Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institute of Neurological Disorders and Stroke (NINDS)
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Mental Health (NIMH)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Center for Complementary and Integrative Health (NCCIH)
National Center for Advancing Translational Sciences (NCATS)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Research on Women’s Health (ORWH)
The purpose of this Funding Opportunity Announcement (FOA) is to solicit cooperative agreement applications that propose clinical trials to test the comparative effectiveness of existing therapies or effectiveness of existing or novel approaches for prevention and management of pain while reducing risk of addiction. The studies must address questions within the mission and research interests of participating NIH Institutes and Centers and evaluate preventive strategies or interventions including medications, biologics, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, rehabilitation strategies, complementary therapies, integrated approaches, and delivery system strategies in well controlled trials in specific pain conditions. The overall goal is to inform clinicians about the effectiveness of interventions or management strategies that reduce opioid use that will improve functional outcomes and reduce pain across the continuum of acute to chronic pain associated with many types of diseases or conditions or pain presenting as a disease itself. Clinical trials will be conducted within the infrastructure of the HEAL Pain Effectiveness Research Network.
December 10, 2018
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
New Date February 12, 2019 per issuance of NOT-NS-19-028. (Original Expiration Date: February 2, 2019)
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
The purpose of this Funding Opportunity Announcement (FOA) is to solicit cooperative agreement applications that propose clinical trials to establish the comparative effectiveness of existing therapies or effectiveness of existing or novel approaches for prevention and management of pain while reducing risk of addiction. The studies must address questions within the mission and research interests of participating NIH Institutes and Centers and evaluate strategies or interventions to prevent and/or manage specific pain conditions, including medications, biologics, procedures, medical and assistive devices and technologies, behavioral change, rehabilitation strategies,complementary therapies, integrated approaches, and delivery system strategies, through well-controlled trials. The overall goal is to inform clinicians about the effectiveness of interventions or management strategies that reduce opioid use that will improve functional outcomes and reduce pain across the continuum of acute to chronic pain associated with many types of diseases or conditions or pain presenting as a disease itself. To rapidly respond to this public health emergency, clinical trials will be conducted in the HEAL Pain Management Effectiveness Research Network (HEAL Pain ERN), which will be established through the infrastructure of the National Center for Advancing Translation Sciences (NCATS) Trial Innovation Network (TIN). Trials will be implemented at the Clinical and Translation Science Award (CTSA) Program hubs, which each may contain multiple clinical sites at different institutions, and/or any other clinical sites selected by the investigator that is not affiliated with the CTSA program.
Awards made under this FOA will support a milestone-driven planning phase (UG3) for 1 year, with possible transition to a clinical trial implementation phase (UH3) of up to an additional four years. Only UG3 projects that meet the scientific milestones and feasibility requirements will transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA.
This FOA may NOT be used for applications that propose testing of interventions to establish initial efficacy of drugs, devices or biologics for approval by the Food and Drug Administration (FDA).
Background
This multisite effectiveness research consortium will be part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. This broad research effort seeks to improve pain care through understanding the development of chronic pain and by accelerating and improving the process of therapy development to more rapidly move discoveries into clinical practice to alleviate the burden of pain. More information about the HEAL Initiative is available at: https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative.
Public Law 115-141, the Consolidated Appropriations Act of 2018 (signed March 23, 2018) includes a requirement that grantees from for-profit applicant organizations must provide a 50% match and/or in-kind contribution of all federally awarded dollars under the grant award (direct costs, as well as facilities and administrative costs) for research related to opioid addiction, development of opioid alternatives, pain management and addiction treatment.
Matching Requirement: A grantee from a for-profit organization funded under this funding opportunity announcement must match funds or provide documented in-kind contributions at a rate of not less than 50% of the total-Federally awarded amount, as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018.The applicant will be required to demonstrate that matching funds and/or in-kind contributions are committed or available at the time of, and for the duration of, the award. Applications must identify the source and amount of funds proposed to meet the matching requirement and how the value for in-kind contributions was determined. All matching funds and/or in-kind contributions must be used for the portion of allowable project costs not paid by Federal funds under the grant award. NIH will not be the recipient, nor serve as a pass-through entity, of any such matching funds and/or in-kind contributions required under this announcement. See 45 CFR 75.306 for additional details.
The Nation faces a crisis of high prevalence of chronic pain and associated opioid use disorder and overdose deaths. More than 50 million adults in the U.S. have experienced chronic pain, and over 25 million report pain every day. Nearly 20 million U.S. adults report high-impact chronic pain, which is defined as pain that interferes with their life. Many groups report a relatively high prevalence of chronic pain and high-impact chronic pain including women, older adults, previously but not currently employed adults, adults living in poverty, adults with public health insurance, and rural residents (2016 National Health Interview Survey data).
Reducing the burden of pain nationwide is a significant unmet need, and individuals need safe, non-addictive treatments to alleviate pain. Severe pain often is associated with diseases and chronic conditions such as diabetes, cancer, endometriosis, and sickle cell disease and it many persist as chronic pain following many surgical procedures or trauma. Chronic pain conditions such as complex regional pain syndrome, migraine, and fibromyalgia are diseases themselves, and many chronic pain conditions co-occur in individuals.
The strength of evidence for the effectiveness of current strategies currently used to manage pain is often low to moderate (CDC Guideline for Prescribing Opioids for Chronic Pain, AHRQ Noninvasive, Nonpharmacological Treatment for Chronic Pain - A Systematic Review). These strategies include some non-pharmacologic treatments for specific chronic pain conditions, long-term opioid therapy and different methods to initiate and titrate opioids, and comparisons of non-opioid and opioid drugs for pain management. More studies also are needed to inform evidence-based non-opioid treatments in the peri-operative setting.
