Approvals Needed for All Research

What

A Financial Conflict of Interest in Research arises when a financial interest or opportunity for personal gain could affect or have the appearance of affecting the design, conduct, or reporting of research. Federal Conflict of Interest (COI) regulations require that all investigators submit conflict disclosures. On the Research Trigger Form (this is the project-specific form), information from the eDMS Disclosure Profile will be imported. Researchers will be asked whether a financial interest is related to the current research project. That information helps guide the project review.  However, the determination whether any given financial interest represents a conflict of interest is made by the Financial Conflicts of Interest in Research Committee (FCOIRC), not the investigator. Not all financial interests represent a conflict of interest. The Research Trigger Form also requires disclosure of related Institutional Financial Interests.

Who

The term “investigator” applies to all individuals involved in research, regardless of job title, who are responsible for the design, conduct, or reporting of the study and who are granted a significant degree of independence in their work. Investigators and key personnel who are listed on the Triggering Event (TE) form will receive an automatic email notification to complete the Research Trigger Form. ISMMS’ policy is that the following personnel always meet this definition:

• Principal Investigator
• Key Personnel
• Anyone with a role that includes the word “Investigator” (Example: Sub-Investigator)
• Primary Mentor on a Fellowship or Mentored Career Development Award
• Faculty Personnel, either key or non-key

Other ISMMS personnel may meet the Investigator definition. ISMMS leaves the following to the discretion of the PI:

• Other Significant Contributor
• Consultant
• Non-faculty, non-key personnel

When

Financial Interest in Research Disclosure Forms must be completed for each research project prior to IRB and/or GCO submission.

How

A Triggering Event (TE) must be created in the eDisclosure Management System (eDMS) prior to IRB and/or GCO submission. This form must list all investigators and key personnel on the study. The eDisclosure Management System (eDMS) generates a Triggering Event (TE) number, which will later be used to complete the IRB submission. Every person listed on the Triggering Event (TE) form will be prompted to complete a Research Trigger Form on eDisclosure Management System (eDMS) through a notification email. For step by step instructions, see Research Trigger Form (project-specific form). Once this has been completed, an IRB submission can be made in RUTH. Please note: FCOI review must be added as an ancillary review for all submissions in RUTH.

What

The Grants and Contracts Office (GCO) reviews all sponsored projects and a subset of ISMMS  projects, including industry sponsored clinical research study.  GCO evaluates each program and proposal for accuracy of administrative information and budget, as well as for compliance with Federal, State, New York City, and ISMMS regulations, such as those pertaining to biosafety, or to the use of human subjects, vertebrate animals, or recombinant DNA.

Projects that Require Submission to the GCO via InfoEd

• All sponsored projects, including industry sponsored projects.
  • Exceptions:
    • Sponsored projects where BRANY (Biomedical Research Alliance of New York) serves as the IRB and also negotiates the clinical trial agreement on behalf of Mount Sinai are not submitted to the GCO. 
    • Cooperative Research Group Projects are studies who are funded by the NIH and the institution is asked to carry out multiple individual clinical studies. However, the individual clinical studies do not require GCO submission.
• All ISMMS supported projects that do not involve humans or animals.
• All ISMMS supported projects for which the GCO signs a research related agreement (e.g., Data Transfer Use Agreement, Study Drug Donation Agreement, etc.)

Projects that Do Not Require Submission to the GCO via InfoEd – Effective September 23, 2020

• ISMMS supported projects involving human or animal research unless it requires an agreement as noted above.

For more information, refer to Does My Project Need to be Submitted to the GCO?

When

The principal investigator must submit projects and proposals to the GCO prior to submitting to a funding agency or starting an industry sponsored clinical research study. Refer to Does My Project Need to be Submitted to the GCO? for more information.

How

Applications are prepared and submitted in InfoEd.

Last Updated: June 2023