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Page 1: HEAL Initiative: Preventing Opioid Use Disorder in Older ... · HEAL Initiative: Preventing Opioid U se Disorder in Older Adolescents and Young Adults (ages 16-30) • Funding instrument

HEAL Initiative: Preventing Opioid Use Disorder in Older Adolescents and Young Adults

(ages 16-30)

RFA Overview Webinar

RFA-DA-19-035 RFA-DA-19-034

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Other Participating Institutes

National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Institute of Mental Health (NIMH) National Center for Complementary and Integrative Health (NCCIH) National Institute of Child Health and Human Development (NICHD) National Institute on Dental and Craniofacial Research (NIDCR)

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Brief Technical Orientation • This we binar is b eing recorded.

• Questions wi ll be taken at the end and read by a moderator.

• Submit questions t o “All Panelists” u sing Q&A Feature.

• We will answer questions ab out eligibility, technical requirements, and budget requirements.

• We will not answer questions ab out specific designs or study i deas. Please email [email protected] to set up a time to discuss s uch questions.

• If you experience technical difficulties d uring the webinar, please send a chat to all panelists.

• Today’s s lides an d a recording will be posted at: https://www.drugabuse.gov/news-events/meetings-events/2019/01/heal-preventing-opioid-use-disorder-in-older-adolescents-young-adults-ages-16-30-foa-technical

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Webinar Agenda Topic Presenter

Welcome and Opening Remarks Jacqueline Lloyd

Overview of HEAL Prevention FOAs

- General Overview Jacqueline Lloyd

- Budget Overview Carol Alderson

- Review overview Gerald McLaughlin

Q & A Moderator: B elinda Sims

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Background • This i nitiative is p art of the NIH Helping to End Addiction Long-term

(HEAL) initiative.

• An estimated 11.4 m illion people misused opioids i n 2017, of which 11.1 million misused prescription opioid analgesics.

• Illicit opioids, including fentanyl and heroin, accounted for more than 60% of opioid-related overdose deaths i n 2016.

• This i nitiative focuses on older adolescents an d young adults ( ages 1 6-30), two of the populations at highest risk for initiation and misuse of opioids, OUD and related consequences, including overdose fatalities.

• There is a gap in the evidence for interventions an d strategies t o prevent non-medical use of opioids an d OUD in the transition from adolescence to young adulthood.

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HEAL Initiative: Preventing Opioid Use Disorder in Older Adolescents and Young Adults (ages 16-30) – Key Definitions

• “Opioids” include prescription opioids and illicit opioids, such as heroin and illicitly made f entanyl (and related analogs).

• Older adolescents and young adults – ages 16-30. • “Prevention” is defined as interventions that occur

prior to the onset of OUD and are intended to prevent or reduce risk for OUD.

• “OUD” refers to the clinical diagnosis defined in the Diagnostic and Statistical M anual of Mental Disorders, Fifth Edition (DSM-5).

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HEAL Initiative: Preventing Opioid U se Disorder in Older Adolescents and Young Adults (ages 16-30) • Funding instrument is a cooperative agreement, “an assistance”

mechanism, in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of activities.

• The cooperative agreement will include: • Up to ten research projects

• One Coordinating Center

• A Steering Committee (SC), a SC chairperson

• One or more Science Officers f rom N IDA and/or other Institutes, and NIDA and/or other Institute Program O fficers).

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HEAL Prevention Initiative (cont.)

• Organization of the Cooperative (cont.) • A Steering Committee will include at a minimum a) a

representative from each research project, b) a NIDA Project Scientist(s), a NIDA/NIH Program Officer(s), and could include select key l eaders/stakeholders from systems or settings named as key personnel in the research project applications.

• NIDA will appoint one Steering Committee Chairperson with relevant expertise to coordinate the activities of the Steering Committee.

See RFAs for fu ll cooperative organization, structure and roles.

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HEAL Prevention Initiative (cont.) • The objectives of this research cooperative are to support rigorous

research to: 1. Develop strategies to identify, reach, and engage older adolescent and

young adult populations at risk for opioid misuse and OUD in prevention interventions and services.

2. Develop and adapt interventions and strategies to prevent initiation of opioid misuse, escalation from initiation to misuse, and escalation from misuse to OUD.

3. Test the effect of prevention strategies and interventions on initiation of opioid use, opioid misuse, OUD and other opioid related outcomes.

4. Develop and test strategies to facilitate implementation and sustainability of prevention interventions and strategies in health care, justice and other systems and settings opportune for accessing and engaging at-risk older adolescents and young adults.

