A Voice for Clinical Positron Imaging, A Voice for ICP

PII S1095-0397(97)00002-2

REVIEW

Clinical Positron Imaging Vol. 1, No. 1, 5–14. 1998 Copyright  1998 Elsevier Science Inc. Printed in the USA. All rights reserved. 1095-0397/98 $19.00 1 .00

A Voice for Clinical Positron Imaging, A Voice for ICP Ernest V. Garcia, Ph.D1, Paul D. Shreve, M.D.2 1

Emory Center for Positron Emission Tomography, Emory University School of Medicine, Atlanta, GA 2 University of Michigan Medical Center, Ann Arbor, MI With the advent of the Clinical Positron Imaging journal, a new vehicle has been created to facilitate the dissemination of information relevant to the clinical positron imaging community. In addition to providing technical, scientific, and medical information, this journal will also be used to address financial, regulatory, and legislative issues in clinical positron imaging. Since this is the journal of the Institute for Clinical PET (ICP), all of its members will receive it as an added service of ICP. (Clin Pos Imag 1998;1:5–14)  1998 Elsevier Science Inc. Key Words: ICP’s history and mission; ICP role and activities; FDG; cost effectiveness; ICP publications

ICP’s Need to Provide Its Own Voice

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ith all the journals available to those who perform positron imaging, it is fair to ask why a dedicated journal is needed. In addition to focusing on the science, technology, and art of positron imaging, drawing knowledge from diverse fields of science and medical subspecialities, Clinical Positron Imaging will also serve as a conduit of the information generated from the educational, regulatory, legislative, reimbursement, and all the many activities of ICP. Just as ICP has done, this journal will represent the views of those in all fields and subspecialities that constitute the field of positron imaging without regard to turf, boundaries, or union cards. The information that is disseminated will be direct, without defocusing filters, amongst those practicing positron imaging. Rather than being exclusive, Clinical Positron Imaging will be an inclusive journal recognizing the contributions of all sciences and subspecialities to our field. The rest of this article briefly describes the activities of ICP as a preamble to the type of information generated by ICP to be found in upcoming issues of Clinical Positron Imaging.

ICP’s History and Mission In 1989, Siemens organized a PET Conference in Bermuda to bring together individuals interested in workAddress correspondence to: Dr. Ernest V. Garcia, Emory Center for Positron Emission Tomography, Emory University School of Medicine, Atlanta, GA 30322.

ing together to make clinical PET a reality. This group became known as the Institute for Clinical PET Practice (ICPP) and this conference has been designated as the First Annual International PET Conference. In 1990, it was decided that this organization should also include all of the industry interested in clinical PET. The name was shortened to the Institute for Clinical PET (ICP) and Dr. R. Edward Coleman from Duke University was named as the Founding President. Subsequently, Presidents of ICP have been elected to serve on an annual basis. Table 1 provides a list of all the Presidents of ICP up to 1998. In January 1991, ICP was incorporated as a non-profit, educational foundation to expedite the development of the clinical use of PET. Mr. J. Michael McGehee was chosen as the Executive Director, a position he held until his untimely death in 1997. In 1997, Jennifer S. Keppler became the Executive Director. The Bylaws of the organization are provided in Appendix A. Up to 1991, clinical PET had unfolded at an excruciatingly slow pace due to a number of impediments. These impediments included: (1) the complexity and cost of PET, (2) regulatory impediments usually overcome by funding from radiopharmaceutical companies, (3) academic isolation of the centers that developed PET as a tool for scientific investigation, and (4) a view of PET as a competing modality by both the Radiology and the Nuclear Medicine communities. ICP’s mission is to promote the worldwide, clinical use of non-invasive, diagnostic positron imaging for measuring metabolic and functional activity of cells in the human body. Thus, ICP’s purpose is to make effective clinical positron imaging available to patients every5

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Table 1. Presidents of ICP Year

Name

1990 1991 1992 1992–1993a 1993–1994 1994–1995 1995–1996 1996–1997 1997–1998

R. Edward Coleman, M.D. John C. Mazziotta, M.D., Ph.D. Mathis P. Frick, M.D. Henry N. Wagner, Jr., M.D. Peter T. Kirchner, M.D. Steven M. Larson, M.D. Richard L. Wahl, M.D. Ernest V. Garcia, Ph.D. Peter E. Valk, M.D.

a One-year term switched to October to October starting at the time of the annual ICP meeting.

where. The term positron imaging is inclusive, including all aspects of effective imaging of positron tracers including dedicated PET scanners and hybrid SPECT/ PET tomographic scanners. ICP’s initial purpose was to move clinical PET forward in the United States, where there were unique impediments. Initially, ICP was formed by the instrumentation industry to focus resources that would otherwise be provided by a radiopharmaceutical company to comply with the regulatory procedure of taking positron-emitting radiopharmaceuticals through the Food and Drug Administration. Today ICP has become a member-driven organization dedicated to overcome all of the impediments described above. To accomplish its mission, ICP offers three types of memberships: individual, institutional, and industry. In 1997, there were 302 individual, 29 institutional, and 13 industry members.

