Notice Number: NOT-DA-11-008
Update: The following update relating to this announcement has been issued:
Release Date: February 15, 2011
Response Date: March 15, 2011
National Institute of Drug Abuse (NIDA)
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 on Drug Abuse (NIDA). The NIH 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.
The National Institute on Drug Abuse (NIDA) is seeking input from the scientific community, health professionals, patient advocates, community-based organizations, students, and the general public about the administrative, logistical and human-subject protection issues involved in the creation of a common database or data repository of functional neuroimaging data from the brains of substance users or abusers. This database would be comprised of neuroimaging data for resting-state and other modes of inter-regional connectivity furnished by individual research scientists or clinicians, and would be available for secondary data analysis by other qualified neuroscientists.
Definitions: Clinical research participant, for the purpose of this Notice, is defined as a human subject who has provided informed consent to participate in a research study protocol, regardless of whether the individual meets criteria for any medical or psychiatric disorder. Substance user or abuser, for the purpose of this Notice, is defined as a clinical research participant who regularly uses either alcohol, nicotine, a prescription psychotropic medication, and/or an illicit drug, regardless of whether the level of use meets criteria for substance abuse or dependence.
Detection and analysis of inter-regional, temporally-correlated activity of the human brain (assessed from functional magnetic resonance imaging (fMRI)), whether the brain is at rest or performing a task, is a widely-expanding practice. Notably, assessment of “resting-state” functional connectivity of the human brain is increasingly popular, given that the requisite imaging data can be acquired in a short period of time, often as brief as 5-6 minutes. In addition, newer analytical techniques hold potential to extract innate connectivity from task-related time-series images. Notably, the NIH Blueprint for Neuroscience Research is currently funding the Human Connectome Project cooperative agreement to collect fMRI and other connectivity data from healthy controls.
Additionally, the 1000 Connectomes Project is a grassroots consortium-based dataset comprised primarily of data obtained from healthy human subjects, where data are voluntarily submitted by individual laboratories. This project reports that fMRI-based functional connectivity is robust across individuals and laboratories/scanners, thus providing proof of the concept that such datasets can be used for secondary analysis, especially for exploratory and discovery based investigations. The success of the 1000 Connectomes Project opens the possibility of creating similar datasets comprised of defined populations.
Of interest to NIDA is assessing the potential for creation of an analogous neuroimaging dataset comprised of substance users or abusers and appropriate comparison subjects as a resource to the neuroscience and substance abuse research community. Notably, functional neuroimaging measures, such as task-based fMRI, resting-state fMRI, as well as positron emission tomography (PET) have indicated that regular users of substances show different patterns of brain activity than healthy controls. Formation of a pooled database may allow investigations of questions that require sample sizes and statistical power too large for any one laboratory to collect. Example questions include relation of brain connectivity metrics to specific drug use patterns, poly-drug use permutations, comorbid psychiatric conditions, as well as other behavioral or environmental phenotypes or traits.
This RFI seeks information from the substance abuse and neuroimaing research community and other stakeholders that will help NIDA identify interest, preferences, and potential technical and administrative challenges with regard to formation and maintenance of a common database of functional imaging data in substance users or abusers. Members of the scientific community, scientific organizations, healthcare professionals, patient advocates, and the public are invited to respond to the following items:
We also welcome any additional comments and suggestions with regard to elements of a proposed database not mentioned above.
Responses will be accepted until March 15, 2011 via email to: James Bjork, Ph.D. at firstname.lastname@example.org. Please mark your responses with this RFI identifier NOT-DA-11-008. Reponses are expected to be no longer than approximately 2000 words.
Respondents will receive an automated email confirmation acknowledging receipt of their response, but will not receive individualized feedback.
Any identifiers (e.g., names, institutions, e-mail addresses, etc) will be removed when responses are compiled. Only the processed, anonymized results will be shared internally with NIDA program staff and leadership, as appropriate. Nonetheless, no proprietary information should be submitted.
Interested parties may contact:
James M. Bjork, Ph.D., Program Official
Clinical Neuroscience Branch
Division of Clinical Neuroscience and Behavioral Research
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Boulevard, Room 3172
Bethesda, MD 20892
Phone: (301) 443-3209
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Department of Health
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