All of Us Research Program Engagement and Retention Innovators (OT2) OT PM 19 003

Transcript

1 ention Innovators (OT2) All of Us Research Program Engagement and Ret Overview Information Funding Opportunity Title All of Us Research Program Engagement and Retention Innovators (OT2) OT - PM - Funding Opportunity - 003 19 Number Participating Organization National Institutes of Health (NIH) Research Program. Components of Participating All of Us This funding opportunity is part of the NIH Organizations The funding opportunity will be administered by the National Center All of Us for Advancing Translational Sciences (NCATS) on behalf of the Research Program. Opportunity Type New OT-PM-16-002 Communication Support for the Related Notices Precision Medicine ® Research Programs at NIH Initiative OT-PM-17-002 All of Us Research Program Engagement Partners Research Program seeks to create one of the world’s Funding Opportunity The All of Us rpose Pu largest and most comprehensive precision medicine research platforms. Its goal is to build a data resource containing multi- layered information on one million or more participants who reflect the rich diversity of the United States. The purpose of this award is to fund engagement innovators who will design strategies and tactics geared toward raising awareness of Research Program through community and provider the All of Us organizations, driving increased enrollment of participants, communicating to existing participants to keep them engaged partners, and engaging the research community to use the data being gathered. These engagement innovators should be expert and experienced rganizations that have a proven track record in at least one of the o following categories: Community engagement Provider engagement Experiential learning Multicultural engagement Digital engagement Programmatic priority will be given to applicants who have demonstrated experience and success working with and reaching into communities historically underrepresented in biomedical research . All of Us considers the following populations historically under - represented in biomedical research: racial and ethnic minority groups; children and seniors; sexual and gender minorities; people with disabilities; people with barriers in access to care, low economic status, or low educational attainment; and rural residents. 1

2 Overview Information Funding Instrument ding instrument is the Other Transaction (OT) award The fun mechanism: an OT award is not a grant, cooperative agreement, or contract, and uses Other Transaction Authority. Actual amounts will depend on funds available, but the program Funds Available expects that applicant direct costs should not exceed $8M Anticipated Number of NIH intends to fund at least one (1) award in FY2019. Other applications may be awarded dependent on applications received and Awards funding availability Key Dates Period The total project period is anticipated to be five (5) years. Award Project 11 , 2019 February Post Date arch 29 , 2019 (5:00 p.m. local time) Application Due Date M Scientific/Technical Review applications. Review will be conducted in April 2019 after receipt of Date Award Timeline Award(s) will be made upon selection and award negotiation. The estimated timeline is June 2019. Application Instructions Required Application to address all five categories of desired expertise This award is meant (community engagement, provider engagement, experiential learning, Instructions multicultural engagement, and digital engagement) and awardees with experience in multiple categories are encouraged to apply. However, awardees are not required to have experience in all categories. If a single awardee is not qualified to fulfill all the requirements mentioned in the categories above, multiple awardees may be selected and will be expected to work collaboratively to achieve the intended outcomes. The materials created by all awardees should be replicable and scalable given that they may be utilized by multiple sites in the program. Eligible organizations may submit only one application. Applicants may opt to partner with other organizations on a single application submission. NIH encourages applicants to partner to provide the best response to the FO. Applications shall include sufficient detail to allow the Government to assess the applicant’s capabilities to provide the requested services. Each application submission must clearly state the applicant's ualifications and expertise. Applications shall also include sufficient q detail to allow the Government to assess the applicant’s capabilities es. to provide the requested servic 2

3 Application Instructions Applications should include the following within the total application package not exceeding 26 pages: Technical Approach: Not to exceed 15 pages Organization Description: Not to exceed 1 page. A d escription of the applicant organization(s), including a summary of their mission statement, a brief history, their projects of note, and lasting impacts, especially with historically underrepresented groups in biomedical research. Past Performance (Corporate/Organizational experience elated to the funding opportunity): Not to exceed 5 pages. r The applicant should indicate which of the five categories (community engagement, provider engagement, experiential learning, multicultural engagement, digital engagement) they have the most proficiency with and provide several examples of previous performance supporting this selection. Responses for individual categories should not exceed 1 page. If an applicant is proficient in multiple categories, the appl icant may include responses corresponding to multiple categories. Applicants should describe their track record of performing the specific type of work required in this project, including previous work with the specific community or population (especially communities that are historically underrepresented in biomedical research) they intend to reach, and experience in meeting goals and milestones. In addition, applicants should describe past instances where es they incorporated user feedback to change approach and/or establish best practices. Key Personnel Not to exceed 3 pages. The applicant should nclude a description (biosketches) of key individuals who i would work on this project. Cost Proposal: Not to exceed 2 pages. Applicants must how they will use the funds requested. rovide details of p This plan should include quarterly milestones. Proposals can use approaches such as cost -sharing, fixed price, adjustable/cost reimbursable, or a combination of approaches. Budget detail should be specific enough for the reviewers to understand the connection between the funds requested and activity to be conducted. A one -page cover letter is allowed and will not count against the 26 - p age limit. It will be included with the application material provided to reviewers. Appendices are not allowed. 3

