Officers President LaMar S. McGinnis, Jr., MD, FACS Atianta,GA President-Elect L. D. Britt, MD, MPH, FACS Norfolk, VA First Vice?President Kirby I. Bland, MD, FACS Birmingham, AL Second Vice?President Karen E. Deveney, MD, FACS P9rtlan d,OR First Vice?President-Elect RichardJ. Finley, MD, FAGS, FRCSC Vancouver, BC Second Vice-President-Elect Frederick L. Greene, MD, FACS Charlolle, NG Secretary Courtney M. Townsend, Jr., MD, FACS Galveston, TX Treasurer Andrew L. Warshaw, MD, FACS Boston,MA Executive Director David B. Hoyt, MD, FACS Chicago,IL Chief Financial Officer Gay l. Vincent, CPA Chicago,IL 633 N Saint Clair St Chicago, IL 60611-3211 Voice: 312-202-5000 Fax: 312-202-5001 e-mail: postmaster@iacs.org ACS Web site: www.facs.org January 20,2010 The Honorable Charles E. Grassley Ranking Member United States Senate Committee on Finance 219 Dirksen Senate Office Building Washington DC 20510 Dear Senator Grassley: The American College of Surgeons (College) is responding to the request for infonnation from the United States Senate, Committee on Finance, dated December 7, 2009. The College's response includes infonnation from the College and College consolidated subsidiaries: The American College of Surgeons Professional Association and The American College of Surgeons Foundation. The College is a scientific and educational association of surgeons that was founded in 1913 to improve the quality of care for the surgical patient by setting high standards for surgical education and practice. The College currently has approximately 77,000 members, including more than 4,000 Fellows in other countries, making it the largest organization of surgeons in the world. Infonnation concerning the College's organization, programs and activities may be found at www.facs.org. The Senate Finance Committee requested a chart of industry funding. The College's fiscal year end is June 30, so our response includes the years ended June 30, 2006, 2007, 2008 and 2009. The College is providing two charts. The first chart (Exhibit 1) reflects cash transactions that fall within the guidelines of infonnation requested. Detailed infonnation by company is included in Schedules 1, 2, 3 and 4 of Exhibit 1. The infonnation is summarized by area: Sponsorship, Satellite Symposia, sale of registration lists and contributions. The College has not provided descriptions for College programs such as Operation Giving Back (surgical volunteerism), Scholar-in-Residence, Resident Research Scholarship, etc. College program infonnation is available on the website as noted above. The second chart (Exhibit 2) is a summary of in-kind commercial support for continuing medical education activities that also fall within the guidelines of infonnation requested. The in-kind commercial support typically involves borrowing medical equipment and use of associated supplies for teaching purposes. The value of the in-kind contributions is provided by the Board of Regents Chair A. Brent Eastman, MD, FAGS San Diego. CA Vice-Chair CarlosA. Pellegrini, MD, FAGS Seattle, WA H. Randolph Baitey, MD, FACS Houston, TX Barbara L. Bass; MD, FACS Houston, TX Bruce D. Browner, MD, FAGS Farmington, GT Martin B. Gamins, MD, FAGS New York, NY Julie A. Freischlag, MD, FACS Baltimore, MD BarrellG. Haik, MD, FAGS Memphis, TN Rene Lalreniere, MD, FAGS, FRCSC GaigarY,AB Charles D. Mabry, MD, FACS Pine Bluff, AR Mark A. Malangonf, MD, FAGS Cleveland, OH LaMarS. McGinnis, Jr., MD, FACS Atlanta, GA Robin S. McLeod, MD, FACS, FRCSC Toronto, ON Raymond F. Morgan, MD, FAGS Charlottesville, VA Leigh A. Neumayer, MD, FACS Salt Lake City, UT Karl C. Podratz, MD, FACS Rochester, MN J. David Richardson, MD. FAGS Louisville, KY Valerie W. Rusch, MD, FACS New York, NY Marshall Z. Schwartz, MD, FAGS Philadelphia, PA HowardM. Snyder III, MD, FACS Philadelphia, PA Mark C. Weissler, MD, FACS Chapel Hill, NC Thomas V. Whalen, MD, FACS Allentown, PA Board of Governors Chair Michael J. Zinner, MD, FACS Boston, MA Vice-Chair TimothyC. Flynn, MD, FAGS Gainesville, FL Secretary James K. Elsey, MD, FACS Atianta,GA FOUNDED BY SURGEONS OF THE UNITED STATES AND CANADA, 1913 The American Colfege of Surgeons Is an Equal Opportunity/Affirmative Action Employer Senator Grassley United States Senate Committee on Finance January 20, 2010 Page 2 contributing company and the College does not audit or verify the value. In some instances, the contributing company assigns no value. The College enters into a Letter of Agreement with the contributing company that is used to document the conditions, limitations and restrictions imposed by the College. The agreement also provides a section for the contributing company to disclose the value ofthe in-kind contribution. Our chart information is based on the information derived from these agreements. Samples of the Letter of Agreement for 2006, 2007, 2008 and 2009 are included as Exhibit 7. Additional Information o Advertising Revenue. The College is associated with various publications and receives a royalty for the use of the College name and logo. In these instances, there is no advertising revenue paid to the College. These publications include: o Surgery News. The official newspaper of the American College of Surgeons. o A CS Surgery Principles & Practice. A textbook of current, practical resource of surgical best practices. o The Journal a/the American College a/Surgeons. The official scientific publication of the American College of Surgeons. The following publication is produced by the College. The printing and distribution costs are covered by the publisher, who retains any advertising revenue generated by the publication. o The A CS Bulletin. A monthly "news magazine" for all members except retired Fellows. The royalty revenue is not included in the financial chart at Exhibit 1. Annual Meeting Exhibit Space Rental Fees. The College conducts one ofthe largest annual surgical meetings domestically and internationally, the Annual Clinical Congress. The Clinical Congress is a scientific and education meeting that is dedicated to enhancing the competence or performance of surgeons to promote the highest quality of care for surgical patients. The meeting reaches an audience of almost 9,000 health care professionals for the purpose of keeping College members and non-ACS physicians abreast of the current status ofthe art and science of surgery. We provide a highly diversified program of continuing education in all specialties of surgery and in important fields of science, socioeconomic and medical education. The College typically rents a convention center for the education courses, meetings and for health care related exhibit space. The exhibit space rental fees cover the cost of the convention center rental, and they help defray the cost to the College. As such, they are not included in the financial chart at Exhibit 1. The College provides ACS Policies, Procedures, and Information that is issued to all exhibitors and included on our Web site. The Technical Exhibitors Prospectus from the 95 th Annual Clinical Congress is attached as Exhibit 8 and includes items such as o Senator Grassley United States Senate Committee on Finance January 20, 2010 Page 3 eligibility to exhibit, approval by our Technical Exhibits Committee, prohibitions, applicability of Food and Drug Administration (FDA) regulations and other restrictions. The College complies with the Accreditation Council for Continuing Medical Education (ACCME) Accreditation Criteria and AMA regulations as discussed further. o American College of Surgeons Insurance Program (Program) and Trust. The College, as a service to members, sponsors various life and health insurance plans, professional liability, and commercial, homeowners and automobile insurance plans for members. Frequent changes have been made since the late 1950s to keep the plans up-to-date. The three primary carriers are New York Life Insurance Company, The Doctors Company and Liberty Mutual Group. All individual eligibility, underwriting, coverage and claim decisions are made by the carriers. The College intercedes on members' behalf to expedite review of decisions and to impact the coverage decision. The plans are marketed under the College's name, and the College receives a royalty for the use of its name and logo. Also included is an administrative fee to cover the management of the program. The royalty revenue and administrative fee are not included in the financial chart in Exhibit 1. In response to questions from the Senate Finance Committee: 1. Please describe the policies for accepting industry funding and whether or not ACS allows companies to place restrictions or provide guidance on how funding will be spent. The College does solicit and accept industry funding with both College and industry-imposed restrictions; however, all restrictions must comply with ACS policies and the ACCME Standards. A signed, written agreement must document the terms, conditions, and purpose of the commercial support for continuing medical education activities. The College is an ACCME Accredited Provider of Continuing Medical Education. As such, the College must be in compliance with the Accreditation Council for Continuing Medical Education (ACCME) Accreditation Criteria and AMA regulations. A copy of the ACCME Standards for Commercial Support is attached as Exhibit 3. Any relevant disclosures of financial relationships of presenters for all accredited continuing medical education programs are disclosed and published, see sample Clinical Congress Program, Disclosures excerpt Exhibit 10. Any conflicts, as per ACCME standards, are managed or resolved prior to the presentation. The Board of Regents of the American College of Surgeons is responsible for the management and control of the business and affairs of the College. The Board of Regents consists of volunteers who are in an active surgical practice when nominated. College Regents have approved an official statement of the College, ST-36 Statement on guidelines for collaboration of industry and surgical organizations in support of continuing education. Senator Grassley United States Senate Committee on Finance January 20, 2010 Page 4 The Statement is posted on the College's Web site, was published in the Bulletin of the American College ofSurgeons and is also attached as Exhibit 4. The Committee on Development, American College of Surgeons Foundation, approved a policy, Foundation Policy Regarding Contributions from Industry. The policy is attached as Exhibit 5. The United States Public Health Service (PHS) regulation, "Public Health Service Policies on Research Misconduct," at 42 C.F.R. Section 93.301 requires that all institutions which receive or request support for a PHS research, research-training or research-related grant or cooperative agreement maintain their research misconduct assurance by annually submitting a report to the Office of Research Integrity (ORl). The College's Board of Regents approved a policy and procedure, Policy for Receiving and Responding to Allegations of Scientific Misconduct. The policy is attached as Exhibit 6. The College annually files the required Report on Possible Research Misconduct and has not had any allegations, inquiries and!or investigations in the previous five years or any other matters related to the regulation. 2. If ACS allows companies to place restrictions on industry funding, then please explain all restrictions and/or guidance for each transfer of value from industry. For every transfer of value with a restriction, please provide the following information: year of transfer, name of company, and restriction placed on funding. The information concerning restrictions is included on the schedules of information attached to Exhibit 1 as Schedules 1, 2, 3 and 4. The Foundation solicits contributions!grants based on the funding needs identified by the College. The majority of the contributions!grants are in response to applications made on behalf of the College for programs fully designed and directed by the College. The Foundation ensures that any restrictions by the donor are within ACCME standards and College policies. 3. Please explain what policies, if any that ACS plans to adopt to ensure transparency of funding in order to provide a greater public trust in the independence of your organization. The College feels the necessary policies and procedures are currently in place. However, policies and procedures are continuously updated and revised when necessary due to changes in business practices, rules and regulations. The request from the Senate Finance Committee has been shared with the Board of Regents and we will discuss this question at our next Board meeting in February. Senator Grassley United States Senate Committee on Finance January 20, 2010 Page 5 4. Please explain your policies on disclosure of outside income by your top executives and board members. College Regents approved a Policy and Procedure, Conflict of Interest Policy - Officers? Elect, Board of Regents, Board of Govemors Executive Committee, Editor-in-Chief of the Journal a/the American College a/Surgeons and its affiliated organizations. The policy requires annual reporting and provides definitions of a conflict of interest and significant financial interest. The policy requires an annual disclosure statement or more frequently if changes arise that impact a conflict of interest. The Policy is included as Exhibit 9. 5. Please provide the disclosures of outside income filed with your organizations by your top executives and board members. Conflict of Interest disclosure statements which include disclosures of outside income within the guidelines of information requested are as follows: Year 2009 2009 Leader/Staff Description Speaking honorariums Spouse employed Company Adolor Corp, Glaxo Smith Kline Tyco Healthcare Group LP, Surgical Devices, dba Covidien Cook Medical Adolor Corp, Glaxo Smith Kline, Merck, Inc. Tyco Healthcare Group LP, Surgical Devices, dba Covidien Cook Medical Merck, Inc. Tyco Healthcare Group LP, Surgical Devices, dba Covidien Cook Medical VP Sales, Tyco Healthcare Group, US Surgical Cook Medical H. Randolph Bailey Carolos A. Pellegrini 2009 2008 2008 Thomas R. Russell H. Randolph Bailey Carolos A. Pellegrini Device royalty - given to the College Speaking honorariums Spouse employed 2008 2007 2007 Thomas R. Russell H. Randolph Bailey Carolos A. Pellegrini Device royalty - given to the College Speaking honorariums Spouse employed 2007 2006 2006 Thomas R. Russell Carolos A. Pellegrini Thomas R. Russell Device royalty - given to the College Spouse employed Device royalty - given to the College Senator Grassley United States Senate Committee on Finance January 20,2010 Page 6 The College has established procedures in working with industry. The details of any transaction are conducted by staff and follow the established procedures approved by leadership. If you have any questions, please contact Ms. Gay Vincent, Chief Financial Officer, at (312) 202-5449 or gvincent@facs.org. Sincerely, l)47J/~+David B. Hoyt, MD, FACS Executive Director Exhibit 1 American College of Surgeons Cash Transactions Year Name of Company Total Annual Amount of Fundiug Reason(s) that the Funding was Provided 2006 Various (Detail on Schedules 1 - 4) $ 530,893 Fees paid for various Sponsorship opportunities. 