ICP Role and Activities ICP promotes clinical applications of positron imaging by developing educational programs for professionals and by increasing public awareness of the value of imaging positron-based radiopharmaceuticals. ICP also works to obtain government approval for the clinical use of positron radiopharmaceuticals and reimbursement for clinical positron imaging procedures. To this end, ICP represents U.S. centers performing positron imaging before U.S. government facilities and coordinates multi-center clinical trials employing positronbased radiopharmaceuticals. This regulatory and clinical information is also shared amongst the members of ICP’s International Council. Over 16% of the membership of ICP are international members from outside the United States, and international membership continues to grow.

ICP Meetings Once a year in late October, ICP hosts an annual scientific conference widely considered the most comprehen-

sive forum available to discuss technical, regulatory, and financial challenges facing the positron imaging field. In addition to state-of-the-art lectures by experts, the CME-accredited program’s features include: (1) read with the experts sessions, (2) FDA current Good Manufacturing Practice (cGMP) workshops, (3) clinical practice workshops, (4) referral marketing workshops, (5) reimbursement workshops, and (6) scientific posters and presentations. Since 1994, one of the highlights of the meeting has been the presentation of the Distinguished Scientist Award and a subsequent lecture. Table 2 lists the four distinguished scientists honored to date and their areas of contribution. ICP also hosts or co-sponsors multiple workshops throughout the year in different parts of the United States. The most recent workshops have been dedicated to clinical applications of positron imaging in oncology, the fastest-growing segment of clinical positron imaging.

ICP Publications ICP also acts as a clearinghouse to disseminate information to both professionals and the public on the clinical utility and cost effectiveness of positron imaging. Some examples of ICP publications include the full new drug application (NDA) with appendix for positron radiopharmaceuticals such as FDG, the Drug Master File (DMF) for FDG, the costs of clinical PET, FDA-PET workshop transcripts, FDA public hearing transcripts, FDA medical imaging advisory committee transcripts, a videotape of cardiac PET applications, and a series of monographs concerning the clinical application and economic implications of positron imaging. For individual members, ICP provides a quarterly newsletter describing the status of active ICP initiatives, up-to-date information on current activity of reimbursement for clinical positron imaging in the United States, notice of upcoming meetings of interest to the positron imaging community, and proceedings of ICP’s international conference. Presently the ICP address is: 26741 Portola Parkway, Suite 1E-520, Foothill Ranch, California 92610-1743, Voice 714-649-0427, FAX 714-649-3548. The ICP address for E-mail is: [email protected]. There is also an award-winning WEB site at http://www.icppet.org.

ICP Regulatory Activities Since regulatory approval for positron-emitting radiopharmaceuticals has been the most important impediment to clinical positron imaging especially in the United States, ICP has worked to coordinate academic and industry efforts to deal with the FDA, HCFA (Health Care Financing Administration), and other U.S. federal government agencies. ICP has served to represent the diverse practice, academic, and industry

A Voice for ICP / Garcia and Shreve

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Table 2. ICP Distinguished Scientist Awards Year

Award recipient

Area of recognition

1994 1995 1996 1997

Giovanni Di Chiro, M.D. Michael E. Phelps, Ph.D. Alfred P. Wolf, Ph.D. Louis Sokoloff, Ph.D.

First clinical trials of FDG-PET imaging in brain tumors Development of clinical PET scanner Pioneering work in Radiochemistry, especially FDG Deoxyglucose method for the measurement of local cerebral glucose metabolism