4 Application Instructions Applicants should familiarize themselves with the report of the PMI Working Group to the Advisory Committee to the Director entitled The Precision Medicine Initiative Cohort Program – Building a . Research Foundation for 21st Century Medicine Instructions for A Applications must be submitted via the NIH eRA ASSIST System by pplication 29, 2019. March an application via ASSIST, the applicant Submission To submit must be registered in eRA Commons (organizations organization registered in eRA Commons do not need to reregister). already the organization Once the in dividual(s) with the ro le of is re gistered, fficial and Program Director/Principal Investigator Signing O (SO) must b e affiliat ed with the organization and have eRA (PD/PI) credentials t Commons the submission process. o complete Use OTA -19-004 in the field requesting Opport unity Funding Announcement. Here are Instructions for submitting via the NIH eRA ASSIST system . In the future, instructions will also be available in the ASSIST online help ). Technical help is available at the eRA (look for the OTA section Service Desk . Eligibility Informatio n Applicants Higher Education Institutions Eligible Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always enc Private Institutions ouraged to apply for NIH support as Public or of Higher Education: • Nonprofits without 501(c)(3) IRS Status • Faith -based or Community -based Organizations • Regional Organizations Independent School Districts • Hispanic -serving Institutions • Historically Black Colleges and Universiti • es (HBCUs) • Tribally Controlled Colleges and Universities (TCCUs) • Alaska Native and Native Hawaiian Serving Institutions • Asian American Native American Pacific Islander Serving Institutions NAPISIs) (AA • State or 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) 4

5 Eligibility Informatio n (cont.) Eligible Applicants • Native American Tribal Organizations (Other than Federally Recognized Tribal Governments) • Public Housing Authorities/Indian Housing Authorities Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions f Higher Education) o Nonprofits without 501(c)(3) IRS Status (Other than I nstitutions of Higher Education) For -Profit Organizations Small Businesses - Profit Organizations (Other than Small Businesses) For Non - domestic (non - U.S.) Entities (Foreign Institutions) are not eligible Foreign Institutions -domestic (non -U.S.) components of U.S. Organizations to apply. Non are not eligible to apply. Foreign components are not allowed. Foreign components are defined as performance of any significant element or segment of the project outside of the United States either by the award recipient or by an individual employed by a foreign organization whether or not . OT2 award funds are expended Application Review Review Process Applications will be evaluated for responsiveness to the Funding Opportunity requirements and merit by an appropriate review group convened by the NIH. Reviewers will evaluate applications based on the following: Experience • Quality of Submission • • Engagement Approach including Measurable Commitments • Proficiency in categories of expertise described in the application: Community engagement Provider Engagement Experiential learning Multicultural engagement Digital eng agement • Innovation • Proposed Commitment to the Project • Past Performance • Key Personnel & Experience • Cost Proposal Applicants may receive a brief written summary of the review. Successful applicants will undergo a negotiation process for award determinatio n. 5

6 Application Review P Evaluation Process rogrammatic priority will be given to applicants who have demonstrated experience and success working with and reaching into communities historically underrepresented in biomedical research as defined in the Funding Opportunity Purpose section. Additionally, reviewers will evaluate applications based on the following: • Demonstrated track record of relevant experience and exp ertise • Engagement approach including measurable commitments • rformance and successes Past pe Proven ability to work collaboratively within a large • c onsortium of key stakeholders • Key personnel and experience • Cost proposal Questions Regarding this :00 4 Informational Webinar: Wednesday , February 27 , 201 9 , 3:00 pm - Funding Opportunity pm EST To register for this webinar and receive instructions, email: . [email protected] Dr. Dara Richardson -Heron, Questions may be submitted via email, to Research Program, for p rogrammatic objectives, or to Ms. All of Us All of Us Research Program Agreements Officer, National Irene Haas, Center for Advancing Translational Sciences (NCATS), for award mechanism and application submission matters, both at [email protected] . Authority Other Transaction awards will be made pursuant to current st authorizing legislation, including the 21 Century Cures Act as specified in Section 402(n) of the Public Health Service Act, 42 U.S.C. 282(n). All of Us Research Program Other Transaction Award Other Transaction awards are subject to the Other Transaction (OT) Policy Guide for the Precision Medicine Initiative® at NIH . Applicants Award Policy Guide may review this policy guide, which will be available at: . https://allofus.nih.gov/funding 6

