Recent updates to the NIH clinical trials policies have caused a heated debate led by affected scientists. By broadening the debate to include diverse stakeholders within and outside the United States, we learn that the steps the NIH takes are in the right direction, but further adjustments are needed to ensure that the policy’s goals are met.
The National Institutes of Health has broadened its definition and changed the reporting requirements for ‘clinical trials’. What are the implications for basic human behavioural and brain science?
The recently updated US National Institutes of Health clinical trials policies will apply broadly to studies involving experimental manipulations of humans. These studies will require registration and reporting in ClinicalTrials.gov, grant application submission under a clinical trials funding opportunity announcement, and Good Clinical Practice training for investigators.
In his capacity as immediate past president of the Federation of Associations of Behavioral and Brain Sciences, Jeremy Wolfe interviews Mike Lauer about the new NIH clinical trials policy. Mike Lauer is NIH’s deputy director for extramural research, serving as the principal scientific leader and advisor to the NIH director on the extramural research programme.