interests as one voice to these government agencies, providing a unified front and demonstrating to the federal agencies that a substantial constituency for clinical positron imaging exists. For example, ICP spearheaded work on a Drug Master File for FDG, standardizing and codifying FDG production and formulation in anticipation of FDA regulations. In part due to the efforts of ICP, FDG has been approved for clinical use in brain PET imaging for localization of epileptic foci, and ICP is working vigorously to extend the FDA clinical indication for FDG to include approval for tumor imaging. To facilitate better communication and understanding between the positron imaging community and the federal regulators, ICP has sponsored multiple workshops, seminars, and joint training sessions. At the 1996 ICP International Conference, ICP organized a joint ICP/FDA regulatory session where those interested in FDG production could interact directly with ranking FDA regulators and discuss the implications of the newly promulgated FDA rules and the timetable for compliance (transcript available). In response to the 1995 decision by the FDA to regulate positron-emitting radiopharmaceuticals, the ICP initiated development of drug master files for radiopharmaceuticals of clinical interest and is helped coordinate the submission of the group-amended new drug applications (ANDAs) by clinical PET centers that produce FDG. In other regulatory-related activities, ICP has undertaken surveys to determine current usage of the different radiopharmaceuticals employed in clinical positron imaging procedures. The ICP Clinical Validation Task Force is coordinating the submission of appropriate data concerning FDG-PET in clinical oncology to the FDA in an effort to broaden the clinical indications for FDG, currently approved only for the detection of brain epileptic foci. Further, ICP has assisted industry with approval/reimbursement of specific devices for positron-emitting radiopharmaceuticals. While the focus on the regulatory front has been in the United States, ICP is already providing materials used in conforming to U.S. regulations to international members, as similar issues are raised by regulatory agencies in Europe and Asia.

ICP Legislative Activities More recently, ICP’s legislative committee successfully pursued an alternate and novel legislative solution to resolve the current positron-emission radiopharmaceutical regulatory issues with the FDA and HCFA. A new bill has been passed that ties for the next two years PET chemistry standards and compounding standards to the standards and drug information monographs of the U.S. Pharmacopoeia (USP). The bill limits the regulatory overhead while ensuring the high quality of positron-emitting radiopharmaceuticals. The bill allows the FDA to regulate the compounding and PET chemistry standards of the USP but an NDA or cGMPs would not be required for most centers. HCFA has also agreed to reimburse for FDG imaging of solitary pulmonary nodules and staging of lung cancer.

ICP Reimbursement Activities Indemnity insurance plans have been resistant to paying for new medical technologies, out of fear of a “piling on” effect adding to their costs. To meet the indemnity resistance, ICP has coordinated clinical trials to demonstrate the cost effectiveness of clinical positron imaging and spearheaded education campaigns for patients, unions and company benefit offices, and insurance carriers in general. Several publications detailing the cost effectiveness of clinical positron imaging have been completed and are available through the ICP publication office. It is of particular interest that in the United States, managed care organizations have been more receptive to clinical positron imaging than the indemnity insurance carriers or the federal government, presumably reflecting the ability of such organizations to control utilization of new technologies and integrate innovative patient care algorithms quickly and relatively uniformly in their patient population. Recognizing this, ICP established a Managed Care Task Force, in a focused effort to educate managed care entities and the employers who purchase health plans regarding how clinical positron imaging can be used to both reduce costs and improve patient management. Individuals have been recruited to work directly with specific managed care plans, corporate health care plans, and trade unions. In addition, source books listing posi-

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tron imaging providers nationwide, current data, journal articles relevant to different clinical circumstances where positron imaging is clinically useful, and cost information have been compiled.

ICP Technology and Outcome Assessment Activities More recently ICP has also created a positron oncology imaging task force. This long-term project will use wellstructured, input-validated, extensive databases as a convincing approach to establishing outcomes from a specific procedure for a specific clinical question. Since generating, validating, maintaining, and assessing these databases is so expensive and time consuming, alternative approaches such as promoting and cataloguing articles of well-conducted clinical trials are being pursued. Initial goals of this task force have been to document the required criteria for clinical trials, define specific outcome questions and the database needed to answer those specific questions, and to generate a list of annotated references for positron oncology imaging. If this proof of concept is successful, similar task forces will be created in cardiac and brain imaging. This technology and outcome assessment effort is a joint project with the Society of Nuclear Medicine, the American College of Nuclear Physicians, and the American Society of Nuclear Cardiology. Again, while ICP’s efforts have been chiefly focused on U.S. health care providers and purchasers, the information will be largely germane to international members working to convince their governments and private payers of the value of positron imaging.

ICP’s Efforts in Bringing Together the Diagnostic Imaging Community ICP from its inception has been formed by various specialty groups, including radiologists, neurologists, cardiologists, nuclear medicine physicians, scientists, administrators, and technologists. Prominent ICP members may be found in both academia and in private practice groups. As an organization, ICP has acted to harmonize activities among major professional organizations with an interest in clinical positron imaging, including The Society of Nuclear Medicine, American College of Nuclear Physicians, American Society of Nuclear Cardiology, American College of Radiology, American Academy of Neurology, American College of Cardiology, and more recently the American Society of Clinical Oncologists. Further, ICP members have worked to report results of clinical positron imaging in the literature and meetings of these specialties in order to educate all interested parties regarding the clinical utility of positron imaging. The same databases used to convince government and payers of positron