7 All of Us Engagement and Retention Innovators Research Program Background: All Program is an historic effort to gather data over many years from one million or more Research of Us The States, with the ultimate goal of accelerating research and improving health. in the United living people studies that are focused on a specific disease or population, All of Us will serve as a national Unlike research to inform thousands of studies, covering a wide variety of health conditions. Researchers research resource to learn about how individual differences in lifestyl e, environment, and the program more will use data from can influence health and disease. Participants biological more about their own makeup may be able to learn and contribute to an effort that may advance the health of generations to come. health and Objectives of All of Us Research Program Engagement and Retention Innovators Purpose opportunity Funding engagement of Us is defined by impactful engagement. Impactful Program means a The Research All relationship between the program and its participants. Relatio bidirectional, are a reward in co-equal nships All Research pro gram, and to build these of Us the program will create a library of digital the relationships, inclusive engagements that are made with – not just for – all communities living in the US. and analogue engagements These inspire, and establish a long -lasting connection with the will delight, educate, they have been with. These engagements are meant to be scalable, used by the entire communities designed of Us consortium, and should be designed to be easily uploaded to a digital repository that will be a All and cost -effectively resource members of the Consortium to download for different fabricate using common also be customizable of choice. These engagements should communities for many different their vendor as the All is reflective of the rich diversity of those living in the US, including communities historically of Us in biomedical research All of Us considers the following populations historically underrepresented . sexual research: in biomedical minority groups; children and seniors; racial and underrepresented and ethnic minorities; people with gender people with barriers in access to care, low economic status, or low disabilities; attainment; residents. educational and rural these the program w ill work with world -class organizations to design innovative To design engagements, based on the principles of community based participatory design experiences co-creation, , community informal -based experiential learning, inclusivity, and user -centric science What makes All of Us design. different from other research programs is its focus on engagement and inclusivity. Interested organizations must have unparalleled in these two areas. The awardee must be innovative, collaborative, flexible, expertise where responsive stakeholders, and comfortable with being self- directed different creative, to many appropriate. should have the capacity to develop ideas Awardees refined and responsive to user that will be iteratively feedback these experiences are deployed. These when s will be living artifacts, constantly evolving experience to be responsive to their target audiences over the life of the program. These experiences shall also be created with core metrics their effectiveness. Metrics may include -but are not that will be used to evaluate at public to-the number limited with these experiences of people events, the number of times engaging consortium members download specific materials, user ratings, the amount of time users engage with metrics experiences, shall outline evalu ation etc. The awardee to be used, analyze these metrics on an ongoing basis, and offer recommendations for modifications to experiences as needed. 7

8 NIH is using the OT mechanism innovation and flexibility. Enrolling and retaining 1 to enable maximum from all walks research program are unprecedented tasks. million or mor e people of life into a longitudinal for success. Using will enable organizations beyond playbook the OT mechanism There is no established innovative strategies frequent with potential participants and NIH applicants to propose to communicate recruitment and retention. participant increase Requirements and experienced organizations that have a proven track record in at least one of We are looking for expert categories: the following Community engagement Provider Engagement Experiential learning Multicultural engagement Digital engagement organizations will serve two principle audiences : These All of Us participants , especially those from populations historically Participants and potential un in biomedical der represented research All of Us Research Program Consortium partners engaging and retaining All of Us who are recruiting, participants program is limited literature regarding best practices for designing inclusive and effective engagement As there a program experiences for materials and the process of material production created of this scale and scope, as a roadm ap for future cohorts. as part of this award will serve Expectations Create experiences focused around community engagement Task 1. engagement is community involvement based around community based participatory design Community An example the life cycle of the experience. might throughout be convening community members for brainstorming sessions, experiences b ased on community preferences identified from these designing creating prototypes of these nd then refining experiences th r ough multiple iterations experiences a sessions, members. Awardees shall understand that participant partners and communities are co- ommunity with c for the program and that the collaborative design process is a relationship building experience vital designers transparency, two of the core values of the All of Us . Aw ardees shall keep detailed records of to trust and interactions to specifically community input community identify how community involvement and note multiple optimized Community involvement may take design. formats: town halls, presentations experience to Participant Ambassadors, engagement studio workshops, surveys, focus groups, etc. Task 2. Create experiences focused around experiential learning design learning doing. Awardees should learning by multimodal experiences that can be Experiential means to be applicable to a wide variety of audiences, require adapted and hands-o n activities based interactivity around All of Us and precision the are relevant to specific individuals and communities, and are medicine, suitable for any age range and physical ability requirement. Experiences should nurture skill development, of Us wonder, with the All play, comfortability , as well as inspire internal motivation through delight, memorable, fun activities that apply to the daily lives of a million people or more. Experiential learning might take the form of games, problem solving activities, immersive presentations, creating artistic items, etc. and audiences. may be utiliz ed for broad 8

