July 7, 2009
NIH Regulations Officer
NIH, Office of Management Assessment
6011 Executive Boulevard, Suite 601, MSC 7669
Rockville, MD 20852-7669
Re: Docket No. NIH-2008-0002 RIN 0925-AA53, Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought and Responsible Prospective Contractors
The Biotechnology Industry Organization (BIO) thanks the National Institutes of Health (NIH) for the opportunity to submit comments on the advanced notice of proposed rulemaking regarding conflict of interest in federally funded medical research, published in the Federal Register on May 8, 2009.
BIO represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.
While observers have been arguing for many years that conflicts of interest in medical research hurt patient care and diminish research integrity, the issue has lately become particularly salient to policy makers, researchers, institutions, industry and other stakeholders, as collaborations among these groups and public-private partnerships have become more common. The result is an environment with increased suspicion about the relationships among industry, research institutions, and physicians, and greater regulation of these relationships.
Read full comments (PDF) July 7, 2009