5. Conduct an economic evaluation (e.g., to quantify programmatic costs and cost-effectiveness of interventions and strategies).

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I. UG3/UH3 Research Projects (RFA-DA-19-035)

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UG3/UH3 Research Projects - RFA-DA-19-035

• Title: HEAL Initiative: P reventing Opioid Use Disorder in Older Adolescents and Young Adults (ages 16–30) ( UG3/UH3 Clinical Trial Required)

• Funding Mechanism: UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement

• Expected # of Awards: 8-10 • Approximate Cost Per Award:

• Up to $500k per year direct cost for UG3 (phase 1)

• Up to $1M per year direct cost for UH3 (phase 2)

• Award project period: Maximum up to 5 years. - Up to 2 years for UG3 (phase 1). Up to 4 year for the UH3 (phase 2).

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UG3/UH3 Research Projects • UG3 phase supports exploratory-developmental activities with

specific milestones to be accomplished by the end of the 1- or 2-year budget period.

• UH3 phase provides funding for up to 3-4 additional years to those projects that successfully complete the milestones set forth in the UG3 pha se. Number of years fo r UH3 de pends o n length of the UG3.

• UH3 phase will support conduct of the clinical trial to test efficacy, effectiveness, mechanisms of action of proposed interventions, in addition to implementation and economic evaluation relevant to research proposed.

• Applications must p rovide the overall goals and hypotheses for the entire project and indicate separate specific aims to be accomplished in the UG3 phase and the UH3 phase.

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UG3/UH3 Research Projects (cont.) • Research studies f unded under this FO A will yield efficacious/effective

interventions an d strategies t o prevent initiation of opioid misuse and development of OUD in older adolescents an d young adults.

• Studies m ay s pan the range of efficacy, effectiveness, and implementation research, and/or propose hybrid study d esigns r elevant to the intervention and research questions p roposed.

• Of interest are research studies d esigned to test whether an intervention engages a proximal target or specified mechanism p resumed to underlie the intervention's e ffect on a distal outcome.

• Applications p roposing effectiveness t rials ar e encouraged to address t he use of scalable and sustainable approaches t o improve the uptake of promising interventions.

• Study d esigns p roposed should be rigorous an d appropriate for addressing the research questions p roposed within the project timeline.

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UG3/UH3 Research Projects (cont.)

• Projects m ust include clearly i dentified transition milestones t o be assessed at the end of the UG3 p hase.

• Funding of the UG3 ( Phase 1) does n ot guarantee support of the UH3 (Phase 2) award.

• Transition to the UH3 p hase will be determined by p rogrammatic evaluation by N IH staff.

• Projects ag ree to work cooperatively wi th other awardees an d the Coordinating Center.

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Specific Topics of Research Interest

• This FOA encourages, but is not limited to, research applications that address the following areas of interest:

• Development of theory-based prevention interventions that c an be integrated into health care, justice, or other human service systems and settings for high-risk individuals.

• Studies to test models of integrating existing substance use prevention and other risk reduction modalities into health care, justice or other human service systems.

• Implementation of evidence based substance use prevention interventions that incorporate technology, such as mobile health and telehealth delivery or models of consultation, to facilitate linkage and delivery in settings such as primary care and other settings where delivery of prevention interventions is novel.

• Research on interventions designed to address known risk factors for risk behaviors such as sensation seeking, impulsivity or others.

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Specific Topics of Research Interest (cont.)

• Studies to develop and test prevention interventions designed to prevent misuse of opioids and development of OUD in older adolescents and young adults at risk for and who have mental disorders.

• Research that utilizes risk-profiles in dental, orthopedic, surgical, pain, primary care, or o ther c linical settings to facilitate case identification, active referral and linkage to prevention interventions and or consultation models.

• Development and t esting of public awareness and com munication strategies as part of a broader intervention or strategy targeted to high risk populations in health care, justice, community and other settings, delivered through mobile technology, social media and other n ovel platforms.

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Specific Topics of Research Interest (cont.)

• Research on novel funding strategies to implement and sustain prevention interventions, such as Medicaid waivers, reimbursement for telehealth service delivery and consultation.

• Research to address system fragmentation and gaps for persons transitioning from pediatric or adolescent medicine practices to adult medicine practices or for persons in specialty settings or social services systems who need linkage to health/behavioral health and prevention services.

