March 18, 2008 (sent via email)

TO:                 Medical Staff, Clinical Investigators, HSRAC, Medical Executive Committee, IRB Wizards and DEC/EC Community:

FROM:           Drs. Michael Gottesman and John Gallin

SUBJECT:     Updated COI Guide, Ethics Clearance and Consent Statements for COI

Attached is an updated version of the “Guide to Preventing Financial and Non-Financial Conflicts of Interest in Human Subjects Research at NIH” dated March 2008.   The new version of the guide includes a statement for non-NIH investigators as follows: “The National Institutes of Health expects that all non-NIH investigators are in compliance with their institutional/employer conflict of interest policies”.    The companion ethics Conflict of Interest Form submitted to the IRB has been renamed “Clearance of NIH Investigator Personal Financial Holdings by IC Ethics Office” to accurately reflect the purpose of this intramural ethics review.   A new fillable form is attached for this purpose as well as a guide to completing the ethics clearance form.

Compliance with the updated COI Guide requires a statement about the distribution of the guide to be included in all informed consent documents. When applicable, a statement regarding the participation of non-NIH investigators, investigator holdings under the deminimus, and participation with a waiver should be included in the consent.   At the request of the HSRAC, attached are suggested statements covering the above scenarios that can be incorporated into the consent form. 

Effective May 1, 2008, all COI clearances must be submitted using the “Clearance of Personal Financial Holdings” form. After this date, all IRB’s should ensure that the corresponding COI language is incorporated into protocol consent documents for new protocols or for existing protocols at the next continuing review. Should you have additional questions, please contact your IRB chair or Deputy Ethics Counselor.

Attachments:
1) COI Guide
2) Fillable Clearance Form
3) Guide to Completing the Clearance Form
4) Suggested COI Statements for Consent