New PHS reporting requirements address public’s conflict of interest concerns

Headshot Dr. J. Ian Gray

Mon, 03/12/2012

MSU’s research reputation throughout the world is based on the integrity and quality of our collective work. In order to safeguard our reputation and maintain the public trust, it is important for us to be transparent about situations that could be perceived to undermine our research integrity, especially in situations where personal financial interests could be viewed as an incentive for someone to relax or set aside, even unconsciously, their objectivity in conducting research.

The existence of a personal financial interest related to a research outcome is not unethical in itself, nor does it necessarily preclude an investigator making significant research advances. Indeed, industrial researchers have a long record of important contributions to science. Many conflicts of interest may be unavoidable, especially as our best ideas are brought forward for commercialization. The ethical approach is to self-identify any conflict of interest at the beginning of a research project and let unconflicted colleagues oversee measures to assure that objectivity will not be compromised. Put another way, conflicts of interest arise naturally in professional life; what is unacceptable is the failure to disclose them for independent management.

The federal government – namely the National Science Foundation (NSF) and the Public Health Service (PHS) – has required the reporting and institutional review of research-related personal financial interests as possible conflicts of interest since the late 1980s. Over the last decade or so, public concerns about the effectiveness of reporting and self-regulation of personal interests in research projects have led to pressure to tighten federal rules for conflicting interests, particularly financial interests.

After a long period of consideration and public input, the Public Health Service (PHS) recently revised its conflict of interest regulations, which will become effective in August 2012. These revisions will require material changes to what MSU requires investigators to report about their personal financial interests and how MSU must act in considering and managing these as possible conflicting interests.

Key elements of the new PHS and ongoing MSU requirements include the following:

  • MSU must implement a new training program, and require investigators to complete it, as well as participate in updates at periodic intervals.
  • Before a proposal to the PHS can be submitted, investigators must report their personal Significant Financial Interests (SFIs) related to their institutional responsibilities as a whole that were held or received in the preceding 12 months. Personal financial interests also include the financial interests of an investigator’s spouse, dependent children, other legal dependents, and domestic partners. 
  • The threshold for determining an SFI has been reduced from $10,000 to $5,000.
  • Investigators must also report the details of any reimbursed or sponsored travel within 30 days of its occurrence (i.e., that which is paid on behalf of the investigator and not reimbursed to the Investigator by MSU, so that the exact monetary value may not be readily available).
  • Income exceeding $5,000 and each reimbursed or sponsored travel must be reported if it comes from commercial entities, foreign governments or universities, or nonprofit organizations.
  • If a reported SFI is deemed to relate to a PHS proposal, MSU must assess – prior to expenditure of any funds – whether or not the SFI constitutes a conflict of interest that could “directly and significantly affect the design, conduct, or reporting” of research. If it does, a plan to manage such financial conflict of interest must be enacted and monitored for compliance.
  • The details of all conflicts of interest must be reported to the NIH and information about them made available upon request by anyone within 5 business days.

For complete information about the new requirements, please visit the NIH Office of Extramural Affairs Financial Conflict of Interest web site.

Those of us who seek PHS or NIH funding, including support from other PHS agencies (for example, the Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), Substance Abuse and Mental Health Services Administration (SAMHSA), and others) have an incentive to comply with the new regulations.

But more than that, MSU recognizes that its reputation is founded on public trust and has long required that conflicting interests of all types be reported for assessment and oversight. I ask your support in helping MSU to address the federal regulatory changes through academic governance. In the long run, we must all comply with these new requirements by being open and transparent about our outside activities and interests.

J. Ian Gray

Vice President for Research and Graduate Studies