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This Notice of Special Interest (NOSI) encourages the translation of the novel neurotechnologies, funded through the Helping to End Addiction Long-Term (HEAL) Initiative and overseen by the NIH Blueprint MedTech program. Academic and Small Business Concerns (SBCs) are encouraged to submit grant applications that propose non-clinical validation for subsequent clinical feasibility studies. Applications supporting the development and translation of groundbreaking neurotechnologies that fit within the mission of the HEAL Initiative are encouraged.

The NIH Helping to End Addiction Long TermSM (HEAL) Initiative NIH aims to improve our understanding, management and treatment of pain by funding high quality scientific research in this relatively understudied area of medicine. For the HEAL Initiative and NIH to meet their long-term goals of providing effective non-opioid options for the treatment of pain conditions and innovative approaches for treating opioid use disorders, it will be necessary to train a new generation of clinical pain researchers. Leveraging HEAL Initiative clinical research programs to train novice researchers and investigators new to pain research in the mechanics, techniques, and best practices of clinical pain research will maximize the impact of HEAL funding for both current and future research endeavors. Increasing the number of individuals trained in high quality clinical pain research is a critical step toward ensuring the highest impact of HEAL, with studies that encompass a broad range of pain conditions and have the potential to include, address the needs of, and positively impact diverse and traditionally underserved patient populations.

The goal of this Notice of Special Interest (NOSI) is to provide support through administrative supplements to strengthen data management, sharing and data readiness efforts within the HEAL Initiative that further fosters collaboration among HEAL awardees and enables maximal data discoverability, interoperability, and reuse by aligning with the FAIR (Findable, Accessible, Interoperable, and Reusable) principles. This NOSI provides an opportunity for existing HEAL Initiative awardees to increase data FAIR-ness, participate in coordinated HEAL Initiative activities to build community around data sharing, and foster sustainability of HEAL Initiative digital assets. This NOSI is soliciting administrative supplements from existing awards funded or supplemented by the HEAL Initiative or otherwise required to meet HEALs Public Access and Data Sharing Policy. Applications from HEAL research teams that are already working with data coordinating centers as requirement of the award must provide justification for applying and will be given lower priority. Sharing HEAL-generated results and associated data as rapidly as possible will allow the broader community to ask and answer new research questions; conduct secondary analyses; and address fast-evolving challenges that surround pain management, opioid use and misuse, and overdose.

This Notice of Special Interest (NOSI) provides an opportunity for clinical trials funded by the Helping to End Addiction Long-term (HEAL) initiative to address challenges of recruiting and engaging the diverse populations suffering from pain and opioid use disorder. NIH will support supplements to current HEAL awards that would either enhance their patient, community, and other stakeholder engagement efforts; improve diversity and inclusion among participants; or both, as appropriate for a particular study. The NIH HEAL Initiative is a trans-agency effort to speed scientific solutions to stem the national opioid public health crisis through understanding, managing, and treating pain and improving treatment for opioid use disorder and overdose. This supplement program is not intended to support research on basic processes but rather to implement strategies to enhance stakeholder engagement and diversity of patient inclusion in HEAL clinical studies.

The goal of this Notice of Special Interest (NOSI) is to provide support through administrative supplements to strengthen data sharing and data readiness efforts within the HEAL Initiative that further fosters collaboration among HEAL awardees and enables maximal data discoverability, interoperability, and reuse by aligning with the FAIR (Findable, Accessible, Interoperable, and Reusable) principles. This NOSI focuses on data discoverability, and provides an opportunity for existing HEAL Initiative awardees to increase data FAIR-ness, participate in coordinated HEAL Initiative activities to build community around data sharing, and foster sustainability of HEAL Initiative digital assets. This NOSI is soliciting administrative supplements only from existing awards funded or supplemented by the HEAL Initiative. Applications from HEAL research teams that are already working with data coordinating centers as requirement of the award must provide justification for applying and will be given lower priority. Centers are not eligible to apply. Sharing HEAL-generated results and associated data as rapidly as possible will allow the broader community to ask and answer new research questions; conduct secondary analyses; and address fast-evolving challenges that surround pain management, opioid use and misuse, and overdose.

