Revision to PHS COI Regs

Complexity

Last summer the US Department of Health and Human Services and the Public Health Service (PHS) issued revised regulations on the “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought.” These regulations establish new standards that must be followed by institutions, such as UCSF, that apply for or receive support from PHS agencies, including the National Institutes of Health (NIH). This memo is the first in a series of communications to let you know about the new regulations and UCSF’s approach to implementing them.

The revised regulations are intended to increase accountability, add transparency, enhance effective management of financial conflicts of interest, and strengthen governmental compliance oversight. They go into effect on August 24, 2012.

These regulations differ in many ways from the existing rules for disclosure and review of personal financial interests related to PHS-funded research.  They also place increased burdens on the University to oversee the reporting process. Thresholds for disclosure of financial interests have been reduced to $5000, while review and reporting obligations have been expanded. Also included are new requirements that include:

  • Mandatory education/training
  • Disclosure of all outside interests related to institutional responsibilities
  • Disclosure of travel reimbursements
  • Public accessibility of information
  • Monitoring of conflict of interest management plans.

The 2011 revised regulations and recently updated FAQs prepared by the NIH can be accessed at:http://grants1.nih.gov/grants/policy/coi/index.htm.

We have launched several initiatives designed to make compliance with these new requirements as efficient as possible. They include:

  • Development of a web-based disclosure system and “smart” forms;
  • Multiple opportunities for satisfying the training requirement;
  • Development of a campus implementation policy that aligns with the regulatory requirements.

Despite our efforts, we are well aware that these new regulations increase the bureaucratic burden on PHS-supported investigators.  We are committed to minimizing that burden to the greatest extent possible and appreciate your patience and cooperation.

In the weeks ahead, please look for additional communication from us.  We will work to address these new federal requirements together.

If you have any immediate questions please do not hesitate to contact me or Senior Director of Research Compliance Eric Mah (eric.mah@ucsf.edu) at 
502-0284.

Cordially,

 

Elizabeth A. Boyd, PhD 
Associate Vice Chancellor, Ethics and Compliance

Memo dated: July 10, 2012; Sent to Administrative Officers, Deans, Department Chairs, Directors, Faculty, and Vice Chancellors