NIDA Mentor-Facilitated Training Award in Substance Use Disorders Science Dissemination Solicitation
Supported by the National Institute on Drug Abuse (NIDA) from the National Institutes of Health (NIH) and sponsored by SAEM Foundation
Deadline: September 15, 2019
Accelerating the dissemination of Substance Use Disorder (SUD), particularly opioid use disorder (OUD) research findings and encouraging the implementation of evidence-based practices in health care settings is a priority for NIDA and represents the core mission of the NIDA CTN Dissemination Initiative - https://www.drugabuse.gov/nidamed-medical-health-professionals/ctn-dissemination-initiative (also refer to: https://www.drugabuse.gov/nidamed-medical-health-professionals). This initiative uses collaboration between expert clinicians, clinical researchers, experienced trainers, and NIDA staff to rapidly disseminate research findings from NIDA’s vast scientific portfolio to a variety of stakeholders, including policy-makers, program administrators and frontline prevention and treatment providers.
The SAEM Foundation has partnered with NIDA to fund training awards to support the development of expertise in SUD, especially OUD, through completion of a mentor-supervised project focused on adoption and/or dissemination of SUD treatment research and the publication of the results. The NIDA Mentor-Facilitated Training Award goals are: 1) to promote and improve knowledge of evidence-based SUD treatment among health care providers, 2) to promote the adoption of evidence-based approaches in medical settings, 3) to promote dissemination of substance use disorder research findings, and 4) to facilitate the professional growth and development of future clinician leaders in the area of SUD management.
This award cannot be used to conduct basic or clinical research studies or trials. Awardees are to develop and execute a plan designed to increase their clinical knowledge of the management of SUD, especially OUD, and complete a project aimed at improving the dissemination and/or adoption of existing SUD treatment research findings. Secondary data analysis of treatment research datasets may be completed in pursuit of these aims, provided the project proposed is eligible for Institutional Review Board (IRB) exemption and displays merit to impact on or increase the adoption of evidence-based practices. Applications proposing non-exempt research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46 will not be accepted.
Purpose of the Award
The purpose of the award is to enhance a trainee’s ability to disseminate the clinical knowledge of SUD management gained via the award experience of conducting a mentored project aimed at either dissemination and/or adoption of evidence-based SUD treatment practices through a plan that will:
- Provide the trainee with experience that eventually fosters interest in either a clinical career providing evidence-based management of SUD in medical settings or potentially stimulates interest in securing a NIH career development or other grant award to pursue implementation and related research in the field of substance misuse and substance use disorder in subsequent years.
- Provide the trainee with a mentored experience in effective dissemination of existing or emerging research findings and/or the implementation/adoption of research in clinical practice. Applicants are encouraged to develop projects that address or improve upon current gaps in the dissemination of research findings or implementation/adoption of evidence-based treatment practices. Project updates will be shared at the NIDA CTN Annual meeting. Project results will be presented at the SAEM annual meeting. Poster presentations are acceptable. The trainee is strongly encouraged to develop a manuscript for submission for publication in a peer-reviewed journal.
- Link the trainee with an experienced mentor to guide and facilitate an up to one year-long mentored experience, culminating in a project related to dissemination and/or adoption of SUD research findings.
- Provide the trainee with a mentored opportunity to learn about key areas of SUD and SUD treatment strategies through systematic literature review, attendance at conferences and workshops, and interaction with leading experts in the field.
The applicant should work in an active, progressive environment that intimately involves the applicant in different facets of SUD treatment. Award recipients should be matched with a faculty mentor with established SUD treatment expertise. It is recommended that the mentor also have dissemination and implementation science expertise. The mentor is responsible for providing a letter of support with plans for regular phone or video meetings; assisting with planning and execution of the project; and assisting with developing the poster presentation. This award will provide a mentor stipend. Applicants are encouraged to develop a project related to ongoing work done by their mentor. More than one mentor may be proposed.
The applicant may be a trainee in an approved clinical residency or a clinical fellowship training program. Eligible candidates will not have a NIH research fellowship or a NIH research career development award.