Research Interests Specific to this FOA
This FOA is soliciting applications for clinical effectiveness research for management of pain in ways that reduce the risk of addiction. Effectiveness research is defined as the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, treat and monitor pain conditions in real world settings. The purpose of this research is to improve functional health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances. To provide this information, comparative effectiveness pain research must assess a comprehensive array of health-related outcomes for diverse patient populations and subgroups. Defined interventions to be tested may include medications, biologics, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, complementary approaches, rehabilitation strategies, integrated approaches, and deliver system strategies in well controlled trials. Therapies may be tested alone or in combination. This research necessitates the development, expansion, and use of a variety of data sources and methods to assess comparative effectiveness and actively disseminate the results.
Modified from Source: https://osp.od.nih.gov/wp-content/uploads/FCCCER-Report-to-the-President-and-Congress-2009.pdf
This FOA may NOT be used for applications that propose testing of interventions to establish initial efficacy of drugs, devices or biologics for approval by the FDA (see instead other opportunities such as EPPIC-Network below). Applicants interested in conducting such trials are also encouraged to contact an NIH Program Official of the scientifically-appropriate NIH Institute or Center to discuss other FOAs for this purpose. Non-responsive applications will be withdrawn.
Opportunities to Submit other Types of Pain Clinical Trials:
For further information on these programs see: https://www.painconsortium.nih.gov/Funding_Research/Funding_Opportunities
The Early Phase Pain Investigation Clinical Network (EPPIC-Net) will provide infrastructure for the rapid design and performance of high-quality Phase 2 clinical trials to test promising novel therapeutics for pain. This network will support exploratory clinical trials of investigational drugs and biologics, investigational devices, natural products, and surgical procedures for the treatment of pain. These trials may include deep phenotyping, validation of biomarkers and proof of mechanism, to support justification and provide the data for designing a future Phase 3 trial. The specific pain conditions of interests for EPPIC -Net include well-defined conditions with high unmet therapeutic needs in patients across the lifespan.
The Pragmatic and Implementation Studies for the Management of Pain (PRISM) program will support studies to integrate interventions that have demonstrated efficacy into health care systems or implement health care system changes to improve adherence to evidence-based pain management guidelines. PRISM encourages cooperative research applications to conduct efficient, large-scale pragmatic trial or implementation science study designs to improve pain management. The program requires that the intervention under study be embedded into health care delivery system, real world settings. The pragmatic trial model collects most data needed for analysis of the research question as part of clinical care, and it is expected that this data will be obtained primarily through the electronic records of the health care system. Studies needing to randomize participants individually, collect in-person measures for research purposes (such as specified clinical laboratory tests, observed studies of mobility or other measures of function) or deliver an intervention in a standardized fashion with fidelity monitoring should consider applying to the HEAL Pain ERN.
The NINDS-NHLBI-NCATS funded initiative, Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) runs clinical studies in the prehospital setting and the emergency department. It includes academic hub sites, spoke hospitals, and EMS providers to support multicenter clinical studies on neurological emergencies, including the pre-hospital and emergency department treatment of acute pain.
Research Objectives
The Federal Pain Research Strategy is a long-term strategic plan to guide the federal agencies and departments that support pain research and to advance the science to better understand pain and improve pain care. The strategy is an interagency effort that identifies a set of research priorities that align with the missions of numerous agencies and departments across the federal government. Overall, the priorities cover basic through clinical, dissemination, and implementation research to support the translation of scientific discoveries into clinical practice and improve the lives of people with pain. The strategy includes several priority recommendations on effectiveness research for pain. Please see the FAQs for more details on the research priorities. For further information on these programs see: https://www.painconsortium.nih.gov/Funding_Research/Funding_Opportunities
Institute Specific Research Interests
Many NIH Institutes, Centers and Offices (ICOs) share the goal to alleviate pain through support of clinical research to develop and evaluate interventions and approaches to alleviate pain across various pain conditions. Participating NIH ICOs are interested in research to evaluate the effectiveness of pharmacological and non-pharmacological interventions to manage mission-relevant acute and chronic pain in ways that reduce the risk of addiction. Summaries of NIH ICO specific research questions that would be responsive to this FOA are outlined below. Potential applicants are urged to contact NIH IC Program Staff (see Section VII) to ascertain whether proposed studies are responsive to their mission interests.
NCATS
Patients in rural settings may lack access to efficacious, non-opioid methods to manage acute and chronic pain, despite the fact they are more likely than their urban counterparts to be older, have serious illnesses and disabilities, and need effective pain management therapies. NCATS is interested in supporting research that establishes methods to translate efficacious non-opioid interventions for management of acute or chronic pain conditions into effective therapies that can be delivered successfully in rural settings.
NCCIH
The NCCIH is interested in supporting comparative effectiveness trials of mind and body approaches that have already demonstrated efficacy for specific pain conditions, such as low back pain, fibromyalgia, osteoarthritis and headache. Types of mind and body approaches to study include, but are not limited to, passive body-based approaches (e.g. spinal manipulation, mobilization, massage, acupuncture), mind-based approaches (e.g. meditation, mindfulness techniques), active movement-based approaches (e.g. yoga, tai chi), or an integrative approach that involves more than one intervention (e.g. Mindfulness Based Stress Reduction). NCCIH is particularly interested in applications utilizing innovative clinical trial designs such as sequential, multiple assignment, randomized trials (SMARTs) design to determine predictors of treatment response, treatment options at decision points, possible tailoring variables, or a sequence of treatment decision rules.