296,631 58,800 280,710 " 2007 2008 2009 2006 Various " " " (Detail on Schedules 1 - 4) " " $ 145,000 Fees for Satellite Symposia 2007 2008 2009 2006 Various " " " $ (Detail on Schedules 1 - 4) 176,500 150,000 134,500 " " " 69,017 Sale of registration lists 2007 2008 2009 2006 Various " " " (Detail on Schedules 1 - 4) 35,353 58,562 6,438 " " " $ 659,942 Contributions " " 2007 2008 2009 523,505 1,165,216 1,490,332 " " " " American College of Surgeons 2006 Cash Transactions Schedule 1 _'"eY',,,,,, Name of company ADDLDR' ICOACH MED GROUP IINDUST , LLC IMEDI-FLEX INITI I UNITED STATES JTlCALS I nr,IF~ 'e', ',"",,".',"'::;';,,,,','e ,,,:?'iC,,:,.'.;<\.',' ";1"?{,,\:\, 'i",',,', Amount of Funding $ $ 1$ 1$ 1$ 1$ 1$ ! $ ,$ $ $ 13,000 307,714 1,500 9,200 5,800 110,079 5,800 5,800 1,000 23,000 48,000 530,893 ;, Name of company : CENTER COOK ,THICON I ~ TOTAL $ ~ i~;.e .' o o ,"., .o"." . oo,.'. "'?'C",';A({D,);t'Iil~~iij;rtite ...ce 3.3 All commercial support aSSOCiated with aCME 1.1 A CME provider must ensure that the following decisions were made free of the control of a commercial interest. (See www.accme.org for a definition of a 'commercial interest' and some exemptions.) (a) (b) (e) (d) Identification of CME needs; Determination of educational objectives; Selection and presentation of content; Selection of all persons and organizations that will be in a position to control the content of the CME; (e) Selection of educational methods; (f) Evaluation of the activity. activity must be given with the full knowledge and approval of the provider. Written agreement documenting terms of support 3.4 The terms, conditions, and purposes of the commercial support must be documented in a written agreement between the commercial supporter that includes the provider and its educational partner(s). The agreement must include the provider, even if the support is given directly to the provider's educational partner or a joint sponsor. 3.5 The 1.2 A commercial interest cannot take the role of non-accredited partner in a joint sponsorship relationship. X written agreement must specify the commercial interest that is the source of commercial support. 3.6 Both ~t~~i?~~~c,~;:;,~~~~,uti~({.9~.:,~iipr()iifici.te.?u se of 3.1 The provider must make all decisions regarding the disposition and disbursement of commercial support. 3.2 A provider cannot be required by a commercial interest to accept advice or services concerning teachers, authors, or participants or other education matters, including content, from a commercial interest as conditions of contributing funds or services. 3.11 Social events or meals at CME activities cannot compete with or take precedence over the educational events. ACCME(R) (C) 2004, 2006,2007 ACCME STANDARDS FOR COMMERCIAL SUPPORTS", PAGE20F3 182_20070824 3.12 The provider may not use commercial support to pay for travel, lodging, honoraria, or personal expenses for non-teacher or nonauthor participants of a CME activity. The provider may use commercial support to pay for travel, lodging, honoraria, or personal expenses for bona fide employees and volunteers of the provider, joint sponsor or educational partner. Accountability 4.4 Print or electronic information distributed about the non-CME elements of a CME activity that are not directly related to the transfer of education to the learner, such as schedules and content descriptions, may include productpromotion material or product-specific advertisement. 4.5 A provider cannot use a commercial interest as the agent providing a CME activity to learners, e.g., distribution of self-study CME activities or arranging for electronic access to CME activities. :lC 3.13 The provider must be able to produce accurate documentation detailing the receipt and expenditure of the commercial support. :lC A:~sp~iat~d!.(!)oll1J11erciaIPromotion Si!\~~~~~~!~;;~p~~~pria;te.i\I(a.l1.a!Jemer1fof???? li'l"AN[))\Ri>5.Col1i:e"t:.?andl'()rrri~t"Wii:hOut C:ommercial.Bias 5.1 The content or format of a CME activity or its related materials must promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest. 5.2 Presentations must give a balanced view of therapeutic options. Use of generic names will contribute to this impartiality. If the CME educational material or content includes trade names, where available trade names from several companies should be used, not just trade names from a single company.:lC ~'I"~NDAR[)6.[)isclosureSReleV~"l:to 4.1 Arrangements for commercial exhibits or advertisements cannot influence planning or interfere with the presentation, nor can they be a condition of the provision of commercial support for CME activities. 4.2 Product-promotion material or product-specific advertisement of any type is prohibited in or during CME activities. The juxtaposition of editorial and advertising material on the same products or subjects must be avoided. Live (staffed exhibits, presentations) or enduring (printed or electronic advertisements) promotional activities must be kept separate from CME. o For print, advertisements and promotional materials will Potential Commercial Bia.s . Relevant financial relationships of those with control over CME content not be interleafed within the pages of the CME content. Advertisements and promotional materials may face the first -or last pages of printed CME content as long as these materials are not related to the CME content they 6.1 An individual must disclose to learners any relevant financial relationship(s), to include the following information: o o o The name of the individual; The name ofthe commercial interest(s); The nature of the relationship the person has with each commercial interest. face and are not paid for by the commercial supporters of the CME activity_ For ctJmputer bosed, advertisements and promotional materials will not be visible on the screen at the same time as the CME content and not interlecfed between computer 'windows' or screens of the CME content For . audio and video recording, advertisements and promotional materials will not be included within the CME. There will be no 'commercial breaks: For live, face-fa-face eM?, advertisements and promotional materials cannot be displayed or distributed in the educational space immediately before, during, or after a CME activity. Providers cannot allow representatives of Commercial Interests to engage in sales or promotional activities while in the space or place of the CME activity. 6.2 For an individual with no relevant financial relationship(s) the learners must be informed that no relevant financial relationship(s) exist. Commercial support for the CME activity. o 6.3 The source of all support from commercial interests must be disclosed to learners. When commercial support is 'in-kind' the nature of the support must be disclosed to learners. 6.4 'Disclosure' must never include the use of a trade name or a product-group message. Timing of disclosure 4.3 Educational materials that are part of aCME activity, such as slides, abstracts and handouts, cannot contain any advertising, trade name or a product-group message. 6.5 A provider must disclose the above information to learners prior to the beginning of the educational activity. :lC ACCME(R) (C) 2004, 2006, 2007 ACCME STANDARDS FOR COMMERCIAL SUPPORT sM PAGE30F3 182_20070824 American College of Surgeons Guidelines for collaboration of industry and surgical orga... Page 1 of 2 Exhibit 4 [ST-36] Statement on guidelines for collaboration of industry and surgical organizations in support of continuing education (Revised February 2009) [by the American College of Surgeons] The following statement was developed by the Committee on Ethics and approved by the ACS Board of Regents at its June 2008 meeting. Collaboration between surgical organizations and the medical industry has benefited patient care in North America for many years. The primary objective of professional interactions between surgical organizations and industry should be the improvement of patient care, and such interactions should not be driven by financial or proprietary interests. Likewise, industry continues to be one source of support for continuing medical education (CME) for surgeons; however, surgical organizations must ensure that education is not influenced by collaboration with industry. These guidelines seek to provide a framework to permit corporate support of CME programs while maintaining the autonomy and impartiality of individual surgeons and surgical organizations. The guidelines are consistent with the Updated Standards for Commercial Support.' I. Independence in planning and implementation of educational programs A. Surgical organizations have the ultimate responsibility for the planning and development of CME programs. They must ensure that all decisions are made without any influence by commercial interests. Industry supporters of CME programs must not influence the planning, content, or implementation of an organization's CME program. B. The organization must ensure that everyone who is in a position to influence the content of an education activity has disclosed ali relevant financial relationships with any commercial interests within the last 12 months. Potential conflicls of interest must be managed through appropriate mechanisms established by the organization and disclosed in writing to the learners prior to the start of the activity. C. All individuals who have any role that has influence over or responsibility for the development, management, presentation, or evaluation of the CME activity must disclose relevant financial relationships. Refusal to do so will preclude their participation in that role. II. Commercial support for educational programs A. The terms, conditions, and purposes of the commercial support must be documented in a written agreement between the commercial supporter and surgical organization. A commercial entity must not directly pay a speaker or an individual involved with the development or implementation of the program. Ali commercial support must be provided to the surgical organization. Expenses for travel, accommodations, or honoraria for speakers are to be paid by the organization in compliance with its written policies and procedures. The surgical organization is responsible for all decisions regarding the disposition and disbursement of the funding. Accurate documentation detailing the receipt and expenditure of the commercial support should be maintained. Industry support through educational grants should be acknowledged in a printed announcement at the meeting, but reference must not be made to any specific product. When commercial support is provided in kind, the nature of the support must also be disclosed to the learners. B. C. http://www.facs. org!fellows_info!statements!st-36 .html 112012010 American College of Surgeons Guidelines for collaboration of industry and surgical orga... Page 2 of2 D. Financial support of CME activities may also be provided through advertising and exhibit opportunities. Advertisements must not be placed in proximity to educational content and must be limited to nonscientific publications such as schedules and content descriptions. Advertisement and exhibit fees must not be combined with an educational grant. No industry promotional materials are to be displayed or distributed in the same room as scientific presentations at single session meetings. In larger meetings with multiple simultaneous sessions, the access to promotional materials must be controlled by the surgical organization in order to avoid the appearance of any connection between the distribution of promotional materials and scientific presentations. Industry supporters are prohibited from use of the surgical organization's name, logo, or seal in conjunction with advertising or promotion without written permission of the organization. Industry supporters must not organize any functions involving attendees that conflict with sessions of the meeting program. All industry-sponsored functions must be approved by the surgical organization prior to implementation. Industry exhibits should enhance the scientific activities of the CME program and not interfere with the scientific program. For industry-sponsored symposia, a disclaimer is to appear on all printed materials, stating that the activity has no connection with the official organization's program. All proposals and printed materials developed in connection with sponsored symposia must be submitted to the organization for approval prior to publication. Such symposia must not interfere with the scientific program of the organization. Representatives of industry sponsors must not engage in sales or promotional activities during sessions of the meeting program. Sales and promotional activities must be limited strictly to the exhibit floor or industry events approved by the surgical organization and will not be conducted in conjunction with CME activities. If work that is supported by industry is presented, the poster, presentation, or manuscript must include an acknowledgment of the funding source. Written or recorded details of the scientific program must not be reproduced without the written consent of the surgical organization. E. F. G. H. I. J. K. *Accreditation Council for Continuing Medical Education. ACCME Standards for Commercial Support: Standards to Ensure the Independence of CME Activities. Revised 2007. Available at: http://www.accme.org. Accessed December 30, 2008. Reprinted from Bulletin of the American College of Surgeons Vo1.94, No.2, February 2009 Statements This page and all contents are Copyright (C) 1996~2009 by the American College of Surgeons, Chicago, IL 60611-3211 http://www.facs.orglfellows info/statements/st-36.html 1120/2010 Exhibit 5 FOUNDATION POLICY REGARDING CONTRIBUTIONS FROM INDUSTRY With the exception of advertising revenue and funds for specifically noted marketing and promotional activities, formal solicitation of individual, corporate, or foundation funding in support of programs of the American College of Surgeons shall be conducted through the American College of Surgeons Foundation. The Foundation strictly reserves the right to refuse to accept any offer of individual or corporate support that might embarrass or damage the ACS and its members or patients. When possible, funds should be solicited to support existing programs ofthe College. When restricted funds are solicited and accepted, a formal gift agreement stating terms of the gift or grant, and specific expectations of both the donor and the College shall be drafted and signed by both the donor and the Foundation. When appropriate, the College may also sign the gift agreement. The American College of Surgeons shall have the responsibility for designing, developing and delivering programs of benefit to members and the general public. Under no circumstances shall corporate