Autism Centers of Excellence (ACE) Program (P50, R01, U01 mechanisms)

Autism Centers of Excellence (ACE) Program (P50, R01, U01 mechanisms) is sponsored by National Institutes of Health (NIH) - Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute of Environmental Health Sciences (NIEHS), National Institute of Mental Health (NIMH), and National Institute of Neurological Disorders and Stroke (NINDS).

The ACE program is an NIH-wide initiative that supports large-scale multidisciplinary studies on autism spectrum disorders (ASDs), with the goal of determining the disorders' causes and potential treatments. The program includes ACE research centers and research networks.

Expired RFA-HD-12-196: Autism Centers of Excellence: Networks (R01) This notice has expired. Check the NIH Guide for active opportunities and notices. Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Institute on Deafness and Other Communication Disorders ( NIDCD ) National Institute of Environmental Health Sciences ( NIEHS ) National Institute of Mental Health ( NIMH ) National Institute of Neurological Disorders and Stroke ( NINDS ) Funding Opportunity Title Autism Centers of Excellence: Networks (R01) R01 Research Project Grant July 12, 2016 - This RFA has been reissued as RFA-HD-17-008 Funding Opportunity Announcement (FOA) Number RFA-HD-12-195 , P50 Specialized Center Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93. 865, 93. 242, 93.

853, 93. 173, 93.

113 Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institute on Deafness and Other Communication Disorders (NIDCD), the National Institute of Environmental Health Sciences (NIEHS), the National Institute of Mental Health (NIMH), and the National Institute of Neurological Disorders and Stroke (NINDS) invite new (type 1) and renewal (type 2) applications for the Autism Centers of Excellence: Networks Program, hereafter termed ACE Networks .

Each ACE Network will consist of a multi-site project focusing on a specific topic of research for R01 support through this FOA. The ACE Networks will focus on supporting the broad research goals of the Interagency Coordinating Each ACE Network will submit one R01 application that includes subawardss to the collaborating sites. A companion FOA ( RFA-HD-12-195 ) invites applications for ACE Centers supported by the P50 mechanism.

Open Date (Earliest Submission Date) Letter of Intent Due Date November 16, 2011, by 5:00 PM local time of applicant AIDS Application Due Date(s) Required Application Instructions It is critical that applicants follow the instructions in 424 (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 Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information I.

Funding Opportunity Description Autism spectrum disorders (ASD) are complex neurodevelopmental disorders with early childhood onset. The prevalence of ASD may be increasing, and ASD is more common than previously thought. These disorders, for which there is presently no cure and only limited treatments, generally have lifelong effects.

The NIH historically has supported a vast array of projects in autism research. Beginning in 1997, the Collaborative Programs of Excellence in Autism (CPEA) focused on research related to the possible causes of autism, including genetic, immunological, and environmental factors. The CPEA program resulted from a congressionally mandated conference on the State of the Science in Autism.

The attendees identified gaps in the understanding of autism and articulated directions for future research. Both NICHD and NIDCD sponsored the CPEA program. As a result of the efforts of researchers affiliated with the CPEA, data now exist on the genetics and phenotypic characteristics of the largest group of well-diagnosed persons with autism in the world.

After the establishment of the CPEA Centers program, Congress enacted the Children's Health Act of 2000. This legislation mandated the establishment of a new autism research program. In response, the five Institutes of the NIH Autism Coordinating Committee (NIH-ACC; represented by NICHD, NIDCD, NIEHS, NIMH, and NINDS) implemented the STAART (Studies to Advance Autism Research and Treatment) program in 2002.

Each of the eight STAART centers contributed to the autism research base in the areas of causes, diagnosis, early detection, prevention, and treatment. Collaborations among the STAART centers included a multi-site psychopharmacological clinical trial. In 2007, consolidation of funding from the CPEA and STAART programs resulted in autism centers and networks called the Autism Centers of Excellence or ACE program.

In FY 2007 and 2008, five centers and six networks were funded. The purpose of this Funding Opportunity Announcement (FOA) is to encourage research grant applications to support research designed to elucidate the etiology, epidemiology, diagnosis, treatment, and optimal means of service delivery in relation to autism spectrum disorders (ASD).

In response to the urgent public health significance of ASD, Congress passed the Combating Autism Act (CAA) of 2006. Through this Act, Congress intends to accelerate the pace, and improve the coordination of requirement of the CAA, was developed with the input of the scientific community, as well as advocates and advocacy organizations, including parents, providers, and individuals with ASD.