NCI
NCI is interested in clinical trials testing innovative and efficacious pharmacologic and non-pharmacologic approaches to treat or prevent acute and chronic cancer related pain syndromes caused by the disease or its treatment throughout the cancer trajectory (from diagnosis to survivorship and end of life). Interests include trials that enhance understanding of the impact of differential pain outcomes on cancer treatment outcomes, other cancer treatment induced toxicities, functionality, health related quality of life, sleep and psychosocial issues. Further, studies examining the differential pain experience and response to pain treatment in diverse populations are of interest. Examples of disease related pain syndromes include bone pain, visceral pain, and neuropathic pain (plexopathies, radiculopathies). Examples of treatment related pain syndromes include post-surgical phantom limb pain, radiation induced plexopathies, mucositis, aromatase inhibitors, and chemotherapy induced peripheral neuropathy.
NEI
The NEI encourages applications that propose clinical trials to establish the effectiveness of therapies or approaches for prevention or management of ocular pain. Ocular surface disease, and particularly dry eye disease, presents a currently unmet need despite clear clinical significance. NEI is also very interested in this area. Contacting the NEI Program Officer prior to submission of the application is recommended.
NHLBI
The chronic pain of sickle cell disease is a major source of decreased quality of life and is poorly responsive to current therapeutic modalities. Trials that are of interest will evaluate the effectiveness of approaches that are informed by the bio-psychosocial model of pain management utilizing multi-disciplinary combinations of behavioral, pharmaceutical, interventional, and rehabilitative modalities to address the co-morbidities often present in patients with chronic pain associated with SCD. While several studies have shown that the incidence of opioid addiction in SCD is low, the prolonged use of often high-dose daily oral opioid medications leads to dependence, risk of overdose, respiratory depression, immune dysfunction and hyperalgesia. Trials that evaluate the reduction or elimination of daily opioid use will also be of interest.
NIA
Examples of clinical trials that are of interest to NIA include studies that determine effective interventions for persistent pain in older adults in ways that maximize function, minimize pain’s interference with life, and/or mitigate pain treatment interactions with underlying aging processes, co-occurring conditions, and medications. Both pharmacologic and non-pharmacologic approaches are of interest. Older adults with cognitive impairment, and other populations who may require more tailored behavioral therapeutic approaches, are of particular interest. Outcomes of interest include pain, functional measures, indicators of organ system function and disease, quality of life, subjective well-being, resource utilization, and cost-effectiveness. Applicants proposing behavioral intervention research should note that, in addition to showing efficacy, issues of real-world training procedures, fidelity of delivery, and scalability should be addressed before proposing an effectiveness study through this FOA. NIA applicants considering a behavioral interventionare referred to the NIH Stage Model (https://www.nia.nih.gov/research/dbsr/stage-model-behavioral-intervention-development ) prior to proposing a (Stage IV) effectiveness study.
NICHD
NICHD is interested in research that includes the populations mentioned in the specific priorities below and which includes health disparity populations (i.e., diverse race/ethnicity, sexual and gender minorities, and underserved/low-resource communities) to the extent possible.
Effective methods to manage persistent pain of women with endometriosis, chronic pelvic pain, vulvodynia, and other gynecologic pain syndromes in ways that maximize function and minimize pain’s interference with life.
Innovative research methods such as adaptive (e.g. SMART) or multiphase optimization strategy (i.e. MOST) clinical trial designs to test the effectiveness of combined non-opioid pharmacological and non-pharmacological treatments, as well as behavioral and psychological interventions, for forms of acute or chronic pain in children, women of reproductive age, pregnant and lactating women.
Studies to address the weak evidence for the efficacy of different classes of analgesics to include acute and post-operative pain management in children, women of reproductive age, and pregnant and lactating women after minor and major surgical procedures.
Clinical trials testing existing pharmacotherapeutics to improve safety and effective treatment/management of pain (chronic or acute) in children and women during pregnancy and lactation.
Dissemination and implementation projects aimed at inclusion of efficacious pharmacological and non-pharmacological pain interventions in children, women of reproductive age, and pregnant and lactating women in clinical settings.
NICHD’s National Center for Medical Rehabilitation Research (NCMRR) is interested in:
Clinical effectiveness trials focused on rehabilitative interventions and strategies involving pharmaceutical, stimulation, and bioengineering approaches, exercise, motor training, occupational therapy and behavioral modifications for management of pain in individuals with physical disabilities.
Clinical trials in high priority research areas (https://www.nichd.nih.gov/about/org/ncmrr) to include pediatric rehabilitation interventions that include the effects of maturation and the impact of early intervention.
Rehabilitation prevention and treatment strategies for mitigating pain, a key secondary condition associated with physical impairments and disabilities are strongly encouraged.
NIDA
NIDA is interested in research to evaluate the effectiveness of pain interventions that may prevent the initiation and progression or reduce the severity of opioid use disorders (OUDs) and overdose. There efforts include the evaluation of effectiveness of existing medications as well as studies of optimal behavioral treatments for pain management that can reduce the need for opioids to treat pain conditions (i.e., opioid-sparring).
NIDCR
NIDCR is interested in clinical trials aimed at reducing the burden of pain associated with acute and chronic oral and craniofacial diseases and conditions including temporomandibular joint disorders (TMD), trigeminal neuropathies, burning mouth syndrome, oral cancer pain, dental pain and other conditions. Examples of research topics that would be appropriate to the NIDCR include: 1) Clinical research to address the weak evidence for the effectiveness of different classes of analgesics for acute pain management after dental procedures; 2) Clinical studies to test clinical tools and/or interventions designed to modify dental practitioner opioid prescribing behaviors, especially for adolescent and young adult patients; and 3) Clinical trials to test the effectiveness of non-opioid pharmacological, non-pharmacological treatments or a combination of these for management of oral and craniofacial pain conditions.