• Testing of strategies to implement preventive interventions in ways that overcome stigma related to substance use and its consequences, such as discrimination based on substance using behavior.

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Research Strategy Applications s hould clearly d etail:

• Inclusion and the role of a collaborator or stakeholder (as co-investigator) from the system or setting where the research will be conducted, who will assist with the adoption of the intervention or strategy in that system or setting if it is found to be successful.

• A clear description of the theoretical basis for the intervention, strategy or model proposed and the process or steps for development, adaptation, tailoring to the population and system or setting proposed.

• Strategies for identifying, reaching, and/or engaging an at-risk population identified for the project, and strategies for linkage to prevention intervention or services.

• A clear description of the primary and secondary outcomes that will be evaluated and the proposed measures for both the UG3 and UH3 phases.

• A description of the analytic plan for the UG3 and the UH3 phases of the research, including statistical and other methods to be employed should be included.

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Research Strategy (cont.) Applications s hould clearly d etail (cont.):

• A description of the team’s experience with developing/testing/implementing prevention interventions, the identified study population (age range/developmental stage and other characteristics), and the systems or settings where the research will be conducted.

• A description of previous experience with cooperative agreements or with multi-site studies that include components such a s common p rotocols or data harmonization.

• Plans to protect the security of participants’ personally identifiable information.

• A discussion of any impediments that could require an addendum to the research plan, milestone, or timeline with a discussion of alternative approaches.

• A strategy to engage and create partnerships with likely end user(s) of the intervention or strategy proposed, and letters of support indicating commitment from end users to implement the intervention or strategies if the outcomes are favorable.

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Resource Sharing Plan

• All applications, regardless of the amount of direct costs requested for any one year, sh ould provide:

• A plan for sharing data with other research sites and the coordinating ce nter.

• A plan to make data publicly available.

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II. Coordinating Center (RFA-DA-19-034)

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Coordinating Center - RFA-DA-19-034

• Title: HEAL Initiative: C oordinating Center to Support NIDA Preventing Opioid Use Disorder in Older Adolescents and Young Adults (ages 16–30) Initiative (U24 Clinical Trial Not Allowed)

• Expected # of Awards: 1

• Approximate Cost Per Award: $1.5M pe r year direct costs limit

• Funding Mechanism: U24 Resource-Related Research Projects – Cooperative Agreements

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Coordinating Center (cont.) • The Coordinating Center will be funded under a cooperative agreement and

will work collaboratively wi th NIH and the investigators as sociated with the individual research projects.

• The Coordinating Center will provide centralized support for research projects supported by the HEAL prevention initiative.

• The Coordinating Center will be responsible for activities in the areas of: coordination and com munication, data collection and m anagement, implementation design and methodology consultation, and economic evaluation.

• The Coordinating Center will:

• Participate on the cooperative Steering Committee (to include research project PIs and Federal Staff) which will manage the overall direction of the collaborative.

• Facilitate activities of the cooperative internal working groups, which will include project PIs, their staff, collaborators and Federal Staff.

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Research Strategy - Coordination and Communication • The Coordinating Center will support collaborations and communication

across the cooperative research projects and other components (e.g., NIDA, Steering Committee, workgroups, research partners). The application should describe a clear and detailed plan for: • Providing operational, logistical and technical support for meetings

held across the sites participating i n the research projects, including in-person meetings, virtual meetings, and webinars.

• Providing logistical support for annual, in-person meetings t hat will take place in the Washington DC area or other locations designated by the Steering Committee/NIDA staff and work with NIH to use government meeting s pace where possible.

• Identifying and providing software platforms to enable conference calls, document sharing and webinars related to the work of internal working groups in core areas of the project such as measures development & harmonization, publication and presentation procedures, etc.

• Working with the Steering Committee to organize and facilitate meetings of an External Advisory Board which will meet periodically to provide input and feedback regarding the research projects funded under the UG3/UH3 mechanism.

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Research Strategy - Coordination and Communication (cont.) • Developing and maintaining a web-based platform to facilitate sharing and monitoring

of study protocols, recruitment, data collection, progress, study findings and publications.

• Maintaining up-to-date versions of policies and procedures developed by the Steering Committee and make them available to the cooperative in a timely manner.

• Overseeing coordination of collaborative publication activities based on procedures developed through working groups in the cooperative, and work with the Steering Committee to develop a plan for dissemination of research findings to key stakeholders in a timely manner.

• Facilitating engagement of local and national stakeholders in relevant cooperative activities (e.g., external scientific workgroups).

