Applications | HIPAA | Informed Consent | Key Information | Other Forms | Emergency Use | Single IRB/Reliance Agreements
NOTE: The forms below are being updated on an ongoing basis. In the meantime, references to "Committee on Clinical Investigations," "CCI," or "MMC IRB" refer to the Einstein IRB. New and recently revised forms have "Revision" dates highlighted in yellow.
Applications
Please note, the use of paper application forms has been phased out. Learn more about iRIS, the Einstein IRB's new paperless application system. |
HIPAA
Note: The iRIS consent form templates include HIPAA language (so separate HIPAA Authorization forms are not needed for studies using consents prepared from the iRIS templates).
Consent
Key Information Section for Consent Documents
Other Forms
Emergency Use Consent Templates
Document |
Revised |
ICD Template for Emergency Use of an Investigational Device |
04/11/16 |
ICD Template for Emergency Use of an Investigational Drug or Biologic |
04/11/16 |
Single IRB/Reliance Agreements
*If you are requesting that Einstein serve as the Lead IRB for more than one external site, please contact us prior to submitting your study in iRIS.*
Questions about the use of a single IRB, SMART IRB, IRB Choice, or collaboration with individual investigators outside of Einstein/Montefiore?
Email us at SingleIRB@einsteinmed.org or call us at 718-430-2237 and ask to speak with someone about reliance agreements or the use of single IRBs.
The Einstein IRB reviews requests to rely on external IRBs (including the SMART IRB and IRB Choice) on a protocol-specific, case-by-case basis, once those requests have been submitted to us in iRIS. We encourage researchers to contact the Einstein IRB as soon as possible (and prior to submitting grants) to discuss the feasibility and process for ceding arrangements between institutions. We also remind researchers to familiarize themselves with the reporting requirements of both Einstein/Montefiore and the external IRB, since PIs will usually need to provide information and ongoing reports to both institutions.
Document |
Revised |
Reliance Request Form (Contains information regarding what must be submitted to the Einstein IRB, gives you a better sense of the process, and must be completed as a first step in any IRB reliance arrangement.) |
5/18/19 |
Individual Investigator Agreement |
2/27/19 |