NIDDK
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is interested in clinical trials testing effective interventions (both pharmacological and non-pharmacological) aimed at prevention and treatment of pain associated with acute and chronic diseases and disorders within our mission. This includes but is not limited to painful diabetic neuropathy, Inflammatory Bowel Disease (IBD), pancreatitis, hepatitis, cholecystitis and choledocholithiasis, Irritable Bowel Syndrome (IBS), functional abdominal pain and other functional gastrointestinal disorders, urologic chronic pelvic pain syndrome, and kidney stone disease.
NIMH
NIMH is interested in prevention and treatment intervention effectiveness trials that address acute or chronic pain and co-occurring mental health symptoms and disorders (e.g., depression, anxiety, post-traumatic stress disorder, suicide ideation and behaviors). Responsive applications will include research to evaluate the effectiveness of pharmacologic, somatic, psychosocial (psychotherapeutic, behavioral), device-based, rehabilitative and combination interventions to prevent or treat co-occurring pain and mental health symptoms and disorders. Effectiveness trial applications need to address: 1) the testing of hypotheses regarding moderators, mediators, and mechanisms of actions of these interventions; and 2) the use of service-ready scalable (including the use of technology) and sustainable approaches to improve delivery. Consistent with the NIMH s, mechanism-based, Experimental Therapeutics approach, the goal is to support effectiveness trials that not only test the intervention effects on outcomes of interest, but also explicitly inform understanding regarding whether the intervention engages associated change mechanisms that were previously identified under more controlled, efficacy conditions. This design will reconfirm the intervention targets and establish whether previously identified change mechanisms are operative in the effectiveness context (see NIMH web page on Clinical Trials). NIMH interest is limited to applications that focus in a substantial manner on the improvement of co-occurring pain and mental health outcomes. Applications that target general health or global functioning are not considered responsive to this initiative.
NIMHD
NIMHD’s mission is to lead, conduct and support scientific research to improve minority health and reduce health disparities. Substantial literature suggests that diverse biological, psychological, and sociocultural mechanisms account for differences by race and ethnicity in the experience, epidemiology, and management of pain. A higher prevalence of risk factors for illness, such as lower socioeconomic status, poor health habits, and inadequate access to healthcare services, predispose rural populations and minority groups to a higher burden of pain. Racial- and ethnic-based differences in the pain care experience have also been described, with there being substantial racial and ethnic disparities in the prevalence, management and treatment, progression and outcomes of pain-related conditions. NIMHD is interested in applications that propose clinical trials that assess the effectiveness of interventions that reduce pain and disparities in pain management in health disparity populations. Secondary data analyses that identify factors contributing to disparities in pain and pain management in health disparity populations are also of interest.
NINDS
NINDS is interested in research to prevent and treat acute and chronic nociceptive and neuropathic pain. Clinical trials designed to compare effectiveness of non-opioid analgesics and devices, either alone or in novel combinations, are of interest to NINDS. Disease areas of interest include migraine and other headaches, post-stroke pain syndromes, and others within the mission of NINDS. NINDS is also interested in trials that test ways to manage pain with strategies that reduce opioid use in patients presenting to Emergency Departments (ED). Investigators interested in such trials should coordinate with the Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN).
NINR
NINR supports research that develops the scientific basis for clinical practice and is interested in clinical trials aimed at determining the effectiveness of non-pharmacologic approaches to reduce the severity of pain and to help individuals manage such pain. Proposed studies may focus on interventions that can be tested in one or across multiple diseases/conditions in diverse settings and populations and across the lifespan. Topics of particular interest include behavioral approaches, e.g., exercise, diet, CBT, motivational incentives, to manage pain; biopsychosocial-centered approaches that emphasize self-management as care rather than cure of pain; studies that seek to optimize non-pharmacologic intervention timing, dosage and sustainability for pain management; and/or studies that assess effective contributions of family/caregivers in managing pain. Outcomes of interest include quality of life, pain reduction, pain interference, and therapeutic reliance.
OBSSR
Although the Office of Behavioral and Social Sciences (OBSSR) does not accept assignment of applications or administer awards, OBSSR does encourage applications relevant to the OBSSR mission and may provide co-funding support to ICs that do manage the awards. OBSSR is specifically interested in studies that apply evidence-based approaches for behavioral change (e.g., provider prescribing practices, adherence to treatment and management recommendations for both the practitioner and patients, provider/patient communications and other topics) to improve outcomes that include reducing opioid use disorder, mitigating the transition from acute to chronic pain and enhancing effective management for those with persistent and chronic pain. Additionally, approaches that include the identification of characteristics of individuals most likely to benefit from nonpharmacologic approaches for pain management are also of interest to OBSSR.
OWRH
Although the Office of Research on Women’s Health (ORWH) does not accept assignment of applications or administer awards, it is expected that trials in the HEAL Pain ERN will recruit women in sufficient numbers to determine sex-specific responses as well as sex differences in trial outcomes. These comparisons have significant clinical relevance given the higher prevalence of pain in women. Studies should, as appropriate, enroll both sexes to better understand the influence of sex as a variable.
Overview of the HEAL Pain ERN Network
Awardees will be required to conduct their studies through the NIH HEAL Pain Management Effectiveness Research Network (HEAL Pain ERN) which will have dedicated pain and clinical trial design expertise. The HEAL Pain ERN will use the infrastructure of the NCATS Trial Innovation Network (TIN) (www.trialinnovationnetwork.org ) to provide scientific guidance and coordination of the HEAL Pain ERN trials. The TIN works with the broad consortium of Clinical and Translational Science Awards (CTSA) hubs (https://ctsa.ncats.nih.gov/ ) that each may contain multiple clinical sites at different institutions, to implement studies. Points of contact (POC) for the HEAL Pain ERN at the individual CTSA hubs will be posted on www.trialinnovationnetwork.org. TIN dedicated pain and trial experts will participate on study teams of awarded UG3/UH3 projects during the planning and implementation phases and will provide clinical coordination center (CCC) services, data coordination center (DCC) services, recruitment and retention services, and biostatistical support.