contributors be permitted to influence program planning, content, implementation or evaluation. The ACS Foundation staff and volunteers shall be aware of, and shall fully comply with the compliance gnidelines issued by the ACCME, PhRMA, and AdvaMed. Nothing of value beyond standard donor recognition for voluntary support, shall be provided in return for corporate contributions unless clearly specified in the formal gift agreement. Reference will not be made to specific products of medical companies when acknowledging support. The Foundation and the College will seek to minimize potential for even the perception of conflict of interest by providing open, full disclosure and accurate and timely documentation relative to corporate support. American College of Surgeons or ACS Foundation endorsement of a sponsoring company or product of a contributing company will not be stated or implied. Page 2 ACS Foundation Policy Statement An employee of the ACS Foundation or volunteer serving on behalf of the Foundation, shall not accept any gift or service with a monetary value in excess of $1 00.00 from contributing companies. ( Approved by the Committee on Development March 6, 2008 ) Exhibit 6 'olicy # BR-050 Page 1 AMERICAN COLLEGE OF SURGEONS Policy and Procedure Policy for Receiving and Responding to Allegations of Scientific Misconduct Approved by: Effective Date: Purpose: Board of Regents June 11, 2001 To define scientific misconduct and to establish procedures for reporting possible misconduct and for responding to and investigating allegations of misconduct. I. Applicability A. This policy and the associated procedures apply to research conducted or sponsored by the American College of Surgeons (the College) supported with funds made available by the U.S. Public Health Service (PHS). Any scientific misconduct observed in connection with College research projects that are not supported by a grant from the PHS should be promptly reported to the Research Integrity Officer, as defined herein, who will recommend to the Chair of the Board of Regents of the College such investigations and other actions necessary to ensure proper protection of the public interest. The policy and associated procedures will normally be followed when an allegation of possible misconduct in science is received by an institutional official. Particular circumstances in an individual case may dictate variation from the normal procedure deemed in the best interests of the American College of Surgeons, the PHS, or other organization providing funding for the research in question. Any change from normal procedures must ensure fair treatment to the subject of the inquiry or investigation. Any significant variation should be approved in advance by the Chair of the Board of Regents of the American College of Surgeons. B. The Board of Regents shall adopt this policy by appropriate resolution pursuant to its Bylaws. The resolution shall be recorded in full in the minutes of the Board of Regents with the complete policy attached. II. Rationale The American College of Surgeons is a not-for-profit organization dedicated to the advancement of knowledge through service, research, and education. It is the College's policy that its employees conduct the business of the College in accordance with the highest legal, ethical, and moral standards. The American College of Surgeons is committed to the highest Policy # BR-050 Page 2 principles of scientific integrity. This Policy on Scientific Misconduct is designed to serve multiple purposes. One is to remind ACS employees of their ethical obligations for integrity in the conduct of research. A second is to inform employees of the consequences of failing to meet these standards. A third purpose is to ensure that employees are aware of and able to correctly utilize procedures to communicate concerns about scientific misconduct to the appropriate institutional officials without fear of reprisal if the allegation is made in good faith. A final purpose is to establish procedures for a fair and impartial determination of the validity of any allegation that scientific misconduct has occurred. III. Definitions A. Allegation means any written or oral statement or other indication of possible scientific misconduct made to an institutional official. Conflict of interest means the real or apparent interference of one person's interests with the interests of another person, where potential bias may occur due to prior or existing personal or professional relationships. Deciding Official means the institutional official who makes final determinations on allegations of scientific misconduct and any responsive institutional actions. The Deciding Official will not be the same individual as the Research Integrity Officer and should have no direct prior involvement in the institution's inquiry, investigation, or allegation assessment. For the American College of Surgeons, the Deciding Official is the Chair ofthe Board of Regents. Goodfaith allegation means an allegation made with the honest belief that scientific misconduct may have occurred. An allegation is not in good faith if it is made with reckless disregard for or willful ignorance of facts that would disprove the allegation. Inquiry means gathering information and initial fact-finding to determine whether an allegation or apparent instance of scientific misconduct warrants an investigation. i Investigation means the formal examination and evaluation of all relevant facts to determine if misconduct has occurred, and, if so, to determine the responsible person and the seriousness of the misconduct ii ORImeans the Office of Research Integrity, the office within the U.S. Department of Health and Human Services (DHHS) that is responsible for the scientific misconduct and research integrity activities of the U. S. Public Health Service. PHS means the U.S. Public Health Service, an operating component ofthe DHHS. B. C. D. E. F. G. H. 2 Policy # BR-050 Page 3 1. PHS regulation means the Public Health Service regulation establishing standards for institutional inquiries and investigations into allegations of scientific misconduct, which is set forth at 42 C.F.R. Part 50, Subpart A, entitled "Responsibility of PHS Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science." PHS support means PHS grants, contracts, or cooperative agreements or applications therefor. Research Integrity Officer means the institutional official responsible for assessing allegations of scientific misconduct and determining when such allegations warrant inquiries and for overseeing inquiries and investigations. Research record means any data, document, computer file, computer diskette, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research that constitutes the subject of an allegation of scientific misconduct. A research record includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files. Respondent means the person against whom an allegation of scientific misconduct is directed or the person whose actions are the subject of the inquiry or investigation. There can be more than one respondent in any inquiry or investigation. Retaliation means any action that adversely affects the employment or other institutional status of an individual that is taken by an institution or an employee because the individual has in good faith, made an allegation of scientific misconduct or of inadequate institutional response thereto or has cooperated in good faith with an investigation of such allegation. Scientific misconduct or misconduct in science means fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data iii Whistleblower means a person who makes an allegation of scientific misconduct. J. K. 1. M. N. o. P. 3 Policy # BR-050 Page 4 IV. Rights and Responsibilities A. Research Integrity Officer The Executive Director will appoint the Research Integrity Officer, who will have primary responsibility for implementation ofthe procedures set forth in this document. The Research Integrity Officer will be an institutional official who is well qualified to handle the procedural requirements involved and is sensitive to the varied demands made on those who conduct research, those who are accused of misconduct, and those who report apparent misconduct in good faith. The Research Integrity Officer will appoint the inquiry and investigation committees and ensure that necessary and appropriate expertise is secured to carry out a thorough and authoritative evaluation of the relevant evidence in an inquiry or investigation. The Research Integrity Officer will attempt to ensure that confidentiality is maintained. The Research Integrity Officer will assist inquiry and investigation committees and all institutional personnel in complying with these procedures and with applicable standards imposed by government or external funding sources. The Research Integrity Officer is also responsible for maintaining files of all documents and evidence and for the confidentiality and the security of the files. The Research Integrity Officer will report to ORI as required by regulation and keep ORI apprised of any developments during the course of an inquiry or investigation that may affect current or potential DHHS funding for the individual(s) under investigation or that PHS needs to know to ensure appropriate use of Federal funds and otherwise protect the public interest. iv B. Whistleblower The whistleblower will have an opportunity to testify before the inquiry and investigation committees, to review portions ofthe inquiry and investigation reports pertinent to hislher allegations or testimony, to be informed of the results of the inquiry and investigation, and to be protected from retaliation. Also, if the Research Integrity Officer has determined that the whistleblower may be able to provide pertinent information on any portions of the draft report, these portions will be given to the whistleblower for comment. The whistleblower is responsible for making allegations in good faith, maintaining confidentiality, and cooperating with an inquiry or investigation. C. Respondent The respondent will be informed of the allegations when an inquiry is opened and notified in writing ofthe fmal determinations and resulting actions. The respondent will also have the opportunity to be interviewed by and present evidence to the inquiry and investigation committees, to review the draft inquiry and investigation reports, and to have the advice of counsel. 4 Policy # BR-050 Page 5 The respondent is responsible for maintaining confidentiality and cooperating with the conduct of an inquiry or investigation. If the respondent is not found guilty of scientific misconduct, he or she has the right to receive institutional assistance in restoring his or her reputation. v D. Deciding Official The Deciding Official will receive the inquiry and/or investigation report and any written comments made by the respondent or the whistleblower on the draft report. The Deciding Official will consult with the Research Integrity Office, the Executive Director, and other appropriate officials and will determine whether to conduct an investigation, whether misconduct occurred, whether to impose sanctions, or whether to take other appropriate administrative actions [see section XI]. v. General Policies and Principles A. Responsibility To Report Misconduct All employees or individuals associated with the American College of Smgeons should report observed, suspected, or apparent misconduct in science to the Research Integrity Officer or to a Director or Manager. If an individual is unsme whether a suspected incident falls within the definition of scientific misconduct, he or she may call the Research Integrity Officer at [telephone number] to discuss the suspected misconduct informally. Ifthe circumstances described by the individual do not meet the defmition of scientific misconduct, the Research Integrity Officer will refer the individual or allegation to other offices or officials with responsibility for resolving the problem. At any time, an employee may have confidential discussions and consultations about concerns of possible misconduct with the Research Integrity Officer and will be counseled about appropriate procedures for reporting allegations. B. Protecting the Whistleblower The Research Integrity Officer will monitor the treatment of individuals who bring allegations of misconduct or of inadequate institutional response thereto, and those who cooperate in inquiries or investigations. The Research Integrity Officer will ensme that these persons will not be retaliated against in the terms and conditions of their employment or other status at the institution and will review instances of alleged retaliation for appropriate action. Employees should immediately report any alleged or apparent retaliation to the Research Integrity Officer. Also, the institution will protect the privacy of those who report misconduct in good faith to the maximum extent possible. For example, if the whistleblower requests anonymity, the institution will make an effort to honor the request during the allegation assessment or vi 5 Policy # BR-050 Page 6 inquiry within applicable policies and regulations and state and local laws, if any. The whistleblower will be advised that if the matter is referred to an investigation committee and the whistleblower's testimony is required, anonymity may no longer be guaranteed. Institutions are required to undertake diligent efforts to protect the positions and reputations of those persons who, in good faith, make allegations. vii C. Protecting the Respondent Inquiries and investigations will be conducted in a manner that will ensure fair treatment to the respondent(s) in the inquiry or investigation and confidentiality to the extent possible without compromising public health and safety or thoroughly carrying out the inquiry or investigation. viii Institutional employees accused of scientific misconduct may consult with legal counsel or a non-lawyer personal adviser (who is not a principal or witness in the case) to seek advice and may bring the counselor personal adviser to interviews or meetings on the case. D. Cooperation with Inquiries and Investigations Institutional employees will cooperate with the Research Integrity Officer and other institutional officials in the review of allegations and the conduct of inquiries and investigations. Employees have an obligation to provide relevant evidence to the Research Integrity Officer or other institutional officials on misconduct allegations. E. Preliminary Assessment of Allegations Upon receiving an allegation of scientific misconduct, the Research Integrity Officer will immediately assess the allegation to detennine whether there is sufficient evidence to warrant an inquiry, whether PHS support or PHS applications for funding are involved, and whether the allegation falls under the PHS definition of scientific misconduct. VI. Conducting the Inquiry A. Initiation and Purpose of the Inquiry Following the preliminary assessment, if the Research Integrity Officer determines that the allegation provides sufficient infonnation to allow specific follow-up, he or she will immediately initiate the inquiry process. In initiating the inquiry, the Research Integrity Officer should identifY clearly the original allegation and any related issues that should be evaluated. The purpose of the inquiry is to make a preliminary evaluation of the available evidence and testimony of the respondent, whistleblower, and key witnesses to detennine whether there is sufficient evidence of possible scientific misconduct to warrant an investigation. The purpose of the inquiry is not to reach a final conclusion about whether misconduct definitely occurred or who was responsible. The findings of the inquiry must be set forth in an inquiry report. 