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New Protocol Forms & Instructions

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

Informed Consent

Effective date for use 4/1/15

Mandatory date for use 5/1/15

Change over to the new consent should be done during continuation submissions or when a modification to the project requires a change to the consent. There is no need to submit a change to the consent to just switch over to the new version.

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)

Notice: All research involving human subjects must be approved or deemed exempt by the IRB before research can begin. 

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

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

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