April 2014 - Update #1
Institutional Review Board Committee News
1. IRB – Updated Conflict of Interest Policy and Form
The IRB Policy: Conflicts of Interest (COI) for Researchers and Research
Staff (Part 1, Policy II-B) and the COI Disclosure Form have been
updated. The major changes to the policy include:
First major revision since 2009.
Revised to mirror some aspects of the 2011 Public Health
Services regulation on Responsibility of Applicants for
Promoting Objectivity in Research.
Instituted a new requirement for training on financial conflicts
of interest to be completed at least every four years online
through the Collaborative Institutional Training Initiative
(CITI) for ALL Researchers and Research staff.
Revised financial interests which must be disclosed. This means
any personal, professional, financial or ownership interest or
other beneficial interest in the research, sponsor, product or
service being tested or held by the researchers or researcher
staff including immediate family (spouse and dependent children)
and may include any of the following interests:
Moved the COI disclosure requirements for IRB members and
consultants to a separate policy.
Ownership or interest of any value including but not
limited to stocks and options (exclusive of interests in
a publicly traded, diversified mutual fund).
Compensation of any value including but not limited to
salary, honoraria, paid authorship, consultant fees,
royalties, equity or other income.
Proprietary interest of any value including but not
limited to, patents, trademarks, copyrights, licensing
agreements or other intellectual property rights and
Per subject or other recruitment bonuses paid in
addition to the negotiated research budget.
A financial interest or compensation of any value which
will be affected by the outcome of the research.
Serves or has ever served as a board member, executive,
employee, consultant, advisor or speaker.
Please review the revised
policy and COI
disclosure form. The policy will go into effect in June, 2014.
Researchers and research staff are encouraged to begin
completing the training
requirements and using the new disclosure form immediately.