Office of Human Research Affairs

OHRA 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. 

PLEASE NOTE: Due to the COVID-19 pandemic, the IRB has limited staff in the office at  this time.  We encourage you to email irb@einsteinmed.org with your name, contact information and a brief description of your issue and someone will call you back the same day.  Please note that if you do call the main number (718-430-2237) the voicemail is checked multiple times per day. You may also schedule a regulatory/ethics consult by clicking the "Training and Consultation" button to the right.

RECENT ANNOUNCEMENTS
: 

 Latest COVID-19 Research Guidance and Information 

iRIS UPDATES 

 Revised Common Rule:  

As of January 20, 2020 the New Common Rule's Single IRB Mandate requiring single IRB review of NEW federally funded non-exempt multi-site cooperative research will be in effect.  If you are preparing a new grant application that you believe may be subject to this policy, please inform the Einstein IRB by completing an IRB Reliance Request Form no later than two weeks prior to the grant application deadline.

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.  
    • 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. 

Need additional guidance on the new requirements? 

Request a regulatory consultation here. Or contact the IRB by email at irb@einsteinmed.org 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.)

  

 RESEARCH TOOLS 

Training and Consultation Request Form 

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@einsteinmed.org 


Staff List 

 

 


 

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