The plan consists of short and long term research objectives across a range of topics. This FOA is intended to support NIH will consider centers as well as networks in response to the ACE initiative. This funding opportunity solicits applications for ACE Networks supported by the R01 mechanism.

A companion solicits applications for ACE Centers supported by the P50 This funding opportunity solicits applications for ACE Networks. A network will consist of multiple sites focusing on a specific topic of research for R01 support through this funding opportunity. Each network will submit one R01 application that includes subawards to the collaborating sites.

An ACE Network application must require multiple sites for optimal design and conduct of the study. For example, an interrelated series of clinical trials of pharmacologic, behavioral interventions, or a combination of these, could be the focus of such a network. Another example could be a multi-site epidemiology study of risk factors for ASD.

Special populations requiring large numbers of participants for each protocol may also be studied best under a network because of enhanced recruitment and other benefits of multi-site subject accrual. A companion FOA solicits applications for ACE Centers ( RFA-HD-12-195 ). Centers bring together expertise, infrastructure and resources focused on major questions about autism.

Centers should involve collaborations of basic and clinical scientists optimally suited to address the research questions posed. NIH expects Centers to provide an environment and core resources to bring together biomedical, behavioral, and clinical science investigators to study autism. Collaborations involving more than one institution are strongly encouraged to provide optimal resources and expertise.

The Centers should provide investigators with well-characterized patients and control subjects, family information, and other scientific resources that facilitate research projects. Applications for Centers must include a minimum of three but no more than six research projects. An ACE Center must support major multidisciplinary research programs, consisting of interdependent and interrelated subprojects.

Meaningful and committed interactions among the disciplines must be evident. Subprojects may share materials, results, data, patient populations, or methodologies. Results of one subproject may well affect the understanding and interpretation of data from another project and thereby influence the nature of the research performed in one or more of the other subprojects.

In addition, each subproject must have goals and objectives that focus on the common unifying theme that interrelates the subprojects.

The highest priority will be given to projects related to appropriate, to which short or long term objective or area of opportunity from priorities must be addressed: Intervention and evaluation of interventions and Identification of individual characteristics that predict response to behavioral, pharmacological and other treatments.

Multi-site clinical trials to identify moderators and effective ingredients (e.g. dose, intensity, mode of delivery, age of onset) of Innovative and newly developed intervention strategies to improve outcomes in school and community settings throughout the lifespan (e.g., academic functioning, social and adaptive behavior, family functioning, employment), including transitions.

Development of efficacious drug treatments that target core Assessment and interventions for nonverbal school-aged children Pilot studies, including exploratory clinical trials, aimed to generate data that inform a decision whether to continue further clinical development of the proposed intervention.

Studies to understand how specific types of services, organizational processes and structures, financing mechanisms and evolving technologies and policies affect access to and delivery of services to people Studies that include children, as well as transition-age youth Studies on adults that include strategies that enable post-secondary education, supported employment, health care and community Other priorities include but are not limited to: Identification of risk factors (e.g., viruses, medications, immune dysfunctions, mitochondrial abnormalities, environmental chemicals, genetics) that contribute to the development of autism and their associated developmental Identification of biological signatures for autism and their relevance to prediction of treatment response and outcomes.

Assessment of characteristics and evaluation of interventions in understudied populations (e.g. adults, individuals from racial and ethnic minorities) and in those with comorbid conditions (e.g. epilepsy). Studies that improve the understanding of underlying biologic pathways that might lead to treatments for genetic conditions related to autism.

NINDS is particularly interested in mechanistic analyses of single gene disorders with autistic features (e.g. Tuberous Sclerosis Complex, Rett syndrome, Fragile X syndrome) that may shed light on pathways that are relevant minimal structural requirements of an ACE Network under this FOA are: Project(s) -- Each network will submit one R01 application that includes subawards to the collaborating sites.

An ACE Network application must require multiple sites for optimal design and conduct of the study. The research project must address one of the above priority areas. Those applying for a renewal of an ACE Network are encouraged to form new collaborations with investigators.

Coordinating Center -- Applications must have a clearly defined Data Coordinating Center (DCC) section in the research plan that describes the DCC’s functions in detail and explains how it will operate independently from data collection sites.

