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A central goal of ASIP is to facilitate the scientific productivity of its members. ASIP reports several recent achievements towards this goal, including a new publication venture; presentation of ASIP's position to the National Bioethics Advisory Commission (NBAC) on proposed procedural changes that would restrict the use of human tissues in research; a meeting with Dr. Klausner and NCI staff to discuss new initiatives of interest to pathologists and to discuss a number of ASIP concerns; and leadership in FASEB discussions on funding for patient-oriented research and support for physician- investigators.Â
A New Publication Venture
ASIP has been instrumental in designing and carrying out bold changes in its journal. The visible result of these initiatives is thatÂ The American Journal of Pathology (AJP)Â has become theÂ premier pathology journal.
In early 1998, theÂ impact factorÂ ofÂ AJPÂ rose to its highest level in recent history, a level equivalent to that of prestigious journals published by other FASEB Societies.
The journal is experiencing aÂ surge in new submissions, realizing a 15 percent increase in 1998 over 1997.
The Editorial Office continues to meet or exceed its goal toÂ return initial decisionsÂ on regular articles within 45 days (30 days for short communications).
ASIP is launching theÂ online versionÂ ofÂ AJPÂ in March 1999. The web site will be hosted by HighWire Press and will feature the full text and graphics starting with the July 1998 issue and abstracts since 1964. Access will be a free benefit to ASIP members and to subscribers to the print version of the journal.
In keeping with its mission, the Society monitors and evaluates the needs of investigators working in all aspects of experimental pathology. ASIP and theÂ Association for Molecular Pathology (AMP)Â agreed that a high quality, peer-reviewed journal is needed to publish cutting-edge research in the relatively new but growing field of diagnostic molecular pathology. ASIP and AMP negotiated co- sponsorship of a supplement to theÂ AJPÂ calledÂ The Journal of Molecular DiagnosticsÂ (JMD). The new journal will be a quarterly supplement to theÂ AJPÂ and will publish high quality peer-reviewed original articles onÂ diagnostic molecular pathology. The first issue of the supplement is scheduled for publication in November 1999.
The focus ofÂ JMDÂ will be on clinical translational research, advances in diagnostic technology, and diagnostic studies in the general areas of molecular pathology and human genetics. It will include papers in molecular oncology, molecular hematopathology, infectious disease and molecular genetics.
JMDÂ will also publish periodic reviews, editorials, and abstracts submitted to the annual AMP meeting.
A national search is being conducted to select the best candidate for the position of Senior Editor ofÂ JMD. The Editor-in-Chief of theÂ AJPÂ will provide oversight to ensure the quality of the new publication.
The Use of Human Biological Materials in Research: Ethical Issues and Policy Guidelines
ASIP members rely heavily on human biological materials for their studies, either on the most basic mechanisms of disease processes, on clinically- based studies of disease manifestation, or on population-based studies of the prevalence of certain disorders. These studies evaluate the effectiveness of current therapies and provide insights into accurate prognosis. Importantly, it is often with these tissue samples that fundamental insights into disease mechanisms are obtained and new definitive therapies developed.
ASIP has taken aÂ leadership role in the pathology community to educate its members about the ethical implications of human tissue researchÂ and the federal regulations that govern such use in federally funded institutions, and has followed the NBAC deliberations closely.
ASIP was one of several pathology organizations thatÂ submitted comments to the NBACÂ in response to their draft report on the Use of Human Biological Materials. ASIP was gratified that the Commission recognized the research value of human biological materials in improving public health. Furthermore, the Society was pleased that the NBAC-sponsored town meetings demonstrated overwhelming support by the American public for medical research. Although ASIP agreed with the necessity to protect human subjects and their privacy, the Society was disappointed with some of the draft recommendations.
The Society was gravely concerned that the Commission had grossly overestimated the potential risk of breach of confidentiality when coded samples are used, and in so doing has made a series of recommendations that will place obstacles in the path of the worthy pursuits of the biomedical research community to gain a better understanding of patients' diseases and how to treat them.
More importantly, it was not clear to the Society that the approach the Commission proposed would be effective in safeguarding human subjects. The Society emphasized that the focus of the Commission should be on prevention of misuse of information rather than on restricting its collection. ASIP stressed the following points:
Risks to human subjects occur not through the gathering of information by researchers, but through the misuse of such information. It is critical that confidentiality and security measures be proposed by departments and institutions, and that those policies be approved by institutional review boards (IRBs).
