Despite concerns from researchers and organizations, the U.S. National Institutes of Health (NIH) is adamant about implementing its new mandate requiring foreign partners to share raw data and notebooks at regular set intervals with their primary U.S. grant recipient, releasing its final guidance on September 15.
The policy is set to go into effect on March 2, 2024.
This policy has drawn criticism from researchers who are concerned that it may impede or erode international collaborations, particularly in developing nations, and may be perceived as an overreach. In addition, they suggest, such a blanket requirement for all foreign grant recipients to submit all raw data would be burdensome, expensive, and unnecessary.
The mandate as originally written requires all foreign subrecipients to “to provide copies of all lab notebooks, all data, and all documentation that supports the research outcomes as described in the progress report. These supporting materials must be provided to the prime recipient with each scientific update (no less than once every three months).” This was amended to “no less than once every six months, or more frequently based on risks” in updated guidance released in June. The final policy further extends the period to “no less than once per year.”
International collaborators have previously only submitted data to U.S. partners as needed for use in publications and have kept their raw data unless requested for an NIH audit.
The NIH says that it developed the policy in response to recommendations from government watchdog reports undertaken following concerns over an NIH subaward given to the Wuhan Institute of Virology (WIV). There have been unsubstantiated allegations that the SARS-CoV-2 virus leaked from the WIV’s laboratory. The WIV has been barred from receiving U.S. government funding for not sharing its lab notebooks and electronic records.