Institutional Review Board

Getting Started

Introduction | IRB Selection | Required Education | Grant Applications | Private Industry Contracts | Protocol Submission | Links & Help 

Introduction

The Einstein Human Research Protection Program (HRPP) promotes and protects the rights and welfare of all human research participants. Affiliated organizations include Einstein (FWA00023382, expires 10/14/2020) all of the other colleges and schools of Yeshiva University (FWA00000140, expires: 8/21/2020), Montefiore Medical Center (FWA00002558, expires: 8/21/2020), Jacobi Medical Center and North Central Bronx Hospital (FWA00009807, expires: 9/9/2020). Einstein's two IRBs (formerly known as the Committee on Clinical Investigations (CCI) and the Montefiore Medical Center IRB) facilitate excellence in human research by extending personalized guidance and support to the research community through timely and high quality service, education, review, and monitoring.

IRB Selection

Studies submitted through iRIS, the IRB's online/paperless application system, are assigned to one of our IRBs based on workload and submission timing by the IRB administrative staff.

Required Education

All Key Personnel (individuals who contribute in a substantive way to the development or execution of a protocol, or are involved in the consent process) are required to complete the Human Subjects Research Education. For studies that involve drugs and/or devices, all Key Personnel must also complete a Good Clinical Practices course.
 

Grant Applications

All federal grant applications for Einstein and Montefiore PIs are submitted through Einstein.  At Einstein, grants are prepared and routed for approval through Cayuse.  For Cayuse support, please contact your departmental administrator or the Office of Grant Support.  For guidance on choosing the right FWA #, see the Merger FAQs.
 

NIH Grant Application Resources:

Below are resources to help address the following questions in an NIH grant application.

  1. Is an activity research involving Human Subjects?

    HHS defines "Human subject" as meaning a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

    HHS Decision Chart #1 

  2. Is your Human Subjects Research eligible for exemption?

    Research may be considered exempt when human participants conform to one of the categories from section 46.101(b) of 45 CFR 46. Research may qualify as Exempt if it involves very minimal or no risk. Projects should not be considered Exempt if they include any degree of deception, involve more than very minimal risk to participants, involve sensitive information, or include protected classes or vulnerable populations.

    HHS Decision chart #2 

  3. Does the NIH Single IRB (sIRB) policy apply to your multi-site research?

    If you are preparing an NIH application and your grant proposes use of a single IRB for non-exempt multi-site research, please complete an IRB Reliance Request Form.

    The policy is applicable to new and competing renewal applications/proposals for NIH funding. It is applicable to NIH-funded multi-site domestic studies involving non-exempt human subjects’ research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program.

    If Einstein or Montefiore is being proposed as one of the participating sites in an application to by another applicant organization, you should also inform the Einstein IRB as soon as possible by completing an IRB Reliance Request Form.

    For more information on fulfilling the requirements of the NIH sIRB Policy, please follow the link here :

    Feel free to contact the Einstein IRB at irb@einstein.yu.edu with any questions.

Private Industry Contracts

The IRB charges a one-time fee of $3,000 for the review of studies supported by private industry.  The Office of Clinical Trials facilitates the review and negotiation of all clinical trial agreements for protocols sponsored by private industry.

Protocol Submission

Protocol Every new submission requires a protocol, or scientific write-up of the research.  Detailed grants generally contain this information and can serve as the protocol.  For protocols without detailed grants, use our Protocol Elements Checklist or the peer-reviewed SPIRIT 2013 guidelines to develop a protocol with all the necessary criteria included.
Application for Exempt, Expedited, or Full Board Review
Policies IRB Policies 
Consent Documents Downloadable Templates  
Required Approvals
(Signatures)
Approval Requirements  

Links & Help

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