NIH is committed to understanding the range of environmental influences on child health and development. A new program under development for fiscal year 2016, Environmental influences on Child Health Outcomes (ECHO), aims to investigate prenatal, perinatal, and postnatal environmental exposures on pediatric development and health outcomes with a particular focus on exposures that will have a significant impact on public health. To accomplish this, NIH proposes to support multiple synergistic, longitudinal studies using existing study populations, called cohorts. The studies will look at a range of different environmental exposures (e.g., physical, chemical, biological, psychosocial, etc.) among the cohorts using standardized research questions and the effects of these exposures on four key pediatric outcomes – upper and lower airway; obesity; pre-, peri-, and postnatal outcomes; and neurodevelopment.
A Request for Information was released on July 13 and multiple webinars and roundtable meetings were held over the past month to solicit feedback from the broader research community. Drawing upon the feedback from these recent outreach activities, NIH is considering the following issues for the ECHO plan:
The feasibility of conducting studies that look at factors that influence genes without modifying their sequence (known as epigenetics), and whether epigenetics should be included as a core element for all studies
The best approaches and methods to harmonize and standardize data collection and analysis across the cohorts
How best to approach the incorporation of basic research into these studies; particularly, whether support should be limited to those basic mechanistic studies that can only be done using human cohorts
How best to address intervention research, and whether it should be supported as a component of the plan
We’d like your feedback on how best to address these issues in the ECHO plan.
The Feedback site will accept comments on these topics through September 8. Comments received via the Feedback site may be considered by the NIH as it plans the ECHO program, but NIH will not respond to comments.
Large studies on health and disease typically collect health and lifestyle data on participant volunteers from medical records and extensive phone or paper surveys. The Precision Medicine Initiative is considering using smart phone and wireless technologies to collect some of this information. These devices could provide the ability to track health behaviors and environmental exposures much more frequently with minimal burden on participants. For example, participant volunteers could respond to a few questions multiple times per day via their smart phones about their health status, activities, emotional states, etc. Location information from their smart phone or wearable device could be used to assess daily activity and also detect exposure to air pollution, etc. Wearable devices can assess heart rate and other physiological states as well as physical activity levels. Smartphones also could keep participants connected to the study, providing feedback on the data they provide as well as the aggregate data and findings of the study. The use of these mobile and wireless devices generates a number of considerations:
Willingness of participants to carry their smartphone and wear wireless sensor devices sufficiently throughout the day so researchers can assess their health and activities.
Willingness of participants without smartphones to upgrade to a smartphone at no expense.
How often people would be willing to let researchers collect data through devices without being an inconvenience.
The kind of information participants might like to receive back from researchers, and how often.
Other ways to conveniently collect information from participants apart from smart phones or wearable devices.
We’d like your thoughts on using smart phone and wireless technologies to collect information.
The Feedback site will accept comments on these topics through July 24. Comments received via the Feedback site may be considered by the NIH as it plans the development of the President’s Precision Medicine Initiative and the vision for building the national participant group, but NIH will not respond to comments.
Welcome to the NIH Precision Medicine Initiative (PMI) Feedback blog! The PMI will build a comprehensive scientific knowledge base to put precision medicine into practice on a much larger scale. To achieve this goal, the initiative will build a national research cohort study of 1 million or more Americans to propel our understanding of health and disease. Every few weeks we will feature a new topic and welcome the opportunity to know your thoughts.
This first post focuses on the critical research questions that can be uniquely addressed by the cohort to advance precision medicine. Currently, NIH is considering a number of areas where the research using such a cohort may be particularly helpful, including:
Determining how an individual will respond to a particular drug based on their genes
Discovering new molecular causes for a variety of rare diseases
Identifying new ways to predict disease development using an individual’s genes or other physical characteristics
Identifying new ways to predict disease using information about an individual’s environment or behaviors
Testing new ways to prevent or treat disease using mobile health technologies, such as smartphones or activity trackers
We’d like your thoughts on the most important scientific questions that the cohort can answer.
The Feedback site will accept comments on these topics through June 26. Comments received via the Feedback site may be considered by the NIH as it plans the development of the President’s Precision Medicine Initiative and the vision for building the national participant group, but NIH will not respond to comments.