Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). 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.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

This Funding Opportunity Announcement (FOA) invites applications from clinical investigators to participate in the National Drug Abuse Treatment Clinical Trials Network (CTN). This FOA is the seventh solicitation for participation in the CTN. NIDA intends to continue to develop and test interventions for the management of the wide spectrum of substance use problems via collaborative partnerships with an expansive range of clinical research investigators, healthcare providers and institutions.

The CTN was established in 1999 to improve addiction treatment using science as the vehicle and was the first network to bring SUD scientists and providers together in an alliance fostering bi-directional communication and collaboration to improve the relevance of treatment research to clinical practice. The CTN is administered within NIDA through the Center for the Clinical Trials Network (CCTN). The CCTN recognizes a need to develop and test substance use disorder (SUD) management options not only for specialty care settings but also for application in a range of general medical settings. Therefore, the purpose of this FOA is to build on the program of research previously conducted in the CTN (http://www.drugabuse.gov/about-nida/organization/cctn/ctn) and expand its scope to include organizations and/or practice based research networks that offer access to large patient populations, practicing clinicians who are interested in engaging in research, and using digitized health records that are amenable to research data collection. The CTN will be a clinical research enterprise in which a variety of SUD service providers, treatment researchers, participating patients and NIDA cooperatively develop and conduct practical trials answering important research questions that, once answered, will impact practice in a wide variety of settings.

For the purposes of this FOA, the term healthcare organization refers to specialty care settings for SUD and general medical settings, including primary care, emergency care, and networks. Networks are defined below in Special Considerations . Projects responsive to this FOA should address clinical problems in SUD treatment in healthcare organizations in accordance with the specific objectives and research topics outlined below.

• Develop and test treatments for the whole spectrum of SUD in adults and adolescents to build an evidence base for SUD care that meets the needs of patients and providers. It is expected that the evidence will inform and support clinical guidelines in specialty care and general medical settings
• Develop and test strategies for the integration of SUD treatment into the mainstream medical care system including strategies linking general medical settings to SUD specialty care settings
• Generate evidence-based SUD treatment using meta-experiment approaches, which include multi-site clinical trials, pragmatic studies, comparative effectiveness studies, patient registries, and other research endeavors to answer a broad spectrum of research questions relevant to diverse patient populations with substance use problems, in real life settings
• Facilitate development and evaluation of comprehensive SUD treatment models that integrate co-occurring medical and mental health conditions
• Facilitate research on the utility of eHealth and other innovative technologies in improving SUD treatment
• Ensure that SUD treatment research encompasses the full spectrum of people affected by SUDs, including racial and ethnic minorities, women, children, adolescents, underserved populations, and other special populations
• Explore the effectiveness of interventions and strategies to reduce the transmission of HIV and other diseases (such as Hepatitis B and C or sexually transmitted infections) and to enhance adherence to treatment for HIV and other diseases among SUD patients
• Strive to promote use of learning healthcare system principles and practices through research conducted in the CTN (see http://www.iom.edu/Activities/Quality/LearningHealthCare.aspx)

NIDA’s priorities for treatment research topics vary over time, largely in response to public health needs, substance use trends, and other related changes in medical and societal problems, governmental legislation and institutional policies. It is necessary to seize new research opportunities brought about by unique scientific discoveries, changes in healthcare practices, clinical infrastructures, and research funding. The list below includes examples of priority research topics.

• Evaluate treatment interventions for the management of a broader spectrum of SUD in general medical settings tailoring treatments for risk categories developed with the aid of validated electronic tools for quick screening and brief assessment
• Generate efficacy and effectiveness evidence of on-site (i.e. in general medical settings) interventions for SUD for adults and/or adolescents including testing of referral methods linking the more severe patients to specialist SUD care.
• Develop interventions that prevent high-risk adolescents from progressing to more severe SUD
• Develop and test chronic care disease management models using a holistic approach that integrate treatments for abused illicit and legal substances (such as prescription analgesics, nicotine, and alcohol, with emphasis on opioid disorders) in the context of comorbid co-occurring medical and psychiatric conditions
• Develop and implement patient registries (or other innovative cohort data collection methods) that facilitate the study of the natural course and outcomes for patients with substance use problems for whom this information is currently unavailable. This patient-level information should be used to enhance the effectiveness of treatment options for SUD, and whenever possible, general medical conditions and psychiatric disorders
• Develop SUD treatment trials that leverage health information technology innovations (e.g., electronic health record systems, patient registries, mobile-health, telemedicine technologies) to improve SUD treatment outcomes
• Develop and test outpatient treatment algorithms for patients with opiate use disorders, with or without chronic pain that incorporate shared decision making practices in improving their health outcomes and reducing the risk of death from overdose and other opioid-use related negative consequences
• Develop effective integrated behavioral and pharmacological treatments for co-occurring nicotine, alcohol, and other substance use disorders (including, but not limited to, determination of which is more effective)