imaging’s usefulness and superiority over other imaging methods in appropriate clinical circumstances have been advanced to the entire diagnostic imaging community. Many of the indications for clinical positron imaging are well known in the diagnostic imaging community to be inadequately characterized by anatomic-based imaging methods such as CT or MR or by a lack of adequate radiopharmaceuticals such as in specific SPECT applications. In targeting such applications where positron imaging provides superior cost effectiveness and clinical outcomes, ICP has facilitated a realization among diagnosticians that positron imaging is not dead or just for research, but has come of age as an important part of the diagnostic imaging armamentarium. Two relatively recent events have helped tremendously in uniting the diagnostic imaging community by making FDG clinical positron imaging available to most diagnosticians. A new generation of cyclotron/ accelerators and automated radiopharmaceutical synthesis devices have markedly reduced the cost and complexity of positron radiopharmaceutical production. Further, companies involved in radiopharmaceutical distribution are establishing distribution networks of FDG. At the same time, imaging device manufacturers have adapted dual-head SPECT systems to perform coincidence imaging of positron-emitting radiopharmaceuticals. This development of a relatively modest upgrade cost over a conventional camera has significantly reduced the cost for a diagnostic imaging laboratory of venturing into clinical positron imaging while at the same time maintaining their SPECT capabilities. This development has also prompted the manufacturers of conventional PET scanners to improve performance and to reduce their prices. ICP is supportive of both these developments and is continuing to evolve as an organization insuring that it represents the interest of all who are interested in performing clinical imaging of positron-emitting radiopharmaceuticals.

Summary Clinical positron imaging has not grown as rapidly as initially expected due to both anticipated and unanticipated impediments. Through efforts directed by organizations such as the ICP, these impediments are now diminishing, and sustained growth in positron-based radiopharmaceutical clinical imaging in clinical practice appears imminent in the United States and parts of Europe and Asia. ICP’s activities have evolved around disseminating relevant information to its members and organizations. This Clinical Positron Imaging journal will now play a key role in disseminating information expediently. It will provide a forum for discussing all issues related to

A Voice for ICP / Garcia and Shreve

the field of clinical positron imaging. Finally, it will provide a vehicle for the ICP to speak with one voice. With this inaugural issue of the Clinical Positron Imaging journal, the brain, brawn, and heart of the positron imaging body finally has a voice. Use it wisely. Use it often.

APPENDIX A. Institute for Clinical PET Bylaws Article I. Objectives The Institute for Clinical PET (ICP) exists for and is dedicated to the following purposes: 1. Support for those principles, policies, and practices that seek the attainment of the best in diagnostic patient care. 2. The pursuit of excellence in medical education, especially as it concerns positron imaging. 3. The pursuit of high standards of excellence in the practice of clinical positron imaging. 4. Support for the quest of scientific knowledge by support for research. 5. The communication of scientific and scholarly information through scientific meetings and publications.

Article II. Membership Section 1—Classes of membership. Membership in the Institute shall consist of four classes: Individual, Institution/Administrative, Honorary, and Industry. There shall be no restriction regarding the number of members in any given category. Section 2—Individuals. Individuals may become members of ICP whose principal interest is directed toward practice, teaching, research, or support of clinical PET. Section 3—Honorary members. Honorary members may be appointed from among distinguished persons including physicians in clinical PET or cognate fields, other holders of an advanced degree, and prominent persons who have a specific familiarity with clinical PET and its use. Nominations for this category must bear the signature of two sponsors who are members of the Institute board of directors. Section 4—Procedure for application for membership. Application for individual membership shall be made in writing on the application form provided by the executive office, supplying in detail all information required, and signed as the name is to appear in the membership records. Application for membership as an Honorary mem-

