HHS releases conflict of interest guidance

The Department of Health and Human Services has released draft interim guidance on financial conflicts of interest for research institutions, clinical investigators and institutional review boards. The guidance, which was produced by the Office of Human Research Subjects Protection, notes that there is no uniform standard for identifying, avoiding and managing financial conflicts of interest in human clinical trials, and expresses concern about the increasing prevalence of financial relationships between the private sector, investigators and academic institutions. According to the document, it may be a conflict of interest for an academic institution to conduct or evaluate data from clinical trials of products produced by biotech companies in which it has an equity stake, and the document suggests that such trials should be run by "independent investigators at sites that do not have a financial stake in the outcome of the trial, or carried out at the institution but with special safeguards to maximally protect the scientific integrity of the study and the research participants." ...