What is a conflict of interest?
A conflict of interest in research refers to situations in which significant financial interests or other personal considerations may compromise or could appear to compromise a researcher's professional judgment or integrity.
What is the purpose of the 2011 revised PHS regulations?
The 2011 revised PHS regulations promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research performed under grants from, or cooperative agreements with, the PHS and agencies following the PHS regulations will be free from bias resulting from Investigator financial conflicts of interest. This regulation is commonly referred to as the Financial Conflict of Interest (FCOI) regulation.
Was Drexel University affected by newly implemented 2011 Revised PHS Regulations?
Yes. Drexel University created a supplemental policy entitled “Managing Conflicts of Interest in Sponsored Projects” (Drexel Policy) to incorporate the new regulatory requirements related to financial conflicts of interest.
What are the four major regulatory changes that affect Drexel Policy?
The four major changes are:
- A lower financial threshold for financial disclosures;
- A new conflict of interest training requirement;
- A new public accessibility requirement; and
- Increased transparency of sponsored travel reimbursements.
What is the effective date of the 2011 Revised PHS Regulations and Drexel Policy?
The 2011 revised PHS regulations and Drexel Policy are effective as of August 24, 2012.
To what type of sponsored projects does Drexel Policy apply?
Drexel Policy encompasses all sponsored projects for which an award (competing and noncompeting) was issued, or an award was modified to result in increased funding, on or after August 24, 2012. When Drexel University is the subrecipient, Drexel Policy is to follow the executed date of: 1) the subrecipient agreement; or 2) a subrecipient agreement modification/amendment that results in additional funding.
Who is covered by Drexel Policy?
University Personnel are covered by Drexel Policy. Per the policy, University Personnel are all individuals engaged in sponsored projects and all individuals responsible for overseeing or managing sponsored projects at Drexel University, including students, post-doctoral fellows, and scholars who contribute to the development or execution of a sponsored project. For purposes of financial disclosure only, the term University Personnel encompasses spouses and dependent children.
What are the two main responsibilities of University Personnel under Drexel Policy?
At the times outlined in Drexel Policy, University Personnel must: 1) complete the required training offered by the Office of Research; and 2) submit the required financial interest disclosure forms to the ORA.
What happens after University Personnel have completed and submitted the financial interest disclosure forms to the Office of Research?
Once your disclosure forms are completed and submitted to the Office of Research, a preliminary review of the forms will be performed to determine whether a financial conflict of interest exists. If the Office of Research determines that an actual or potential financial conflict of interest exists, the disclosure will be referred to an Outside Interest Committee for further evaluation and a final determination
Can University Personnel appeal any FCOI determinations made by the Office of Research and/or the Outside Interest Committee?
Yes. The details of the appeals process can be found in Drexel Policy.