Project Examples and Recommended Topic Areas
For this Mentored training award, NIDA and the SAEMF encourage clinically relevant applications with a focus on treatment of substance use disorders and the dissemination of research findings or facilitation of adoption of evidence-based practices in clinical settings. This award cannot support new, free-standing pilot research, clinical trials, or clinical research studies. As stated above, any proposed activities such as secondary analyses or quality improvement initiatives must be eligible for IRB exemption and display merit to impact on or increase the adoption of evidence-based practices. Focus groups and informal interviews may be conducted if eligible for IRB exemption and will inform the mentored project.
Examples of appropriate activities and projects include but are not limited to:
- Reviewing available curricula or training programs, identifying status of education on SUD, especially opioid misuse, OUD diagnosis and management in various settings, and proposing and conducting activities to improve or increase the adoption of evidence-based practice;
- Developing materials that could be used for quality improvement or integration of an evidence-based approach or process, in the management of SUD, including OUD, in a medical setting and conducting activities for quality improvement or adoption;
- Identifying training gaps and research findings and/or products developed by NIDA or other federal agencies or professional associations that could bridge gaps, identifying potential partners for effective dissemination of these findings and disseminating them within existing or newly developed communication channels;
- Other activities consistent with the goals of the Dissemination Initiative to accelerate the dissemination of research findings and implementation or adoption of evidence-based SUD treatment in clinical practice.
- Analysis of de-identified data from completed clinical trials such as those found on the NIDA Data Share website (https://datashare.nida.nih.gov/) to inform dissemination or implementation efforts; to characterize availability of data on substance use or practice patterns; identify gaps in the provision of evidence-based practices; and/or identify needs for dissemination or implementation.
AWARD ADMINISTRATION, APPLICATION, AND SELECTION PROCESS
SAEMF will administer the NIDA Mentored Training Award. SAEMF conducts the planning, on-site coordination, and evaluation of applications. Candidates cannot have had previous or simultaneous funding from the National Institutes of Health (NIH) or research funding sources. Eligible candidates may not have a training award.
Award recipients are selected through a competitive process. Applicants must submit the following information:
- A completed application form, abstract, candidate statement, training plan, project description, timeline for the award year, budget and budget justification, literature cited, and other support. The project description will include objectives, background information, and method or proposed activities.
- A letter detailing any current and previous funding.
- The applicant’s and mentor’s current biosketch.
- A letter of support from a proposed mentor.
- A letter of support from their current department chair (or appropriate program director).
- A letter of support from a proposed co-mentor (if applicable).
Each application will be reviewed by researchers, program managers and/or clinicians who are involved and informed in dissemination of findings from the field of SUD. Each application will be judged primarily by the likelihood of producing dedicated, qualified clinicians and champions in the field of medicine and SUD as indicated by 1) the qualifications of the applicant, 2) the qualifications of the mentor, 3) the overall merit of the training plan and project, 4) the adequacy of the proposed budget to meet the objectives, and 5) the willingness of the institution to provide the necessary facilities and support to complete the project as described.
PROGRAM ACTIVITIES AND REQUIREMENTS
Progress and Final Reports: The trainee and designated mentor are required to submit a 6-month narrative progress report and a final narrative report at the end of the performance period. Failure to provide the report may negatively impact your institution’s ability to apply for future awards. These reports will be submitted to the SAEMF for subsequent submission to NIDA. In the event that the awardee’s project is not completed at the end of the designated performance period, and appropriate approvals to continue have been granted, the final report must still be submitted as an outline of work done and projections for work/expenditures remaining.
Institutional Annual Meeting: Attendance is expected at the SAEM annual meeting, where the awardees will present a poster abstract of their work following the completion of the award.
NIDA CTN Meeting: Trainees are also expected to attend the NIDA Clinical Trials Network Annual Steering Committee Meeting. Mentors are highly encouraged to attend. The Coordination Office will ensure that funds from each stipend are used to coordinate air travel and hotel accommodations. Any remaining funds will be returned to the trainee to assist with research projects.
Publications: All discoveries resulting from work supported in part by the NIDA Award should be made available to the public and scientific community through approved scientific channels such as national meetings and peer reviewed publications. Publications will acknowledge the support of NIDA and SAEMF. Two reprints of each publication should be forwarded to the SAEMF and NIDA.