The HEAL Pain Management Clinical Effectiveness Research Program Overview
An expert Panel of External Program Consultants (EPCs) comprised of experts on pain and pain clinical trials will be established by NIH leadership. The role of the EPCs is to provide individual level advice to the NIH. This group will assess the overall progress of the trials awarded through this FOA, including the collaborative interactions with the HEAL Pain ERN CCC, DCC, and biostatistics core, and make recommendations to NIH leadership about the overall program. Dedicated pain experts and clinical trial experts from the HEAL Pain ERN CCC, DCC, and biostatistics core, NIH staff, and the awardees investigative team (PIs, biostatistician and study coordinator) will serve as the Clinical Trial Steering Committee, one for each trial, and will work collaboratively to plan and implement the trials. A consortium of all the Clinical Trial Steering Committees across all funded trials defined here as the Program Steering Committee - will convene for a face-to-face kick off meeting during the planning year and subsequently by conference call. The individual Clinical Trial Steering Committees will meet regularly throughout the duration of the implementation phase of the trials.
Specific functions provided by the HEAL Pain ERN CCC, DCC and biostatistical core include but are not limited to:
Developing the final study protocol with the study team investigators;
Providing study design support, statistical analysis and interpretation of results for manuscripts and publications;
Finalizing recruitment and retention plans with the site investigators before initiation of the trial;
Developing associated trial documents, including the Manual of Procedure or Standard Operating Procedures; materials for site investigators, case report forms and training materials for study personnel with the study team;
Training clinical site investigators and staff for the individual trials. Training areas include, but are not limited to, regulatory requirements, Good Clinical Practice (GCP), adverse event reporting, human subject protections, informed consent, and NIH policies and procedures;
Developing and maintaining a data management system for trial data collection and storage and adverse event reporting;
Providing randomization support;
Providing clinical operations and monitoring support including project management, to oversee and coordinate activities associated with the clinical trials, study implementation, from study start-up through additional site selection as needed, enrollment, site management, study monitoring and close out. This includes assistance finding additional CTSA hub sites if needed in the UG3 and UH3 phase to meet enrollment goals.
Monitoring enrollment and retention at the individual sites and working with sites that fail to meet their enrollment targets;
Preparing reports for the Data and Safety Monitoring Boards;
Providing central IRB services for the trial;
Working with the awardees to execute the Master Clinical Trial Agreement to the individual clinical sites, and
Providing logistics for face to face meetings of the cooperatives investigators, including a cross award investigator kick off meeting in the planning phase.
Applicants should make note of the following:
Applicants should propose their primary outcome based on that most appropriate for the trial question. Standardized pain measures and functional outcomes are strongly encouraged to ensure that data is translatable across all HEAL initiative pain studies. Secondary outcomes, including selected patient reported outcomes related to pain, addiction, and selected pain and associated measures, will be added to the protocol during the UG3 development phase. A final list of these required measures will be developed at the kick-off meeting held in the planning year collaboratively by the Program Steering Committee and addition experts as appropriate.
The award and continuation of funding are subject to milestones to be specified in the notice of grant award. At the time of an award, the PD(s)/PI(s), TIN personnel, and NIH staff will negotiate the scope and study development activity timeline for UG3 award and implementation activity timeline for the UH3 award. The project work scope and timeline will include identifying the primary individual or entity and other contributors responsible for study development, start-up and implementation activities, and the timeline for completion of these activities.
Applications that do not include milestones will be considered non-responsive to this FOA and will be withdrawn (see section below: Milestones and UG3/UH3 Transition)
Applicants are strongly encouraged to consider using the PROMIS domains (http://nihpromis.org ) related to pain, such as pain interference, physical function and depression instruments, as measures in their studies.
Given the variety of pain conditions that are eligible for study in the HEAL Pain ERN, applicants should include letters of intent to participate from sites named in the application, whether they be within and outside the CTSA consortium.
NIH Resources: As appropriate, applicants are encouraged to make use of the following resources for clinical research including:
(a) Clinical and Translational Science Award (CTSA) program https://nacts.nih.gov/ctsa ;
(b) NIH Toolbox (http://www.nihtoolbox.org );
(c) PROMIS (http://www.nihpromis.org ); and
(d) NINDS Common Data Elements (http://www.commondataelements.ninds.nih.gov ).
Scope of the UG3/UH3 FOA
Each UG3/UH3 Clinical Trial Implementation Cooperative Agreement application can propose the planning and implementation of only one clinical trial.
NIH is interested in supporting clinical trials that are designed to answer questions based on a strong scientific premise and are carried out through a robust approach. To adequately plan and finalize the details for implementation of the clinical trials, investigators, in coordination with the CCC and DCC, and NIH staff, need time to prepare. Therefore, the UG3 component of the award will support a one-year planning phase during which limited funds will be awarded. Applicants and recipients of UG3 funding should note that the UG3 award does not guarantee subsequent UH3 funding for implementation of the clinical trial. Only those trials that successfully meet the scientific milestones and feasibility requirements for transition will be funded to move to the trial implementation phase (UH3).
Clinical Trial Planning Phase (UG3)
The UG3 award supports the planning period and is not intended for the collection of preliminary data (neither clinical nor pre-clinical studies) about the efficacy or effectiveness of an intervention, or the collection of prospective data to support the rationale for a clinical trial. During this year, the awardees, as part of the Clinical Trial Steering Committee will develop their protocols and associated study documents.
After awards are made, the awardees will assess and refine the study design and statistical analysis collaboratively through the Clinical Trial Steering Committee. A kick-off meeting will be held shortly after the award is made, during which the awardees across the Program Steering Committee (all trials), additional pain experts and NIH Program staff will ensure that standardized and consistent outcome measures, and NIH supported sets of common data elements are used appropriately and when possible in the studies to ensure translation of shared data across HEAL supported clinical studies.