Research findings that are not subjected to rigorous peer review should not affect clinical care and should not be entered into the medical record unless they meet federal standards designed to protect the public from poor quality control tests and misdiagnosis.
Agreement that oversight over human subject research is necessary to protect the public from inadvertent harm.
A simple consent process that authorizes the future use of excess human tissues for studies that follow IRB-approved confidentiality and security policies should be sufficient to respect the personal rights of human subjects when their coded samples are used.
The Commission did not appreciate how difficult it is for a researcher or staff member of a repository to break the key to a code.
The wording of the draft report did not provide adequate guidance to the biomedical research community or to institutional review boards concerning assessment of what should be considered minimal risk and respect for personal rights and welfare.
The Society felt that the Commission failed to make direct recommendations concerning the use of the millions of tissue samples already archived in various repositories throughout the country. Some of those samples were obtained with a consent process that is inadequate by today's standards.
To avoid confusion, the Society requested that the Commission clarify that the report does not pertain to the use of human tissue samples in quality control studies or education.
The NBAC is now reviewing the responses it received and is preparing to release a final draft of its report. One significant change they are considering is to define research with human biological materials as a presumed minimal risk.
ASIP meets with the Director and Staff of the National Cancer Institute
The Society is constantly evaluating where the field of pathology is going, what its needs will be, and how new technology can be used to address important diagnostic issues. ASIP members met with Dr. Richard Klausner, Director of the National Cancer Institute (NCI), and his staff in early December to discuss several NCI initiatives of interest to pathologists.
The NCI has released several requests for grants (RFAs) that are of significant interest to pathologists.
Director's Challenge: Toward a Molecular Classification of TumorsÂ (RFA CA-98-027). The purpose of this initiative is to lay the groundwork for changing the language of tumor classification from morphology to molecular profiles.
The Early Detection Research NetworkÂ (EDRN): Biomarkers Developmental Laboratories (RFA CA-98-028). This will support collaborative research on molecular, genetic and other biomarkers in human cancer detection and risk assessment. Like the Director's challenge, it seeks to create a mechanism for moving basic scientific discoveries into the clinical setting. Its structure will be a consortium consisting of development and validation laboratories, as well as clinical or epidemiology centers.
These initiatives may have a significant impact on pathology.
ASIP members expressed concern over the potential impact ofÂ NBAC recommendationsÂ on research.
Another concern is the unexpected consequences ofÂ exclusive licensingÂ on diagnostic laboratories.
ASIP discussedÂ training needs in pathologyÂ to provide the appropriately trained workforce to apply these techniques
The outcomes of the session include:
ASIP and NCI will meet from time to time to discuss new directions and methodologies. Additionally, ASIP representatives will be invited to participate in NCI Technology Workshops of particular interest to ASIP and other pathology organizations.
ASIP will assist NCI in disseminating information about molecular pathology research and other initiatives with a particular focus on pathology.
Support of Physician-Scientists and Patient- Oriented Research
Each year, FASEB convenes a consensus conference to discuss research funding support by various federal agencies. The consensus conference is highly regarded "inside the Beltway" for its well-researched and reasoned positions on federal funding levels for the upcoming fiscal year and for recommended changes in policy or focus. Dr. Fred Sanfilippo chairs the NIH Committee and Dr. Peter Ward chairs the VA Committee. The NIH Committee, with particularly strong support from ASIP and ASCI, made vigorous recommendations about support for patient-oriented research and physician-scientist training. The VA Committee recommended that the VA research and development budget be increased by $44 M to at least $360 M in FY 2000.
ASIP and a View of the Future
The role of the ASIP embodies both stability and change. The society continues to work with faculty across the country to develop and improve investigative pathology, preserving that which is most valuable in its structure and history, while acting as an agent for positive change. Following from our mission, the goals of the ASIP respond to changing trends within the discipline and the pressures from today's environment.
Â Â Â Â Â OurÂ mandatesÂ include:
Disseminate information on experimental pathology through national venues and by publication of influential scientific journals.
Introduce and integrate new technologies in the molecular and genetic diagnosis of disease.
Ensure high quality investigation and teaching programs.
Expand a community of experimental pathologists that fosters collegiality, encourages the career development of women and minorities and provides recognition for faculty.
Promote an optimum research environment for ASIP members.
In this way the ASIP will reach out to a more diverse group of investigators in a way that solidifies and encourages cohesiveness, communication, and progress for the larger society we all serve.