Notice Number: NOT-MH-10-034
Key Dates
Release Date: October 27, 2010
Response Date: December 3, 2010
Issued by
National Institute of Mental Health (NIMH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute on Aging (NIA)
National Institute of Neurological Disorders and Stroke (NINDS)
Purpose
The National Institute of Mental Health (NIMH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute on Aging (NIA), and National Institute of Neurological Disorders and Stroke (NINDS) recognize that human Brain Tissue Repositories (BTR) can contribute to the advancement of many aspects of research in addiction, developmental disorders, mental illness, neurological diseases, and aging. To facilitate collaborative research and enhance the ability of BTR to serve a diverse set of constituents, these institutes are evaluating existing collections and the possibility of new approaches to acquiring, storing, and distributing these important tissues, through collaborations and partnerships with other organizations, foundations and/or groups. The participating Institutes also anticipate discussions with those who maintain other similar human tissue repositories to develop common collection protocols, QA/QC standards, processing, storage, and distribution policies and procedures for specimens and associated data. This Request for Information (RFI) serves to gather information about these topics from the research, advocacy, and other stakeholder communities.
Background
The NIMH, NICHD, NIDA, NIA, and NINDS are evaluating approaches to synergize the collection of human brain tissues important for research into diseases of the central nervous system. The objective of most existing biorepositories is to systematically collect, store, catalog, preserve, and distribute human brain tissues to qualified scientific investigators. However, there has been little standardization in the approach to these activities, and practices and policies vary widely from repository to repository.
Research utilizing human tissue is poised for novel and clinically relevant discoveries as a result of the rapidly expanding spectrum of sophisticated techniques and approaches to tissue analysis that are currently available. In order to facilitate collaborative research and increase the ability of Brain Tissue Repositories to serve a diverse set of constituents, the participating Institutes are exploring approaches to extend and enhance these resources, including collaborations and partnerships with other governmental and non-governmental organizations and groups.
Information Requested
The participating Institutes invite public input in several areas; feel free to respond to as many as you wish:
I. The NIH is seeking information on best practices for the recruitment of subjects for future brain donation including patients with addiction, developmental disorders, mental disorders, neurological diseases, normal brain development, and aging.
Interested parties may wish to comment on strategies for:
- Recruitment of relevant subjects, including methods of outreach and education to encourage tissue donation. For example, some organizations may have unique expertise or access to patient groups which will facilitate the goals of a BTR
- Collection of information including clinical data (phenotyping) and tissue genotyping
- The provision of advisory functions to a BTR
- Collection, processing, genotyping, and storage of tissue and associated data that may be facilitated by other organizations
- Outreach to communities about the importance of brain and tissue donation, particularly for underserved populations and those that may be difficult to recruit
- Clinical phenotyping of subjects for a BTR either through a registry prior to donation or after donation
- Suggestions for best practices to identify how (or to whom) tissue should be allocated for research, especially those for tissues with limited availability or those in high demand
II. The NIH is also seeking information from individuals, groups, and organizations on best practices to develop and manage a coordinated network and/or centralized Brain Tissue Repository.
NIH invites interested parties to submit the following:
- General or specific comments regarding the nature, activities, and/or organization of a networked or centralized BTR, either an existing repository or one that might be developed in the future
- Suggestions for best practices for collecting, storing, and sharing tissue specimens (including fetal tissues); and/or obstacles to creating managing, or deploying a successful BTR
- Suggestions for how investigators should submit and share newly collected and/or existing collections with a coordinated network or centralized BTR
III. The NIH is seeking information about the existence and availability of so-called “legacy” or pre-existing collections of human brain tissues.
NIH invites interested parties to comment on the following:
- What legacy collections exist; where are they located; what phenotypes and quality metrics are included
- Whether a collection could be transferred to a networked or centralized BTR to facilitate its use by other scientists
- What would encourage individuals or institutions with brain tissues alreadycollected to contribute these to a networked or centralized BTR. This could include tissues from investigators who are retiring, moving, or otherwise in transition
How to Submit a Response
Responses will be accepted until December 3, 2010. All responses must be submitted via email to: [email protected]. Please include the notice number NOT-MH-10-034 in the subject line and include your complete contact information with your response. You will receive an email confirmation acknowledging receipt of your response. The submitted information will be reviewed by the Brain and Biospecimen Repository workgroup. Submitted information will not be considered confidential.
Inquiries
Inquiries regarding this notice may be directed to:
Roger Little, Ph.D.
Office of Science Policy, Planning and Communications
National Institute of Mental Health
6001 Executive Boulevard, Room 8211, MSC 9667
Bethesda, MD 20892-9667
Telephone: (301) 402-5844
FAX: (301) 443-1328
Email: [email protected]
and Human Services (HHS)