6 Policy # BR-050 Page 7 B. Sequestration of the Research Records After determining that an allegation falls within the definition of misconduct in science, whether or not it involves PHS funding, the Research Integrity Officer must ensure that all original research records and materials relevant to the allegation are immediately secured. The Research Integrity Officer may consult with ORI for advice and assistance in this regard if the misconduct involves PHS funding. C. Appointment of the Inquiry Committee The Research Integrity Officer, in consultation with other institutional officials as appropriate, will appoint an inquiry committee and committee chair within I 0 days of the initiation of the inquiry. The inquiry committee should consist of individuals who do not have real or apparent conflicts of interest in the case, are unbiased, and have the necessary expertise to evaluate the evidence and issues related to the allegation, interview the principals and key witnesses, and conduct the inquiry. These individuals may be scientists, subject matter experts, administrators, lawyers, or other qualified persons, and they may be from inside or outside the institution. The Research Integrity Officer will notify the respondent of the proposed committee membership within 5 days following appointment of the committee. If the respondent submits a written objection to any appointed member ofthe inquiry committee or expert based on bias or conflict of interest within 5 days, the Research Integrity Officer will determine whether to replace the challenged member or expert with a qualified substitute. D. Charge to the Committee and the First Meeting The Research Integrity Officer will prepare a charge for the inquiry committee that describes the allegations and any related issues identified during the allegation assessment and states that the purpose of the inquiry is to make a preliminary evaluation of the evidence and testimony of the respondent, whistleblower, and key witnesses to determine whether there is sufficient evidence of possible scientific misconduct to warrant an investigation as required by the PHS regulation. The purpose is not to determine whether scientific misconduct definitely occurred or who was responsible. At the committee's first meeting, the Research Integrity Officer will review the charge with the committee, discuss the allegations, any related issues, and the appropriate procedures for conducting the inquiry, assist the committee with organizing plans for the inquiry, and answer any questions raised by the committee. The Research Integrity Officer and institutional counsel will be present or available throughout the inquiry to advise the committee as needed. E. Inquiry Process The inquiry committee will normally interview the whistleblower, the respondent, and 7 Policy # BR-050 Page 8 key witnesses as well as examining relevant research records and materials. Then the inquiry committee will evaluate the evidence and testimony obtained during the inquiry. After consultation with the Research Integrity Officer and institutional counsel, the committee members will decide whether there is sufficient evidence of possible scientific misconduct to recommend further investigation. The scope of the inquiry does not include deciding whether misconduct occurred or conducting exhaustive interviews and analyses. VII. The Inquiry Report A. Elements of the Inquiry Report A written inquiry report must be prepared that states the name and title of the committee members and experts, if any; the allegations; the PHS support, if any; a summary of the inquiry process used; a list of the research records reviewed; summaries of any interviews; a description of the evidence in sufficient detail to demonstrate whether an investigation is warranted or not; and the committee's determination as to whether an investigation is recommended and whether any other actions should be taken if an investigation is not recommended. Institutional counsel will review the report for legal sufficiency. B. Comments on the Draft Report by the Respondent and the Whistleblower The Research Integrity Officer will provide the respondent with a copy of the draft inquiry report for comment and rebuttal and will provide the whistleblower, ifhe or she is identifiable, with portions of the draft inquiry report that address the whistleblower's role and opinions in the investigation. 1. Confidentiality The Research Integrity Officer may establish reasonable conditions for review to protect the confidentiality of the draft report. 2. Receipt of Comments Within 14 calendar days of their receipt of the draft report, the whistleblower and respondent will provide their comments, if any, to the inquiry committee. Any comments that the whistleblower or respondent submits on the draft report will become part of the [mal inquiry report and record. ix Based on the comments, the inquiry committee may revise the report as appropriate. C. Inquiry Decision and Notification 1. Decision by Deciding Official The Research Integrity Officer will transmit the final report and any comments to the Deciding Official, who will make the determination of 8 Policy # BR-050 Page 9 whether fmdings from the inquiry provide sufficient evidence of possible scientific misconduct to justify conducting an investigation. The inquiry is completed when the Deciding Official makes this determination, which will be made within 60 days of the first meeting of the inquiry committee. Any extension of this period will be based on good cause and recorded in the inquiry file. 2. Notification The Research Integrity Officer will notify both the respondent and the whistleblower in writing ofthe Deciding Official's decision of whether to proceed to an investigation and will remind them of their obligation to cooperate in the event an investigation is opened. The Research Integrity Officer will also notify all appropriate institutional officials of the Deciding Official's decision. D. Time Limit for Completing the Inquiry Report The inquiry committee will normally complete the inquiry and submit its report in writing to the Research Integrity Officer no more than 60 calendar days following its frrst meeting: unless the Research Integrity Officer approves an extension for good cause. If the Research Integrity Officer approves an extension, the reason for the extension will be entered into the records of the case and the report. Jd The respondent also will be notified of the extension. VIII. Conducting the Investigation A. Purpose of the Investigation The purpose of the investigation is to explore in detail the allegations, to examine the evidence in depth, and to determine specifically whether misconduct has been committed, by whom, and to what extent. The investigation will also determine whether there are additional instances of possible misconduct that would justify broadening the scope beyond the initial allegations. This is particularly important where the alleged misconduct involves clinical trials or potential harm to human subjects or the general public or if it affects research that forms the basis for public policy, clinical practice, or public health practice. The fmdings of the investigation will be set forth in an investigation report. B. Sequestration ofthe Research Records The Research Integrity Officer will immediately sequester any additional pertinent research records that were not previously sequestered during the inquiry. This sequestration should occur before or at the time the respondent is notified that an investigation has begun. The need for additional sequestration of records may occur for any number of reasons, including the institution's decision to investigate additional allegations not considered during the inquiry stage or the identification of records during the inquiry process that had not been previously secured. 9 Policy # BR-050 Page 10 The procedures to be followed for sequestration during the investigation are the same procedures that apply during the inquiry. C. Appointment of the Investigation Committee The Research Integrity Officer, in consultation with other institutional officials as appropriate, will appoint an investigation committee and the committee chair within 10 days of the notification to the respondent that an investigation is planned or as soon thereafter as practicable. The investigation committee should consist of at least three individuals who do not have real or apparent conflicts of interest in the case, are unbiased, and have the necessary expertise to evaluate the evidence and issues related to the allegations, interview the principals and key witnesses, and conduct the investigation. xii These individuals may be scientists, administrators, subject matter experts, lawyers, or other qualified persons, and they may be from inside or outside the institution. Individuals appointed to the investigation committee may also have served on the inquiry committee. The Research Integrity Officer will notify the respondent of the proposed committee membership within 5 days. If the respondent submits a written objection to any appointed member of the investigation committee or expert, the Research Integrity Officer, in consultation with the Executive Director, will determine whether to replace the challenged member or expert with a qualified substitute. D. Charge to the Committee and the First Meeting 1. Charge to the Committee The Research Integrity Officer will define the subject matter of the investigation in a written charge to the committee that describes the allegations and related issues identified during the inquiry, defines scientific misconduct, and identifies the name of the respondent. The charge will state that the committee is to evaluate the evidence and testimony of the respondent, whistleblower, and key witnesses to determine whether, based on a preponderance of the evidence, scientific misconduct occurred and, if so, to what extent, who was responsible, and its seriousness. During the investigation, if additional information becomes available that substantially changes the subject matter of the investigation or would suggest additional respondents, the committee will notify the Research Integrity Officer, who will determine whether it is necessary to notify the respondent of the new subject matter or to provide notice to additional respondents. 2. The First Meeting The Research Integrity Officer, with the assistance of institutional counsel, 10 Policy # BR-050 Page 11 will convene the first meeting of the investigation committee to review the charge, the inquiry report, and the prescribed procedures and standards for the conduct of the investigation, including the necessity for confidentiality and for developing a specific investigation plan. The investigation committee will be provided with a copy of these instructions and, where PHS funding is involved, the PHS regulation. E. Investigation Process The investigation committee will be appointed and the process initiated within 30 days of the completion of the inquiry, if findings from that inquiry provide a sufficient basis for conducting an investigation. xiii The investigation will normally involve examination of all documentation including, but not necessarily limited to, relevant research records, computer files, proposals, manuscripts, publications, correspondence, memoranda, and notes of telephone calls. xiv Whenever possible, the committee should interview the whistleblower(s), the respondents(s), and other individuals who might have information regarding aspects of the allegations. xv Interviews ofthe respondent should be tape recorded or transcribed. All other interviews should be transcribed, tape recorded, or summarized. Summaries or transcripts ofthe interviews should be prepared, provided to the interviewed party for comment or revision, and included as part of the investigatory file. xvi IX. The Investigation Report A. Elements of the Investigation Report The final report must describe the policies and procedures under which the investigation was conducted, describe how and from whom information relevant to the investigation was obtained, state the [mdings, and explain the basis for the findings. The report will include the actual text or an accurate summary of the views of any individual(s) found to have engaged in misconduct as well as a description of any sanctions imposed and administrative actions taken by the institution. xvii If PHS funding was involved, this is the report that will be submitted to ORl. B. Comments on the Draft Report 1. Respondent The Research Integrity Officer will provide the respondent with a copy of the draft investigation report for comment and rebuttal. The respondent will be allowed 10 days to review and comment on the draft report. The respondent's comments will be attached to the final report. The findings ofthe [mal report should take into account the respondent's comments in addition to all the other evidence. 11 Policy # BR-050 Page 12 2. Whistleblower The Research Integrity Officer will provide the whistleblower, ifhe or she is identifiable, with those portions of the draft investigation report that address the whistleblower's role and opinions in the investigation. The report should be modified, as appropriate, based on the whistleblower's comments. 3. Institutional Counsel The draft investigation report will be transmitted to the institutional counsel for a review of its legal sufficiency. Comments should be incorporated into the report as appropriate. 