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Institutional Review Board (IRB)

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:

  1. Industry protocol, multi-center trial, where our institution will act just like other sites (and IRB is accredited)
  2. 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:

  1. The IRB is not accredited
  2. The study is investigator-initiated
  3. The PI here is the overall PI for the trial
  4. Our site has other responsibilities, such as serving as the DCC
  5. Our PI has any oversight responsibilities for another site

Training Documentation

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.

Financial Interests in Research Disclosure

All personnel involved in the design, conduct or reporting of a particular research study are covered. Below is a brief summary of what this means for you as a Principal Investigator or study team member; those of you at member hospitals will find that the policy and some of the COI research processes differ from what you have done until now:

  • Financial Interests in Research Disclosure Form (“FCOIR Form”)
    All Mount Sinai Health System Investigators and personnel who are listed on the GCO’s Investigator Form (“IF Form”) will receive an email asking them to complete research project-specific disclosures of their financial interests. You will do this electronically using the Financial Interests in Research Disclosure Form (“FCOIR Form”) in Sinai Central. This project-specific approach is a change from existing practices at some member hospitals. View instructions on completing the FCOIR form. (Note: All Physicians employed by the Mount Sinai Health System must complete the online Annual Report of Outside Relationships prior to submitting the research-specific Financial Interests in Research Disclosure Form (“FCOIR Form”). If you have not completed the Annual Report of Outside Relationships, instructions may be found at the following link: http://icahn.mssm.edu/research/resources/conflict-of-interest-coi.)
  • Review of Financial Disclosures by the Mount Sinai Conflict of Interests Office
    Your disclosures will be reviewed by the Mount Sinai Financial Conflicts of Interest in Research (FCOIR) staff and/or Committee to determine whether those interests pose a conflict for a specific research project. If a conflict is identified, you will be contacted by the FCOIR Office regarding creation of a management plan. The finalized plan will be signed by the PI, any other team member who might have a conflict, and the Conflicts of Interest in Research Committee Chair, Rhoda Sperling, MD (Professor and Vice Chair of the Department of Obstetrics, Gynecology and Reproductive Science).
  • Mandatory Training on Financial Conflicts of Interest in Research (FCOIR)
    Prior to finalization of a research project application by the GCO, the project Investigator(s) and named study personnel must complete the School’s FCOIR training, which will take about 15-20 minutes. (Note: The School’s FCOIR training replaces the CITI COI training, and is required of all project investigator(s) and study personnel.)
    • Following initial training, refresher training is required at least every four years. To access your online COIR Training:
      • Log in to Sinai Central
      • Select from the left-most menu: GCO > Investigator Forms > COI Education Module

We hope that you will find the policy and associated processes to be informative and user-friendly. If you have questions, the Conflicts of Interest Office is available to help you via the COI Helpline at (212) 241-0845. We look forward to working with you.

Accessing Sinai Central

  • All current employees of the Mount Sinai Health System already have accounts in Sinai Central (use your current username and password to log in).
  • For those researchers that are not Mount Sinai employees, you must request an extranet account be set up for your use. (http://sinaiknowledge.mssm.edu/instructions/extranet). You must have a Sponsor (usually your department administrator, or other designated individual in your department) sign into SAILPOINT at https://sailpoint.mountsinai.org/ to request an account be set up. Contact your department for help with this.

Which courses must I take?

View a list of required courses that must be completed before any involvement in any human subject research project. All courses are available through http://www.citiprogram.org.

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)
http://www.hhs.gov/ohrp

Contact Us

Robert Jordan, CoordinatorTel: 212-979-4447

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