Upcoming changes to the National Institutes of Health’s (NIH) policy regarding human research are reviewed by international experts in a special issue of Nature Human Behaviour published online this week.
As of 25 January 2018, the NIH, the biggest funder of biomedical research in the world, is implementing policy changes that will affect the majority of US laboratories working with human subjects. In addition to opinion pieces reviewing these changes, the special issue also includes a response from Mike Lauer at the NIH that contributes vital insights into the development of the NIH policies and practical information about how the policies will be applied. Years of publicly debated concerns about funding decisions, reliability of scientific findings and the public’s access to tax-funded scientific research have motivated the NIH to implement new policy changes. These changes will mean that pre-registration of experimental designs, reporting of all results, and training of principal investigators in scientific conduct will become mandatory for a wide range of human studies that were previously exempt from these requirements. Following months of debate between affected scientists and the NIH, this special collection contains Correspondences by representatives of international funding agencies and science regulators, non-profit organizations and think tanks, and leading basic and clinical researchers in the US and Europe that highlight shortcomings and future opportunities as the policy changes are rolled out. The contributions suggest that the developments may eventually affect science regulation internationally, making this a topic relevant not only to US citizens.
The accompanying Q&A with Mike Lauer, Deputy Director for Extramural Research at the NIH, who was involved in the development and delivery of the new policies, contains details of the funding application and evaluation process for scientists. It also addresses concerns about public understanding, highlighting how vital it is that these changes are clearly and effectively communicated to the wider community, including mainstream policy makers.