Notice Number: NOT-PM-17-004
Key Dates
Release Date: September 1, 2017
Response Date: September 12, 2017
NOT-PM-17-005
Issued by
National Institutes of Health (NIH)
Purpose
The purpose of this RFI is to solicit input from the community to help inform the scientific vision for the enrollment of pediatric participants in the All of Us Research Program. The Child Enrollment Scientific Vision Working Group (CESVWG) of the All of Us Advisory Panel seeks public input on the pediatric research that All of Us may be uniquely positioned to enable through the enrollment of children from diverse backgrounds into the cohort.
The All of Us Research Program is an historic effort to gather data from one million or more people living in the United States to accelerate research and improve health. The enrollment of children in the cohort has consistently been an important goal of the program: the Advisory Committee to the NIH Director (ACD) Precision Medicine Initiative Working Group, which developed the final report that informs the All of Us Research Program, strongly supported the inclusion of children in the cohort, recommending that the NIH work thoughtfully and carefully to develop specific approaches to address the needs of [children] so that they may be included and retained in the cohort. The efforts of the CESVWG, and this RFI, are key to the program’s efforts to develop a thoughtful and appropriate plan for the addition of children to the program.
Overview of the All of Us Research Program
The mission of All of Us is to advance the science of precision medicine and ensure everyone shares in its benefits. The overall objective of the All of Us Research Program is to build an observational research resource that will provide the information needed to address a wide range of scientific questions, facilitating the exploration of biological, clinical, social, and environmental determinants of health and disease. The program will collect and curate health-related data and biospecimens from one million or more individuals who reflect the diversity in the United States; these data and biospecimens will be made broadly available for research uses.
The All of Us Research Program recently released its initial protocol, which is for participants ages 18 years old and older (a protocol is a scientific document with in-depth plans for a specific research effort; writing one is an important first step in the research process, to help researchers explain what they want to learn and how they will carry out their work). As described in the protocol, participants will be invited to share their electronic health records (EHRs), if any, and answer health-related questionnaires. Some participants may also be invited to undergo physical measurements and provide biospecimens from which genomic information and other biomarkers may be derived through analytics. The DNA, for example, will be sequenced when samples and funds are available, and will be linked with behavioral and environmental data and data in the EHR. Qualified researchers from many organizations will, with appropriate protection of participant confidentiality, have access to the cohort's de-identified data for research and analysis. After completion of beta phase, anyone over the age of 18 who is living in the United States will be able to join All of Us, either directly through the JoinAllofUs.org website or through participating health care provider organizations. All of Us aims to be open to all interested individuals, to reflect the rich diversity of America and to serve as a catalyst for innovative research programs and policies (see the All of Us core values).
Information Requested
The goal of the CESVWG is to prepare a report that describes the pediatric precision medicine research that All of Us may be uniquely positioned to enable through the enrollment of children from diverse backgrounds into the cohort, and to outline the associated research outcomes that may be achievable in the short-, medium- and long-term. The questions posed below seek public input for the CESVWG to consider when developing its report. In order to best respond, it is important that respondents to this RFI understand the unique mission and objectives of the All of Us Research Program captured in the ACD PMI Working group final report, the initial adult protocol, and become familiar with the kinds of science that the data collected by the program seeks to enable. Please review the information provided above, including information in hyperlinks, prior to responding.
The CESVWG seeks the public’s inputs on the three topics listed below. All responses must be submitted online by September 12, 2017 through our Web form:
- What are the most significant short- (0-5 years), medium- (5-10 years), and long-term precision medicine research (>10 years) questions that could be addressed by the inclusion of pediatric populations in the All of Us Research Program?
- What are the key gaps in current pediatric study designs that might be appropriate for All of Us to address through the enrollment of children (for example, preconception studies, sibling studies, etc.)?
- What are the research resources that the inclusion of children into the All of Us Research Program could potentially generate (for example: innovative algorithms, methodologies, etc.)?
We look forward to your input and hope that you will share this RFI document with your colleagues.
Response to this RFI is voluntary. Responders are free to address any or all of the items listed above; respondents should not feel compelled to address all items. Please note that the text box for each topic has a maximum limit of 1,500 characters, including spaces. Concise, bulleted responses are encouraged.
This RFI is for planning purposes only and should not be construed as a solicitation for applications or as an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the United States Government will not pay for the preparation of any information submitted or for its use of that information.
Responses will be compiled and may be shared publicly.
Inquiries
Please direct all inquiries to:
Please direct all inquiries to the All of Us Research Program via email to CESVWG@nih.gov
and Human Services (HHS)