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ber must be accompanied by the signature of two members of the Board and approved by a majority vote of the full Board. Completed applications will be forwarded to the board of directors or their designated representative for review. Recommendations regarding either approval or rejection for all categories of membership must be approved by a majority of the executive board. Section 5—Voting and holding office in the Institute. Only those members in good standing at the time of the annual meeting will be entitled to vote on any matter during any annual or special business meeting of the Institute. Only a member in good standing shall be entitled to hold any elected office in the Institute. Section 6—Fees, dues, and assessments. 1. The dues, assessments, and other fees for each class of membership shall be established annually by the Executive Board. 2. Annual dues shall be established on the basis of a calendar year, i.e., from January 1 to December 31. The dues for a year shall be payable on the first of January of each year and shall be considered delinquent if not paid by March 1 of the current year. Any additional assessments and fees shall be payable at the time or times that the Executive Board shall determine. 3. No dues, assessments, or other fees shall be payable by Honorary members. Section 7—Termination of membership. A member whose required dues, assessments, or other fees for a fiscal year are not paid by March 1 of that year shall be considered “delinquent.” With appropriate notice, membership benefits and services will be suspended at that time. The membership in the Institute of a delinquent member whose delinquent dues, fees, and assessments for a year are not paid in full by June 1 of that year shall be considered for termination by the executive board. Once a delinquent member is dropped from Institute membership, he or she may pay back dues or reapply to be reinstated. Either action must receive the approval of the executive board. Section 8—Disciplinary action. The executive board shall have the duty to consider disciplinary action for any professional misconduct on the part of any member of the Institute for which similar disciplinary action has been taken by a state or county board of medical examiners, board of professional medical responsibility, or like body. Such disciplinary action shall be in the form of censure, suspension, or expulsion from the Institute; and if the member be an officer of the Institute, that member shall be removed from office

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whether censured, suspended, or expelled. The word “censure” means that the individual shall be advised in writing that his or her professional conduct is not consistent with the objectives of the Institute and that it should be changed; the word “suspended” means that the individual shall be advised in writing that his or her privileges as a member of the Institute have been temporarily suspended (or terminated) until the professional misconduct has been corrected to the satisfaction of the State Board of Medical Examiners, or other professional bodies supervising professional conduct; “expulsion” means that the member shall be advised that membership in the Institute is automatically terminated.

Article III. Meetings and Vote of Members Section 1—Annual meeting. An annual meeting of the Institute shall be held each year at the place or places and on the date or dates designated by the Executive Board. The primary purpose of the annual meeting shall be to provide educational courses and forums for the presentation of scientific papers and the latest developments in clinical PET. There shall be not less than one (1) business session at each annual meeting of the Institute. Section 2—Special meeting. Special scientific and/or business meetings of the Institute may be called by the Executive Board for the times and places it may designate. Section 3—Notice. Notice of each annual meeting of the Institute shall be given to all Institute members not less than 90 days prior to the date on which the meeting is to begin. Notice of special scientific and business meetings of the Institute shall be provided at least thirty (30) days prior to the date on which the meeting is to begin. Section 4—Order of business. The annual business meeting shall be chaired by the President of the Institute and the order of business shall be: 1. 2. 3. 4.

Report of the Executive Board Report of Standing Committees Unfinished Business New Business

Section 5—Quorum. At any annual or special business meeting of the Institute, a quorum shall consist of not less than fifty (50) voting members, except as required by further provisions in these Bylaws. Section 6—Vote. If a quorum is present, a majority vote of the voting members present shall be required to constitute an action by the voting members on any matter, unless otherwise provided by applicable law, the Articles of Incorporation, or these Bylaws. There

shall be no voting by proxy or mail ballot by the members of the Institute at the annual meeting or special meetings. Section 7—Standing rules. The Standing Rules of the Institute are contained in the document attached to these Bylaws in effect on the effective date of the adoption of the Bylaws. The Standing Rules of the Institute may be amended or revised from time to time as provided therein, but may not be inconsistent with the Articles of Incorporation or Bylaws of the Institute. Section 8—Parliamentary authority and rules of order. The deliberations of the Institute, its Executive Board, and all committees shall be governed by the rules contained in the then-current edition of Roberts’ Rules of Order Revised in all cases in which they are not inconsistent with the Articles of Incorporation, Bylaws, Standing Rules, customary practices, and procedures of the institute.

Article IV. Board of Directors and Officers Section I—Election of Board of Directors of the Institute. Election of the Board of Directors shall be held and the affirmative vote of a majority of the voting members present and voting shall be required for election to the Board of Directors. Board members shall serve for a term of three (3) years, or until a successor is elected, commencing on the first day following the annual meeting at which they were elected. Section II—Election of Executive Committee. The newly elected Board of Directors shall convene and elect among themselves the following officers who shall compose the Executive Board of the Institute—President, President-Elect, Secretary, and Treasurer. Members of the Executive Board, with the exception of the President and President-Elect, may be nominated for a second consecutive term in the same office. Section III—Nominations. The Executive Board, acting on the recommendations of the Nominations Committee, shall nominate members of the Institute for each vacancy that occurs on the Board of Directors. Institute members shall be notified of the names of all nominees at least sixty days prior to the election. In the event of death or withdrawal from candidacy of any of these nominees, the Executive Board shall designate a substitute nominee at any time before the election and shall announce that designation before the election. In addition, nominations for positions on the Board of Directors may be made by the membership provided that at least two weeks before the date of the election, a written petition, signed by ten (10) or more voting members, has been filed with the Executive Di-