Awardees will be contacted annually by the Dissemination Initiative following completion of the funding year regarding career paths, ongoing dissemination or implementation activities, leadership in promoting the adoption of evidence-based practices in clinical settings, subsequent grants/contracts obtained, and publications. Awardees will be expected to respond to this outreach.
The budget consists of up to $10,000 for the trainee stipend and up to $2,000 stipend for the mentor. Awards are contingent on availability of funds. Funds may be used for travel to the SAEM annual Meeting and the CTN Annual Meeting. Funds may also be used for educational and resource materials/courses.
The applicant must submit letters of support if the proposed project uses facilities not routinely available to or directly under the supervision of SAEM.
The applicant assumes responsibility for conducting the project and the mentor for supervising the work and advanced education of the applicant and associates. The application must show that adequate and appropriately equipped space will be available during the funding period. If a project proposes secondary data analysis or when appropriate, projects must be eligible for and obtain IRB exemption.
The NIDA Mentor-Facilitated Training Award in Substance Use Disorders is designed to provide opportunities to enhance knowledge of SUD and SUD treatment, to promote dissemination of substance use disorder research findings, and to promote the adoption of evidence-based approaches in clinical settings. By participating in this program, awardees gain valuable training and mentored experience in the management of substance use and SUD, facilitate the dissemination of research findings in medical settings, and work on improving treatment of SUD. The goal is for more healthcare providers to choose to continue their education and training in the field, providing a stronger integrated health workforce, both in numbers and expertise.
TERMS OF THE AWARD
Duration: Applications will be accepted for one-year of training only.
Extension of Award Period: In unusual circumstances, arrangements can be made for an extension of an award. Such a request must be made by the trainee at least 60 days before the expiration date of the award. This request must be made in writing, specify reasons for requesting the extension, and state a new expiration date. Project extensions of greater than six months will not be considered.
Change of Status of Designated Mentor or Trainee: If the trainee changes affiliations or ceases work in the field for which the award was made, the award will terminate and the remaining balance will be returned unless the trainee and his or her new institution demonstrate the ability to successfully complete the planned project and the plan for this is approved. If the named mentor changes affiliations or ceases work in the field for which the award was made, the award will terminate and the remaining balance will be returned unless another appropriate mentor or plan to ensure appropriate mentoring is identified and approved.
Location of work: Awards are for projects in the United States at an accredited medical school, medical center, or institution affiliated with a university teaching program. The trainee, with the direction of the mentor, will make all arrangements for conduct of the proposed projects.
Liability of SAEMF and National Institute on Drug Abuse: SAEM Foundation and NIDA assume no financial liability if patient care responsibilities of any kind are undertaken by the NIDA trainee or mentor. The mentor, the trainee, and their respective institution(s) acknowledge that NIDA and SAEM Foundation are not legally liable for the conduct of the trainee or the mentor and associate investigators.
Patent Policy: The mentor, the awardee, and their respective institution(s) acknowledge that if a patentable invention or discovery is conceived, or conceived and reduced to practice by the award during the term of the award year, NIDA and the SAEM Foundation must be apprised of the invention and the institution’s plans for protecting such invention under existing institutional patent policy. SAEM Foundation will defer to institutional policies where they are in compliance with those of the Federal government. NIDA and SAEM Foundation reserves the right where the institution has no patent policy, or policies not in compliance with those of the federal government, to claim rights and interests in the invention or discovery consistent with FAR Clause 52.227-11, Patent Rights- Ownership by the Contractor.
Submission in electronic format is required.
Use English only and avoid jargon and unusual abbreviations. For terms not universally known, spell out the term the first time it is used with the appropriate abbreviation in parentheses; the abbreviation may be used thereafter. Type the application, single-spaced, and stay within the margin limitations indicated on the forms and continuation pages. The type must be clear and readily legible, no smaller than 15 characters per inch. (If in doubt, use 12 pt. size font.)