Nodes: The Node is the functional unit within the CTN and resides within the grantee institution of the cooperative agreement award. The Node:

• Provides scientific leadership for the clinical trials conducted within the CTN,
• Proposes, arranges and coordinates the research, training, and dissemination activities of the network, in collaboration with NIDA and other Nodes
• Builds partnerships with the research organizations (clinical research sites) within the Node and seeks collaborative opportunities with other established networks, such as the CTSA, the PCORnet, and other relevant research projects, such as the CMMS-supported Innovative Health Care Awards to simultaneously study SUD care and general medical care (see http://www.clinicalconnection.com/exp/EPVS.aspx?studyID=350349&slID=10919690 for an example project)Works with each collaborating research organization as an equal partner
• Works cooperatively with the CTN Clinical Coordinating Center (CCC) and Data and Statistics Center (DSC).

Specifically, the Node will be responsible for:

Research Agenda: Nodes develop research concepts for potential CTN research projects in close partnership with the clinical and research personnel within its Node, NIDA/NIH and with colleagues across the CTN. Nodes submit research proposals to the CTN Steering Committee (or its designated subcommittee) for discussion and review.

Each collaborating research organization/site agrees to:

• Designate the Director (or other senior official) of the research site to represent the site for CTN activities and to ensure fulfillment of CTN obligations
• Participate fully in the development of research concepts and protocols for trials to be conducted in the CTN
• Participate in clinical trials and adhere fully to Good Clinical Practice and to the specific protocol and operations manual applicable to each trial
• Cooperate with periodic on-site audits by NIDA or its designees to ensure appropriate use of investigational drugs, compliance with all applicable federal, state and local regulations for human subjects research, including Institutional Review Board (IRB) approval and informed consent (e.g., 45 CFR 46) compliance with protocol specifications, quality assurance and accuracy of data recording and completeness of reporting of adverse drug reactions
• Coordinate all data collection and statistical analysis with the DSC and within the parameters and guidance outlined in the CTN policy and procedures.

Training Agenda: The CTN structure provides many opportunities for pre-doctoral, post-doctoral and junior faculty researchers to gain valuable experience in designing, participating in, and managing complex clinical trials.

Principal Director(s)/Principal Investigator(s) (PD(s)/PI(s)). Nodes are led by the PD(s)/PI(s), who should be able to make a substantive and long-term commitment of effort to CTN responsibilities. The PD(s)/PI(s) are responsible for all projects conducted within their Node.

Center for the Clinical Trials Network (CCTN). Organization within NIDA responsible for the scientific collaboration, administrative oversight, and operational management of the CTN research program.

Data and Statistics Center. The entity established under a contract awarded by NIDA to provide data management and analysis systems as required to implement and support standards established by NIDA's CCTN. The major tasks of the DSC are to:

• Establish systems for the collection, management and storage of study data
• Plan and perform statistical analyses
• Review and monitor the quality of study data
• Monitor trial progress
• Prepare reports for the Data and Safety Monitoring Board
• Provide expert consultation and support services as directed by NIDA.

Clinical Coordinating Center. The entity established under a contract awarded by NIDA to provide certain resources and services for CTN clinical trials, including support for regulatory requirements and oversight functions mandated by NIH and DHHS. Specific functions of the CCC include:

• Support the development and maintenance of protocols
• Regulatory affairs and human subjects research support
• On-site monitoring of clinical study sites, quality assurance support, and serving as NIDA's safety officer for CTN trials
• Central pharmacy services for medication packaging, shipping, and inventory control;
• Clinical laboratory support and drug testing
• Coordinating the distribution of trial supplies, medications, forms, and manuals
• Providing regulatory, Quality Assurance and training plans for protocols
• Providing training in a variety of venues
• Providing other expert consultation and support services as needed.