4. Confidentiality In distributing the draft report, or portions thereof, to the respondent and whistleblower, the Research Integrity Officer will inform the recipient of the confidentiality under which the draft report is made available and may establish reasonable conditions to ensure such confidentiality. For example, the Research Integrity Officer may request the recipient to sign a confidentiality statement or to come to his or her office to review the report. C. Institutional Review and Decision Based on a preponderance of the evidence, the Deciding Official will make the final determination whether to accept the investigation report, its findings, and the recommended institutional actions. If this determination varies from that of the investigation committee, the Deciding Official will explain in detail the basis for rendering a decision different from that of the investigation committee. Ifthe report is transmitted to ORI, this information will be included in the institution's letter transmitting the report to OR!. The Deciding Official's explanation should be consistent with the PHS definition of scientific misconduct, the institution's policies and procedures, and the evidence reviewed and analyzed by the investigation committee. The Deciding Official may also return the report to the investigation committee with a request for further fact-finding or analysis. The Deciding Official's determination, together with the investigation committee's report, constitutes the final investigation report for purposes of OR! review. When a final decision on the case has been reached, the Research Integrity Officer will notifY both the respondent and the whistle blower in writing. In addition, the Deciding Official will determine whether law enforcement agencies, professional societies, professional licensing boards, editors of journals in which falsified reports may have been published, collaborators of the respondent in the work, or other relevant parties should be notified of the outcome of the 12 Policy # BR-050 Page 13 case. The Research Integrity Officer is responsible for ensuring compliance with all notification requirements of funding or sponsoring agencies. D. Transmittal ofthe Final Investigation Report to ORI After comments have been received and the necessary changes have been made to the draft report, the investigation committee should transmit the final report with attachments, including the respondent's and whistleblower's comments, to the Deciding Official, through the Research Integrity Officer. E. Time Limit for Completing the Investigation Report An investigation should ordinarily be completed within 120 days of its initiation,]{Viii with the initiation being defined as the first meeting of the investigation committee. This process includes conducting the investigation, preparing the report of findings, making the draft report available to the subject of the investigation for comment, submitting the report to the Deciding Official for approval, and submitting the report to the ORI. xix x. Requirements for Reporting to ORI A. The College's decision to initiate an investigation must be reported in writing to the Director, ORI, on or before the date the investigation begins."" At a minimum, the notification should include the name ofthe person(s) against whom the allegations have been made, the general nature of the allegation as it relates to the PHS definition of scientific misconduct, and the PHS applications or grant number(s) involved.,oo ORI must also be notified of the fmal outcome of the investigation and must be provided with a copy of the investigation report. ""ii Any significant variations from the provisions of the institutional policies and procedures should be explained in any reports submitted to ORI. B. If the College plans to terminate an inquiry or investigation for any reason without completing all relevant requirements of the PHS regulation, the Research Integrity Officer will submit a report of the planned termination to ORI, including a description of the reasons for the proposed termination.""iii C. If the College determines that it will not be able to complete the investigation in 120 days, the Research Integrity Officer will submit to ORI a written request for an extension that explains the delay, reports on the progress to date, estimates the date of completion of the report, and describes other necessary steps to be taken. If the request is granted, the Research Integrity Officer will file periodic progress reports as requested by the ORI.""iv D. When PHS funding or applications for funding are involved and an admission of scientific misconduct is made, the Research Integrity Officer will contact ORI for consultation and advice. Normally, the individual making the admission will be asked to sign a statement attesting to the occurrence and extent of misconduct. When the case involves PHS funds, the institution cannot accept an admission of scientific misconduct as a basis for closing a case or not undertaking an investigation without prior approval from ORI.= 13 Policy # BR-050 Page 14 E. The Research Integrity Officer will notify OR! at any stage of the inquiry or investigation if: 1. 2. 3. there is an immediate health hazard involved;xxvi there is an immediate need to protect Federal funds or equipment;XXVii there is an immediate need to protect the interests of the person( s) making the allegations or of the individual(s) who is the subject of the allegations as well as hislher co-investigators and associates, if any;xxviii it is probable that the alleged incident is going to be reported publicly;XXiX or the allegation involves a public health sensitive issue, e.g., a clinical trial; or there is a reasonable indication of possible criminal violation. In this instance, the institution must inform OR! within 24 hours of obtaining that information. xxx 4. 5. 6. XI. Institutional Administrative Actions The American College of Surgeons will take appropriate administrative actions against individuals when an allegation of misconduct has been substantiated. xxxi If the Deciding Official determines that the alleged misconduct is substantiated by the findings, he or she will decide on the appropriate actions to be taken, after consultation with the Research Integrity Officer. The actions may include: withdrawal or correction of all pending or published abstracts and papers emanating from the research where scientific misconduct was found. removal of the responsible person from the particular project, letter of reprimand, special monitoring of future work, probation, suspension, salary reduction, or initiation of steps leading to possible rank reduction or termination of employment; and restitution of funds as appropriate. XII. Other Considerations A. Termination of Institutional Employment or Resignation Prior to Completing Inquiry or Investigation 14 Policy # BR-050 Page 15 The termination of the respondent's institutional employment, by resignation or otherwise, before or after an allegation of possible scientific misconduct has been reported, will not preclude or terminate the misconduct procedures. If the respondent, without admitting to the misconduct, elects to resign his or her position prior to the initiation of an inquiry, but after an allegation has been reported, or during an inquiry or investigation, the inquiry or investigation will proceed. If the respondent refuses to participate in the process after resignation, the committee will use its best efforts to reach a conclusion concerning the allegations, noting in its report the respondent's failure to cooperate and its effect on the committee's review of all the evidence. B. Restoration of the Respondent's Reputation If the College fmds no misconduct and ORI concurs, after consulting with the respondent, the Research Integrity Officer will undertake reasonable efforts to restore the respondent's reputation. Depending on the particular circumstances, the Research Integrity Officer should consider notifying those individuals aware of or involved in the investigation of the final outcome, publicizing the final outcome in forums in which the allegation of scientific misconduct was previously publicized, or expunging all reference to the scientific misconduct allegation from the respondent's personnel file. Any institutional actions to restore the respondent's reputation must first be approved by the Deciding Official. C. Protection of the Whistleblower and Othersxxxii Regardless of whether the College or ORI determines that scientific misconduct occurred, the Research Integrity Officer will undertake reasonable efforts to protect whistleblowers who made allegations of scientific misconduct in good faith and others who cooperate in good faith with inquiries and investigations of such allegations. Upon completion of an investigation, the Deciding Official will determine, after consulting with the whistleblower, what steps, if any, are needed to restore the position or reputation of the whistleblower. The Research Integrity Officer is responsible for implementing any steps the Deciding Official approves. The Research Integrity Officer will also take appropriate steps during the inquiry and investigation to prevent any retaliation against the whistleblower. D. Allegations Not Made in Good Faith If relevant, the Deciding Official will determine whether the whistleblower's allegations of scientific misconduct were made in good faith. If an allegation was not made in good faith, the Deciding Official will determine whether any administrative action should be taken against the whistleblower. E. Interim Administrative Actions College officials will take interim administrative actions, as appropriate, to protect Federal funds and ensure that the purposes of the Federal financial assistance are carried OUt. xxxiii 15 Policy # BR-050 Page 16 XIII. Record Retention After completion of a case and all ensuing related actions, the Research Integrity Officer will prepare a complete file, including the records of any inquiry or investigation and copies of all documents and other materials furnished to the Research Integrity Officer or committees. The Research Integrity Officer will keep the file for three years after completion of the case to permit later assessment of the case. ORI or other authorized DHHS personnel will be given access to the records upon request. xxxiv XIV. Intended Compliance This policy is intended to comply with PHS regulations. In the event of any conflict between this policy and PHS regulations, the PHS regulations shall control and the Research Integrity Officer shall conform the procedures set forth herein to such regulations. The Research Integrity Officer and the College Executive Director may waive applicability of any portion of this policy to particular facts and circumstances to ensure the best use of college resources while protecting the public interest; provided, that no portion of this policy required by PHS regulations may be waived. 16 Policy # BR-050 Page 17 NOTES: I 42 C.F.R. ' 50.102. 42 C.F.R. ' 50.102. 42 C.F.R. ' 50.102. 42 C.F.R. ' 50.103(d)(12). 42 C.F.R. ' 50.103(d)(13). 42 C.F.R. ' 50.103(d)(2). 42 C.F.R. ' 50.103(d)(13). 42 C.F.R. ' 50.103(d)(3). 42 C.F.R. ' 50.103(d)(1). 42 C.F.R. ' 50.103(d)(1). 42 C.F.R. ' 50.103(d)(1). 42 C.F.R. ' 50.103(d)(8). 42 C.F.R. ' 50.103(d)(7). 42 C.F.R. ' 50.103(d)(7). 42 C.F.R. ' 50.103(d)(7). 42 C.F.R. ' 50.103(d)(7). 42 C.F.R. ' 50.104(a)(4); 42 C.F.R. ' 50.103(d)(15). 42 C.F.R. ' 50.104(a)(2). 42 C.F.R. ' 50.104(a)(2). 42 C.F.R. ' 50.104(a)(1). 11 m IV V VI V11 viii ix x Xl xii xiii XIV xv XVI XV11 xviii XIX xx 17 Policy # BR-050 Page 18 xxi xxii XX111 42 C.F.R. o 50.104(a)(1). 42 C.F.R. o 50.103(d)(15). 42 C.F.R.o 50.104(a)(3). 42 C.F.R.o 50.104(a)(5). 42 C.F.R. o 50.104(a)(3). 42 C.F.R. o 50.104(b)(l). 42 C.F.R. o 50.104(b)(2). XXIV xxv XXVI XXVII xxviii 42 C.F.R. o 50.104(b)(3). XXIX 42 C.F.R. o 50.104(b)(4). 42 c.F.R. o 50. 104(b)(5). 42 C.F.R. o 50.103(d)(14). xxx xxxi xxxii 42 C.F.R. o 50.103(d)(14). xxxiii 42 C.F.R. o 50.103(d)(11). xxxiv 42 C.F.R. o 50.103(d)(10). 18 09/17/2009 12:14 FAX fil]0011002 Am'",rican Collage of Surgeons LETTER OF AGREEMENT Terms and Conditions of an Educational Grant Exhibit 7 POAt-ll" Fax Note Regarding the followIng CME ActiVIty: MeetIng Name: Breast Ductoscopy Course Data and Location of Meeting: Monday, October 12, 2009 ~oH~ G-h;" 7671 L o?.. 1.,.,...?cLlp~""~ ;;> Ftom c~ ,e~",<=> 3 ~s I-c"'~ , , i Discussion of Unapproved Uses The ACS will require that presenters disclose when a product fs considered off-label or investigationa!. Page 1 of 2 09/17/2009 12:14 FAX Opportunities for Debate The ACS will ensure meaningful opportunities for questioning or scien~fic debate. ~002/002 Funds anould be in the form of an Educational Grant made payable to the American College of Surgeons. No ather fllnds from the commercial supporter will be paid to the program director, faculty, or others involved with the CME activity (additional honoraria, extra social events, etc.) The Commercial Supporter agrees to abide by all requirements of the ACCME'9 standards for Commercial ~ __ ~~upport of Continuing Medical Education. .. ~- ...- - -..- - - The American College of Surgeons agrees to: ~ ~ ---t Comply with the ACCME's Stendards of Commercial Support of CME. Acknowledge educational suppert from the commercial supporter in on?site program materials. Upon reques~ furnish the commercial supporter a report concerning the expenditure of the funds provided. . . > ===--=~======~==--=============e======:;======================================--=;:;===~:=== AGREED SignaturelDat9,_ _ _ _ _2.c;.....::-L=::::....__~_____ p rint NamemtI8c-_.e;.....~""'!:__<.;..s::?_....::;.:Q.._ _ _ __ For the Commercial Company: For the American College of Surgeons: \. Rev 1/2009 Page 2 of 2 SEP-03-200B 15:59 American College of Surgeons LEITER OF AGREEMENT Terms and Conditions of an Educational Grant P.001 Exhibit 7 Reoarding the following CMf Activity: Meeting Name: 94th Annual American College of Surgeons Clinical Congress Date and Location of Meeting: October 12?16, 2008; Moscone Convention Center, San Francisco, CA __ l-cammercialCOmpanv.:-----------AIoka-lJIUascund--------------------Commercial Company Address: Company Contact Name: Telephone: 10 Fairfield Blvd_ Tom Oko e-mail: toko@aloka_com 203-269?5088 ;(20?. Fax: This grant will provide support for the above named CMf adivity by means of X Other gift in kind (equipment loan) Approximate Value: $}oD 0 .... EqUipment Sunday, October 12,2008 SC03 Uluasound Course fOT Residents 9:35 AM o 12:35 PM 2 Machines wI abdominal and small parts probes, full complement of probes for the machines including high and low frequency and micn>-conv.x_ Sunday, October 12, 2008 SC04 UltraSound Instructors Course IO:15AM?12:15PM 2 Machines o Transabdomial & Small Parts Probes seos Sunday. October 12, 2008 Ultrasound in the Surgical reu 1:00 PM? 5:30 PM 1 FAST station - ? 