AFIP Tissue Repository Consensus Statement/Auburn Health Strategies

AFIP Tissue Repository Consensus Statement

Tissue Repository Consensus Conference

Consensus Conference Statement

August 30-31, 2005

Introduction

A consensus conference was convened on August 30-31, 2005, to discuss the present status and future prospects of the Armed Forces Institute of Pathology (AFIP) Tissue Repository.

AFIP houses a globally unique tissue repository with cases dating back to 1917. AFIP has accessioned over three million medical cases and maintains over 50 million glass slides, 30 million paraffin-embedded blocks and 12 million preserved wet tissue specimens, providing the world’s largest and most comprehensive tissue repository. This collection includes a highly valued and widely used radiological pathology archives. New cases from both military and civilian medicine representing the entire spectrum of human and animal disease have been accessioned and coded regularly into the repository. In addition to supporting a treasured diagnostic resource, the repository has enabled a rich array of educational programs from which probably every pathologist and radiologist have benefited at one time or another during his/her career.

In May, the Department of Defense issued is report on Base Closure and Realignment (BRAC) recommendations. The report recommended the “disestablish(ment) (of) all elements of the Armed Forces Institute of Pathology Except the National Medical Museum and the Tissue Repository…” However, no specifications were made for the future maintenance and administration of the tissue repository. In August, the Base Closure and Realignment Commission concurred with the earlier Department of Defense recommendation by declaring “…disestablish all elements of the Armed Forces Institute of Pathology except the National Medical Museum and the Tissue Repository.” Additionally, the BRAC stated, “AFIP capabilities not specified in this recommendation will be absorbed into other DoD, Federal, or civilian facilities, as necessary.”

Stimulated by the BRAC recommendation, the AFIP Tissue Repository Consensus Conference was convened to explore the scientific, technological, legal and ethical considerations that surround the utilization of archived human tissues.

The consensus conference addressed the following key questions:

What are the importance and utility of the AFIP Tissue Repository today?
What are the ethical and legal issues that must be considered with respect to the AFIP Tissue Repository?
Who today owns the tissue in the AFIP Tissue Repository? How transferable is the custodianship of the tissue in the AFIP Tissue Repository?
What resources (financial, environmental, and human) are needed to operate the AFIP Tissue Repository?

What is the quality of the tissue and correlated clinical data in the AFIP Tissue Repository? Based on this quality assessment, what can be predicted about the future utility of this tissue in biomedical research?

In order to maximize its research potential, who should have access to the materials n the AFIP Tissue Repository? Should the AFIP Tissue Repository continue to collect material or should the current materials be exhausted?
What are the recommendations for the future location and operations of the AFIP Tissue Repository?

Consensus Statement

The panel reached consensus on the following points:

The AFIP Tissue Repository is of great value and use to the public health and military medicine. To preserve this value and utility, the Repository should be maintained as a vibrant, living entity that permits appropriate access. This will require management by expert professional staff.

The Repository has and will continue to have, with proper operation, great importance and utility in research, education, and in clinical applications. Appropriate resources are needed to ensure continued utility of the collection.

The United States government, either within the military or civilian sectors, should retain ownership of the Repository.

Adequate financial and human resources are needed to maintain the Repository. Adequate human resources include professional medical and scientific staff, skilled technical and administrative personnel, including informatics professionals, and access as necessary to legal support.

The Repository will require verification of diagnoses in order to validate and authenticate the tissue specimens. To accomplish this, the Repository must have access to nationally recognized pathologists and other medical experts, who may be located on-site or at a proximate tertiary medical center, or may be distant consultants.

If the physical location of the Repository is to be moved, it will be important to assess the environmental issues. In its operations, the Repository should remain free of environmental hazards, and provide appropriate ventilation, and climate control to maintain the collection at optimal conditions. The Repository must follow appropriate federal, state and local environmental regulations.

The site visit report states that the current glass slide collection is in good condition and has an excellent retrieval process in place. For the future, the Repository should continue to digitize the slides deemed of greatest value in order to save space, provide for ease of access, and protect the future integrity of the collection.

The paraffin tissue blocks are also deemed to be of good condition, or better. The blocks are adequately stored, but would benefit from more modern storage capability. The blocks are an important research resource that will become even more valuable as new technologies are developed.

The panel recognizes that there are several discrete components to the Repository. All components should be considered as part of the Repository for the purpose of these recommendations.

A scientific review process should be instituted for obtaining materials from the Repository. The process should assure the quality of the proposed scientific study and the need for the Repository tissue. The review process should be cognizant of present and future needs of military medicine. It is critical to the public health that the Repository should be widely accessible and responsive to the needs of the research community.

Continued modernization is essential to the efficient and effective operation of the Repository.

A Scientific Advisory Committee should be established to evaluate the operations of the Repository and make recommendations on its scientific, medical and ethical practices on a regular basis. The panel recommends consideration of public representation on the Scientific Advisory Committee.

Financial support must be sufficient to support the mission of the Repository. The Repository should explore business models that will generate income in support of its operations. The panel recognized that certain business models may require new statutory authority.

The panel agreed that the Repository requires access to nationally recognized diagnostic pathologists and would benefit from ready access to top-rated medical research facilities. Although the panel did not attempt to consider all possible locations, it did note that Bethesda, Maryland would offer the new Walter Reed National Medical Center, the National Institutes of Health, the Uniformed Services University of the Health Sciences, and the Howard Hughes Medical Institute. In addition, this location would offer proximity to other academic and VA medical centers, and to the biotechnology industry. The panel further noted that change in operational management does not necessitate moving the materials from the present Forest Glen location.

Consensus Panel

David Korn, MD

Panel and Conference Chair

Senior Vice President

Division of Biomedical and Health Sciences Research

Association of American Medical Colleges

Washington, DC

Randal Charlton

Chief Executive Officer

Asterand, Inc.

Detroit, Michigan

Jeffrey S. Davis

Associate General Counsel

General Law Division

U.S. Department of Health and Human Services

Washington, DC

William Grizzle, MD, PhD

Director, Comprehensive Human Tissue Network and

Professor of Pathology

University of Alabama

Birmingham, Alabama

David F. Hardwick, MD

Special Advisor on Planning

Faculty of Medicine

University of British Columbia

Vancouver, BC Canada

Vinay Kumar, MD

Alice Hogge & Arthur Baer

Professor and Chairman

Department of Pathology

University of Chicago Hospitals

Chicago, Illinois

Virginia LiVolsi, MD

Professor, Department of Pathology & Laboratory Medicine

University of Pennsylvania Medical Ctr

Philadelphia, Pennsylvania

LaMar McGinnis, MD

Clinical Professor of Surgery

Emory University School of Medicine

and

Senior Medical Consultant

American Cancer Society

Atlanta, Georgia

Timothy O’Leary, MD, PhD

Director

Biomedical Laboratory Research and Development Service

Department of Veterans Affairs

Washington, DC

Sharon Terry, MA

Founding President, Genetic Alliance BioBank

President & CEO Genetic Alliance

Washington, DC

Peter Ward, MD

Godfrey D. Stobbe

Professor and Chairman

Department of Pathology

University of Michigan

Ann Arbor, Michigan

Shawna C. Willey, MD

Director, Betty Lou Ourisman Breast Health Center

Georgetown University Hospital

Washington, DC

The consensus panel included representatives from both the public sector and the private sector. Views expressed by panel members were their own, and did not represent the official views of any federal agency.