuming that the PRAF is accurate and complete, the IRB Liaison 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–every other Thursday as follows
- Oct 1 & 15
- Nov 5 & 19
- Dec 3 & 17
- Jan 7 & 21
- Feb 4 & 18
- Mar 3 & 17
- Apr 7 & 21
- May 5 & 19
- Jun 2 & 16
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, Kendal Kubitz (firstname.lastname@example.org), 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.
Continuing a Study
All investigators are required to submit a Continuing Review Form annually to the IRB. This document should be submitted to the IRB Liaison, Kendal Kubitz, email@example.com, one month prior to the study’s renewal date. Investigators are responsible for submitting this form on time; the NCNM IRB does not provide annual reminders. If documentation is submitted on or after the renewal date then all study related activities will be suspended until Continuing Review is approved by the IRB.
Ending a Study
Once all study related activities are complete (including data analysis and publication), investigators are required to close the study by submitting a Final Review Form to the IRB via the IRB Liaison.