Office of Human Research Affairs

Overview

The Office of Human Research Affairs at Albert Einstein College of Medicine promotes and protects the rights and welfare of all human research participants. The OHRA facilitates excellence in human research by extending personalized guidance and support to the research community through timely and high quality service, education, review, and monitoring.  

Important Updates 

 Revised Common Rule: On January 21, 2019 a new version of the HHS IRB regulations (the Common Rule) will go into effect (the original implementation date was January 19, 2018 – this date was delayed twice).  This is the first update to the regulations since they were published in 1991. A detailed summary of the changes is available here. 

How will the changes affect your research? 

Consent forms will now require a Key Information section that briefly covers study activities, risks, and benefits presented to research participants in advance of the body of the consent document.  Information about the concise summary requirement and other new consent language requirements is available here.  Key Information section examples are available hereThe IRB will be providing workshops on this new requirement starting in December 2018.  Existing studies are not required to meet the new consent language requirements. 

There is a new Exempt Category for Benign Behavioral Research.  More information about Benign Behavioral Research is available here.  A detailed summary of all the new Exempt Categories is available here.  And a decision chart for the new Exempt Categories is available here. The IRB will be providing workshops on this new requirement starting in January 2019. 

The IRB will no longer review grant applications or proposals. The IRB instead requires that a working protocol be submitted that meets all the requirements in the protocol elements checklist

How will existing studies be impacted? 

The revised regulations will only apply to new submissions (and the ongoing submissions associated with them) approved on or after January 21, 2019. 

Submission Date 

Falls Under 

Approval Date 

On or before December 20, 2018

Old “Common Rule”

Before January 21, 2019

After January 1, 2019

Revised “Final Rule”

After January 21, 2019


What if I have a study that is currently under IRB review? 

We have asked all new Expedited and Full Board submissions received by the IRB by December 20th, 2018 to comply with the Final Rule.  We have asked all new Exempt submissions received by the IRB by January 1st, 2019 to comply with the Final Rule.  If you are currently working with the IRB staff on a submission, and it receives final IRB approval by January 21, 2019, you may be approved under the old Common Rule.

Need additional guidance on the new requirements? 

Request a regulatory consultation here. Or contact the IRB by email at irb@einstein.yu.edu or phone at 718-430-2237.  You may also register for training sessions here.  (Slides from the presentation on new consent requirements are available here.  Slides from the presentation on the new Exempt Categories are available here.)


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.

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.

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

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

 

 Training and Consultation Request Form   

 Research Agreement Request Portal   

Contact Us

Office of Human Research Affairs

Belfer Building #1002
1300 Morris Park Avenue
Bronx, NY 10461
Phone: 718.430.2237 Fax: 718.430.8817
Email: irb@einstein.yu.edu 


Staff List 

 

 
 
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