'J. Sunday, October 12, 2008 Se06 Vascular Ultrasound: New Applicalions and Laboratory Management 2:00 PM? 5:00 PM 3 Machines All Probes Convex Low Smatiparts Linear Vascular Linear Monday, October 13, 2008 SC09 Thyroid and Parathyroid Ultrasound 1:30PM-5:15PM 2 machines, small parts probes Tuesday, October 14, 2008 Sel3 Breast Ultrasound 2:00 PM? S:45 PM 3 Machines Page 1 of 72 SEP-03~2008 15:59 P.002 Wednesday, Ootober 15, 2008 SCIS AdVllllced Ultrasound and StereofBctic Breast Imaging Tecbnologies for Diagnosis and Therapy 3:15PM-5:30PM 3 Machines Wednesday, October 15, 2008 . SC16 The Minimally Invasive Approach to Breast Biopsy: Basic Stereotactic Technique and Application 10:00 AM - 12:30 PM 3 Macnines Conditions Statement of Purpose This activity is for scientific and educationafpurposes only. It will not promote the company's products, directly, or indirectly. Control of Content & Selection of Presenters and Moderators Sponsors are responsible for full control of content and selection of presenters and moderators. The ACCME Standards require that the Sponsors conduct the Program independently and without control or influence by the commercial company over the Program's planning, content (including the selection of speakers or moderators), or execution. Disclosure of Financial Relationships . The Sponsors will ensure meaningful disclosure to the audience, at the time of the program of the Company funding and any signiflCal1t relationship between the sponsor and Company (e.g., grant recipient) or between individual speakers or moderators and the Company. InllOlvement in Content There will be no "scripting", emphasis, or direclion on content by the Company or its agents. Ancillary Promotional Activities No promotional activities wiU be permitted in the same room or vicinity before, during, or alter the educational activity. No product advertisements will be permitted in the activity room. Objectivity & Balance Sponsors are required by ACS policy and the ACCME StandaRds to ensure that the program be objective, balanced, and scientifically .rigoTOUS. Llmilation on Data The Sponsof& will ensure, to the extent possible, meaningful disclosure of limitations on data [e.g., ongoing research, interim analyses, preliminary data, or unsupported opinion). Discussion of Unapproved Uses The ACS will require that presenters disclose when a product is considered off-label or investigational. Opportunities for Debate The ACS will ensure meaningful opportunRies for questioning or scientific debate. Funds should be in the form of an Educational Grant made payable to the American Col/ege of Surgeons. No other funds from the commercial.supporter will be paid to the program director, faculty, or others involved with the CME activity (additional honoraria, extra social events, etc.) The Commercial Supporter agrees to abide by all requirements of the ACCME's Standards for Commercial Support of Continuing Medical Education. The American College of Surgeons agrees to: >> Comply with the ACCME's Standards of Commercial Support of CME. Page 2 of 72 SEP-03~2008 16:00 ~ P.003 Acknowledge educational support from the commercial supporter in on-site program materials. . ~ Upon request, furnish the commercial supporter a report concerning the expenditure of the funds provided. =~========================~===============================~====--===============~==-===== AGREED For the Commercial Company: ....~_ ~ rt-PrintNamemtle7 ~",iW L..nE,.--t"44tl'dtr@ii'4~--~1 1- 3-..s i For the American College .of Surgeons: Signatu'elDate'--_hh_~H!:--:-C-!..:...c=~.,..,......J....::..t_+-..::.... Print NamelTrtle,_~:gJru~UJ]j~ru~L~~Jt~~~lJy Rev 5/08 Page 3 of 72 OCT-02-2007 10:18 P.001 LETTER OF AGREEMENT Terms and Conditions of an Educational Grant Between The American College of Sl1zgeoDs and the Commercial Supporter: Company Providing the Grant: Aloka Ultrasound Address: 10 Fairfield Blvd. Wallingford, CT 06492 ExJllbit 7 Company Contact Name: Tom Oko _-------------------------------------------------1----f Telephone: 203-269-5088 Fax: 203-269-6075 E-man: toko@..aioka.com Regarding the following CME Activity:_ ~~ - Pmgmm Name: 93 ,,' Annual American College of SWl!eoflS Clinical Congress Date and Location: OcWber 7 - 11, Moria! Convention Center, New Orleans, LA This grant ,,,11 provide support for the above named CME acti..ny by means of: .;Et:) , Other gift in kind (e.g., equipment loan, brochure distribution)_ Approximate Value $ for: SC04:Thyroid and Parathyroid IDtrasoUXId Sunday, 10/7/2007; 1:00 - 5:30 pm EMCC ROS-R09 2 Machines Small Parts Probes scos: Breast IDtzasound Monday, 10/8/2007; 1:00 - 5:45 pm EMCC ROS-R09 2 Macltines SC09: Vascular IDtrasoUDd: New Applications and Laboratoxy Mallagement Monday, 10/8/2007; 2:45 - 5:45 pm EMCC R04-R05 3 Macltines All Probes Convex Low Smallparts Linear Vascular Linear SC13A. Laparoscopk and Open Inuaoperati",e tntrasound in Abdomi!J:ll Sw:gruy Tuesday, 10/9/2007; 9:30 am - 12:00 noon EMCC R04-R05 3 macltines - B-Mode with Color/PoWer Doppler - 3 Abdominal (Transabdominal) Probes - 1 IOUS probe o 1 uis probe SC1311: Lapa.....,opic aDII. OpeD Intraoperative tntrasoUDlI. in Abdominal S1Ugery Tuesday, 10/9i2oo7; 2:00 - 5:30 pm EMCC R04-R05 3 macltines - --B-Mode with Color/Pawer Doppler - 3 Abdominal (Transabdominal) Probes - .110US probe OCT-02-2007 -1 WSprobe 10:18 P.002 SC16: Ultrasound Course for Reslde..ta Tuesday, 10/9/2007; 3:00 - 5:30 pm EMCC R08-R09 2 Machines - Abdominal and Small Parts Probes (I Breast Station, 1 Abdominal/Biliary Station) SC18: Ultrasound Instructors CoUnle Wednesday, 10/10/2007; 9:30 am - 12:30 pm ?---?--EMCC-ROS?R09 2 Machines - Transabdomial & Small Parts Probes SC22: AdV8llced Technology in Image-Guided Diagnosis and Treatment of the Bxeast Wednesday, 10/10/2007; 2:45 - 5:30 pm EMCC R02-R03 2 Machines SC23: Ultrasound In the SUrgical ICU Wednesday, 10/10/2007; 12:30?5:30 pm EMCC R04-R05 2 Machines .j - Low Frequent:;- Transducers Conditions Statement of Purpose This activity is for scientific and educational purposes only_ It will not promote the company's products, directly, or indirectly. Cantrol of Content & Selection of Presenters and Moderato... ACS is responsible for full control content and selection of presenters and modemtnrs. The Company agrees nO[ to direct the content of the program. The Company or its agents will respond only to sponsorinitiated requests for suggestions of presenters or sources ofpossible presenters. Com~w.iIl suggest more than one name (if possiblel; will provide speaker qualifications, will disclose financial or other reIalionsbips between the Campen)' and the speaker, and will provide this information in w.riting. ACS will record role of th". Company or its agents in suggesting presenter{s); will seek suggestions from other sources and will make selection of presenter(s} based on balance and independence. of Disclosure of Financial ReIatioDShips The ACS will ensure meaningfll.l disclo= to the audience, at the time of tho: program of (a) Company fimding and {h} any significant relationship between the sponsor and Company (e.g., grant recipient) or bet .. een indi.idual speakers or moderatDrs and the Company. Involvement hi Content There will? be no ?scripting", emphasis, or direction on content by th" Company or its agents. Ancillary Promotional Activities No promotional activities will be pennittedin the same room or vicinity befure, during, or after the educational activity. No product adverti."ments will be permitted in the activity room. Objectivity & Balance ACS will make every effort to ensure that data regarding the Company's products (or competing products) are objectively select"d and presented, with favorable and unfavorable information and balanced discussion af prevailing infonnation on the product!s) and/or alternative treatments. Limitation on Data . The ACS will ensure, to the extent poSSIble, meaningfll.l disclosure of limitations on data {e.g., ongoing research, interim analyses, preliminaIy data, or unsupported opinion). OCT-02-2007 10:19 P.003 Discussion of Unapproved Uses The ACS will require that presenters disclose when a product is considered off-label or investigational. Opportunities for Debate The ACS will enSUre meaningful opportunities for questioning or scientific debate. Independence of Sponsors in the Use of Contrlbuted Funds All funds and other support associated with tlris CME activity must be given with the iilll knowledge and approval of the American College of SUrgeons. Fwuls should be in the form of an Educational Grant made payable to the American College or Smgeoos. !!fa other funds ?tam the commerclil supporter 11m be pauno---uepmlTaniirector,i&C'alty;-or--!-------! others involved with the eYE activity {additional honoraria, exI:%a!lOCial ~ts, etc.} The Commerc:ial Supporter agrees to abide by all requlrements of the ACCME'. Updated Standanis ?Or Commercial Support of Contiouing? Medical Eclucation. The American College of Surgeons agrees to, ,. Comply \\ith the ACCME's Updated Standards of Commercial Support of CME. "" Ackno....leage educational support from the commercial SUPPOltel. ,. Upon request, furnish the commercial supporter a report concerning the e,> ~ >> Comply with the ACCME's Standards of Commercial Support of CME. Acknowledge educational support from the commercial supporter. Upon request, furnish the commeicial supporter a report concerning the expenditure of the funds provided. For the commercial Company: For the American College of Surgoons: Rev 7106 j I Exhibit ?viii~ii ir ,i 0 QEVR >>.r,r -V 1 ;Vii1??VirVs1$*' VV VV ~z Vi~; ir; a2V- . yVVVLV frcV.ii>>ViVVVV1V1 1 I VV si gi V11V1VV ''ViiV VV iV 1 I .V.VV.V -- V.V.V..V.Tinleline 3 ACS Polities,Ptocedures, and InforI1lation for Exhibiting 4-:-11 AdvertisingOpp()rtunities 13 Contractors 14 Who Does >What at McCormiCk Place 15 Offitial Service Contractors 16 General Freigbt/prayage/Shipping Information 16 Freigbt HandlingandShipping 17 Installation? and Decorating 17 McCormickPlace Utilities 18-:-19 2008 TechriicalExhibitors 20 Index 21 AMERICAN COLLEGE OF SURGEONS 95TH ANNUAL Clinical Congress This fall, approximately 9,000 domestic and international surgeons will arrive in Chicago for one of the largest surgical meetings of its kind! The 95th Annual Clinical Congress will be held at McCormick Place West on October 11-15, 2009. Our attendees come highly motivated to participate in our cutting edge educational programs. They also look forward to the technical exhibits as a logical extension of the educational experience. Current thinking and innovative products and services go hand-in-hand to help surgeons provide the best possible care for their patients and to improve their practice management skills. Last year at your request, our Board approved several changes to the Clinical Congress to make the meeting more valuable to our membership as well as a better market place for you. Once again, we will have a Ph hour lunch break-with no competing General Sessions, and the exhibit hall hours will remain the same-Monday through Wednesday, 9:00 am to 4:30 pm. Don't hesitate in responding and securing your desired booth space for the 95th Annual Clinical Congress. Just complete the enclosed application and return it to us with your deposit check as soon as possible. We look forward to seeing you at the 2009 Clinical Congress, and so do the health care professionals who are looking for "answers" to today's professional needs. Felix P. Niespodziewanski Director, Convention & Meetings Jacquelyn Mitchell Manager, Exhibits & Convention Services 1 Initiates 'Ass'ociate Fellows Residents GU,est'Pnysicians Affiliates Me,dical Students Allied.Health 500 461 1,469 1,308 93 361 479 797 210 (3%) (3%) (10%) (9%) (1%) (3%) (3%) (6%) (1%) SOcial,program Staff & Press Mfscellaneous 597 Latin"A,merk:alCaribbe~m (7%) (6%) (3%) (0%) (1%) (4%) 497 307 27 117 347 74 Canada Australia/Oceania Middle East Asia 6,798 53 59 32 34 125 ~ediatrIc: Surg,ery Pla's~ic: Surg,~ry 4,509 63 47 13 39 102 164 149 300 84 237 612 6,065 152 58 34 56 98 209 105 399 129 315 451 8,372 6,827 69 54 30 40 102 217 196 454 135 266 351 8,961 200 189 385 119 347 271 , U~qlog,ica,l, ~,urgerY >V~sct.il~iSurg~~>,; .. 2 If you have any questions regarding these dates and deadlines, please contact Jacquelyn Mitchell, Manager, Exhibits & Convention Services, Convention & FEBR UARY IMARCH APR ILl 7 APR I LIM A Y Prospectus mailing. Exhibitor block housing form due to ACS. Space assignment/invoice mailing. Full payment for exhibit space due ... Service kit information sent upon receipt of final payment. No refunds issued for cancellations or reductions. Exhibitor-appointed contractor request deadline. Forms and certificates of insurance must be received in writing from the exhibitor by 9:00 am. Faxes will not be accepted (see Rule IVB). Independent contractor certificate naming ACS as an additional insured. ORIGINALS ONLY. Peninsula ("end cap") and freeform island elevation and overview drawings due. Rooming lists and deposits for block housing due. Application for hotel accommodations due to ACS Housing Bureau. Exhibit personnel advance registration deadline. Setup of free-form exhibits begins (prior arrangement required). General setup begins (all exhibitors). Exhibit installation must be completed by 6:00 pm. The exhibit hall will be closed to all personnel at 7:00 pm for cleaning and to prepare for opening. Exhibits open at 9:00 am. Exhibitscloseat4:30pm (move-out begins). J ULY 1 Meetings, at 312/202-5292, fax 312/202-5003, jmitchell@facs.org. AUG U ST 14 AUG U ST 1 4 AUG U ST 1 7 S EPTE M BE R 4 SEPTE M B ER 30 OCTO B ER 8 OCT 0 B ER 9 OCTO B ER 11 OCTOBER 12 OCTOBER 14 A. Objective The purpose of our poliCies and procedures is to provide a professional and educational environment in which the exhibitor can demonstrate, and the attending surgeon can view, products and services that improve the quality of care given to the patient, enhance the management of the surgical practice, or contribute to the educational and instructional atmosphere of the meeting. Our poliCies and procedures, along with the application for exhibit space, are an integral and binding part of your contract with the American College of Surgeons (ACS) and have been designed to be implemented in a fair, effective, and equitable manner. The abbreviation "ACS" used in the policies and procedures shall mean the American College of Surgeons, a not-for-profit corporation, and, as the context may require, its directors, officers, agents, and/or employees duly acting for ACS in the management of the exhibition. returned with full refund. Exhibitors shall not in any manner indicate that ACS endorses or approves of exhibitor's product or service merely because tbe Technical Exhibits Committee approved such product or service for display at the Clinical Congress. Distribution of any printed material, showing of equipment, product presentations to ACS registrants or guests by exhibitors, other than in the exhibitors' assigned booth space during the official dates of the Clinical Congress, is prohibited. 