Institutional Review Board

Overview

IRB News

Single IRB Request/Review Process: The IRB has published updated guidance and FAQs for the new NIH Single IRB policy and the Request/Review process at Einstein. Details can be found here.

Delay of Revised Common Rule:On June 18, 2019 HHS announced another 6 month delay to the effective and implementation deadline for the revised HHS IRB regulations (the Common Rule) from July 19, 2018 to January 21, 2019 (the deadline was originally changed from January 19, 2018 to July 19, 2018). This is the first update to the regulations since they were published in 1991. There are four categories of changes that will directly affect the research community: (1) additional consent language requirements, (2) new and revised Exempt Categories of research, (3) revised continuing review requirements, and (4) removal of the requirement for the IRB to review grant applications or proposals. The Einstein IRB had published revisions to its application materials and consent templates to reflect these changes for the original January deadline. These materials have now been updated to reflect the new date. A detailed summary of the changes is available here.

ClinicalTrials.gov: The IRB has published updated guidelines and FAQs for registration of studies on ClinicalTrials.gov. Instructions for registering your study are available here. Instructions for updating your registration are available here.

Certificates of Confidentiality: On October 1, 2017 NIH updated its Certificates of Confidentiality (CoC) policy. The IRB has published a policy and guidance and FAQ to help researchers meet the requirements of the new policy.

Video on NIH Policies on Human Subjects Research and Clinical Trials: The NIH has provided a 15 minute video giving an overview of the new NIH human subjects research and clinical trial policies.

Einstein's New FWA Number: Einstein has a new FWA Number: 00023382. For more info see our FAQs.

IRB Roster Requests: The Einstein IRB does not release its membership list. However, we do provide this letter.

The IRB has new staff: Check our staff list to see an updated contact list.

Informed Consent Documents have been updated: Updated consent documents are available here and in the iRIS help menu.

Epic is here: Learn more about required language in consent documents.

Documentation of Human Subjects Education for NIH-funded Studies: Learn more about creating these documents for NIH-funded studies.

Migration of "pre-iRIS" studies to iRIS is complete: Learn more about how to complete the process.

Required Clinical Research GCP Certification: Learn more about the new requirement for GCP training that applies to all key personnel involved in the conduct of new and ongoing drug and device studies which took effect January 1, 2017.

iRIS is now required for all new study submissions (Exempt, Expedited, and Full Board)! Learn more, visit the iRIS Info Page, review the Frequently Asked Questions (FAQ), and register for an optional training session.

The Einstein Human Research Protection Program (HRPP) promotes and protects the rights and welfare of all human research participants. Affiliated organizations include all of the colleges and schools of Yeshiva University, Montefiore Medical Center, Jacobi Medical Center and North Central Bronx Hospital.

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. Two IRB meetings are held monthly to review full board items while all other transactions are reviewed upon receipt on an ongoing basis.

*An Institutional Review Board is a committee, operating under Federal regulations, State laws, and institutional policy, that reviews research involving human subjects to ensure the ethical and equitable treatment of those subjects.

Contact Us

Staff List and "Whom to Contact" Guide
Phone: 718.430.2237
Email: irb@einstein.yu.edu   

East Campus
Belfer Building #1002
1300 Morris Park Avenue
Bronx, NY 10461
Fax: 718.430.8817

West Campus
3308 Rochambeau Avenue
Bronx, NY 10467
Fax: 718.798.5687

 

Training and Consultation

Training and Consultation Request Form 

 
 
 
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