Applicants must provide evidence that the data collection sites and DCC are functionally separate, with separate chains of Training and Education -- ACE Networks must provide a training environment for pre-doctoral and post-doctoral investigators and engage the broader community in educational and research activities.

The ACE Networks are expected to play leadership roles in training new researchers in the field of Autism Spectrum Disorders and in educating and disseminating research findings to the community. Involvement of junior and established researchers who are new to the field of autism is encouraged.

Recruitment of investigators from underrepresented racial and ethnic groups and disadvantaged backgrounds is also minimal data collection requirements of an ACE Network under this FOA are: Network applications must include collection of data using the following forms or a justification of why the forms are not appropriate. Additional modifications to these forms may occur periodically.

Physical Examination Form Genetic Testing Information Form Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS), for use according to their published Vineland Adaptive Behavior Scales, Second Edition An IQ or developmental assessment measure that includes both nonverbal and verbal components and results in standardized scores for both The NIH National Database for Autism Research (NDAR) houses research data of all types (genetic, imaging, clinical assessment, etc.) from human subjects involved in ASD studies, and is currently on track to receive data from tens of thousands of such subjects.

NDAR’s first data release occurred in November 2010, making mostly clinical assessment data from over 10,000 research subjects available to qualified investigators. It is expected that in the next several years, ASD data from more than 90% of new investigations will be available in or through NDAR. All ACE Networks will be required to contribute data to NDAR.

Data sharing is required and NDAR will be involved to facilitate sharing activities. NDAR will function as a data repository for all ACE projects. Central clinical coordination and local data management for data cleaning and entry and bio-statistical consulting will be the responsibility of the ACE Network.

For more information on NDAR, please visit http://ndar. nih. gov/ndarpublicweb/ .

Application Types Allowed Glossary and the SF 424 (R&R) Application Guide provide details on Funds Available and Anticipated Number of Awards The NICHD, NIDCD, NIEHS, NIMH, and NINDS intend to commit approximately $26 million total for the first year of funding for this funding opportunity and the companion FOA for ACE Centers (RFA-HD-12-195). The first year of funding will be in either FY2012 or FY2013.

Approximately 10 to 15 ACE awards are anticipated in response to the two FOAs. Although the financial plans of the IC(s) provide support for this program, the number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation (see NOT-OD-05-004 ). To estimate the cost of data sharing, please visit http://ndar.

nih. gov/ndarpublicweb/Documents/NDAR_Data_Submission_Costs. xls .

Applicants for an ACE Network may request up to $2 million in direct costs per year (excluding subaward F & A costs). The scope of the proposed project should determine the project period. The maximum project period is 5 years.

described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA. Section III.

Eligibility Information 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 Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession 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 Foreign institutions may not serve as the applicant organization.

However, they may participate as part of the network consortium. For example, a site within an ACE Network may be located at a foreign institution and supported through a subaward. Funding requests for foreign subawardss must be made in U.S. dollars.

Facilities and administrative costs on foreign consortia will be awarded at 8 percent of the total direct costs less equipment. Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award.

Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) 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 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 SF 424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

NIH will not accept any application that is essentially the same as one already reviewed. Each PD/PI may submit only one application for either an ACE Center or an ACE Network. This does not exclude multiple applications from a single institution, provided each application is submitted by a different principal investigator.

IV. Application and Submission Information 1. Requesting an Application Package 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 . Form of Application Submission It is critical that applicants follow the instructions in (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 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 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 research Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel Participating institutions Number and title of this funding opportunity The letter of intent should be sent to: Program Director for Research on Autism Spectrum Intellectual and Developmental Disabilities Branch Center for Developmental Biology and Perinatal Kennedy Shriver National Institute of Child Health and Human 6100 Executive Boulevard, Room 4B09F, MSC 7510 Rockville, MD 20852 (for express/courier service; Required and Optional Components The forms package associated with this FOA includes all applicable components, mandatory and optional.

Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components. All page limitations described in the SF424 Application Page Limits must be followed.

Other Project Information Component and Other Resources (Item 10. of R & R Instructions) Overall Environment -- Briefly describe the features of the institutional environment that are or would be relevant to the effective implementation of the proposed ACE program.

As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographical distribution of space and personnel, and consultative resources.

Research Sites -- Provide a detailed description of each participating site within the Network, including the institution, departmental affiliations, resources, and role in the overall Data Coordinating Center (DCC) -- Applications must provide a Data Coordinating Center (DCC) section that describes the DCC’s capabilities and functions in detail and explains how it will operate independently from data collection sites.