Do not submit an incomplete application. An application will be considered incomplete if it is illegible, if it fails to follow instructions, or if the material presented is insufficient to permit an adequate review. Unless specifically required by these instructions (e.g. human subjects certification, vertebrate animals verification) do not send supplementary material. The application consists of the following sections:
1. LETTER OF INTENT
(limit 1 page)
The Applicant will be the Principal Investigator (PI) of the proposed project. A letter signed by the Applicant (PI) and Mentor should accompany the application. Choose a project title that is descriptive and specifically appropriate, rather than general. In addition to your Mentor, list and any associate investigators. Address the following:
a. your interest in the topic and this project
b. your perception of your role in the project
c. any additional pertinent experience or interests you wish the committee to consider
Provide a brief summary of the project proposal, and any associated activities (e.g., coursework, other technical training). Include rationale, specific aims, and significance.
3. PROJECT PROTOCOL
(limit 12 pages)
NIH form Continuation Format Page available at www.grants.nih.gov/grants/funding/phs398/phs398.html#
Please use the following subheadings:
- Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses.
- Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields.
- State concisely the goals of the proposed project, including the impact that the results of the proposed project will exert on the field(s) involved.
- List succinctly the specific objectives of the project proposed, e.g., create a novel curriculum, challenge an existing paradigm or clinical practice, or address a critical barrier to progress in the field.
- Specific Aims are limited to one page.
- Explain how the application addresses and seeks to shift current knowledge bases or treatment practices
- Describe any novel theoretical concepts, dissemination approaches, curricula or instrumentation to be developed or used, and any advantage over existing practices.
- Explain any refinements, improvements, or new applications of theoretical concepts, approaches or curricula that will improve the field.
- Describe the overall strategy, methodology, and evaluation to be used to accomplish the specific aims of the project.
- Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims.
- If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high-risk aspects of the proposed work.
- Preliminary Studies. Include information on Preliminary Studies and how they will inform the proposed dissemination project. Discuss the PD/PI’s preliminary studies, data, and or experience pertinent to this application.
4. DESCRIPTION OF THE TRAINING PLAN
(limit: 3 pages)
Describe how the award year will be structured. Outline major goals and objectives and indicate how they will be achieved. Provide a training plan, including the structure and details of the relationship between the applicant and mentor, and how the applicant and mentor will work together to achieve the goals of the award year. Indicate how the mentor will monitor the progress of the trainee.
5. ROLE OF PARTICIPANTS
(limit 1 page)
In addition to the PI, list the mentor and each associate investigator or consultant. Include a brief description of how and to what extent each will be involved in the proposed project.
6. BIOGRAPHICAL SKETCHES
NIH Biographical Sketch Format Page available at www.grants.nih.gov/grants/funding/phs398/phs398.html#
Information is requested for the applicant, mentor and any associate investigators who will be involved with the projects. The 5-page NIH format has been adopted.
7. RESOURCES AND ENVIRONMENT
NIH Resources format Page available at www.grants.nih.gov/grants/funding/phs398/phs398.html#
Describe the facilities available for grant training. If computer access or statistical support is available, it should be described in this section.
8. BUDGET AND JUSTIFICATION
NIH Form Detailed Budget for Initial Budget Period available at www.grants.nih.gov/grants/funding/phs398/phs398.html#
Indicate how the money will be spent. Justify all major expenditures.
9. OTHER SUPPORT
NIH form Continuation Format Page available at www.grants.nih.gov/grants/funding/phs398/phs398.html#
List all current and pending intramural and extramural research funding for the applicant, mentor and co-investigators. For each item indicate the grant identification number, grant type, PI, funding source, annual direct costs, funding period, percent effort, grant title, and brief description of project. For all items indicate whether there is any scientific or budgetary overlap with the current proposal.
NIH (If Applicable) form Continuation Format Page (no page limit) available at www.grants.nih.gov/grants/funding/phs398/phs398.html#
Human subjects. For all projects involving human subjects, a part of the peer review process will include careful consideration of protections from research risks, as well as the appropriate inclusion of women, minorities, and children. The SAEM Grants Committee will assess the adequacy of safeguards of the rights and welfare of participants, and the appropriate inclusion of women, minorities, and children, based on the information in the application. This evaluation will be factored into the overall score. The information on the protection of human subjects that you are required to provide in this section is identical to information that you will be required to provide for IRB at your own institution and are required by most Federal agencies. This section must address the following items. These can be copied and pasted directly into your application. The applicant should include specific measures on how protected health information (as defined by the Human Health Services) will be handled in accordance with the Privacy Rule of the Health Insurance Portability Accountability Act (HIPAA).”
