Please see below for guidance regarding IRB review related to securing grant approval

IRB REVIEW FOR JUST-IN-TIME OR DELAYED ONSET HUMAN RESEARCH

JUST-IN-TIME APPROVAL IN CONCEPT:

Some funding sponsors allow for documentation of IRB Approval in Concept to be submitted after the proposal has received a certain impact score through the Just-in-time (JIT) process. You may be required to provide the date of IRB approval of the research plan for JIT.

DELAYED ONSET HUMAN RESEARCH:

For projects lacking definite plans for the use of human subjects, some funding sponsors can accept a determination notice that establishes a limited time period under which the PI may conduct preliminary or conceptual work that does not involve human subjects.

IMPORTANT: Please note that “delayed onset” is not the same as “delayed start.”

You must have approval from the funding sponsor’s grants management officer in order to apply for a delayed onset award. See NOT-OD-15-129.

 

You can request a JIT Approval in Concept of the research plan or confirmation of delayed onset of human research via email by submitting a copy of the grant, minus appendices, to the IRB POBOX.

In the body of your email, please identify:

  1. Principal Investigator
  2. Study Title (exactly as it should appear on the letter)
  3. Funding Source
  4. Your given deadline
  5. Any additional information that the IRB may need to confirm in the determination letter (e.g. proposal number).

Approval in Concept of the research plan will granted for a period of one year. Please note that this is not authorization to begin human research activities. A full protocol application (including consent forms and supplemental documents) must first be submitted through HS ERA for assessment and approval by the IRB prior to engagement in human research activities.

IRB APPROVAL AND RUSH REVIEW FOR GRANT APPROVAL

Some funding sponsors will not issue a Notice of Award until IRB approval has been obtained. This is different from the Just-In-Time and Delayed Onset processes, as this is a requirement to provide IRB approval and authorization to begin human research activities.

Please contact the Office of Research Services Pre-Award in order to identify your IRB review requirements. For example, you may be able to provide the upcoming IRB review date in lieu of the IRB approval date. If you are required to provide an IRB approval date, please identify the approved-by deadline

If through consultation with ORS it is determined that you require a rush IRB review, please forward documentation (e.g. email correspondence) from ORS highlighting the specific review requirements and deadline to the IRB POBOX (irb@pobox.upenn.edu). Please provide your HS-ERA confirmation code or protocol number with this email. A member of the IRB staff will respond with the anticipated review timeline and any additional items that may be required to complete the review.

Due to the high volume of submissions, the IRB will not honor rush requests without confirmation of the necessity of the rush request and specific deadlines for review/approval.

IMPORTANT: You must submit a protocol through HS-ERA in order to be eligible for IRB review. An email to the IRB is not sufficient. Please see instructions on creating the initial submission on the How to Submit Page. 

 

REQUESTING A LETTER FROM PENN IRB TO RECEIVE PA DEPARTMENT OF HEALTH (DOH) APPROVAL

Please submit a copy of the following to the IRB PO Box:

  1. Your PA Department of Health IRB application as the PA DOH requires this to be signed by the IRB
  2. If the study involves secondary analysis of data / specimens collected on another research study, please provide the IRB number, IRB of record, and study title to be referenced in the letter.