Examples of activities to be completed during the UG3 phase include, but are not limited to:
The final protocol must be accepted by NIH and receive approval by the single IRB and the Data and Safety Monitoring Boards (DSMBs) overseeing the individual trials.
In addition, each site must agree to use a Master Clinical Trial Agreement that will be provided by the HEAL Pain ERN CCC, which serves as a one-time contract for participation in a HEAL Pain ERN study, and are expected to use a single Institutional Review Board (sIRB).
Clinical Trial Implementation Phase (UH3):
The planning year will be followed by up to four additional years of higher funding levels, during which the study will be implemented. The objective of the up to 4-year UH3 implementation phase is to conduct the clinical trial in accordance with activities planned in the UG3 phase. The trial outcome measure(s) must be clinically meaningful and important to stakeholders including patients and health care providers. The NIH expects clinical trials supported during the UH3 phase to be hypothesis driven, milestone-defined, and have the potential for high impact within the research mission of the HEAL Pain initiative. The clinical trial must meet all applicable NIH, Food and Drug Administration (FDA), and Office of Human Research Protections (OHRP) policy requirements.
Milestones and UG3/UH3 Transition
Applications must include well-defined milestones for the planning phase (UG3) and annual milestones for the clinical trial implementation phase (UH3). Prior to a pending award, the PD/PI and NIH will negotiate a final list of milestones for each year of support. The proposed milestones for the UH3 phase may be revised during the award period in coordination with NIH staff, the CCC and DCC, as activities in the UG3 phase progress.
At the completion of the UG3 planning phase or if possible sooner, the applicant will be required to submit a detailed transition proposal for the UH3 clinical trial implementation phase. The UH3 transition proposal will undergo an administrative review to determine whether the study will be awarded the implementation phase (UH3). The review will determine if the UG3 planning milestones named in the Milestone Plan have been met, and that the UH3 phase can successfully test the chosen hypothesis in a timely fashion.
Informational Webinar. Prospective applicants are strongly encouraged to attend an informational webinar with NIH staff on December 17, 2018. Applicants should refer to
https://painconsortium.nih.gov/Funding_Research/NIH-HEAL-Effectiveness-Research-Program-Pain
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
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NIH intends to fund approximately five awards, corresponding to a total of $4,000,000 for fiscal year 2019 and $16,000,000 for each fiscal year 2020 to 2023. This excludes costs for HEAL Pain ERN CCC, DCC and biostatistical core. Future year amounts will depend on annual appropriations.
The scope of the proposed project should determine the project period. The required project period for the UG3 phase is one year, and the maximum project period for the UH3 phase is four years.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
For grantees from a for-profit organization, this FOA does require cost sharing, as defined in the NIH Grants Policy Statement. More information on cost matching requirements is in Section IV.2 R&R or Modular Budget
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Linda Porter, Ph.D.
Telephone: 301-435-7572
Email: [email protected]
All instructions in the SF424 (R&R) Application Guide must be followed.
Cost Matching Requirement for For-profit Applicants
Cost matching or documented in-kind contributions is required for for-profit organizations responding to this FOA. The for-profit awardee is required to match funds or provide at least a 50% matching of funds or documented in-kind contributions at a rate of not less than 50% of the for the total-Federally awarded amount (direct costs, as well as facilities and administrative costs), as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018.
Federal funds may not be used as a source of matching funds. Generally, cost matching requirements may not be met from the following sources:
a) Costs borne by another Federal grant or sub award;
b) Costs or contributions toward cost sharing on another Federal grant, a Federal procurement contract, or any other award of Federal funds;
c) Cost of services or property financed by income earned by contractors under a contract from the recipient (or sub recipient);
(d) Program income; and
(e) Patient incentives.
The for-profit organization will be required to demonstrate that matching funds and/or in-kind contributions are committed or available at the time of, and for the duration of, the award. Applicants must submit budgets that clearly document the total costs, the source and amount of matching funds, and how valuation was determined in the case of in-kind contributions, as well as the Federal and Institutional (non-Federal) components of the budget. All matching funds and/or in-kind contributions must be used for the portion of allowable project costs not paid by Federal funds under the grant award. NIH will not be the recipient, nor serve as a pass-through entity, of any such matching funds and/or in-kind contributions required under this announcement. See 45 CFR 75.306 for additional details.
Budget Justification: All for-profit applicants must document the matching (non-Federal) component and the federal (non-matching) component in the total project budget. That is, the requested budget plus the cost-matching budget must be detailed in tabular format to document the cost-matching (non-Federal) component and the federal (non-cost matching) component. The amount of matching is subject to adjustment based on total allowable costs incurred. All costs and contributions used to satisfy the matching requirement must be documented by the recipient, including how the value for in-kind contributions was determined, and are subject to audit. The cost matching requirement is not negotiable for for-profit organizations.
Research Strategy:
Significance and Clinical Relevance: Describe the significance of the proposed effectiveness clinical trial in the context of the status of interventions for pain management and the risks and benefits of the proposed study interventions. Discuss how the trial will test the hypotheses proposed and how the results of the trial (positive or negative) will advance the field. Applicants are encouraged to include evidence such as letters or references that relevant stakeholders (e.g. potential subjects, referring and treating physicians, patient organizations, or professional organizations) view the question to be important.
Previous Studies: Present the major findings of the previous efficacy clinical studies that led to the proposed effectiveness trial. Ensure that the data supporting the proposed trial meet the NIH scientific rigor guidelines (seehttps://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-103.html). Preliminary data supporting efficacy of the proposed intervention may come from the applicant’s previous work or from published literature.
