HHS Tightens Financial Conflict of Interest Rules for Researchers

The U.S. Department of Health and Human Services today issued an updated Final Rule on conflict of interest, providing a framework for identifying, managing, and ultimately avoiding investigators’ financial conflicts of interest Staff from the National Institutes of Health worked with others in HHS to revise the 1995 regulations to update and enhance the objectivity and integrity of the research process.

Major changes to the regulations include the definition of significant financial interest (SFI), the extent of investigator disclosure, the information reported to the Public Health Service (PHS) awarding component, the information made accessible to the public, and investigator training. For example, the revised regulations:

• Require investigators to disclose to their institutions all of their significant financial interests related to their institutional responsibilities.
• Lower the monetary threshold at which significant financial interests require disclosure, generally from $10,000 to $5,000.
• Require institutions to report to the PHS awarding component additional information on identified financial conflicts of interest and how they are being managed.
• Require institutions to make certain information accessible to the public concerning identified SFIs held by senior/key personnel.
• Require investigators to complete training related to the regulations and their institution’s financial conflict of interest policy.

Additional details about the major changes to the regulations can be found at: (http://grants.nih.gov/grants/FCOI_Final_Rule_inspection_Desk.pdf).

The regulations will be implemented no later than 365 calendar days after publication of the final rule in the Federal Register.

Read more via http://www.nih.gov/news/health/aug2011/od-23.htm.

Research Club Meets Wednesday, Aug. 25

The WSU Medical Student Research Club will hold its first lunchtime meeting of the 2011-2012 academic year on Wednesday, August 25, 12:00-1:00 p.m. , in 260 White Hall. Students who completed the inaugural course of SMD 616, Introduction to the Research Learning Community, will discuss their summer research experiences.

Lunch will be provided on Aug. 25. Please RSVP to Adam Deardorff (deardorff.2@wright.edu) if you plan to attend.

New Research Elective Approved for Second-Year Medical Students

The Biennium 1 Electives Subcommittee at WSU Boonshoft School of medicine has approved a new elective course titled “Research Learning Community 2.” It will be listed as SMD 617 in the B1 elective catalog published later this year. It will run longitudinally from September 2011 through April 2012.

The elective for M2 students builds on the concepts and activities established in SMD 616 (Introduction to the Research Learning Community). The M2 elective provides a supportive environment for continuation or completion of research projects begun in SMD 616, but SMD 616 is not a prerequisite.

The M2 elective also supports students who have participated in research SIE’s (student initiated electives) or extracurricular research projects, and it can accommodate students looking for a research mentor during year 2. Students who have not taken WSU’s training workshop on research misconduct and the CITI course on the protection of human subjects (training included in SMD 616) will need to acquire both certifications sometime during the M2 elective.

According to the course description:

In September-December, students will participate in monthly seminars and Collaboration Labs surveying models and methodologies in translational research, clinical research, clinical trials, and evidence-based medicine. In addition, students will participate in ongoing meetings of the Translational Research Lecture Series, the Medical Student Research Club, and the Medical Student Journal Club, completing reading and reflective writing assignments associated with program content. Each student will prepare and lead a discussion of a recent research article at a seminar or Journal Club meeting.

In January-April, students will participate in skills development workshops on making and presenting scientific posters. Students will prepare a capstone project that may take several forms. Option 1 is presenting a scientific poster at the annual Medical Student Research Symposium in April. Option 2 is writing a paper on a critically-appraised topic (CAT) in evidence-based medicine that could serve as a roadmap for a future translational research project. Option 3 is participating in a faculty-mentored research project during the academic year.

SMD 617 represents approximately 80 contact hours and counts as one of two required elective experiences in Biennium 1.

Permission of the course director is required to enroll in SMD 617. Please contact Mark Willis (937-775-3814; mark.willis@wright.edu) to schedule a meeting to discuss enrollment.