Notice Number: NOT-ES-11-009
Release Date: June 3, 2011
Response Due Date: July 15, 2011
National Institutes of Health (NIH)
National Institute of Environmental Health Sciences (NIEHS)
The NIEHS is seeking input on ways to encourage broader data sharing among researchers in the field of environmental health sciences who are conducting clinical or epidemiologic studies. Input is being sought from the environmental health science extramural research community and other interested stakeholders. Information is requested regarding additional perspectives on what, if any, unique considerations exist for sharing of data in studies collecting environmental exposure information, what are the primary characteristics of successful data sharing resources and strategies in use currently by researchers, what are the barriers to broad sharing of data and what additional resources and tools are needed to promote timelier, more efficient sharing of environmental health science data.
The current data sharing policy of NIEHS aligns with NIH guidelines. That is, all investigator-initiated applications with direct costs of $500,000 or more in any one year are expected to address data sharing in their applications. Program staff are responsible for overseeing the data sharing policy and for assessing the appropriateness and adequacy of the proposed data sharing plan. NIEHS-led Program Announcements (PAs), Requests for Applications (RFAs), and Requests for Proposals (RFPs) have often included data sharing instructions consistent with NIH policies and program needs.
The NIEHS is interested in seeking input to be used in the development of a more robust strategy for encouraging data sharing. The NIEHS recognizes the need for a more robust policy in light of our considerable investment in clinical and epidemiologic studies investigating the role of environmental exposures in a wide range of health outcomes. Many of these studies capitalize on populations with unique exposures or vulnerabilities, making the data generated of special value.
The NIEHS is committed to encouraging broad sharing of data generated in clinical and epidemiologic data, with the goal of accelerating the identification of environmental linkages to human disease and translation of that knowledge to improve public health. Comments from your perspective on the following issues are sought.
1. The NIEHS recognizes that data sharing in the context of environmental health sciences may present unique challenges related to the protection and confidentiality of the study participants (e.g., environmental monitoring and estimates at the neighborhood, local, or county level). Included in your comments could be the discussion of the special considerations that exist, (if any) And the specific measures that could be taken by NIEHS to address these special concerns.
2. A variety of data sharing tools and activities are currently in use in the environmental health science community, ranging from a study investigator responding ad hoc to individual requests for data; establishing informal collaborative networks among investigators with common interests to conduct focused analyses (e.g., data pooling); and regular deposits of study data in a data enclave or externally-managed public archive. Your response can include the t methods of data sharing you have used and found to be particularly useful and/or problematic?
3. Sharing of primary data shortly after publication is typically regarded as a reasonable time period to meet the legitimate interests of study investigators to benefit from their investment of time and effort, or no later than the acceptance for publication of the main findings from the final data set. Clinical and epidemiologic studies routinely collect a large amount of data in addition to those related directly to the primary aims of the study. Analysis and publication of these secondary ancillary data are often delayed for a considerable period after the primary specific aims have been accomplished and published. Consider the advantages and pitfalls to making these data subject to rapid data sharing and instances on how this could be accomplished.
Please identify the nature of your interest in the topics discussed. If you are a member of a particular advocacy or professional organization, please indicate the name of the organization. Within research, please indicate your main area of investigation (e.g., primary disease area(s) or population(s) under study).
How to Submit a Response
All comments must be submitted electronically to the following email address: firstname.lastname@example.org Comments will be accepted through July 15, 2011. You will receive an electronic confirmation acknowledging receipt of your response, but will not receive individualized feedback. Responders need not address all the issues presented in this document and may comment on as few as one issue.
Responses to this RFI are voluntary. Any personal identifiers (e.g., names, addresses, e-mail addresses, etc.) will be removed when responses are compiled. Only the de-identified comments will be used. Proprietary, classified, confidential, or sensitive information should not be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
This Request for Information (RFI) is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government, the National Institutes of Health (NIH), and/or the National Institute of Environmental Health Sciences (NIEHS). The NIH and/or the NIEHS does not intend to make any awards based on responses to this RFI or to otherwise pay for the preparation of any information submitted or for the Government's use of such information.
Specific questions about this Notice may be directed to:
Kimberly McAllister, Ph.D. (primary point of contact)
National Institute of Environmental Health Sciences
530 Davis Drive
RTP, NC 27709
For specific inquiries regarding particular research areas, please contact:
Kimberly Gray (Environmental Epidemiology), email@example.com, (919-541-0293)
Cindy Lawler (Neurodegeneration, Autism), firstname.lastname@example.org, (919-316-4671)
Kimberly McAllister (molecular and genetic epidemiology), email@example.com, (919-541-4528)
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
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