Suzanne Stratton, the former vice president for research at the Carle Foundation Hospital in Urbana, Ill., has filed a whistleblower lawsuit against the hospital and Carle Clinic Association alleging she was fired in November 2008 in retaliation for warnings that the hospital and clinic violated federal human subject protection regulations.

Institutional identification, management and oversight of financial conflicts of interest are lacking for National Institutes of Health (NIH) grantees, a Department of Health and Human Services Office of Inspector General (OIG) report concludes. The report, released Nov. 19, calls for grantee institutions to provide details to NIH regarding the nature of all reported financial conflicts of interest and how they are managed, reduced or eliminated. A similar OIG recommendation was made in January 2008.

Once again, the pharmaceutical industry has extended its commitment to register clinical trials and provide study results. In a revision of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) joint policy released Nov. 10 the group now calls for the registration of “all clinical trials in patients conducted on a medicinal product” and the disclosure of results from those trials.

The Department of Health and Human Services’ Office for Human Research Protections (OHRP) released draft guidance Nov. 6 on institutional review board (IRB) continuing review of research and on IRB approval of research with conditions. The guidance on the approval of research with conditions is the agency’s first formal guidance on the subject. When finalized, the continuing review guidance will supersede OHRP’s Jan. 15, 2007 guidance (see “OHRP Revises Continuing Review, Written Procedures Guidances for Unanticipated Problem Information,” January 2007).

The State of Maine adopted its final rule on the state requirements for clinical trial registration and results reporting, effective Nov. 2, with some significant changes from the rule proposed in June (see “Proposed Maine Regulations Could Alter Trial Reporting Requirements,” June 2009). Among the changes, the final rule excludes Phase 1 trials from its definition of a clinical trial. The final rule also removed the statement that said an applicable clinic trial is “any investigation relied upon by a manufacturer or labeler for claims made in marketing, promotional or educational efforts or materials to prescribers or consumers.”