Investigator(s): Describe the expertise of the study team in the conduct of multi-center trials, the team’s ability to plan and implement the proposed study, and the plan for the team to work cooperatively across the consortium (CCC, DCC, biostatics core experts, NIH staff, and other trial teams)
Approach:
The approach should clearly justify the clinical relevance for the length of observation for the pain outcome and the additional outcomes such as adverse effects associated with treatment. Do not duplicate information described in the Study Record: PHS Human Subjects and Clinical Trials Information form.
The Approach section should have a clear demarcation of the UG3 and UH3 portions of the application.
For the UG3 phase:
For the UH3 phase, include the following:
The following modifications also apply:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:
Section 2 - Study Population Characteristics
2.5 Recruitment and Retention Plan
Applicants should state how many sites will be needed and survey the potential clinical sites to ensure that recruitment targets can be met. A list of HEAL CTSA points of contact will be posted on www.trialinnovationnetwork.org. Present the survey results using a table where the rows represent potential clinical sites and the columns include survey responses. . The survey questions will depend on the nature of the trial and the protocol-specified screening procedures but might include these:
Given the variety of pain conditions that are eligible for study in the HEAL Pain ERN, applicants should include letters of intent to participate from as many sites as possible named in the application, whether they be within and outside the CTSA consortium.
Include a description of how additional sites not named in the application (Clinical and Translational Science award (CTSA) Program hubs sites or any other investigator-selected sites) will be selected and used as clinical sites to implement the trial. . Specify the criteria for selecting additional sites. Existing other network clinical sites suitable to answer the study question may also be used, but the other network must use the TIN DCC and CCC and participate in all HEAL Pain ERN activities.
The plan should also include a contingency plan for adding new sites if enrollment falls behind targets or discontinuing enrollment of new participants at sites that do not meet individual goals.
Section 3 - Protection and Monitoring Plans
3.2 Single Institutional Review Board (sIRB)
It is expected awardees will use a single Institutional Review Board (sIRB) to conduct the ethical review required by HHS regulations for the Protections of Human Subjects Research unless review by the proposed sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy. For this FOA, the three Trial Innovation Network (TIN) cIRBs are available to serve as the sIRB of record. If the awardee elects to use these sIRBs, the assignment will be made post award. There is no need to request the services. For more information about the cIRBs affiliated with the TIN, see https://trialinnovationnetwork.org/elements/central-irb/
3.3 Data and Safety Monitoring Plan
It is expected that a Data and Safety Monitoring Board (DSMB) will oversee each trial, consistent with the policy of the IC managing the trial. Applicants should refer to the specific guidelines of the Institute or Center with a scientific interest in the proposed trial to guide development of their Data and Safety Monitoring Plan (DSMP). The final DSMP will be developed with the managing IC after award. For IC specific DSMB policies see https://www.painconsortium.nih.gov/Funding_Research/Funding_Opportunities
A Clinical Site Monitoring Plan will be developed with the Clinical Trial Steering Committee during the first year of the study. This plan will include how site adherence to the protocol and consenting process will be ensured, who is responsible for site monitoring, the frequency of planned monitoring activities and the plan for handling deficiencies, or closure of sites. Plans for training and, if needed, certifying site personnel to complete study procedures will be developed by the PD/PI and HEAL Pain ERN DCC and CCC during the UG3 phase of the study.
A detailed Data Management Plan, including the methods and systems for data collection and quality control, and for ensuring data confidentiality and privacy, and the process for locking the final dataset will be developed by the HEAL Pain ERN DCC and the PD/PI during the UG3 phase of the study.
Describe the plans, if any, to use non-traditional data collection approaches (e.g., digital/mobile/sensor technologies and web-based systems) and why these are appropriate.
Section 4 - Protocol Synopsis
4.2.a Narrative Study Description
As applicable, state how the following resources for clinical research will be utilized:
4.4 Statistical Design and Power
Applicants should provide a Statistical Analysis Plan (SAP) including details onabout the power analysis used to determine how the study sample size was determined, analyses specified in the study protocol, including a description of how the statistical analysis of the primary, secondary and other endpoints will be performed, how missing data will be handled, plans for interim analyses for safety and futility, plans for recalculation of the sample size midway through the trial (if applicable), etc. If computer simulations were used to investigate the operating characteristics of complex clinical trial designs (such as adaptive designs), to choose between alternative outcome measures, or to determine sample size, accounting for the impact of noncompliance, missing data, subject eligibility criteria, etc., sufficient details about the simulations should be provided if the SAP. It is particularly important to discuss the range of conditions that were considered in the simulation and why this range was considered appropriate, how robust the findings were across the range of conditions considered, and how the study will adjust for any design deficiencies (e.g., bias, loss of power) the simulations revealed.
The final SAP will be developed with statistical guidance of the TIN biostatistics core.
4.6 Will the study use an FDA-regulated intervention?
This FOA will not support studies of interventions of investigational products under IND or IDE.
4.7 Dissemination Plan
UG3/UH3 applicants must submit a plan for the dissemination of NIH-funded clinical trial information that will address how the expectations of the NIH Policy on the Dissemination of NIH-funded Clinical Trial Information will be met. Responsibility for adhering to this policy lies with the UG3/UH3 grantee institution, not with the TIN Coordinating Center awardees.
Section 5 Other Clinical Trial-related Attachments
5.1 Other Clinical Trial-related Attachments
Additional Instructions: The information provided here will be considered by reviewers and is meant to supplement, not duplicate, information provided in the Research Plan or other sections of the PHS Human Subjects and Clinical Trials Information form. The following documents must be uploaded as separate pdf files with the names indicated below.