9 Task 3. Create around multicultural engagement experiences focused is to create The goal of the and among its target audiences are groups historically a diverse All of Us cohort u research in the purpose and objectives section in biomedical . Awardees above nderrepresented , as defined and regardless expertise accessible for many cultures experiences of barriers have shall in how best to make ability, technological comprehension, etc. Awardees shall in language, special effort to tailor physical make images of the experience’s intended community, keep experience reading level at experience to be reflective be easily norms to multiple languages, and be reflective of the cultural level or lower, a fifth -grade translated be making nities. of multi -cultural engagement might commu game instruction cards of specific An example collaborating with community partners to identify relevant experience topics, etc. bilingual, 4. Create Task around digital engagement experiences focused of the based. dictates that much of the program is digitally and scope Awardees shall be The scale All of Us exp and game -based design to not only create materials and activities that are easily erts in cyberlearning and deployable but are also deeply immersive . Awardees shall create innovative digital materials scalable to be used by individuals that will have the capacity experience levels and access. of different technological shall to be able to translate analog experiences to digital one s. Digital Awardees have the capability might include app development, virtual reality ( VR) and augmented reality ( AR ) experiences, engagements have the capacity web -based etc. Finally, awardees shall experiences to capture digital engagement creating engage metrics to determine Metrics ment effectiveness. using may include —but are not limited to—the amount of time using engagements, website metrics, usability testing data, etc. Applicants must work digital with other award to create appropriate interfaces and c onnections to existing IT collaboratively partners appropriate. infrastructure where experiences focused 5. Create provider engagement Task around individual consulted by many potential participants and pa rticipants about their health, As a trusted health c Awardees are a crucial All of Us ’s engagement strategy. of shall create materials are providers component that can serve to two (2) purposes: 1. Serve hing aids to educate health care providers as teac nurses, physician assistants, etc.) (physicians, about the All of Us Research Program, its implications for their patients and providers, and the means by which and patient’s family members c an enroll. patients ve aids that health care providers may use in their discussions with their patients to as education 2. Ser conversations about the program and program components and support health help initiate care providers efforts in engaging with pote ntial participants in one -on -one or group ’ on -going settings (e.g. town halls, panel discussions, etc.) . Awardees shall have the capacity to iteratively design materials in collaboration with health care providers ’ needs. and be able to record specific to health care providers metrics Some examples of these and analyze metrics might be creating and analyzing surveys regarding specific engagement materials generated for care providers health recording how many health care providers, are using materials and in what capacity, etc. recording how the patients of health care providers respond to these materials, 9

