Browse Institutional Review Board (IRB):
Meeting Dates | Forms | Contact Info

 

Mount Sinai Common Reciprocal Reliance IRB Agreement

About Submission Deadlines

Go to the IRB website at https://irbmanager.becirb.com to submit paperwork.

Complete new protocol paperwork (including new protocol fee of $1,250.00 for sponsored protocol), renewal ($250.00 for sponsored protocol) requests, SAE reports, consent revisions, etc. MUST BE SUBMITTED AT LEAST TEN WORKING DAYS PRIOR TO IRB MEETING IN ORDER TO ALLOW TIME FOR REVIEW BY CHAIR AND DISTRIBUTION TO IRB MEMBERS.

Investigators submitting a new protocol or new or additional investigator to an approved protocol must show proof of training in the protection of human subjects in research for all involved.

Notice: In order to publish results of your study in the future, you must first register your study at www.clinicaltrials.gov. See website for further information.

NOTICE:

The IRB Chair STRONGLY recommends submitting CITI training certificates for all ASAP, regardless of their NIH certificate expiration date.

As we are are now operating under Mount Sinai IRB regs. and Mount Sinai does not recognize NIH's training, we will soon start rejecting any submissions for studies that have not submitted the required documentation for ALL research staff involved

Which courses must I take? Listed are the required courses that must be completed before any involvement in any human subject research project. All courses are available through www.citiprogram.org.

NOTE: When setting up your account, affiliate with Icahn School of Medicine at Mount Sinai. Use your work email account, your name as recognized by HR, and your life number (enter nyeei here) for your profile. These steps will enable your credits to register under this account and will provide easy access to viewing which courses you have completed.

Human Research Questions & Answers
Office for Human Research Protections (OHRP)
http://www.hhs.gov/ohrp/

TOP    

Meeting Dates

Meetings take place on Tuesdays, 2:30 PM - 4:00 PM in the Board Room.

2014

January 14

There will be no August meeting

February 11

September 9
The deadline for submission for the September 9, 2014 IRB mtg. will be Thursday, August 7, 2014.

March 11

October 14

April 8

November 11

May 13

December 9

June 10

January 13, 2015

July 8

 

TOP

Forms

New Protocol Forms & Instructions

Instructions - Directions for submitting a complete protocol for quorum review REV 8/12
Policies and Procedures for the Protection of Human Subjects REV 11/02/11
Financial Disclosure *fillable fields!*

HHS Issues New Regulations on FCOI Disclosure in Research

New U.S. Department of Health and Human Services regulations concerning financial conflicts of interest (FCOI) in research took effect on August 24. As of that date, any new or renewing grant, contract, Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) submission will not be processed unless all investigators associated with the submission meet the new requirements.

There are four significant areas of change from the previous requirements:

  • An increase in the extent of information investigators must disclose to institutions

  • Institutions are required to provide investigators with FCOI training

  • An increase in FCOI-related information that institutions must make accessible to the public and to sponsors

  • Enhanced institutional responsibility for managing the disclosure process and identified FCOIs

The National Institutes of Health Office of Extramural Research has a resource page on FCOIs, including “Frequently Asked Questions and Answers,” which can be accessed at http://grants.nih.gov/grants/policy/coifaq.htm

Investigators can complete their training requirement by taking the on-line NIH course on federal FCOI regulations: http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm

Instructions on Research Authorization
Research Authorization Form - English *fillable fields!*
Research Authorization Form - Spanish
Research Authorization Form - Russian
Consent Form   REV 2/14/2014
Abstract Guide
HIPAA Business Agreement *fillable fields!*

Renewal / Annual Report / Termination Form

TO submit a continuing review, renewal request, or amendment, log into the IRBManager web site at https://irbmanager.becirb.com, choose the study you would like to submit a form for by clicking on the study number and choose 'startxform' within that study.

IRB Exemption / Reviews Preparatory to Research (chart reviews)

NOTE:  ALL RESEARCH INVOLVING HUMAN SUBJECTS MUST BE APPROVED OR DEEMED EXEMPT BY THE IRB BEFORE RESEARCH CAN BEGIN. 

How to Submit a Chart Review
HIPAA De-ID Form
HIPAA Limited Data Set LDS Form
HIPAA Researcher Certification Form
If you would like to request exemption of IRB review for your study, please fill out researcher certification form completely and submit along with your detailed abstract and REASON for exemption

To Report Adverse Reactions

Guidance on Reporting Adverse Events
To report adverse event, log onto the IRBManager web site at https://irbmanager.becirb.com and choose 'startxform'.

Contact Information

Robert Jordan, Coordinator
New York Eye and Ear Infirmary of Mount Sinai
310 E. 14th Street
Residence Building, 5th Floor - Apt. #5J
New York, NY  10003
Phone: (212) 979-4447
Email: RJordan@nyee.edu

TOP

 

Home > Current Research > INSTITUTIONAL REVIEW BOARD (IRB)