Schedule of Events. The filename "Schedule of Events" should be used to name this attachment. If multiple attachments are needed, amend the file name accordingly (e.g., Schedule of Events 1, Schedule of Events 2, etc.). Provide a schematic, table, or text description of the protocol-specified schedule of events for an individual study participant. It should capture each study visit/assessment time point and planned activity(ies) for each time point.
Milestone Plan. The filename "Milestone Plan" should be used to name this attachment. If multiple attachments are needed, amend the file name accordingly (e.g., Schedule of Events 1, Schedule of Events 2, etc.).
Milestones to be completed during the UH3 phase:
Milestones and timelines will be refined and finalized in consultation with Program staff at the time of award.
Applications that lack the Milestone Plan attachment are considered incomplete and will be withdrawn.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding? If applicable, is the proposed effect size of the trial clinically meaningful?
Does the application provide evidence that relevant stakeholders (e.g. potential subjects, referring and treating physicians, patient groups) view the question to be important?
Is there adequate data supporting efficacy of the proposed intervention to warrant an effectiveness trial for the selected outcome(s) in the proposed population?
Are the results from the proposed trial likely to inform evidence-based guidelines for management of acute or chronic pain in ways that would reduce the risk of addiction?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
Does the application adequately address the following, if applicable?
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Are pain outcomes from participants collected for a period that is clinically meaningful to inform clinical decision making?
Does the application adequately address the following:
UG3 Planning Phase
Are there clear plans to obtain any study agents? Are there clear plans to work in collaboration with the DCC and CCC for developing a final clinical protocol and associated documents? Are there appropriate plans for the final selection of the clinical sites and necessary populations for the future study? Is there an adequate discussion of potential challenges that are anticipated during planning and study implementation, and how they will be addressed? Is there evidence of how the investigators will work with the consortium to finalize the UH3 study plans? Is the plan appropriate?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults) , justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
If proposed, are the administrative, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Does the application provide sufficient rationale for the settings selected for the UH3 effectiveness trial?
Study Timeline and Milestones
Are appropriate, evaluative milestones clearly defined for the UG3 phase, and is it likely that the investigator team will meet these milestones within the proposed project period ?
Is the study timeline proposed for the UH3 described in detail, considering start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are appropriate, evaluative milestones clearly defined for the UH3 phase? Are the milestones feasible and quantifiable with regard to specific aims and timeline? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Not Applicable.
Not Applicable.
Not Applicable.
Not Applicable.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Specific to this FOA:
How likely is it that the plans for cost matching will be adequate?
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
Special award condition specific to this FOA: A grantee from a for-profit organization funded under this announcement must match funds or provide documented in-kind contributions at a rate of not less than 50% of the total-Federally awarded amount, as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018. See 45 CFR 75.306 for additional details. Matching funds must be non-Federal funds set aside for this project and are available from the source(s) identified in the application, as committed to by the recipient. Cost matching will be evaluated by the awarding office to ensure that this requirement is being met. Compliance with the matching requirement must be verified on an annual basis and must be documented in the annual and final FFR.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for the HEAL PAIN ERN program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below. Awardee will retain custody of and have primary rights to the data and software developed under this award, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
The PD(s)/PI(s) will have the primary responsibility for:
NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The NIH Project Scientist(s) will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination. The Project Scientist(s) will participate as members of the HEAL Pain ERN Program Steering Committee and the Project Scientists together will have a single vote. The Project Scientist(s) will have the following substantial involvement:
In addition, an agency Program Official or IC Program Director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned Program Official may also serve as an NIH Working Group Project Scientist(s) to assist the awardee. Prior to funding an application, the Program Official will contact the applicant to discuss the proposed milestones and any changes suggested by NIH staff or the NIH review panel. The Program Official and Project Scientist will negotiate with the applicant and agree on a final set of approved milestones which will be specified in the Notice of Award. The NIH Program Official, in consultation with the Project Scientist and NIH HEAL Pain ERN Working Group, will determine if the awardee has met the milestones required for each year of funding.
NIH reserves the right to withhold funding or curtail an award in the event of:
Areas of Joint Responsibility include:
Close interaction among the participating investigators will be required, as well as significant involvement from the NIH, to manage, assess, and implement the HEAL Pain ERN program. The awardees and the Project Scientist(s) will meet through the HEAL Pain ERN Program Steering Committee times during the planning year, and through the Clinical Trials Steering Committees regularly over subsequent years, and on conference calls as needed to share information on methodologies, analytical tools, and preliminary results. PDs/PIs, key co-investigators and pre- and post-doctoral trainees, especially those who are members of under-represented minority groups or those from different but related disciplines, are eligible to attend these meetings.
The HEAL Pain ERN Program Steering Committee will be responsible for coordinating the activities conducted by the program and is the committee through which the individual NIH HEAL Pain ERN Clinical Trials Steering committees will formally interact. The HEAL Pain ERN Program Steering Committee membership will include PD(s)/PI(s) of each HEAL Pain ERN award, other staff as needed, the NIH Project Scientist(s) and the dedicated pain and clinical trial experts from the CCC, DCC, and biostatistics core. The HEAL Pain ERN Program Steering Committee may add additional members, and other government staff may attend the HEAL Pain ERN Program Steering Committee meetings as desired.
The HEAL Pain ERN Program Steering Committee may establish subcommittees as needed to address particular issues, which will include representatives from the program and the NIH and possibly other experts. The HEAL Pain ERN Program Steering Committee will have the overall responsibility of assessing and prioritizing the progress of the various subcommittees.
The HEAL Pain ERN awardee agrees to work collaboratively to:
External Program Consultants (EPCs):
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. The three members will be: a designee of the HEAL PAIN ERN Program Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
A final Research Performance Progress Report (F-RPPR), invention statement, and the expenditure data portion of the Federal Financial Report, including Federal and non-Federal share for cost matching, are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
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