• Providing methodological and statistical support in the areas of study design, complex statistical analyses, economic evaluation, and implementation d esign a nd methodology consultation, as needed.

• Providing expertise in and coordinating ethical, regulatory, and other required activities for research involving human subjects.

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Research Strategy – Data Collection and Management

• The Coordinating Center will provide data infrastructure and support across t he cooperative and also conduct foundational analyses t o inform and support cooperative research projects. The application should include a detailed plan for:

• Developing standard formats f or data collection instruments u sing measures i dentified by t he research projects an d cooperative.

• Providing logistical, scientific, and technical support for data collection and management, including identification of common data elements, data harmonization, and data sharing across p rojects as r elevant.

• Managing and monitoring data across c ooperative projects, including cleaning and maintaining data files, monitoring data quality, and performing systematic checks f or completeness an d comparability.

• Developing and executing a plan for data sharing across p rojects and to investigators wh o are not part of the cooperative.

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Research Strategy – Data Collection and Management

• Providing a federally compliant online infrastructure to support the submission/transmission of research data, including cl inical data. This incl udes a ddressing is sues s uch as HIPAA compliance, as well as procedures for de-identification of clinical or research data.

• Compiling integrated datasets, developing codebooks, and other data file documentation across projects and support individual research projects w ith these activities a s ne eded.

• Preparing de-identified public use data fil es a nd documents for submission into the NIDA supported repository National Addiction and HIV Data Archive Program (NAHDAP), a nd work with grantees on project-specific sharing plans.

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Research Strategy – Data Collection and Management (cont.)

• The Coordinating Center will be expected to conduct two systematic reviews. The application should include a plan for conducting the two systematic reviews described below:

• (1) Risk and protective factors specific to the populations and settings targeted for the research projects.

• (2) Existing preventive strategies (already in place in the kinds of systems and settings where the research will be conducted).

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Research Strategy – Implementation Design & Methodology Consultation and Economic Evaluation • The Coordinating Center is responsible for providing expertise, scientific and

analytical support to the cooperative in the areas of implementation design and methodology consultation and economic evaluation. The application should include a detailed plan for:

• Coordinating with the research projects to provide support and consultation pertaining to implementation design and m ethods for individual projects to inform implementation aspects of the UH3 phase research.

• Working with research projects to facilitate harmonization of implementation data and meaningful ways to compare outcomes across research projects.

• Working with individual research projects to develop and execute economic evaluations (e.g., to determine programmatic costs, cost-effectiveness, conduct budget impact analysis) for the interventions and strategies studied. This should result in common metrics and methods, where applicable across the cooperative.

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Budget Information & P roject Period • UG3/UH3

• Approximate Cost Per Award:

• Up to $500k per year direct cost for UG3 ( phase 1)

• Up to $1M per year direct cost for UH3 ( phase 2)

• The maximum p roject period is 5 y ears: up to 2 y ears f or the UG3 ( phase 1) and up to 4 y ears f or the UH3 ( phase 2) with the total project period for both the UG3 an d UH3 p hases n ot to exceed 5 y ears.

• U24

• Approximate Cost Per Award:

• $1.5M per year direct costs l imit

• The maximum project period is 5 years.

** Direct c ost c eilings d o not i nclude consortium F&A ** 30

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Budget Information for RFAs

• Reviewers wi ll consider whether the budget and the requested period of support are fully j ustified and reasonable in relation to the proposed research.

• Budgets s hould include funds f or travel for the PD(s)/PI(s) and other key p ersonnel (e.g., key p roject staff, a stakeholder/collaborator from the system/setting where the study will be implemented) to participate an in-person Steering Committee meetings one time per year, every y ear of the award, in Rockville, MD. An additional in-person kickoff meeting to be held in Rockville, MD should be included in the year one budget of the award.

• Provide all appropriate letters of support, including any l etters necessary t o demonstrate the support of collaborators, stakeholders (e.g., end users), and others.

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Budget preparation: reminders • Your budget is a fiscal expression of your science

• Prepare a detailed budget justification.

• Any programmatic escalation in future years should be described clearly in your budget j ustification.

• Justify, j ustify, j ustify !

How to prepare a competing detailed budget - please see

https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/develop-your-budget.htm#personnel

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Matching Requirement for For-profit applicants:

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.

• For-profit applicants must include a letter(s) of support confirming that the required secured cost matching (cash; in-kind commitments such as salary, consultant costs, equipment) is available and confirm that the essential personnel have the authority within the organization to allocate resources.

