Go to the IRB website at https://irbmanager.becirb.com to submit paperwork.
Complete new protocol paperwork (including new protocol fee of $1,250.00 for sponsored protocol), renewal ($250.00 for sponsored protocol) requests, SAE reports, consent revisions, etc. must be submitted at least 10 working days prior to IRB meeting in order to allow time for review by Chair and distribution to IRB members.
Investigators submitting a new protocol or new or additional investigator to an approved protocol must show proof of training in the protection of human subjects in research for all involved.
Notice: In order to publish results of your study in the future, you must first register your study at https://www.clinicaltrials.gov. See website for further information.
Use of External IRBs
We allow for the use of a commercial IRB under the following circumstances:
- Industry protocol, multi-center trial, where our institution will act just like other sites (and IRB is accredited)
- NIH consortium project where NIH requires use of central IRB (and it is AAHRPP-accredited)
We will (typically) not allow the use of a commercial IRB if:
- The IRB is not accredited
- The study is investigator-initiated
- The PI here is the overall PI for the trial
- Our site has other responsibilities, such as serving as the DCC
- Our PI has any oversight responsibilities for another site
As we are are now operating under Mount Sinai IRB regulations and Mount Sinai does not recognize NIH's training, we will soon start rejecting any submissions for studies that have not submitted the required documentation for ALL research staff involved.
Which courses must I take?
When setting up your account, affiliate with Icahn School of Medicine at Mount Sinai. Use your work email account, your name as recognized by HR, and your life number for your profile. These steps will enable your credits to register under this account and will provide easy access to viewing which courses you have completed.
Human Research Questions & Answers
Office for Human Research Protections (OHRP)