CTN Steering Committee. The Steering Committee (SC) constitutes the primary governing body of the CTN, with representation by each of the Nodes, NIDA/NIH, the CTN Clinical Coordinating Center, and the CTN Data and Statistics Center. The SC uses both established and ad hoc committees and workgroups (e.g., Executive Committee, Research Development Committee, Research Utilization Committee, Publications Committee) to assist in carrying out its functions. The SC meets in person at least annually, and via webinars as the need arises.

NIDA expects the CTN to conduct research in SUD specialty care settings, general medical settings, and networks. A network is defined here as a collaborative group of clinicians and researchers with a linked source for healthcare data collection and retrieval. Examples of networks include, but are not limited to:

• Networks of health maintenance organizations (HMOs) or federally qualified health centers (FQHCs)
• Networks of accountable care organizations (ACOs), coordinated care organizations (CCOs), or patient-centered medical homes (PCMHs)
• Practice-Based Research Networks
• Consortiums of Care (multi-hospital corporations)
• Patient Powered Networks
• HRSA Health Center Controlled Networks
• PCORI-funded Clinical Data Networks
• U.S. Veterans Health Administration

The following network features are highly desirable: 1) capacity to support large-scale trials of treatment and prevention interventions to answer important SUD health research questions without disrupting the business of healthcare, 2) willingness to cover the costs of healthcare that would be given to the patient whether or not the patient participates in CTN-sponsored research, 3) capacity to conduct pragmatic/effectiveness trials with rapidity, efficiency, safety, quality, and at a low cost, 4) ability to use electronic health record system (EHRs) data integrated within typical clinical visits to simplify clinical trial implementation, including the identification, assessment, monitoring, and follow-up of SUD patients, and, 5) willingness to participate in collaborative studies with data sharing as part of a national clinical research infrastructure.

The following are highly desirable:

Participating institutions be willing to agree to acceptance of oversight by a single IRB of record rather than a local IRB to standardize the oversight for human subjects protection in CTN trials, especially those operating in multiple states. Institutions should also agree to potential future requirements of a single IRB of record for each protocol.

Research sites have previous experience and success in conducting multi-site clinical trials.

Applicants are encouraged to leverage the resources of the NIH such as the Health Care Systems (HCS) Research Collaboratory Program, and The Clinical and Translational Science Awards (CTSA) program. Also consider linkages with projects/networks funded by non-NIH entities including but not limited to The Patient-Centered Outcomes Research Institute (PCORI) and private foundation-supported initiatives that focus on generating patient-centered and clinically meaningful findings that help guide the decision making of various stakeholders such as providers, policy makers and patients and their families.

Special Considerations

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: In light of recent significant advances in rapid testing for HIV and in effective treatments for HIV, NIDA has revised its 2001 policy on HIV counseling and testing. NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV. This policy applies to all NIDA funded research conducted domestically or internationally. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-07-013.html.

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects: The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Web site at http://www.drugabuse.gov/funding/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects.

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community. Please see http://www.drugabuse.gov/about-nida/advisory-boards-groups/national-advisory-council-drug-abuse-nacda/council-statements/points-to-consider-regarding- for details.

Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit: NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org). Please see NOT-DA-12-008 (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s), including partnering healthcare organizations
• Number and title of this funding opportunity

The letter of intent should be sent to: [email protected].

Applicants are encouraged to send the letter of intent by email to the email address above but as an alternative the letter may also be sent to:

Director - DA-15-008
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Suite 4243, MSC 9550
Bethesda, MD 20892-9550

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed. Applicants should describe their research organization and include plans, information, and documentation that indicate their institutional or organizational capability to manage funds and to accomplish the proposed research successfully. Applicants should provide names and addresses of each partner organization.

All instructions in the SF424 (R&R) Application Guide must be followed.