10 Other Program Requirements : Data Security and Management All of Us Maintaining the trust of participants and ensuring the security of their data are essential elements of the program. Applicants should comment on policies and procedures to maintain compliance with the Research Program principles: All of Us following • Precision Medicine Initiative: Data Security Policy Principles and F ramework Precision Medicine • Initiative: Privacy and Trust Principles All of Us Research Program Organization and Governance S tructure Research Program functions as a Consortium, with all awardees considered members. Under the The All of Us including committees, present and boards are established by the All of Us Research structure, task forces, ee the development and The governance of c onsortium activities. to overs structure Program implementation personne periodically the evolving needs of the program. Awardee change l may hold specific may to meet in program governance structure based on their role in thei r institution’s program activities. For roles the example, Research Program Steering Committee currently consists of the contact Program A ll of Us All of Us (PDs/PIs) all aspects of the awards. The from Research Program Directors/Principal Investigators includes participant representatives throughout its governance structure. consortium All of Us rogram h as a single Institutional Review Bo ard ( IRB) t hat ensures p rompt an d Research P The of t he e volving p rotocols an d t he c entral importance o f participants as r esearch thoughtful consideration The s rs in t All of Us Research Program. he ingle IRB includes r epresentatives fr om t he p articipant partne community. E ach aw ardee will be r equired t o e ither agree t o an existing IRB reliance ag reement with t he program o r e stablish reement, d epending on p rogram r equirements. a new IRB reliance ag Budget NIH S alary Cap in effect at the Funds requested for salary support for all personnel must comply with the f aw ard. time o alls an Application lan f or several w eekly c PI/PDs an d t eam meetings as n eeded over d k ey personne l should p ourse of the a ward. I the c t hree members f rom t he a wardee s hould p lan a nd b udget f or u p t o f our n a ddition, trips an o B ethesda, MD, fo r All of Us nually t Program S teering C ommittee an d other s trategic Research meetings. The t otal b udget w ill b e b ased o n f unds a vailable, b ut not e xpected t o exceed $8M p er year in d irect c osts. Inventions a nd Patents he b road s rogram, nformation a nd i nventions i n t he All of Us Research P To p romote t a wardee haring of i ill be g overned b y F AR c lause 52.227 -13, which p rovides title t o t he Government i n a ny inventions w invention m ade u nder t his award, s ubject t o a r evocable, n onexclusive, p aid -up l icense i n each p atent application f on a s ubject i nvention and a ny r esulting patent i n which t he Government iled i n a ny c ountry obtains t e u se d t o his i s t o a ssure t hat p atents d irected t o inventions made u nder this a ward c annot b itle. T block a ccess b y the r esearch p ublic t o this i mportant r esource a nd a ssociated t echnology. 10

11 (1) The Awardee shall include the substance of this patent rights clause in all third -party agreements for experimental, developmental, or research work. This patent rights clause must be modified to dentify the parties as follows: references to the Government are not changed, and the third parties i (subcontractor, sub -awardees, and vendors) have all rights and obligations of the Awardee in the -party agreement, clause. The Awardee shall not, as part of the consideration for awarding the third obtain rights in the third party’s subject inventions. (2) In the event of a refusal by a prospective third party to accept the clause, the Awardee— All of Us Researc a. Shall promptly submit a written notice to the h Program Agreements y’s reasons for such refusal and other pertinent Officer setting forth the third p art information that may expedite disposition of the matter; and -party a b. Shall not proceed with such third greement without the written authorization of esearch Program Agreements Officer. the All of Us R (3) In third party agreements at any tier, the agency, the third party, and the Awardee agree that the mutual obligations of the parties created by the patent rights clause constitute a contract between th e third party and the agency with respect to those matters covered by this clause. A (4) The Awardee shall promptly notify the in ll of Us Research Program Agreements Officer writing upon the award of any third party at any tier containing a patent rights clause by identifying the third party, the applicable patent rights clause, the work to be performed under the third -party agreements, and the dates of award and estimated completion. Upon request of the All of Us Research Program Agreements Officer, the Awardee shall furnish a copy of such third -party agreement, and, no more frequently than annually, a listing of the third -party activities that have been awarded. Ownership of Data, Software, and Other Products in data, software and other products (collectively “Works”) made or de veloped under NIH will own all rights subject this award, worldwide license to reproduce, prepare to a paid -up, nonexclusive, irrevocable and display distribute to the public, and perform publicly works, publicly, by or on behalf of derivative copies The parties furt her agree that these Works are “works made for hire” as defined by the the awardee. software Act. Award agree that no commercial IP (e.g., data, recipients or other products), whether Copyright those by the awardee or a third party except in the application, specifically referenced owned will be utilized without express permission of NIH. prior Requirement Termination/Expiration of this Other Transaction award A fundamental is to ensure that all specimens and objective announcement available without interruption to the research public, even in the event that awardees withdraw, data remain are terminated, no longer manage the project. Upon termination or expiration of this OT or can otherwise generated award, custody, and control of the resources ownership, by the All of Us NIH may take exclusive Research Program, including specimens, data, and software, at its reasonable discretion . For purposes of this solicitation, “exclusive and control” means that upon termination or expiration of this award, the custody awardee may not retain departing or disclose a copy of any data and may not use any and its partners (or portions specimen acquired or generated under the award. the reof), If the NIH decides to terminate this award, the termination of the award will be considered a unilateral ch and the recipient will not have the right to appeal. Although a decision is made to terminate an ange Reporting the recipient must continue to comply with the Record Retention and Access, and Final award, process. requirements, and may need to sign a non -disclosure agreement to complete the termination 11

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