A Voice for ICP / Garcia and Shreve

rector together with a signed statement by the nominee setting forth willingness to serve if elected. Section IV—President. The President shall be the Chairman of the Executive Board of the Institute; shall preside at all business sessions of the membership of the Institute; shall act as chief spokesman of the Institute to the public, the press, legislative bodies, the medical community at large and federal, state, and local governmental and private agencies and organizations; shall work with the Executive Director to ensure that basic Institute policies and programs are formulated and executed; shall serve no more than one (1) term as President; is responsible for making appointments to replace members rotating off standing committees; may create ad hoc committees and appoint Institute representatives to civic, professional, and governmental organizations as may be required to execute the business and affairs of the Institute. Section V—President-Elect. The President-Elect shall automatically become the President of the Institute upon expiration of the President’s term; shall, in the absence or disability of the President, have and perform the duties and responsibilities of the President; shall, in the event of a vacancy in the office of President, however occurring, fill the vacancy in the office of President for the unexpired portion of the President’s term and also serve a full term as President; shall assist the President in the performance of his or her duties whenever requested to do so; and shall have all other duties and responsibilities that the President or the Executive Board may determine. The President-Elect shall serve as program chairman for the annual meeting. The President-Elect shall automatically assume the position of President upon completion of the annual meeting at which he or she has served as program chairman. Section VI—Treasurer. The Treasurer shall serve as chairman of the Finance Committee; ensure that the Institute maintains accurate financial records; review Institute expenditures and financial status on a regular basis to ensure overall financial integrity; submit the financial accounts of the Institute to an annual independent audit; develop and present financial recommendations to the Executive Board; and perform other duties assigned by the President or Executive Board. Section VII—Secretary. The Secretary shall ascertain that records are maintained for all business meetings and Executive Board meetings of the Institute; ensure that copies of the minutes of each meeting are provided to the President and other officers and directors as appropriate; maintain current copies of the association rules and bylaws for use by the President and the Executive Board; perform other duties assigned by the President or Executive Board.

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Section VIII—Immediate Past President. The Immediate Past President shall have all duties and responsibilities that the President or the Executive Board may determine and shall serve as an ex-officio member of the board of directors. Section IX—Board of Directors. The Board of Directors shall consist of twelve (12) members, each elected to three (3) year terms of office. The terms of office shall be staggered so no more than four Board members are elected at any one annual meeting. The nominating committee shall strive to incorporate geographic distribution of nominees and every effort made to incorporate individuals with diverse education, experience, and perspective. Section X—Vacancies. In the event of incapacitation, withdrawal, demise, resignation, or removal of any officer or member of the Executive Board, the President, with the approval of the board, shall appoint a successor who will hold the appointed office until a successor has been elected by the board. In the event of incapacitation, withdrawal, demise, resignation, or removal of the President, the President-Elect shall automatically become President and complete the President’s term of office. Upon completion of this term, he will then serve the full term of his office. Section XI—Removal from office. Any board member of the Institute elected by the voting members may be removed from office by the affirmative written ballot of two-thirds of the board members whenever, in their judgment, the removal will serve the best interests of the Institute.

Article V. Executive Board Section I—Authority. The Executive Board shall manage all the business and affairs of the Institute. The Executive Board shall have all powers and responsibilities conferred upon the board of directors of a nonprofit corporation by section 501(c)3 of the Internal Revenue Code, as now or hereafter amended, except as those powers or responsibilities may be limited by the Articles of Incorporation or these Bylaws. The Executive Board shall have the final responsibility and authority for all actions and policies that are recommended or adopted by any and all standing and ad hoc committees, sections, representatives to professional and governmental organizations, agents, and employees; and no action or policy shall be the action or policy of the Institute unless and until it is adopted, ratified, or approved by the Executive Board. The Executive Board shall employ an Executive Director who shall function in the usual capacity of such office when those functions are not contrary to the Articles of Incorporation and bylaws of the Institute.

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The board shall determine the duties and salary of such an executive director and the policies pertaining to that office.

telephone conference of the board for the purpose of transacting Institute business.

Section II—Members of the Executive Board. The members of the executive board shall consist of the president, the president-elect, secretary, and treasurer.