The data management plan should take into account the interface with the National Database for Autism Research (NDAR). Provide an organizational chart for the entire Network, including the central administration, Network sites, and DCC. The Applicant organization should submit R & R budget forms for the ACE network R01, following the standard R & R Budget Component instructions.

Participating research sites should prepare subaward budget pages according to Section 4. 8 of the R & R Instructions (Special Instructions for Preparing Applications with a Subaward/Consortium). Budgets for the applicant organization and all network sites should include a detailed budget for the entire proposed project and a Budget Justification for each site according to the R & R instructions.

Data Coordinating Center If the DCC will be located at an organization distinct from the applicant organization and the network research sites, the DCC budget should be prepared as a subaward to the R01 budget. If the DCC will be located at the applicant organization, the DCC budget should be included as part of the overall R01 budget.

If the DCC is located at one of the participating research sites, the DCC budget should be included as part of the subaward budget for that particular site. DCC budgets that are included as part of either the R01 or research site budgets should be explained and justified in the respective budget justification section.

ACE Network budgets and subaward budgets must include travel funds for key investigators to attend annual two-day ACE meetings in Bethesda, Maryland.

The Network PD/PI(s), leaders of the various network sites, and the leader of the Data Coordinating Center (DCC) should plan to attend the annual meeting to share findings, research approaches, and information about core Justifications and Explanations -- Describe the specific functions of all key personnel, consultants, collaborators, and support staff.

For all years, explain and justify any unusual items such as major equipment or alterations and renovations. For additional years of support requested, justify any significant increases or decreases in any category over the first 12-month budget period. If a recurring annual increase in personnel or other costs is anticipated, give the percentage; however, current NIH practice limits escalation to 3%.

In addition, for renewal applications, justify any significant increases in any category over the current level of support.

PHS 398 Research Plan Component All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: and Objectives of the ACE Network -- Provide an overview of the entire proposed ACE Network, including the relevant history leading up to the ACE network application, the central theme, and the overall objectives. Describe how the network will achieve those objectives.

Explain the contribution of each of the proposed research studies in achieving the objectives of the network. The administrative arrangements and support necessary to effect the research should be carefully described in the application. In addition, provide detailed information on collaborations, subject recruitment, facilities, and any resources not described in the Resources section.

Provide documented evidence of subject recruitment capability specific to each study proposed.

Discuss the philosophy and objectives of the ACE network and general plans for the Administration, Organization, and Operation of the ACE Network -- Include information on the support and commitment of the institution serving as clinical coordinating center for the ACE network, the authority of the ACE network Director, and the use of advisory committees.

Identify any investigators new to the field of autism (junior and/or established investigators) that will be involved directly in network activities. Describe any additional efforts that will be made to recruit and/or train new investigators over the course of the award.

Coordinating Center -- Applications must have a clearly defined Data Coordinating Center (DCC) section in the research plan that describes the DCC’s functions in detail and explains how it will operate independently from data collection sites.

Applicants must provide evidence that the data collection sites and DCC are functionally separate, with separate chains of Network Preliminary Data -- The proposal should present, in condensed form, previously published and/or preliminary data that support the rationale for the proposed ACE network activities and research project. Cite relevant publications where appropriate.

Renewal applications must submit a progress report detailing the progress made on ACE Network projects funded by the previous ACE FOA. Citations should be listed in the Progress Report Publication List (see below). Any arrangements for collaborative and cooperative endeavors or subawards should be described here.

Include letters of assurance/agreement from consultants. For projects to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance signed by the off-site institutional officials must be submitted with the application.

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 modifications: Human Data via the National Database for Autism Research: Sharing Human Data via the National Database for Autism Research: In order to advance the goal of advancing autism research as broadly and effectively as possible, investigators funded under this FOA who are collecting data from humans are expected to share those data among ASD researchers through a broadly accessible repository addressing the needs of the autism research community, e.g., via the National Database for Autism Research (NDAR; http://ndar.

nih. gov ). Fulfilling this expectation by the awardee will be among the terms and conditions of the award.

Established by the NIH, NDAR, for example, is a secure bioinformatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, tools, and supporting documentation. NDAR links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology.