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Letter of Intent for RFAs • Letter of intent due date: February 13, 2019

• Although a letter of intent i s not r equired, i s not b inding, a nd does not enter into the review of a subsequent application, the information that it contains a llows I C staff to estimate the potential review workload and plan the review.

• Prospective applicants are asked to submit a letter of intent that includes t he following info rmation:

• Descriptive title of proposed activity

• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)

• Names of other k ey personnel

• Participating institution(s)

• Number a nd title of this funding opportunity 34

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Application Review Information for RFAs

• Each non-conflicted reviewer present at an application’s evaluation discussion, provides an overall i mpact score (1 -9 initially, average score multiplied times 10 to final scores 10-90 (similar to A (1) to F (9) old style grading), to reflect their assessment of the likelihood for the project to exert a s ustained, powerful influence on the research field(s) involved, in consideration of t he following review criteria and additional review criteria (as specified in the RFAs and applicable for the project proposed).

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Application Review Information – UG3/UH3

• The UG3/UH3 exploratory/developmental phased grant supports investigation of novel scientific ideas or new interventions, model systems, tools, or technologies that have the potential for significant impact on biomedical or behavioral and social sciences research.

• Not required to have e xtensive p reliminary data, background material or preliminary information, but t hese may be included if available.

• Justification for the proposed work can also be provided through literature citations, data from other sources, or, when available, from investigator-generated data.

• Reviewers will focus on the conceptual framework, the level of innovation, the potential to significantly advance knowledge or understanding and have an impact.

• Reviewers will assign a single impact score for the entire application, which includes the UG3 and UH3 phases.

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Application Review Information – U24

• The U24 Resource-Related Research Projects grant supports research projects contributing to improvement of the capability of resources to serve biomedical research.

• The application should describe a plan for carrying out the responsibilities of the Coordinating Center in the following areas: Coordination and Communication, Data Collection and Management, Implementation Design & Methodology Consultation and Economic Evaluation.

• The plan should include a description of the proposed Coordinating Center structure, activities, strategies, timeline, platforms and available resources to use.

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Scored Review Criteria

•Significance • Investigator(s) • Innovation •Approach •Environment

Overall impact

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Additional Review Criteria • As ap plicable for the project proposed, reviewers wi ll evaluate the following

additional items wh ile determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores f or these items:

• Protections for Human Subjects: For research that involves h uman subjects but does not involve one of the categories of research that are exempt under 45 C FR Part 46, the committee will evaluate the justification for involvement of human subjects an d the proposed protections f rom r esearch 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 t o the subjects an d 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.

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Additional Review Criteria (cont.)

• Inclusion of Women, Minorities, and Individuals Across the Lifespan: When the proposed project involves h uman subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans f or the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as we ll as t he inclusion (or exclusion) of individuals of all ages ( including children and older adults) to determine if it is j ustified in terms of the scientific goals an d research strategy p roposed. For additional information on review of the Inclusion section, please refer to the Guidelines f or the Review of Inclusion in Clinical Research.

• Vertebrate Animals

• Biohazards

NIH Website o n Clinical Trials - https://grants.nih.gov/policy/clinical-trials.htm

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Cooperative Agreement Terms & Conditions

• As cooperative agreements, the FOAs outline responsibilities for:

• PD(s)/PI(s)

• NIDA Project Scientists

• NIDA Program Officials

• NIH as funder

• Areas of joint r esponsibility

• Grantees accepting an award via this FOA agree to the terms and conditions as specified in the RFAs.

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Key Dates (for both RFAs) • Earliest S ubmission Date February 13, 2019

• Letter of Intent Due Date February 13, 2019

• Application Due Date March 13, 2019

• Scientific Merit Review June/July 2019

• Advisory Council Review October 2019

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Contacts For more information contact:

• Scientific/Research Contact(s)

• Jacqueline Lloyd, PhD, MSW Telephone: 301-443-8892 Email: [email protected]

• Peer Review Contact(s)

• Gerald McLaughlin, PhD Phone: 301-827-5819 Email: [email protected]

• Financial/Grants M anagement Contact(s)

• Edith Davis Telephone: 301-827-6697 Email: [email protected]

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Questions

Moderator: Belinda Sims

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Thank you for joining the webinar.

Today’s slides and a recording will be posted at: https://www.drugabuse.gov/news-events/meetings-events/2019/01/heal-preventing-opioid-use-disorder-in-older-adolescents-young-adults-ages-16-30-foa-technical

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