Article VI. Miscellaneous

Section III—Meetings. The executive board shall meet no less than twice yearly, with at least one of those meetings to take place during the annual meeting of the Society of Nuclear Medicine. Special meetings of the executive board may be called by the president or at the written request of five members of the board addressed to the secretary at no less than twenty (20) calendar days’ notice. Section IV—Notice. Notice of each meeting of the executive board shall be given by the executive director not less than fifteen (15) calendar days prior to the date on which the meeting is scheduled to be held. The matters to be discussed and voted upon at any duly called meeting of the executive board shall not be limited to those set forth in the notice of the meeting. Individual members who wish to have issues discussed by the board at any business meeting of the board shall request in writing to the executive director that the item be placed upon the agenda for the meeting. The executive director shall place the item on the agenda to be discussed at the next business meeting of the board. Section V—Quorum. Three (3) members of the executive board shall constitute a quorum for the transaction of business. Section VI—Manner of acting. A majority vote of the executive board members present and voting at a meeting at which a quorum is present shall be the act of the executive board, unless the vote of a larger number is required by applicable law, the Articles of Incorporation, or these bylaws. Section VII—Written action. Any action that the executive board could take at a duly called meeting of the board may be taken by a written action signed by twothirds of the board members. The same written action need not be signed by all board members, and each may sign a separate counterpart of written action, but all board members will be notified in writing before voting takes place. Section VIII—Telephone conference. Any action that the executive board could take at a duly called meeting of the board may be taken during a telephone conference of the board members. A quorum must participate in the telephone conference in order to transact business. A notice of two business days is required to all executive board members in order to schedule a

Section I—Fiscal year. The fiscal year of the Institute shall be from January 1 to December 31. Section II—Notice and waiver of notice. Notice is deemed given by a member of the Institute or to an officer of the Institute when it is in writing and mailed or delivered to the Institute or the officer at the principal executive office of the Institute. In all other cases, notice is deemed given to a person when it is communicated to the person orally in person or by telephone or is in writing and telegraphed, mailed, or delivered to the person at the persons’s last known address. Notice by mail is given when it is deposited in the United States mail with sufficient postage affixed. Whenever any notice is required to be given by law, the Articles of Incorporation, or these bylaws, a waiver of the notice may be executed in writing by the person or persons entitled to the notice, whether before, during, or after the time stated therein, and the waiver shall constitute the equivalent of receiving the notice. Section III—Indemnification. To the full extent permitted by any applicable law, any person who is or was director, officer, employee, or agent of the Institute shall be indemnified by the Institute against any and all liability and reasonable expense incurred by reason of the person being or having been a director, officer, employee, or agent of the Institute, or by reason of any action taken or not taken in the course and scope of the person’s service as such director, officer, employee, or agent of the Institute, in the event that such person was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit, or proceeding, wherever brought, either civil, criminal, administrative, or investigative, other than an action by or in the right of the corporation. Such person shall be entitled to reimbursement by the Institute of reasonable expenses in advance of the final disposition of a proceeding in accordance with, and to the full extent permitted by, any applicable law. The rights of indemnification provided in this section shall not limit, but shall be in addition to, any other rights to which such director, officer, employee, or agent may otherwise be entitled by contract, law, or statute, or otherwise; and in the event of such person’s death, such rights shall extend to such person’s heirs, legal representatives, or successors. The foregoing rights shall be available whether or not such person continues to be a director, officer, employee, or agent at the time of incurring or becoming subject to such liability and expenses, and whether or not the claim

A Voice for ICP / Garcia and Shreve

asserted against such person is based upon matters which antedate the adoption of this section. The Institute, its directors and officers, shall be fully protected in making any determination under this section, or in making or refusing to make any payment under this section in reliance upon the advice of counsel. The Institute may, to the full extent permitted by applicable law, purchase and maintain insurance on behalf of any person who is or was a member of the executive board, an officer or employee of this corporation, or a member of a committee of this corporation who gains any liability asserted against such person in any such capacity. If any provision of this section shall for any reason be determined to be invalid, the remaining provisions hereof shall not be affected thereby but shall remain in full force and effect.

Article VII. Amendments These Bylaws may be amended, altered, or repealed at any meeting, annual or special, by the vote of a majority of the voting members present and voting, provided that any proposed amendment 1) has been submitted in writing to the Executive Board and 2) notice thereof has been mailed to each voting member at least one month prior to the session at which it will be acted upon. Bylaws amendments may be proposed only by voting members of the Institute. These Bylaws shall be subject to a complete review and re-approval every ten years.

