Office of Human Research Affairs

Getting Started

As you prepare to submit a study to the Einstein IRB, or if you are wondering whether you have to submit your project to the IRB at all, here are the basic keys to getting started. Familiarizing yourself with these fundamental points will save you time and effort in the long run.

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.

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
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
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@einsteinmed.org with any questions.

Private Industry Contracts

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. Use our Protocol Elements Checklist or the peer-reviewed SPIRIT 2013 guidelines to develop a protocol with all the necessary criteria included. Please note that grants may not serve as the protocol as the IRB will no longer review grant applications or proposals.
Application for Exempt, Expedited, or Full Board Review	Complete in iRIS (optional training is available)
Policies	IRB Policies
Consent Documents	Downloadable Templates
Required Approvals (Signatures)	Approval Requirements