Notice Number: NOT-HD-11-001
Key Dates
Release Date: February 2, 2011
Response Date: April 1, 2011
Issued by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Purpose
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) recognizes that human tissue repositories that include brain tissue can contribute to the advancement of many aspects of research in intellectual and developmental disorders, particularly Down syndrome. To facilitate collaborative research and enhance the ability of such repositories to serve a diverse set of constituents, NICHD is evaluating existing collections and the possibility of new approaches to acquiring, storing, and distributing these important and valuable tissues, through collaborations and partnerships with other organizations, foundations, and/or groups. NICHD also anticipates discussions with those who maintain similar human tissue repositories to collect information about 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 research, advocacy, and other stakeholder communities.
Background
Human tissue repositories that include brain tissue can contribute to the advancement of many aspects of research in intellectual and developmental disorders, particularly Down syndrome. Down syndrome usually results from three copies of the entire of human chromosome 21 (Trisomy 21) and occurs in 1:700-1:800 live births each year. Although Down syndrome is not a rare disorder, few tissue repositories contain sufficient tissue donated by individuals with Down syndrome and their families to meet the current needs of the basic and clinical research community. This need has been underscored by participants in two recent meetings, a Down Syndrome Registry Meeting sponsored by the National Down Syndrome Society in September, 2010, and Down Syndrome: National Conference on Patient Registries, Research Databases, and Biobanks, sponsored jointly by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the Global Down Syndrome Foundation in December, 2010. As a consequence of these two meetings, significant needs were identified with regard to information on DS-related clinical and research databases (See companion RFI, NOT-HD-11-002).
The NICHD plans to evaluate approaches to consolidate the collection of human brain and other tissues donated from individuals with Down syndrome and their families, tissues important for research into this particular genetic disorder that affects multiple organ systems and tissues. Most existing repositories systematically collect, store, catalog, preserve, and distribute such tissues to qualified scientific investigators. However, the approach to these activities by individual repositories lacks standards, and practices and policies vary widely from repository to repository.
As the spectrum of sophisticated techniques and approaches to tissue analysis continues to expand, researchers are poised to make novel and clinically relevant research discoveries utilizing human tissue, particularly brain tissue. To facilitate collaborative research and increase the ability of such repositories to serve a diverse set of constituents, NICHD is exploring ways to extend and enhance these resources, including collaborations and partnerships with other governmental and non-governmental organizations and groups. The creation of a consolidated or federated Down syndrome tissue repository might be one way to facilitate novel and clinically relevant research.
Information Requested
NICHD invites public input in several areas; feel free to respond to as many as you wish:
- What are the best strategies for recruiting individuals with Down syndrome and their families for future brain and tissue donation?
Interested parties may wish to comment on strategies to:
- Recruit relevant subjects
- Engage communities about the importance of donation
- Link subjects for a tissue repository to a registry
- Define the provision of advisory functions (e.g., internal Steering Committee, External Advisory Committee) for a tissue repository
- Facilitate linkages of clinical or research databases for DS (see companion RFI, NOT-HD-11-002)
- Identify best practices of how (or to whom) tissue should be allocated for research
- How can the NICHD obtain information from individuals, groups, and organizations on best practices to develop and manage a coordinated network and/or centralized DSTR?
NICHD invites interested parties to submit the following:
- General or specific comments regarding the nature, activities and/or organization of a networked or centralized tissue repository
- Best practices for collecting, storing, and sharing tissue specimens (including fetal tissues)
- What obstacles exist to creating, managing, or deploying a successful tissue repository
- How investigators should submit and share any newly acquired samples or collections with a coordinated network or centralized tissue repository
- Suggestions for which tissues or fluids may be most useful to collect in a longitudinal manner
- How can NICHD obtain information about the existence and availability of so-called “legacy” or pre-existing collections of Down syndrome brain and other tissues?
NICHD invites interested parties to comment on the following:
- What legacy collections exist and what are their locations?
- What phenotypic information and quality metrics do they include?
- What would encourage individuals or institutions with tissues already collected from DS individuals to contribute these to a networked or centralized tissue repository?
- What are the bioethical issues (e.g., consent/assent) to overcome to move tissues from a legacy collection to a network or centralized tissue repository?
How to Submit a Response
Reponses will be accepted until April 1, 2011. All responses must be submitted via email to: [email protected]. Please include the notice number NOT-HD-11-001 in the subject line and include your complete contact information with your response. The submitted information will be reviewed by the Trans-NIH Down Syndrome Working Group. Submitted information will not be considered confidential.
This request 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), or the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The NICHD 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.
NICHD will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder’s submission. However, responses to the RFI submitted may be reflected in future solicitation(s). NICHD may contact any responder for the sole purpose of enhancing NICHD’s understanding of your RFI submission. The information provided will be analyzed and may appear in reports. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
Inquiries
Mary Lou Oster-Granite, PhD
Health Scientist Administrator
Chair, Down Syndrome Working Group
Intellectual and Developmental Disabilities Branch (IDD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH), Department of Health and Human Services (DHHS)
6100 Executive Boulevard
Room 4B05L, MSC 7510
Bethesda, MD 20892-7510
EXPRESS/COURIER: Rockville, MD 20852
Phone: 301-435-6866
Fax: 301-496-3791
Email: [email protected]
and Human Services (HHS)