2. fDA REGULATIONS Food and Drug Administration policy and procedures (particularly with respect to the marketing and labeling of investigational drugs and investigational devices) and other applicable policy and procedures. Exhibitors are reminded that the FDA prohibits the advertising or other promotion of investigational or unapproved drugs and devices. The FDA also forbids the promotion of approved drugs or devices for unapproved uses. In addition, under FDA rules, the background of the exhibit must show the generic name of any drug product featured. For additional information, contact: FDA Division of Drug Marketing & Advertising 888/463-6332 B. Eligibility, Fees, Dates, Space Assignment 1. EXHIBIT ELIGIBILITY All products and services to be exhibited must be directly related to patient care and safety or the practice of surgery and approved by the Technical Exhibits Committee in its sole and absolute discretion. All decisions of the Technical Exhibits Committee are final. Exhibitors may only display those products and services that they regularly manufacture or distribute. Exhibitors shall not exhibit any products or services other than those described in their application or approved in writing by the Technical Exhibits Committee. Applications deemed ineligible by the Technical Exhibits Committee will be Exhibitors must abide by all applicable Food and Drug Administration (FDA) regulations, including, but not limited to, any or all approved requirements. Any product that is an investigational device or an investigational drug must be clearly marked as such. Exhibitors must ensure that with respect to all such devices or drugs, only permissible pre approved dissemination of scientific and educational information is provided at the exhibit and that appropriate disclosures and cautionary notices are included with the devices or drugs. All products and services exhibited at the Clinical Congress shall comply with www.fda.gov If the FDA or a court of competent jurisdiction determines that a company's exhibit at an ACS meeting is in violation of any FDA regulations, including, but not limited to, the promotional restrictions and rules described above, the company will be subject to sanctions, including, but not limited to, exclusion from exhibiting at subsequent ACS meetings. 3. TECHNICAL EXHIBIT DATES AND HOURS SAT. 10110 8:00 am-4:30 pm 8:00 am-:6:00 pm 9:00 am-4:30 pm 9:00am-,-4:30 SUN. 10/11 MON,10112 TUE.l0/1~ pm 4:30-9:00 pm 8:00 am-'4:30 pm 8:00 am-12:00 noon WED. 10114 THUo. 10/l5 FRI. 10116 9:00 am-4:30 pm *Exhibitors will be on the floor at 8:00 am 4 4. OFFICIAL MEETING DATES The 95th Annual Clinical Congress of the American College of Surgeons commences on Sunday, October 11, 2009, at 7:30 am and adjourns on Thursday, October 15, 2009, at 1:00 pm. During this period, neither exhibitors nor their agents may conduct, participate in, or sponsor any educational or marketing ACS may use the information supplied by an exhibitor in the application as part of ACS's marketing, advertising, and other informational materials. all your requests are near the main entrance, it is probable that we will not be able to accommodate your choices. By scattering location choices around the floor, you increase your chances of receiving one of your selections. The person who signs the application or their designee shall be the exhibitor's official representative, who certifies Point allocation is as follows: 1 point for every 100 sq ft (10' x 10') of booth space 3 paints for each year of exhibiting, inclusive of 2000 Double paints for companies who exhibited consecutively for the past 5 years, maximum of 54 Triple paints for companies who exhibited consecutively for the past 9 years, maximum of 81 5 bonus points for applications received within 10 business representatives and acts on behalf of the exhibitor for all negotiations and approvals. Distribution of any printed material, showing of equipment, activities directed toward ACS Clinical Congress registrants, other than as part of an approved exhibit, without the permission of ACS. Further information regarding sponsoring a satellite symposium will be sent to all exhibiting companies in late April. Please contact Erin Quinn at 312/202-5034 or equinn@facs.org. 5. EXHIBIT SPACE RENTAL FEES product presentation to ACS registrants or guests by exhibitors, other than in the exhibitors' assigned booth space during the official dates of the Clinical Congress, is prohibited. 7. SPACE ASSIGNMENT NOTIFICATION AND PAYMENT SCHEDULE Space will be rented at $33 per square foot for island and corner locations and $32 per square foot for in-line booths. Standard booth rental for in-line booths includes side (3') and back wall (8') drape and a 7" x 44" sign indicating booth number, company name, city, and state. 6. EXHIBIT SPACE APPLICATION! CONTRACT AND DEPOSIT Space assignment and invoices will be mailed on or about April 27, 2009. Space must be fully paid by July 1, 2009, or it may be reassigned or sold by ACS without notice. The Technical Exhibitors' Service Kit will not be accessible until receipt of final payment. II. PRIORITY POiNT SYSTEMS days of the mailing date 3 bonus points for applications received within 11 to IS business days of the mailing date 1 bonus point for applications received within 16 to 20 business days of the mailing date Exhibiting companies involved in mergers or acquisitions will receive the AND SPACE ASSIGNMENT Points, date of receipt, and exhibitor's preference for proximity to other Each exhibitor shall fill out the application completely and accurately. The Exhibit Space Application/Contract must be accompanied by a $1,000 deposit per 10' x 10' and received by March 27, 2009, to qualify for initial assignment of space using priority paints. Faxes will not be accepted unless accompanied by a credit card number. Applications received after March 27 will be assigned in order of receipt. Applications received from exhibitors who have any outstanding balances due ACS or its vendors will not be processed without resolving unpaid balances. exhibiting companies will be taken into consideration in determining booth location, subject to availability of space and services required, such as water, drain, and electricity. Preferences indicated are for guidance points that were earned by the company with the most favorable exhibit history. 9. CANCELLATIONS, REDUCTIONS, AND REFUNDS Written notification of a reduction or space cancellation must be received only and are not guaranteed. Although you may not have exhibited at ACS previously, bonus paints can still be earned by returning your application with a deposit as quickly as possible. Since the point system for space assignment uses exhibit history, by ACS on or before July 1, 2009, to be eligible for any refund. A $1,000 service charge will be assessed for each 100 sq ft of canceled or reduced space. Space not claimed or occupied after 2:00 pm Sunday, October 11, 2009, for which no special arrangements it is likely that prime spaces will be assigned to long-term exhibitors. If have been made with ACS, may be s Exhibit 9 Policy #BR-040 page 1 AMERICAN COLLEGE OF SURGEONS Policy and Procedure Conflict of Interest Policy - Officers, Officers-Elect, Board of Regents, Board of Governors Executive Committee, Editorin-Chief of the Journal of the American College Surgeons and its affiliated organizations. Approved by: Effective Date: Purpose: Board of Regents June 7,2002 To define, identify, and resolve potential conflicts of interest on the part of officers, board members and other leadership of the American College of Surgeons ("the College")and its affiliated organizations. I. Applicabilitv A. This policy shall apply to the Officers, Officers-Elect, Board of Regents and Directors, Board of Governors Executive Committee, Editor-inChief of the Journal of the American College of Surgeons ("leadership ," "member of leadership"). B. The Board of Regents shall adopt this policy by appropriate resolution pursuant to its Bylaws. The resolution shall be recorded in full in the minutes of the Board of Regents with the complete policy attached. II. Rationale The American College of Surgeons is a nonprofit organization dedicated to the advancement of knowledge through service, research, and education. It is the College's policy and its affiliated organizations that its leadership conduct the business of the College and its affiliated organizations in accordance with the highest legal, ethical, and moral standards. This policy statement is designed to reinforce a standard of conduct that is proper for the College or its affiliated organizations and that protects the reputation, financial well-being, and legal obligations of the College and its affiliated organizations. III. Definitions Conflict of Interest. A conflict of interest may arise as the result of any of the following: whenever a member of the College's or its affiliated organizations leadership has a significant financial interest in an actual or proposed transaction or arrangement that may be of some business interest to the College or its affiliated organizations; or the receipt of significant gifts or other favors. Any Page 1 of 8 3/27/02 Policy #BR-040 page 2 conflict of interest on the part of a member of leadership must be disclosed and acted on as prescribed in this policy. Significant Financial Interest. Significant financial interest means anything of monetary value, including, but not limited to, salary or other payments for services (for example, consulting fees or honoraria); equity interests (for example, stocks, stock options or other ownership interests); and intellectual property rights (for example, patents, copyrights and royalties from such rights). The interest of the leadership may be direct or indirect, including, but not limited to, an interest of an immediate family member or of any other person having a substantial personal relationship to the member. Significant financial interest includes direct and indirect remuneration as well as gifts or favors that are substantial in nature. The term does not include (1) Salary, royalties, or other remuneration from the College or its affiliated organizations. (2) Income from seminars, lectures, or teaching engagements sponsored by public or not-for-profit entities. (3) Income from service on advisory committees or review panels for public or not-for-profit entities. (4) An equity interest that, when aggregated for the member and the member's spouse and dependent children, meets both of the following tests: _ Does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and Does not represent more than a five percent ownership interest in any single entity. (5) Salary, royalties or other payments that, when aggregated for the member and the member's spouse and dependent children over the next 12 months, are not expected to exceed $10,000. (6) Gifts or other favors of in substantial value. Immediate Family Member. Immediate family member includes spouse and dependent children as well as other family members residing in the same household. IV. Members of Leadership A. All leadership of the College or its affiliated organizations shall exercise the utmost good faith in all transactions touching upon their duties and responsibilities to the College and its property or its affiliated organizations. In their dealings with and on behalf of the College or its affiliated organizations, members of leadership shall be held to a strict rule of honesty and fair dealing among themselves and with the College or its affiliated organizations. They shall not use their positions, or knowledge gained from their leadership role, in such a Page 2 of 8 3/27/02 Policy #BR-040 page 3 way that a conflict might arise between the interests of the College, its affiliated organizations or that of the member. B. All acts of members related to the conduct of the business of the College or its affiliated organizations shall be for the best interest of the College or its affiliated organizations. C. Although it is recognized that a degree of conflict of interest may exist from time to time, such conflicts shall not be permitted to adversely influence the decision-making process of the College or its affiliated organizations. To this end, the member shall promptly report in writing the possible existence of a conflict of interest for himself or herself or any other member subject to the policy. The report shall be made to the Treasurer described in paragraph V or to his or her delegate. D. A full disclosure of all facts pertaining to any transaction that is subject to any doubt concerning the possible existence of a conflict of interest shall be made before consummating the transaction. Disclosure shall be made in writing to the Treasurer or to his or her delegate. E. Leadership shall be required to disclose all conflicts of interest to the Treasurer or to his or her delegate utilizing the Disclosure Statement form attached as Exhibit A. The Disclosure Statement shall be filed annually not later than January 31. The procedures to be followed in filing Disclosure Statements shall be established by the Treasurer or by his of her delegate. V. Treasurer The Treasurer shall provide oversight of all leadership conflicts of interest matters in the College or its affiliated organizations pursuant to its conflict of interest policies; recommend changes in conflict of interest policies when appropriate; conduct an annual review of policies and procedures implemented for the purpose of identifying and handling conflicts of interest matters in the College or its affiliated organizations; and take such actions and perform such duties as are otherwise specified for the Treasurer. VI. Examples of Conflicts of Interest For purposes of guidance in applying this policy, the following are examples of conflicts of interest. A. Financial Interests The following are prohibited activities unless specifically approved by the Conflict of Interest Committee: Page 3 of 8 3/27/02 Policy #BR-040 page 4 1. Participation by a member of leadership in a decision by the College or its affiliated organizations (including making a recommendation) to enter into a contract or transaction for the acquisition of goods or services with an entity in which the member or his or her immediate family or any other person having a substantial personal relationship to the member has a significant financial or ownership interest. Ownership in a mutual fund or similar investment that may have holdings in an entity that does business with the College or its affiliated organizations will not constitute a significant financial ownership interest that creates a conflict of interest. 2. Use of employees of the College or its affiliated organizations to perform services for a company or other organization in which the member has a significant financial interest. 3. Use of the College's or its affiliated organizations' supplies or equipment to support the activities of a company or institution in which the member has a significant financial interest. 4. Use of the name of the College, its seal, or its letterhead for other than official business. Use of the name, seal or letterhead of an affiliated organization for other than official business. 5. Participating in the negotiation of or approval of contracts between the College or its affiliated organizations and a company or organization in which the member has a significant financial interest. 6. Use of information acquired as a result of the member's relationship with the College or its affiliated organizations for personal purposes or benefit. 7. Offering or giving something of value beyond what is permitted by law for the purpose of influencing the action of an official in the discharge of his or her public or legal duties. B. Gifts and Other Favors 1. The acceptance of bribes is prohibited under all circumstances. 