Facilities and Other Resources. Briefly describe proposed partnerships with healthcare organizations explaining how productivity of the network will be increased and how the partnerships will advance the objectives of the program. Specialty programs should be able to describe their relationships with primary care programs or the available integrated medical services. In addition, programs should be able to describe how they will integrate existing EHR data with proposed research projects.

All instructions in the SF424 (R&R) Application Guide must be followed.

Biosketches of applicants who are current CTN members should describe their participation and contribution to the Network in detail (e.g., leadership roles, leading protocols, participation in common protocols, collaborations with addiction treatment providers, etc.), including their particular contribution to CTN trials and studies, patient enrollment, etc. Relevant research studies should be described and all related publications listed.

Biosketches of new applicants must describe their recent experience and participation in randomized clinical trials, preferably of a multicenter nature. Specific roles (PD/PI, participating site, leadership committee, lead investigator, trial design and development) should be described for each study. Publications should be listed that resulted from participation in the studies.

Applicants are expected to provide evidence of their unique strengths, accomplishments and capabilities to contribute to shared CTN activities. Applicants should provide evidence of expertise in the conduct of clinical trials, particularly cooperative, pragmatic, randomized clinical trials. Persons responsible for participant recruitment, enrollment, data collection and data management should be shown to have extensive experience and high qualifications.

All instructions in the SF424 (R&R) Application Guide must be followed.

PD/PIs must expend 2.4-4.2 person-months effort annually on the award over the entire period of support.

Once an application has been favorably recommended and is being considered for funding, the applicant will be required to propose protocol budgets to participate in those protocols underway in the CTN. For trials starting after awards are made from this FOA, annual negotiated protocol budgets will consist of specific protocol-related allowances (protocol costs) and will be awarded as such. Successful applicants will be required to project patient enrollment for a specific protocol during a specified time frame. Federal agencies shall use the negotiated rates for F&A costs in effect at the time of the initial award throughout each competitive cycle of the project. Supplemental funding will be considered for research costs in excess of annual awards.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy:

Research Agenda

Applicants should provide a detailed description of a research agenda likely to have substantial public health significance or clinical practice impact and consistent with the goals and objectives of this FOA (see Section 1., Priority Research Topics), which could be carried out to take advantage of the unique capabilities of the CTN. The proposed research agenda is not meant to be limited to the description of a single study; rather it must encompass a broader set of research ideas that address current public health needs in addiction treatment and describe how knowledge gaps would be filled if the agenda were to be accomplished. It should include high priority, pragmatic, comparative clinical effectiveness research (CER) projects that are informed by and will provide needed evidence to help providers at health settings and patients/caregivers make better-informed decisions. It should discuss the types of critical research questions that the applicant asserts must be addressed by the addiction treatment research field in order to advance scientific knowledge and improve practice.

This discussion should include the relevance and feasibility of the proposed research agenda to the treatment field, research methods that might be used, patient populations that might be studied, cost-efficiencies, the potential for implementation and adoption by health care systems, and how potential findings would lead to changes in clinical practice in addiction treatment. The discussion should also address how the applicant proposes to work collaboratively at all levels (including other network members and NIDA) to advance the research agenda. It should be understood that this agenda is not expected to be a detailed concept for a research protocol and that the proposed research agenda will not necessarily be conducted in the CTN; however, the proposed visions for a CTN research agenda could constitute one source of research ideas to be considered during the project period. Each of the specific research areas within the proposed agenda should include: scientific rationale and significance, main research questions; explanation of reliance on electronic health records, feasibility for execution in the CTN; public health impact; and plans for dissemination, implementation, and adoption of findings.

History of Collaboration

Applicants must describe any relevant collaborative research activity undertaken between the applicant institution and the proposed healthcare organizations (or healthcare system networks). Contributions and collaborations in areas such as protocol design, study recruitment, data analysis and interpretation, publication and dissemination should be highlighted. Documentation of recruitment and retention rates in clinical trials should be provided.

Population Available for Clinical Trials

Applicants must describe populations who are available to them and their multidisciplinary colleagues to perform community, point of care-focused or health facility multi-center protocols as described in the scope section. Investigators must demonstrate the ability to recruit and retain diverse racial and ethnic participants, including women, from their proposed healthcare providers.

