RESEARCH INTEGRITY OFFICE
Conflict of Interest in Research (COIR)
LINK TO NEW FINANCIAL DISCLOSURES FORMS:
HumcComplytrackMediRegs,
Conflicts of Interest in ResearchNews
The NIHhas announced final revisions to the Conflict of Interest in Research regulations. The compliance date for the revised regulations is August 24, 2012. As a result, the Research Integrity Office is in the processofworking to revise our policies andprocedures to reflect these new requirements. You may read more about the new guidelines at : http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf
How are Conflicts of Interest in Research (COIR) Managed at HackensackUMC?
The Research Integrity Office is pleased to announce the implementation of a new application to facilitate the financial disclosure process for research investigators at HackensackUMC. The new system, MediRegs, will replace the previous paper-based disclosure forms. As of May 1, 2012, all registered research investigators havereceived an email with an electronic link to the survey. All new investigators who require a disclosure form may call the Research Integrity Office at 551-996-4585.
Frequently asked questions:
How do the new rules change COIR reporting?
· The disclosure process has changed significantly. These changes include reporting guidelines that cover:
· Compensation or stock amounts greater than $5,000.00
· Any significant financial interest that are related to institutional responsibilities
· All reimbursed or sponsored travel, excepting travel sponsored by qualifying universities or government agencies
· All new financial interests must be disclosed within 30 days of claiming the interest
· Investigators must be re-trained on disclosure requirements at least every 4 years
When are the annual financial disclosures due?
Annual Financial Disclosures must be completed and submitted by July 02, 2012.
What if an annual disclosure is not submitted?
If a disclosure is not submitted by July 02, 2012, the investigator is at risk of study suspension and/or suspension of research privileges.
Who must submit an annual disclosure?
All investigators listed on a research study must complete an annual disclosure.
Where do I submit the annual disclosure form?
Annual disclosures are sent to investigators with via personalized email with a live link to the survey. The surveycan be submitted through that link,orby using the new electronic financial disclosure reporting system byclicking on: HumcComplytrackMediRegs, or by copying and pastingthe following link into the browser window: https://humc.complytrack.mediregs.com/surveyAssignView.ctx?
What if an annual disclosure is not submitted?
If a disclosure is not submitted by July 02, 2012 the investigator is at risk of study suspension and/or suspension of research privileges.
How do I locate the policy and the form?
The Administrative Policy 541 is located under the Research Integrity Policies and Procedures section of the IRB home page. You may access the site by clicking the following link: Admin policy 541.
The Annual Disclosure Form is located by entering your username and password to access the questionnaire on the new secure electronic COIR submission website at: Annual Financial Disclosure Form
Who can I call if I have questions?
Questions may be directed to the Research Integrity Office Conflict of Interest Committee at 551-996-4585.