The purpose of this request for administrative supplements to current NIH-fundedstudies is to encourage clinical and translational research that will increase our understanding of the prevalence, psychological variables, and response to therapy in those individuals with multiple chronic overlapping pain conditions (COPCs). Recent clinical findings suggest that substantial overlap may exist between chronic pain conditions. Individuals diagnosed with one pain disorder often exhibit characteristics of additional chronic painful conditions or transition to other diagnostic categories. A better understanding is needed of the characteristics of overlapping pain conditions, the progression of these conditions, and therapeutic approaches best suited for treating individuals with COPCs. Research efforts in chronic pain conditions have focused on single disorders or types of pain such as neuropathic and inflammatory pain. These research efforts have generated a substantial body of information advancing our understanding of the underlying mechanisms of pain onset and development, the transition from acute to chronic pain, and therapeutic targets for treating acute and chronic pain. Over the past twenty years reports have documented the presence of more than one chronic pain condition in subjects with pain. Studies have identified overlap between a number of chronic pain conditions, including lower back pain, fibromyalgia (FM), vulvodynia, endometriosis, functional gastrointestinal disorders such as irritable bowel syndrome (IBS), temporomandibular joint disorder (TMD), migraine, tension headache, low back pain, and urologic chronic pelvic pain syndromes (UCPPS). These results suggest that chronic pain conditions may not be localized conditions but may share symptoms and mechanisms that involve a general central nervous system dysfunction as well as disorder-specific symptoms.

The NIH Helping to End Addiction Long TermSM (HEAL) Initiative NIH aims to improve our understanding, management and treatment of pain by funding high quality scientific research in this relatively understudied area of medicine. For the HEAL Initiative and NIH to meet their long-term goals of providing effective non-opioid options for the treatment of pain conditions and innovative approaches for treating opioid use disorders, it will be necessary to train a new generation of clinical pain researchers. Leveraging HEAL Initiative clinical research programs to train novice researchers and investigators new to pain research in the mechanics, techniques, and best practices of clinical pain research will maximize the impact of HEAL funding for both current and future research endeavors. Increasing the number of individuals trained in high quality clinical pain research is a critical step toward ensuring the highest impact of HEAL, with studies that encompass a broad range of pain conditions and have the potential to include, address the needs of, and positively impact diverse and traditionally underserved patient populations.

This Notice of Special Interest (NOSI) provides an opportunity for researchers funded by the Helping to End Addiction Long-Term (HEAL) initiative to devote more time for mentorship activities. The NIH defines a mentor as experienced scientist who can help guide the research of junior investigators and challenge them to develop independence as researchers. The objectives of mentoring include to enhancing a mentees approach to scientific investigation, developing their critical thinking and communication skills and assisting with their progression the research community. Mentoring responsibilities involve helping junior investigators defining research goals, supporting the achievement of those goals, and discussing and evaluating progress throughout training. A mentor should provide constructive and timely feedback, support training, networking and professional development opportunities, and acknowledge a mentees contribution to research. The award is intended to provide protected time for established investigators supported by the HEAL Initiative to simultaneously provide mentoring to junior investigators. The supplement is intended for investigators (principal investigators or co-investigators) who have a record of supervising and mentoring clinical pain researchers. The NIH HEAL Initiative is a trans-agency effort to speed scientific solutions to stem the national opioid public health crisis through understanding, managing, and treating pain and improving treatment for opioid use disorder and overdose.

This Notice of Special Interest (NOSI) provides an opportunity for clinical trials funded by the Helping to End Addiction Long-term (HEAL) initiative to address challenges of recruiting and engaging the diverse populations suffering from pain and opioid use disorder. NIH will support supplements to current HEAL awards that would either enhance their patient, community, and other stakeholder engagement efforts; improve diversity and inclusion among participants; or both, as appropriate for a particular study. The NIH HEAL Initiative is a trans-agency effort to speed scientific solutions to stem the national opioid public health crisis through understanding, managing, and treating pain and improving treatment for opioid use disorder and overdose. This supplement program is not intended to support research on basic processes but rather to implement strategies to enhance stakeholder engagement and diversity of patient inclusion in HEAL clinical studies.

This Notice encourages eligible awardees in the HEAL Initiative community to apply for administrative supplements in response to PA-20-222, Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed). The NIH has a strong interest in the diversity of the NIH-funded workforce (see NOT-OD-20-031) and encourages institutions to diversify their populations by enhancing the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral, and social sciences.