1. RISKS TO THE SUBJECTS (If Applicable)
a. Human Subjects Involvement and Characteristics
Describe the proposed involvement of human subjects in the work outlined in the Study Design and Methods section. Describe the characteristics of the subject population, including their anticipated number, age range, and health status. Identify the criteria for inclusion or exclusion of any subpopulation. Explain the rationale for the involvement of special classes of subjects, such as fetuses, neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations. Note that 'prisoners' includes all subjects involuntarily incarcerated (for example, in detention centers) as well as subjects who become incarcerated after the study begins. List any collaborating sites where human subjects research will be performed and describe the role of those sites in performing the proposed project.
b. Sources of Materials
Describe the material obtained from living human subjects in the form of specimens, records, or data. Describe any data that will be recorded on the human subjects involved in the project. Describe the linkages to subjects and indicate who will have access to subject identities. Provide information about how the specimens, records, or data are collected and whether material or data will be collected specifically for your proposed project.
c. Potential Risks
Describe the potential risks to subjects (physical, psychological, social, legal, or other), and assess their likelihood and seriousness to the subjects. Where appropriate, describe alternative treatments and procedures, including the risks and benefits of the alternative treatments and procedures to participants in the proposed project.
2. ADEQUACY OF PROTECTION AGAINST RISKS (If Applicable)
a. Recruitment and Informed Consent
Describe plans for the recruitment of subjects (where appropriate) and the process for obtaining informed consent. If the proposed studies will include children, describe the process for meeting requirements for parental permission and child assent. Include a description of the circumstances under which consent will be sought and obtained, who will seek it, the nature of the information to be provided to prospective subjects, and the method of documenting consent. Informed consent document(s) need not be submitted to the PHS agencies unless requested.
b. Protection Against Risk
Describe planned procedures for protecting against or minimizing potential risks, including risks to confidentiality, and assess their likely effectiveness. Where appropriate, discuss plans for ensuring necessary medical or professional intervention in the event of adverse effects to the subjects. Studies that involve clinical trials (biomedical and behavioral intervention studies) must include a description of the plan for data and safety monitoring of the project and adverse event reporting to ensure the safety of subjects.
3. POTENTIAL BENEFITS OF THE PROPOSED PROJECT TO THE SUBJECTS AND OTHERS (If Applicable)
Discuss the potential benefits of the project to the subjects and others. Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to subjects and others.
4. IMPORTANCE OF THE KNOWLEDGE TO BE GAINED (If Applicable)
Discuss the importance of the knowledge gained or to be gained as a result of the proposed project. Discuss why the risks to subjects are reasonable in relation to the importance of the knowledge that reasonably may be expected to result.
5. DATA AND SAFETY MONITORING PLAN (If Applicable)
If your project includes a clinical trial, create a heading entitled "Data and Safety Monitoring Plan." Provide a general description of a monitoring plan that you plan to establish as the overall framework for data and safety monitoring.
11. LITERATURE CITED
Include letters of support from the mentor, department chairs and associate investigators (required). No page numbering is necessary for Appendix. The appendix can include:
- Up to 5 publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to this project. Do not include manuscripts submitted for publication.
- Publications in press: Include only a publication list with a link to the publicly available on-line journal article or the NIH PubMed Central (PMC) submission identification number. Do not include the entire article.
- Manuscripts accepted for publication but not yet published: The entire article should be submitted and may be stapled.
- Manuscripts published but an online journal link is not available: The entire article should be submitted and may be stapled.
- Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents.
- No photographs or color images may be included in the Appendix that are not also represented within the Project Plan. Do not use the appendix to circumvent page limitations for project plans. Do not include methods, protocols or figures that should be incorporated within the project description.