Standing Rules of the Institute for Clinical Pet I. Creation of Standing Committees of the Institute Standing Committees of the Institute may be created by a majority vote of the Executive Board. These standing committees provide the ongoing functions vital to the Institute on a long-term basis. The scope of responsibility of each standing committee shall be established by the President on the advice of the Executive Board. The chairman of a standing committee shall be appointed by each new president when taking office. Chairmen, except for the nominations committee, may be re-appointed by the President, but with a maximum of three years service; i.e., three 1-year terms. Members of the nominating committee shall include the past presidents of the Institute and any other board member appointed by the President. Members of the Administrative Committee shall include the President who will serve as chairman, the remaining executive committee members elected by

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the Board and not more than two additional members named at the discretion of the President. Members of standing committees shall be subject to re-approval as each new President takes office. Members of standing committees shall serve for a maximum of three 1-year terms, and terms of membership shall be staggered so that normally no more than one-third of the committee members have terms ending in the same year.

II. Standing Committees of the Institute Administrative. The committee shall be responsible for monitoring all administrative aspects of the Institute including proper auditing of financial activities, dues collection, and notifications. The committee is responsible for defining the Institute’s requirements for professional management and making recommendations to the Board of Directors regarding employment of a management firm and Executive Director. The committee, in conjunction with the executive director, shall be responsible for the development of an annual budget for approval by the Board of Directors. The committee is responsible for assuring that proper membership status is provided for all present and potential Institute members and recommending methods for strengthening membership activities within the Institute. Legislative. Evaluates issues affecting the Institute membership which are being discussed on a national legislative level and makes appropriate recommendations to the Executive Board. The committee also recommends and develops procedures and policies for the Institute to maintain positive public relations activities. Continuing education. The committee develops and recommends policies for structure, format, and operation of the Annual Meeting; recommends meeting sites to Executive Board; and coordinates planning with Institute staff. The committee also develops and maintains an effective educational program for the Institute Annual Meeting; develops recommendations and monitors activities related to other educational issues of importance to the Institute. Industry. Membership fees for the Industry Committee shall be set by the Executive Board at each annual meeting in conjunction with members of the committee. The committee will be comprised of representatives from those corporations interested in supporting Institute activities and initiatives. Membership dues shall be paid in full by January 31 unless the industry committee approves an alternative schedule of payments. In no case shall industry dues not be paid in full by June 1 of any calendar year. Institution. Evaluates issues affecting Institution members of the Institute and makes recommendations to the Board for appropriate action. Membership is

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Clinical Positron Imaging, Volume 1, Number 1

granted upon an amount to be annually determined by the Board of Directors donation to ICP and shall be subject to the same assessment schedule as individual members. Nominations. Nominates a slate of board members consistent with Institute Bylaws for election as allowed by the voting members of the Institute.

III. Creation of Ad Hoc Committees of the Institute Ad hoc committees may be appointed as the need arises by the President to carry out a specified task that is not the assigned function of an existing standing committee of the Institute. The committee’s charge and date of expected report should be specified by the President. The Chairman and members of ad hoc committees shall be appointed at the discretion of the President. Ad hoc committees shall submit to the President reports as deemed appropriate by the President. The Chairman of each ad hoc committee shall be responsible for submitting all reports of the committee.

IV. Committee Longevity Standing committees will continue to exist indefinitely at the discretion of the Executive Board. When, in the judgment of the Executive Board, a standing committee is no longer necessary, it may discharge a committee by a majority vote. Ad hoc committees are discharged automatically 1) upon the acceptance of their final report by the executive board or 2) upon completion of the current president’s term of office. Ad hoc committees may be discharged at any time by the president.

V. Sections The Executive Board shall have the power to establish Scientific Sections of the Institute to provide a forum for discussion in selected areas of clinical PET. Requests for the establishment of a section must be submitted to the executive board for approval, and the

Bylaws for governing the section must also be approved by the board. Membership in any section is open to any member of the Institute interested in the subject addressed by a particular section. Officers of a section will be elected by the section’s members.

VI. Representatives to Civic, Professional, and Governmental Organizations from the Institute The President may nominate representatives of the Institute to other scientific organizations. The representatives shall serve at the pleasure of the President upon approval by the Executive Board. Representatives shall submit to the Executive Board an annual report and special reports as deemed appropriate by the representatives or as requested by the President.

VII. Eligibility Requirements for Committee Members and Representatives All members of Institute committees and Institute representatives to organizations shall be Institute members. Non-members of the Institute may, with the specific approval of the President, serve as consultants on committees; however, they shall not vote on matters of administration or policy affecting the Institute.

VIII. Reports of Standing Committees, Special Committees, and Representatives to Organizations Standing Committees, Ad Hoc Committees, and representatives to organizations shall submit to the Executive Board an annual report and special reports at other times as deemed appropriate by the committee or representatives or as requested by the Executive Board. The chairman of each committee and the representative to each organization shall be responsible for submitting all reports. All reports shall be in writing.

IX. Amendments and Revisions These standing rules may be amended or revised by the Executive Board of the Institute.