Login  
IRB Home
 
Text Block

 

    Full AAHRPP Accreditation June 15, 2007, Re-Accreditation June 15, 2010, and Re-Accreditation June 16, 2015.
 
Click on the Login link above if you are a registered user.  If you are not a registered user you will need to click on Registration.  After registering, you will be notified (by email) of your account information.  This is not an automatic registration process, you will not receive an instant response.  There may be additional steps for non-MHS personnel.
 
 **********
 

 

Flyer Title

 

 

 

 

 

 

 

MetroHealth IRB Information Regarding COVID-19

(29 April 2020)

 

The MetroHealth IRB is fully operational and we expect this to continue. IRB Staff have been mandated to work from home, so email is the best method of communication.

For IRB research, highest priority will be given to all inquiries, requests and modifications related to COVID-19. Given the current pandemic, please note the following:

Amendments:

  • Any changes to your protocol or the conduct of your research procedures still require an amendment with the IRB with the exception of those made to prevent immediate hazards (see below). Please be sure to include COVID-19 in the title so that we can prioritize those amendments.
  • All changes should be documented in your regulatory binder. Be sure to include details about communication with the funding agency, sponsor, or FDA as well as justifications for any changes made.

Changes to Prevent Immediate Hazard:

  • Any changes in IRB-approved research must be reported to the IRB and may not be implemented prior to review and approval by the IRB except when necessary to eliminate apparent immediate hazards to the subject. This is permitted by both the Common Rule and FDA regulations.
  • Examples of modifications or safety changes include, but are not limited to:

o   Cancelling non-essential study visits

o   Conducting phone visits in lieu of in-person visits

o   Conducting safety screening (initiated by the Principal Investigator) prior to in-person visits occurring.

o   Other changes as deemed appropriate to eliminate immediate hazards to subjects because of the risk of exposure to this highly communicable disease.

  • Please make all reasonable efforts to report deviations according to IRB policy and submit required amendments to the IRB promptly.

MHS Relying on Another IRB:

  • Please monitor any communications from the IRB of Record and ensure compliance with the IRB of Record’s policies and procedures.
  • Email David Webb directly at dwebb2@metrohealth.org with single IRB questions as we cannot access our IRBReliance@metrohealth.org email.

 

* Please check the eIRB homepage for frequent updates.

 

Welcome to The MetroHealth System IRB Website

We are here to help you navigate the complex federal, state and local human subjects research regulations so that innovative and collaborative research may flourish. Our mission is to protect the rights and welfare of individuals who participate in research throughout The MetroHealth System. I encourage you to check back for updates.  

* As of May 1, 2019, Sarah Partington is responsible for processing COI submission. Please contact her at 216-778-5077 if you have any questions.

* Update: New Guidance Document- Quality Improvement vs Research

Quality improvement activities are an important component of hospital operations. Because QI activities are data-driven and involve human participants, it is not surprising that there can be overlap with research methodologies common to human subjects research. Working together, the IRB and the MetroHealth Quality Institute have developed a guidance document to help distinguish quality improvement activities from human subjects research. The guidance document can be found under the IRB Forms & Template tab. For additional questions, please contact the IRB Office or Dr. Brook Watts, Chief Quality Officer.

 

Contact Us

Name                                                       Title                                                                        Phone                               Email

Carey Gorden, JD, MA                               Manager, Human Research Protection Program          (216) 778-2021                 cgorden@metrohealth.org

India Eaton, MS                                        IRB Specialist                                                         (216) 778-7742                 ieaton@metrohealth.org

David Webb, MBA                                     IRB Specialist                                                          (216) 778-7741                 dwebb2@metrohealth.org

Matthew Jordan, MA                                  IRB Specialist                                                         (216) 778-7575                 mjordan1@metrohealth.org

 

IRB Office Location

The MetroHealth System

Institutional Review Board

2500 MetroHealth Drive

Rammelkamp- Room 103

Cleveland, OH 44109

Watermark

The MetroHealth System
Footer



© 2004 The MetroHealth System
2500 MetroHealth Drive Cleveland, Ohio 44109-1998 (216) 778-7800
MetroHealth Linesm: (216) 778-7878 Toll Free: 1-800-332-4060