Letters of Support: Applications indicating opportunities to conduct research in multiple types of healthcare organizations are preferred. Letters of support from all healthcare organizations outside of the awardee institution with whom the applicant desires to collaborate in conducting CTN-sponsored research should be included. These letters should summarize their research experience and demonstrate their capacity to conduct research. These letters should also be coupled with evidence of support for these activities from administrative and executive leadership of the collaborating organizations.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

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.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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?

Additional criteria: Is the proposed research project focused on topic(s) likely to have substantial public health significance or clinical practice impact and support objectives of the CTN which are, briefly, to build an evidence base for SUD care that will inform and support clinical guidelines, link SUD specialty care to general medical settings using a variety of study designs, is mindful of co-ocurring disorders, uses electronic medical records and mHealth technologies, serves all populations, promotes reductions in HIV and other STDs, and uses learning healthcare system principles? ? Does the proposed trial include a multi-site intervention of high clinical impact aimed at improving the clinical management of substance use problems and/or improving the substance use outcomes of patients seen in health care settings?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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?

Additional Criteria: Do the PD(s)/PI(s) have a well-documented record of leading multi-site controlled clinical trials? Have the PD(s)/PI(s) demonstrated successful collaborations with co-investigators, healthcare providers and other collaborators in the conduct of clinical research? Do team members responsible for participant recruitment, enrollment, data collection and data management have extensive experience and high qualifications?

Innovation

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?

Additional Criteria: Is the proposed project embedded in the context of a well-articulated, comprehensive longer-term research agenda? Will the proposed trial demonstrate cost-efficiencies in its design and conduct?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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?

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 children, justified in terms of the scientific goals and research strategy proposed?

Environment

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?

Additional Criteria: Has the applicant described and provided a justification for a streamlined research infrastructure with the capacity to expand as needed for the conduct of specific scientific projects and related activities? Does the description of the Node infrastructure demonstrate core capabilities for the satisfactory conduct of CTN research activities? ? Are the partner healthcare organizations well suited to contribute to research studies aimed at improving SUD clinical practices? Have the partner healthcare organizations demonstrated the capability to leverage electronic health record systems and other HIT resources to facilitate research designs that make use of data collected during routine clinical care?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six 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 six 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.

Inclusion of Women, Minorities, and Children

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 children 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.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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.

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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).

Resource Sharing Plans

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) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIDA, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit will be discussed and assigned an overall impact score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Drug Abuse. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described 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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement (NIH UG1), 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 above.

The PD(s)/PI(s) will have the primary responsibility for:

The Program Director/Principal Investigator (PD/PI) will have the primary responsibility for defining the details for the project within the guidelines described in the Request for Applications DA-15-008 and for performing the scientific activity. The PD/PI agrees to accept close coordination, cooperation, and participation of NIDA Program staff in those aspects of scientific and technical management of the project described in these terms and conditions. The PD/PI agrees to accept close coordination and to cooperate fully with NIDA designated coordinating centers and contractors. The PD/PI further agrees to participate fully in the activities of the Clinical Trials Network (CTN) Steering Committee and in other committees and workgroups as formed.

Awardees will retain custody of and have primary rights to the data under these awards, subject to Government rights of access consistent with current DHHS and NIH Policies.

a. Generally, Awardees under this agreement have the following rights and responsibilities:

