Request for Information (RFI): Input on Strategies for Leveraging Existing Health Data Linked to New or Existing Bio-specimen Repositories for Large Scale Epidemiology Research

Notice Number: NOT-RM-11-008

Key Dates

Release Date: February 16, 2011

Issued by

National Institutes of Health (NIH)
Common Fund (Roadmap)


The NIH Common Fund HMO Collaboratory working group is seeking input on the ability of existing or newly established health care research networks with electronic health records and linked bio-specimen repositories to conduct large scale epidemiological or genetic studies in a cost effective way. Advice is being sought from stakeholders within healthcare delivery systems, the extramural research community, and other interested groups on the current capacity of the field to leverage existing databases linked to new or existing bio-specimen repositories. Information is being sought regarding what questions can be addressed, what resources are currently available for this purpose, and what additional resources need to be developed to further capitalize on the available data to answer pressing health questions.


NIH is working to foster research collaborations across a number of U.S. health care delivery systems. Several of these networks have extraordinary administrative and clinical data resources to support research, including comprehensive electronic medical records and robust disease-specific registries for multiple key health behaviors and chronic conditions (e.g., coronary heart disease, heart failure, diabetes, hypertension, dyslipidemia). In addition, some of these databases are linked to bio-specimen repositories. Efforts are underway to determine the feasibility and best ways to harmonize data collected across multiple databases to facilitate large, multi-institution epidemiological or genetic studies that take advantage of linked bio-specimen repositories. It is envisioned that within such distributed networks, participating health care organizations might combine their clinical data for phenotypic assessment, but retain tissue samples within each health care system. It is thought that a distributed model could permit large sample sizes more cost effectively than standard centralized resources. Advice is sought from stakeholders on how these resources can best be leveraged for this purpose.

Information Requested

The Common Fund HMO Collaboratory working group at the NIH solicits input from organizations and individuals interested in epidemiological and genetic research in healthcare delivery systems with existing data repositories adaptable for research purposes. The NIH is committed to fostering the development of collaborative relationships between the bio-medical research community and healthcare delivery systems to facilitate data sharing and use of existing large databases and bio-repositories for large scale epidemiological and genetic research. Comments on the following issues are sought.

1. What large-scale epidemiological or genetic studies can be conducted utilizing an extensive, distributed research network linked to bio-specimen repositories? Would these studies be of substantial immediate or sustained clinical impact? Would these studies address currently unanswerable but pressing health questions?

2. What additional efforts or resources should be developed to enhance the value and utility of distributed clinical databases for use in epidemiological and genetic studies, and pragmatic trials?

2A. Standard data elements typically collected in large clinical databases include demographic variables, health services utilization, prescription drug use, and disease diagnosis (ICD codes). Which of these elements should be harmonized across database to facilitate the development of distributed research networks? What additional data elements or information would add significant scientific value and utility to an expanded databases?

3. What additional efforts or resources should be developed to improve the collection and use of network bio-specimen repositories?

3A. Describe the optimal model for a distributed research network bio-specimen collection. Can current bio-repositories be expanded or adapted for this purpose or will new primary collection sites be required?

3B. What are the advantages or disadvantages, including cost-effectiveness, of the following:

- A large repository for each network partner

- A central repository for the entire network

- A large repository with samples from multiple networks

3C. What are the advantages or disadvantages of using discarded clinical bio-specimens (e.g., blood, plasma, serum, urine, placenta) versus collecting bio-specimens obtained from re-contacting and consenting subjects? What are the expected genotypic or phenotypic information that can be expected from these different types of tissue? Are these samples adaptable to tissue microarrays?

3D. Under what conditions would re-contacting subjects be inappropriate, unethical or impossible?

3E. Describe the anticipated resource needs of a large scale central bio-specimen repository.

General Information

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.

How to Submit a Response

All comments must be submitted electronically to the following web address: Comments will be accepted through June 1, 2011. You will receive an electronic confirmation acknowledging receipt of your response, but will not receive individualized feedback from the NIH Common Fund HMO Collaboratory on any comments. 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 NIH Common Fund HMO Research Network. 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.


Specific questions about this Notice may be directed to:

Richard Nahin, Ph.D.
Senior Scientific Advisor
National Center for Complementary and Alternative Medicine
2 Democracy Plaza, Room 401
6707 Democracy Blvd
Bethesda, MD 20892-5475
Telephone: 301-496-7801