Investigators funded under this FOA would be able to use these technologies to submit data to NDAR. To accomplish this objective, it will be important to formulate a) an enrollment strategy that will obtain the information necessary to generate a GUID for each participant, and b) a budget strategy that will cover the costs of data submission.

The NDAR web site provides two tools to help investigators develop appropriate strategies: 1) the NDAR Data Sharing Checklist ( http://ndar. nih. gov/ndarpublicweb/Documents/NDAR_Data-Sharing_Checklist_10152009.

pdf ) -- A list of critical steps in the data submission process, including informed consent language and GUID generation; and 2) the NDAR Data Submission Planning Cost and Effort Model ( http://ndar. nih. gov/ndarpublicweb/Documents/NDAR_Data_Submission_Costs.

xls ) -- A customizable Excel worksheet that includes tasks and hours for the Principal Investigator and Data Manager. Investigators are expected to certify the quality of all data generated by grants funded under this FOA prior to submission to the repository and to review their data for accuracy after submission.

Submission of descriptive data is expected semi-annually (every January 15 and July 15); submission of all other experimental data is expected after the primary objectives of the grant have been met (the primary objectives of a grant will be determined in consultation with the investigator’s Program Officer prior to award). For reference, the NDAR Data Sharing Policy ( http://ndar. nih.

gov/ndarpublicweb/policies. go ) is available for review on the NDAR web site. NDAR staff will work with investigators to help them submit data types other than phenotypic, genetic, or imaging.

For answers to frequently asked questions and how to contact the NDAR Manager, please see: http://ndar. nih. gov. and other Data Sharing in the ACE Program The rapid dissemination of data and biomaterials is of increasing importance to the NIH for advancing research.

The mission of the NIH and a goal of NIH policies are to promote discoveries to improve the health care and treatment of people, which is a mission that should be shared by the research community. The expedient sharing of data and biomaterials collected under scientific studies facilitates that mission.

The NIH supports several databases through the NCBI, and the NIMH supports a repository for biospecimens of interest to mental health ( http://nimhgenetics. org ) to enable rapid sharing of data and biospecimens. These resources offer centralized sources of curated materials that are widely accessible to investigators in the international scientific community.

Investigators applying for awards under this FOA are encouraged to deposit data and biospecimens in NIH designated databases and appropriate repositories. However, depending on the nature of the data or biomaterials, there may not be an appropriate NIH supported resource for deposition. In such cases, alternative venues for data sharing can be considered.

The sharing of data through NIH resources would not necessarily be exclusive and the data could be additionally shared through other investigator suggested venues.

It is expected that the investigator’s data sharing plan will specify the following elements: (1) description of what data will be collected including clinical data, diagnostic data, and physiological measurements such as MRI, (2) description of what biospecimens will be collected, (3) description of the data that will be derived from the biospecimens such as genotyping, sequence, metabolomic measures, proteomic measures, etc., (4) what data and/or biospecimens will be made available for deposit in databases or in a repository accessible to the research community, (5) a timetable for deposition of the data and/or biomaterials, and a specified time interval after which those data and materials can be released to the Guidelines have evolved from extensive discussion within NIH Program staff, consultations with human genetics researchers and advocacy members, recommendations from the Genetics Workgroup of the National Advisory Mental Health Council (NAMHC), and requirements of the National Database for Autism Research recommending shortened timelines for data deposition and reduced proprietary periods before the data is released to the research community.

The deposition of data is encouraged to occur at intervals throughout the period of the award and not be detained until the end of the award period. Similarly, the proprietary period for data release is encouraged to be short to facilitate rapid data release. Adherence to shortened time intervals for data deposition and release is highly desirable.

This is expected to result in all data being released to the scientific community no later than the end of the award period, even if a competing renewal application is submitted. More rapid sharing is strongly encouraged. Requests for exemptions or extensions will require compelling justification and will be fully evaluated through peer review and by program staff.

NIMH, in consultation with NIH’s Office of the General Counsel, the National Human Genome Research Institute's Ethical, Legal, and Social Implications Research Program and the Department of Health and Human Services' Office for Human Research Protections, has developed a model consent form for use in human genetic research at: https://www. nimhgenetics. org/documents/NIMH%20Human%20Genetics%20Initiative%20Consent.

pdf . This model consent may serve as a template that is subject to modification and/or approval by local institutional review boards. It is expected that the applicant’s approved consent form addresses the following: Disclosure that any applicable biomaterials (DNA and cell lines), clinical data, and genotyping information