Notice Number: NOT-OD-09-099

Key Dates
Release Date: May 8, 2009
Deadline for Submission of Comments: July 7, 2009

Issued by
National Institutes of Health (NIH), (http://www.nih.gov)

Purpose:

The National Institutes of Health (NIH) has issued an Advance Notice of Proposed Rulemaking (ANPRM) in the Federal Register to gain public input on whether modifications are needed to the PHS regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94).

To assure consideration, comments must be received by July 7, 2009.

Individuals and organizations interested in submitting comments, identified by RIN 0925-AA53 and Docket Number NIH-2008-0002, may do so by any of the following methods. Electronic submission is preferred.

• Electronically through Regulations.gov.
• By regular mail to:
  Attention: Jerry Moore
  NIH Regulations Officer
  NIH Office of Management Assessment
  6011 Executive Boulevard
  Suite 601, MSC 7669
  Rockville, MD 20852-7669.

• By fax to: 301-402-0169
• Hand Delivery/Courier (for paper, disk, or CD-ROM submissions).
  Attention: Jerry Moore
  6011 Executive Boulevard
  Suite 601, Rockville, MD 20852-7669.
  

Background

In 1995, the Public Health Service (PHS) and the Office of the Secretary of Health and Human Services (HHS) published the regulations at 42 C.F.R. Part 50, Subpart F and 45 C.F.R. Part 94, designed to promote objectivity in PHS-funded research by establishing standards to ensure that the design, conduct, and reporting of research funded under PHS grants, cooperative agreements, or contracts is not biased by any conflicting financial interest of an Investigator.

In the intervening years since the publication of these regulations, the pace of translation of new discoveries from the research bench into effective treatment of patients has significantly accelerated. As a result, the biomedical research enterprise in the United States is extensive and growing in size and complexity. Recognition of the increasing complexity of biomedical research and the increased interaction between Government and the private sector in meeting common public health goals have heightened public scrutiny regarding the regulatory requirements for Investigator disclosure, management of conflicts, and Federal oversight and have raised the question of whether changes to the regulation may be needed.

NIH developed an ANPRM to gather public comment on possible revisions to the PHS regulations. The NIH believes that the complex and controversial issues surrounding FCOI warrant a carefully considered, open dialogue with all affected parties to enhance regulatory compliance and effective oversight. Consequently, with the ANPRM we invite public comments on all aspects of potential regulation in this area, and particularly on the following issues:

• Expanding the scope of the regulation and disclosure of interests;
• The definition of Significant Financial Interest ;
• Identification and management of conflicts by Institutions;
• Assuring Institutional compliance;
• Requiring Institutions to provide additional information to the PHS; and
• Broadening the regulations to address Institutional conflicts of interest.

Inquiries

Email: FCOI-ANPRM@NIH.GOV