Policy on Centralized Banking and Sharing of Human Subject-Derived Living Cells and Reprogrammed Derivatives for Mental Illness Research

Notice Number: NOT-MH-13-002

Key Dates
Release Date: November 2, 2012

Issued by
National Institute of Mental Health (NIMH)

Purpose

Increasing efforts are being directed toward using human subject-derived reprogrammed cells (e.g. induced pluripotent stem cells or iPSCs, induced neuronal cells or iNCs) to study molecular and cellular abnormalities underlying mental illnesses, including schizophrenia, bipolar disorder, autism spectrum disorders, attention deficit hyperactivity disorder and anxiety disorders. These technologies utilize (epi)genetic manipulation of adult somatic cells that reprograms them to stem cell or alternative cell fates, thereby generating an individualized in vitro system to enable mechanistic studies  of mental illness pathophysiology.

In order to realize the full potential of these tools and technologies to yield discoveries in mental illnesses, it is important to have open sharing of cellular material with associated phenotypic and genotypic data among researchers. For mental illnesses and other complex diseases, sharing will most easily allow for achieving sample sizes that have adequate statistical power for detecting subtle genotypic and phenotypic differences representative of the disorder. Other scientific advantages of sharing research resources include facilitating the rapid replication of new findings, stimulating multidisciplinary translational research programs that involve clinical and basic scientists, providing needed resources to promising young investigators, avoiding duplicative data collection efforts and laboratory work, and rapidly applying novel technologies and analytic methods to human data sets. Exploiting these advantages will accelerate our understanding of pathophysiology and the development of new therapeutic compounds and diagnostic tests.

In order to enhance open sharing of resources with the scientific community, NIMH has established a repository for human subject-derived cells and their reprogrammed derivatives to support cellular research relevant to mental illnesses. This NIMH Stem Cell Center is integrated into the existing NIMH Center for Collaborative Genomic Studies on Mental Disorders (http://nimhgenetics.org).  Submission of biomaterials to this central repository will maximize NIMH investment in reprogrammed cell research, ease investigator burden to provide biomaterials upon request, and facilitate resource sharing with other investigators in the spirit of NIH sharing policy.

Policy

This Notice informs potential applicants that the National Institute of Mental Health (NIMH) expects grantees who generate or use human subject-derived reprogrammed cells in their NIMH-funded research to submit relevant source cells (e.g., fibroblasts, olfactory epithelial cells, blood) or reprogrammed derivatives (e.g., induced pluripotent stem cells/iPSCs or other renewable cell lines) to the NIMH Center for Collaborative Genomic Studies on Mental Disorders, Stem Cell Center.  Human subject consent language associated with such biomaterials collection should be consistent with banking and wide sharing through a centralized repository. The Resource Sharing Plan of applications for NIMH funding should include arrangements and a timeline for submitting relevant biomaterials to the Center, or else provide a clear rationale for why such submission cannot be provided, along with alternative sharing arrangements. Applicants are strongly encouraged to contact NIMH Program staff when preparing this Plan. Consideration will be given to investigator adherence to this standard of sharing when determining funding priorities; the final terms of sharing will be negotiated with NIMH Program staff and will be included in the Terms and Conditions of the Notice of Award.

Inquiries

Inquiries regarding this Notice may be directed to:

David M. Panchision, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7189, MSC 9641
Bethesda, MD 20852
Telephone: (301) 443-5288
FAX:  (301) 443-5615
Email:  panchisiond@mail.nih.gov


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