IRB AMENDMENT SUBMISSION CHECKLIST

Change in Principal Investigator or Addition of Co- investigator/Professional Participant

Log Number:

Change in PI:

Cover Memo

  • Name of the new PI and study log number.

Updated college forms face page with new PI’s name and contact information and

Updated assurance page with PI’s and Academic Dept. Chair’s signatures.

Completion of onlineNYMC financial disclosure form and Conflict of

Interest CITI education.(see appendix on page 2 for details).

A hard copy of the NYMC Human Subjects CITI completion report, if not previously

submitted (see appendix on page 2 for details).

Highlighted and clean consent form with PI’s name and contact information.

Highlighted and clean protocol with new PI’s name and updated FDA 1572
(if applicable).

Addition of Co-investigator:

Cover Memo requesting addition of research personnel

Updated college forms face page with co-investigator’s/professional participant’s

name(s).

Completion of onlineNYMC financial disclosure form and Conflict of

Interest CITI education (see appendix on page 2 for details).

A hard copy of the NYMC Human Subjects CITI completion report, if not previously

submitted.

Appendix

Educational Program for Those Involved with Human Subjects Research

All persons participating in any research activity involving human subjects is required to complete the appropriate (Biomedical Research Personnel or Social & Behavioral Research Personnel) Collaborative Institutional Training Initiative (CITI) course, which is available on-line at: Failure to meet this requirement will result in delayed permission to initiate or continue.

Conflict of Interest Requirements
The College has revised its Conflict of Financial Interest and Code of Conduct Policy; the corresponding new Annual Disclosure Form for Conflicts of Interest and Commitment can be completed online. The new form replaces both the existing annual disclosure and the financial conflict of interest disclosure included in the College forms.

The new College Conflict of Financial Interest Policy requires that:

  • investigators disclose significant financial interests annually and within 30 days of discovering or acquiring a new significant financial interest (investigator means the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research, which may include, for example, collaborators, research coordinators, postdoctoral fellows, or consultants)
  • investigators must complete education regarding these policies by completing the online Collaborative Institutional Training Initiative (CITI) Conflicts of Interest course (see below).

Please note:

  • The annual online Disclosure Form must be completed prior to SUBMISSION of applications. Only completion of this form will meet the requirement. Updates of the disclosure are required any time there is a change.
  • Prior to initiation of any research project, If ORA determines the existence of a conflict it must be removed or managed.
  • CITI course must be completed prior to EXPENDITURE of grant funds.

To access the Disclosure Form at the NYMC main web site () :

Click on or click on “ISWeb Portal” from the Quick Links drop down on the main page of the College’s website

• Login using your NYMC logon name and password

• Click on “NYMC Compliance” on the left, under “NYMC Applications”

• Click on: “Submit a New Form” or “Update a Prior Submitted Form”, “View Saved/Submitted Form” or “Help Using this Form”

If required individual(s) can’t access the form, the principal Investigator must send an email request for Form access to Elaine Muia, Management Systems Administrator, Human Resources at . The request should include first and last name of each individual, their department, birth date, phone number and email address. Each individual will receive a response from Information Services indicating the NYMC login ID and a temporary password.

Questions about the new College Conflict of Financial Interest and Code of Conduct Policy and Annual Disclosure Form for Conflicts of Interest or Commitment should be directed to the College Compliance Officer, at 594-4567 or . To access the NYMC policy:

To access the CITI test :

Click on the CITI link:

If you are registered:

Select Add a Course

Select Conflicts of Interest

If you are not registered:

Follow the registration instructions on the CITI website.

Once you have completed the required modules and received a grade of at least 80% on the related tests, notification will be sent to the Office of Research Administration.

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