• Provide leadership for their Node. The Node refers to the combination of the awardee organization and the partnering health care organizations. The awardee provides scientific leadership and management of clinical trials as well as administrative and study operations services for the Node. The awardee agrees to negotiate and establish formal working relationships with healthcare organizations such as SUD specialty treatment centers, hospitals, healthcare networks, Federally Qualified Healthcare Centers (FQHCs), patient-centered medical homes (PCMHs), accountable care organizations (ACOs), or other general medical setting entities to participate in CTN activities and conduct research and training projects. These agreements will include, at minimum: 1) a statement of work defining the goals and objectives of the research projects to be undertaken under this cooperative agreement; 2) a budget for support of the research projects that clearly identifies the personnel, equipment, materials, and other costs required to successfully conduct high quality research according to the requirements of specific protocols approved for implementation by the CTN Steering Committee and NIDA; and 3) a financial and program reporting requirement, including access to data and materials, to facilitate CTN program operation and research project oversight and monitoring. Initial agreements between the awardee institution and healthcare organizations may be general as specific details will depend on the particular research projects and participating sites. The awardee will also agree to follow all CTN standards as established by the Steering Committee.
• Core functions - This includes but is not limited to 1) arranging and managing the participation of partnering healthcare organizations; 2) providing scientific and technical expertise for protocol development and research operations; 3) coordinating and providing resources for activities within the Node; 4) collaborating with NIDA and other Nodes to develop, disseminate, and implement findings from CTN research projects; and 5) working with the CTN Clinical Coordinating Center and Data and Statistics Center. The Principal Investigator agrees to provide adequate support for Node personnel participation in Steering Committee and other CTN meetings as required.
• Research Concept Development and Implementation - In close partnership with the partnering healthcare organizations, and in collaboration with other CTN members, the awardee develops research concepts for potential CTN trials and submits them to the CTN Steering Committee (or its designee) for discussion and review, and to NIDA for approval.

b. Data Rights:

• The NIH expects investigators supported by NIH funding to make their research data available to the scientific community for subsequent analysis based on a data sharing plan approved as part of the award; see the NIH data sharing policy website at http://grants.nih.gov/grants/policy/data_sharing. The CTN is intended as a national resource for the advancement of treatment for addicted individuals and other affected persons. The Awardee of this agreement acknowledges that NIH has access to any and all data generated under this cooperative agreement and the Awardee agrees to provide royalty-free, nonexclusive, and irrevocable license for the government to reproduce, publish, or otherwise use the material and data derived from research conducted under this cooperative agreement. The Awardee agrees to register the trials in the clinicaltrials.gov database and submit results according to NIH policy http://clinicaltrials.gov/ct2/manage-recs/fdaaa . The Awardee also agrees to cooperate with NIDA’s contracted Data and Statistics Center with regard to (1) collection and analysis of data generated under the CTN, including but not limited to collection of PhenX Toolkit Core Tier 1 measures (https://www.phenxtoolkit.org/) and NIDA common data elements (CDEs); and (2) providing timely, accurate, and complete data for purposes of monitoring the safety and progress of research projects conducted within the CTN. For each protocol, the Steering Committee will appoint a Lead Investigator (LI). Data from all participating sites will be included in a single dataset and the dataset will be provided to the study LI. At the conclusion of each protocol, the LI will be required to make available a public use file of all related participant-level study data. The awardees will retain custody and primary rights to their Node data consistent with current DHHS and NIH policies, including a policy to provide public access to selected, significant data sets generated with the use of public funds, within a reasonable period of time after primary analysis or publication by the CTN. The awardee must agree to retain records for each completed study for a minimum of 3 years (or more if necessary) after study data lock. Each site must also comply with their respective IRB and other regulatory entities regarding records retention.

c. Study Management:

The awardee is responsible for the proper conduct of CTN studies at each site within their Node. All studies conducted in the CTN are subject to the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. The awardee must provide resources to ensure that (1) staff receive adequate training and resources to conduct the studies; (2) the studies are conducted according to the protocol and applicable regulatory requirements; (3) the studies recruit and retain participants per approved recruitment plans, including appropriate number of women and minorities per NIH policy; (4) staff perform adequate data entry; (5) corrective actions are implemented when appropriate; (6) study materials and records are kept and/or disposed appropriately; and (7) study personnel participates in study related activities as planned by the Lead Investigator, NIDA Center for the Clinical Trials Network (CCTN) and/or Coordinating Centers. Each study site must agree to monitoring activities that will be specified in each protocol.

d. Reporting Requirements:

In addition to periodic financial and administrative reports required by NIH for administration of this cooperative agreement, the Awardee agrees to furnish the following reports according to the schedule indicated:

• Investigational New Drug (IND) Reports: Awardees are required and agree to provide reports according to regulations and guidelines established by the Food and Drug Administration (FDA).
  
