“In response to the public health emergency of opioid misuse, addiction and overdose, NIH has launched the HEAL (Helping to End Addiction Long-termSM) Initiative. The NIH HEAL InitiativeSM is a trans-agency effort focused on improving prevention and treatment strategies for opioid misuse and addiction and enhancing pain management. As part of its response to this crisis, NIH intends to maximize the availability of Publications and the sharing of underlying data for NIH-Supported HEAL research projects. Given the urgency of this crisis as highlighted by the declared public health emergency, rapid availability of Publications and the primary data behind them promotes dissemination of new knowledge, enhances reproducibility, and accelerates the ability of researchers to build upon HEAL research to make new discoveries.

Through the HEAL Initiative Public Access and Data Sharing Policy (the “Policy”), NIH seeks to create an infrastructure that addresses the need for researchers, clinicians, and patients to collaborate on sharing their collective data and knowledge about opioid misuse and pain to provide scientific solutions to the opioid crisis. Under the Policy, applicants for extramural research funding (grants, cooperative agreements, contracts, and other transactions) (collectively, “Applicants”), for HEAL research projects are required to submit a Public Access and Data Sharing Plan that (1) describes their proposed process for making resulting Publications and to the extent possible, the underlying Primary Data immediately and broadly available to the public; or (2) if applicable, provides a justification to NIH if such sharing is not possible. Underlying Primary Data should be made as widely and freely available as possible while safeguarding the privacy of participants, and protecting confidential and proprietary data….”