(Towson, MD) August 31, 2011: The U.S. Department of Health and Human Services (HHS) has issued a final rule amending the 1995 Public Health Service (PHS) regulations on the responsibilities of applicants for promoting research objectivity. Since the promulgation of the regulations in 1995, biomedical and behavioral research and the resulting interactions among government, research Institutions, and the private sector have become increasingly complex. The standards established by this new ruling will ensure that all stages of research funded under PHS grants and cooperative agreements will be free from bias resulting from investigator financial conflicts of interest (FCOI). Institutions must be in full compliance with these new requirements by August 24, 2012.
The primary reasons for the amendments are a) the necessity of a more strict approach to investigator disclosure, management of financial conflicts, and federal oversight within research settings, and b) the increasing governmental pressure on research institutions and their faculty to expand their relationships and strengthen their engagement with industry.
The amended regulations include several changes with which PHS applicants must comply:
· Lowering the de minimis threshold from $10,000 to $5,000 for payments and equity interests, including equity interests in non-publically traded entities;
· Appointing institutional officials to solicit and review disclosures of significant financial interests (SFI) from each investigator participating in PHS-funded research;
· Excluding income from seminars, lectures, teaching, or service on advisory or review panels;
· Expanding investigator disclosure requirements to include SFIs related to an investigator’s institutional responsibilities;
· Requiring that institutions maintain, document and enforce a policy on FCOIs that is available to public online;
· Requiring regular FCOI training for investigators on any PHS-funded grant or contract prior to engaging in research;
· Requiring that awardee institutions take steps to ensure any subrecipient investigator’s compliance with institutional policy;
· Expanding scope of the regulations to include Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR) Phase I applications; and
· Requiring all investigators participating in PHS-funded research to submit an updated disclosure of SFIs at least annually.
At Towson University, RCR (Responsible Conduct of Research) training is provided by the Office of Sponsored Programs & Research. This Office is also the administrative office for the C-IRB (Conflict of Interest Review Board). Further information about FCOI regulations can be found at: http://grants.nih.gov/grants/policy/coi/
Office of Sponsored Programs & Research