  
• Final Study Report: Lead Investigators are required to provide CCTN with a Final Study Report within 120 days of data lock upon completion of the protocol. In addition, the Lead Investigator will present primary outcome results to the trial DSMB, the participating sites and the Steering Committee prior to publication.

e. Publication of Data:

Prompt and timely presentation and publication in the scientific literature of findings resulting from research undertaken in the CTN is required. It is expected that the Lead Investigator will complete and submit the initial outcome paper to an appropriate peer-reviewed scientific journal within 180 days of study data lock. The Awardee agrees to acknowledge NIDA support in the publications and oral presentations resulting from research conducted under this cooperative agreement. Review and approval by the Steering Committee will be required for all analyses prior to publication or presentation. The Awardee agrees to present all CTN manuscripts to the CTN Publications Committee for review and approval prior to journal submissions.

f. Protocol Closure:

Throughout the term of the cooperative agreement NIDA may request that a research project be terminated for reasons including but not limited to: 1) insufficient subject accrual; 2) poor performance in conducting the protocol; 3) safety of the subjects in the study; 4) achievement of conclusive study results; 5) emergence of new information that diminishes the scientific importance of the study question; 6) misuse of federal funds; and 7) shortfalls in appropriated funds available to pursue the study. Financial support from NIDA and access to further investigational drug supplies through this cooperative agreement will cease upon project closure, except that funds and other resources may remain available for patients already enrolled in the study.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The Center for the Clinical Trials Network (CCTN) is the organization within NIDA responsible for the scientific collaboration, administrative oversight, and operational management of the CTN research program funded by NIDA.

NIDA Program staff has substantial scientific and programmatic involvement throughout this cooperative agreement through technical assistance, and advice and coordination extending beyond normal program stewardship for grants as described below.

a. NIDA’s Scientific Role

The Director of the CCTN will appoint NIDA Project Coordinators, CCTN Protocol Coordinators (CPCs) with expertise in clinical research to participate in the development of study plans and protocols, and to coordinate projects across scientific disciplines and CTN Nodes. NIDA CPCs may initiate or participate in publications in accordance with established professional and NIH guidelines for authorship.

The CCTN Director, and/or designated staff, will work closely with the CTN Steering Committee to assure that CTN efforts are consistent with NIDA’s research objectives and complement other clinical trial activities supported by NIDA under other means.

NIDA CPCs will advise the clinical investigators, as requested or needed, of results from other trials (e.g., adverse experiences and study termination) that could influence the design, development, or conduct of clinical trials under this cooperative agreement. NIDA will serve as a resource, and will communicate information regarding promising new therapies.

NIDA will appoint advisory boards within and outside of the CTN as deemed necessary during the development and progress of protocols and trials.

For ongoing research projects NIDA CPCs and its contractors will monitor study progress through incremental review of case report forms. NIDA and its contractors will prepare periodic reports profiling the conduct of the study including the safety of study participants for review by the CTN Data and Safety Monitoring Board (DSMB). The DSMB may recommend to NIDA a need to alter, suspend, or close an ongoing trial due to safety concerns, study performance issues, or early evidence of efficacy or futility.

b. NIDA’s Role in Protocol Review and Approval

In order for a CTN research project to be initiated, a research concept must be mutually approved by the CTN Steering Committee and NIDA CPCs. Once a concept is presented for consideration, NIDA will evaluate the proposed trial according to: NIDA’s research agenda; potential impact on the science and public health; relevance to current national priorities; likelihood for timely completion; patient safety; compliance with Federal regulatory requirements; an estimated budget; and resource requirements. The CCTN Director will appoint a Protocol Review Board that will review each protocol and provide recommendations to the CCTN Director. CCTN Director will consider PRB recommendations and will make final decisions regarding protocol approval or disapproval.

NIDA will provide no trial materials or permit expenditure of CTN funds unless and until the proposed protocol is officially approved by NIDA.

c. NIDA Access to Data

The CCTN Director, and/or designated staff or agents, shall have access to all data generated under this cooperative agreement. Monthly reports on trial progress will be prepared by the Data and Statistics Center and reviewed by CCTN, the CTN Steering Committee, and the study Lead Investigator. Data must be available for external checking against original source documents as required by NIDA, and Federal regulations pertaining to the responsibility of NIDA as an IND sponsor.

Monitors from the Data and Statistics Center and the Clinical Coordinating Center will perform periodic review of data recorded on clinical source documents, case report forms, or in electronic form. Both the Data and Statistics Center and the Clinical Coordinating Center are established under contracts awarded by NIDA to provide certain resources and common services for CTN clinical trials, including support for regulatory requirements and oversight functions mandated by NIH and DHHS.

d. NIDA Monitoring of Trials

All studies conducted in the CTN are subject to monitoring according to protocol-specific monitoring plans. The Node must agree to periodic monitoring by Clinical Coordinating Center representatives. In addition, formal site audits will be conducted if necessary. Nodes must also agree to remote, central monitoring by Data and Statistics Center representatives. The monitoring may include periodic on-site visits and remote document reviews by staff from the Node and the NIDA appointed Coordinating Centers to perform the following: (1) investigational drug accountability; (2) compliance with applicable federal, state and local regulations for Human Subject Research, including Institutional Review Board (IRB) approval and informed consent (compliance with 45 CFR 46); (3) compliance with protocol specifications; quality control and accuracy of data recording; and (4) completeness of reporting adverse events. Monitoring is conducted to assure that: the rights and well-being of participants are protected; the reported trial data are accurate, complete, and verifiable from source documents; and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with all applicable regulatory requirements. Reports of all monitoring activities and audits will be reviewed by the CCTN and study performance will be reported to the DSMB. Summary reports from DSMB meetings will be provided to the Lead Investigator, who in turn will provide necessary documentation to the participating sites Institutional Review Board(s). Finally, NIDA program and grants management staff will review protocol accrual, and fiscal and administrative procedures. NIDA reserves the right to discontinue site participation in protocols based on poor performance.

e. NIDA Review of Performance

CCTN will periodically review the performance of the CTN as a whole and of individual Nodes. The review will be based on information provided in periodic trial progress reports compiled from data on recruitment, retention, follow-up, treatment exposure, monitoring reports, and other factors, as well as from evaluations of site performance conducted by the CCTN staff. Insufficient patient accrual, substandard data quality, inadequate progress in executing the research agenda, or noncompliance with the Terms and Conditions of Award may result in a reduction in budget, withholding support, suspension, or termination of award.

f. Normal Program Stewardship

A separate NIDA Program Official other than the CCTN director will be responsible for the normal programmatic stewardship of the award and will be identified in the Notice of Grant Award.

Areas of Joint Responsibility include:

CTN Steering Committee. The Steering Committee constitutes the primary governing body of the CTN. Membership shall comprise voting representation from each of the Nodes, the CCTN Director, the Clinical Coordinating Center, and the Data and Statistics Center. The Steering Committee uses both established and ad hoc committees and workgroups (e.g., Executive Committee, Research Development Committee, Research Utilization Committee, Publications Committee) to assist it in carrying out its functions. By accepting a Cooperative Agreement award, all participating Nodes must agree to abide by the policies and By-laws approved by the Steering Committee. The Steering Committee shall meet face-to-face at least once each year and via webinar/conference call as necessary during the year.

Protocol Review Board (PRB). An independent expert board, appointed by and reporting to the CCTN Director, that reviews proposed protocols and informed consent documents. Clinical Protocol Coordinators may nominate PRB members and observe the board proceedings. To minimize delay and provide continuity, this board may be combined with a DSMB (see below) for a given study.

Data and Safety Monitoring Board (DSMB). An independent expert board, appointed by and reporting to the CCTN Director, that oversees and monitors the conduct of the clinical trials to ensure the safety of participants and the validity and integrity of data from each study. The DSMB may conduct a scientific review of the protocol if necessary (see above). The DSMB also makes an independent assessment of the interventions under study and whether or not any trial undertaken in the CTN will continue. One or more NIDA staff serves as a non-voting administrator of the DSMB.

Central Institutional Review Board (IRB). In order to reduce the burden on local IRBs and to standardize the oversight for human subjects protection in our trials, the use of a single IRB for CTN research studies is strongly encouraged. The grantee agrees to the use of a central IRB when participating in studies requiring a central IRB.

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 consist of a designee of the 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 in no way affects the Awardee’s right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and DHHS regulations 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report 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.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY 301-451-5936
Email: [email protected]

Betty Tai, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6397
Email: [email protected]

Mark Swieter, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1389
Email: [email protected]

Jennifer Schermerhorn
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6710
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.