2. The following are prohibited activities unless specifically approved by the Finance Committee: acceptance of gifts or excessive entertainment from any outside concern that does, or is seeking to do, business with the College or its affiliated organization under circumstances from which it might be inferred that such action was intended to influence or possibly could influence the individual in the performance of his or her duties. Page 4 of 8 3/27/02 Policy #BR-040 page 5 Any gifts accepted by a member of leadership from suppliers, research sponsors, organizations, corporations, or persons who have business dealings with the College or its affiliated organizations should not be of substantial value. 3. Acceptance of reimbursement for travel expenses or other expenses related to a conference or meeting is prohibited except in those instances in which the member is making a presentation or providing a similar contribution at the meeting or conference. It is customary for companies in the medical/health care industry to underwrite medical conferences or other professional meetings that permit academic institutions, professional associations, and health care organizations to provide continuing education. Subsidies from industry, however, should not be accepted to pay for the costs of travel, lodging, or other personal expenses of the members who are merely attending conferences or meetings, nor should subsidies be accepted to compensate for their time. Subsidies for hospitality should not be accepted outside modest meals or social events held as a part of a conference or meeting. It is appropriate for members who are participating in a conference or meeting as presenters or panelists to accept reasonable honoraria and reimbursement for reasonable travel, lodging, and meal expenses. It is also appropriate for members who supply genuine consulting services to receive reasonable compensation and to accept reimbursement for reasonable travel, lodging, and meal expenses. The giving of a gift directly to a member from a company's sales representative may create a personal relationship that could influence the use of the company's goods or services. Accordingly, when a company contributes funds for conferences that are sponsored by academic or other educational institutions, the funds should be given by the company to the conference sponsor who, in turn, can use the money to reduce the registration fee. Payments to defray the costs of a conference should not be accepted directly from the company by the member attending the conference. VII. Disclosures Required In order to identify and to resolve any potential conflict of interest situations, the following disclosures are required: A. All members of leadership of the College or its affiliated organizations will be required to file a Disclosure Statement annually or more frequently if changes arise that may either give rise to a conflict of interest or eliminate a previously reported conflict of interest. Page 5 of 8 3/27/02 Policy #BR-040 page 6 B. Disclosure Statements will be reviewed by the Treasurer or his or her delegate, and any suspected conflicts of interest shall be reported promptly to the Finance Committee of the Board of Regents. C. Members whose Disclosure Statements have been referred to the Finance Committee will be notified by the Treasurer or his or her delegate. D. The Treasurer or his or her delegate will verify annually that Disclosure Statements have been filed and approved and will file a report with the Finance Committee annually of the results of the review of these statements. VIII. Administrative Action in Response to Identified Conflicts of Interest The Finance Committee, when appropriate, shall rule on the propriety of transactions referred to it involving a possible conflict of interest. Prior to any Such ruling, the member of leadership will be provided an opportunity to communicate with the committee concerning the transaction in question. The committee shall recommend to the Board of Regents Executive Committee of the College the administrative action required to avoid a conflict of interest. The Board of Regents Executive Committee shall take action on any presumed or potential violation of this policy by an member of leadership to ensure that a conflict of interest does not arise or does not continue. In addition to any legal penalties, such action may include, but shall not be limited to, oral admonishment, written reprimand, resignation, and restitution. A member of leadership who disagrees with the findings or recommendations of the Finance Committee or the action of the Board of Regents Executive Committee may appeal the decision to the Board of Regents. IX. Distribution of the Policy All members of leadership of the College or its affiliated organizations shall be given a copy of this policy. Page 6 of 8 3/27/02 Policy #BR-040 page 7 DISCLOSURE STATEMENT I have read the College's and its affiliated organizations' Conflict of Interest Policy, understand its application to me and to members of my family, and agree to abide by the policy. Pursuant to the policy, I hereby state that, to the best of my knowledge and belief, I or members of my immediate family have the following interests and activities (check "None" where applicable): 1. OUTSIDE INTERESTS Identify all positions (officers, director, trustee, etc.) and significant financial interests that you or your immediate family own or hold in any entity (i) that provides goods or services to the American College of Surgeons or its affiliated organizations; or (ii) that has made or is making any type of research grant or other award to the College or its affiliated organizations. ( ) None 2. OUTSIDE ACTIVITIES Identify any and all instances in which you or your immediate family render or have rendered services to any entity that to the best of your knowledge, (i) does business with the College or its affiliated organizations (ii) provides services similar to the services of the College or its affiliated organizations, or (iii) that provides services in competition with services of the College or its affiliated organizations: ( ) None 3. OTHER List any other activities or transactions in which you or your immediate family are engaged that might be regarded as constituting a conflict of interest. ( ) None 4. GIFTS, GRATUITIES AND ENTERTAINMENT If you or any member of your immediate family has knowingly accepted gifts, gratuities, or entertainment that might influence your judgement or actions Page 7 of 8 3/27/02 Policy #BR-040 page 8 concerning business of the College or its affiliated organizations, identify such items. ( ) None INSIDE INFORMATION I certify that neither I nor any member of my immediate family has knowingly disclosed or used information relating to the College's or its affiliated organizations' business for my personal profit or advantage or that of my immediate family. I agree that I will advise the Treasurer in writing if there are any changes from the foregoing which should be disclosed under the policy. DATED this _ _ day of _ _ _ _ _ _ , 200_ Leadership Signature Print Name Approved: Signature: Disapproved: _ _ _ _ _ _ _ _ _ _ _ _ __ Signature: Page 8 018 3/27/02 Exhibit 10 Disclosures/1S7 Disclosures In accordance with the ACCME Accreditation Criteria, the American College of Surgeons must ensure that anyone in a position to control the content of the educational activity has disclosed all relevant financial relationships with any commercial interest: Members of the Program Committee were required to disclose all financial relationships and speakers were required to disclose any financial relationship as it pertains to the contentof the ------pres-entaTions:-All reporfe-d- ccrnfilctS-ar"e manageCI-b~ia-aesT?(riated-orncJal a-Sfas-fre-e pl-esenta-tiorl~------- However, if you perceive a bias during a session, please report the circumstances on the session evaluation form, to-ensure Please note we have advised the speakers that it is their responsibility to disclose at the start of their presentation if they will be describing the use of a device, product, or drug that is not FDA approved or the off-label use of an approved device, product, or drug or unapproved usage. The requirement for disclosure is not intended to imply any impropriety of such relationships, but simply to identify such relationships through full disclosure, and to allow the audience to form its own judgments regarding the presentation. If a speaker's name is not listed, this indicates the speaker had nothing to disclose. Full Name Disclosure Session Code Eddie K. Abdalla, MD Arnold P. Advincula, MD, FACS Jeff WAllen, MD FACS Jose I. Almeida, MD, FACS Anthony Atala, MD, EI\CS Sharon L. Bachman, MD Sanofi-Aventis: Honorarium: Speaker's bureau Cooper Surgical: Consultant; Ethicon Endo-5urgery: Consultant; Intuitive Surgical: Consultant; Olympus/Gyrus ACMI: Consultant Allergan Medical: Honoraria: Proctor; Ethicon: Honoraria: Proctor AngioDynamics: Research grant: Principle investigator Plureon Inc: Ownership interest; Tengion Inc: Ownership interest Covidien (Tyco Healthcare): Research grant funding: Co-I; Ethicon GmbH: Laboratory funding; Salary support; Ethicon Inc.:~Mesh registry: Salary support; MTF: Research grant funding: Co-I; w.L. Gore: Laboratory funding: Salary support Forest Laboratories: Honoraria: Consultant; Lilly: Honoraria: Consultant, Speaker's bureau; Mersk: Honoraria: Consultant, speaker's bureau; Schering-Plough: Honoraria: Consultant; Wyeth: Hono~aria: Consultant, speaker's bureau Davol, Inc: Speaker's honoraria: Speaker regarding hernia repair. Porex Surgical, Noonan. GA: Honorarium: Lecturer BARD: Consulting fee: Consultant; GI Dynamics: Consulting fee: Consultant; Satiety: Research support: Investigator; USGI: Research support: Consultant Abbott Laboratories: Honoraria, Consulting fees; Centocor: Honoraria, Consulting fees, grant support; Elan Biogen: Consulting fees; Proctor & Gamble Pharmaceuticals: Grant support; UCB Pharma: Honoraria, Consulting fees Surgical Review Corporation: No compensation: Board member Genomic Health: Honoraria: Speaker Ethicon Endo-Surgery: Consultant fee: Consultant; Fulfillium, Inc: Stocks: Consultant; MetaCure: Consultant fee, stock options: Consultant Covidien: Honorarium: Women in Surgery Advisory Council Financial RelaUonships: Consulting Eisa!: honorarium: Consultant; Sanofi-Aventis: Honorarium: Consultant LifeCel! Corporation: Honoraria: Consultant Ethicon Endosurgery: MIS Bariatric Surgical Fellowship funded by Ethicon: fellowship Intuitive Surgical: Honorarium: Consultant/proctor/speaker Richard Wolf Medical Instruments Co.: Honorarium for speaking/teaching: Speaker Beckman Coulter Incorporated: Research support: Investigator, consultant, speaker; Smith Kline Glaxo Inc: Honorarium: One-time speaker; deCode Genetics: Research support: Investigator, consultant, speaker BARD: Research investigator; Ethicon: Speaker; Sanofi-Aventis: Speaker Covidien: Honoraria: Speaker/course instructor Endo: Advisory board Edwards Lifesciences: Consultant; Scanlan International: Royalties; Intuitive Surgical: Consultant VE18 PG18 VE04 PS116 PS62 PS40 PS113 PSOS PS04 VE04 PS36 SP09 PS64 PS10l PS6l.PS82 SC13 PS95 SP09. VEOS. VE06 VE02? PG18 PG22 ME107 PhUip S. Barie, MD, FACS Reginald C. W Bell, l'vID, FACS C. Robert Bernardino, MD, FACS Marc Bessler, MD, FACS David G. Binion, MD Robin L. Blackstone, MD, FACS Aaron D. Bleznak, MD, FACS Henry Buchwald, MD, FACS Jo Buyske, MD, FACS Diego R. Camacho, MD, FACS Joseph A. Caprini, MD, FACS Alfredo M. Carbonell, DO, PACS, FACOS Robert O. Carpenter, MD Erik P. Castle, MD Peter A. Cataldo, MD, FACS William J. Catalona, MD, FACS Bipan Chand, MD, FACS George Jae-Shik Chang, MD, FACS Sam S. Chang, MD, FACS W. Randolph Chitwood, MD, FACS SC06 PS1l2, SC07, SF27 PS08 PS24 158/Disclosures Full Name Disclosure Session Code Jose R. Cintron, MD, FACS Cook, Surgical Inc: Research grant: Researcher; Baxter: Research grant: Researcher Covidien: Residency lab grant; Covidien: Honoraria: Speaker's bureau; Ethicon, Inc: Honoraria: Speaker's bur?au; WL. Gore & Associates: Fe!1owship financial support; w.L. Gore & Associates: Honoraria: Consultant Johnson and Johnson stock: Nothing: None; Medtronic stock: Nothing: None American College 01 Surgeons: Grant support: PI; Edwards Lifesciences: Grant support: Co-PI; NIH: Grant support: Co-PI; Thoracic Surgery Foundation Research and Education: .Q.~,a~~.support.:T! P5110 PSOS William S. Cobb IV, MD, FACS Fred A. Crawford, Jr., MD, FACS PS24 SFIS Juan A. Crestanello, MD Paul G. Curcil!o, Jr., MD, FACS Timothy A. Damron, MD, FACS Ethicbn, Olympus, Storz: Honorarium: Speaker Genentech, Inc.: Research support for investigator initiated study: Principle investigator; Lippincott, Williams, and Wilkins: Royalties for textbook: Editor and author; Orthovita, Inc.: Research support for investigator initiated study: Principle investigator; Wright Medical: Research support for investigator initiated study: Principle investigator; eMedicine, Inc.: Royalties: Editor and author Adolor: Research funding / Unrestricted educational support I Honorarium: Research, teaching; Covidien: Research funding / Unrestricted educational support / Honorarium: Research, teaching; Ethicon: Research funding / Unrestricted educational support / Honorarium: Research, teaching; Gore: Research funding / Honorarium: Research / teaching Covidien: Education/research grant; Surgical Review Corporation: Consultant Power Medical Interventions: Consulting fee: Consultant Speaker and consultant for Covidien: Honoraria for teaching Single Incision Labs: Course instructor or faculty for prior labs events; Speaker and consultant for Olympus: Honoraria for teaching Single Incision Labs: Course instructor at my facility Clanna Medical (SAVI brachytherapy catheter): Shareholder; Hologic (MamrnoSite brachytherapy catheter): Shareholder Luminous Technologies: Founding member Ethicon Inc: Consulting fees: Consultant; Mentor Corp: Consulting fees: Consultant Genentech: Received royalty payments for patents related to Herceptin Covidien: AdVisory board: Advisor, consultant Covidien: No financial remuneration: Member, M!S and NOTES advisory board; Ethicon: Research grant: Investigator, NOTEs Technology; NeoguJde: Honorarium: Advisory board Porex: Honorarium: Speakers bureau Consultant/speaker; Wyeth: Consultant/speaking fees: Consultant/speaker 5F19 Conor P. Delaney, M8, BCh, PhD, FAC5 5C07, VE22 Eric J. DeMaria, MD, FACS Steven R. DeMeester, MD, FACS George DeNoto, MD, FACS P589,5P06, YE04 PS35 SC13 Frederick M. Dirbas, MD, FACS William C. Dooley, MD, FACS Susan E. Downey, MD, FACS Jeffrey A. Orebin, MD, FACS PG20-1, P57S 5C10 P537 SF12 Quan-Yang Duh, MD, FACS Brian J. Dunkin, MD, FACS SP12, VE16 P5104,5F20, 5C06, YEOS, VE22 Vikram D. Durairaj, MD P504 P566 PG20-1 5C07, VE24 PS3S PS104 Soumitra R. Eachempati, MD, FACS Cubist: Consultant/speaking fees: Consultant/speaker; Pfizer: Consultant/speaking fees: David W Easter, MD, FACS Jonathan E. Efron, MO, FACS Covidien: Honoraria: Speaker Covidien: Honoraria: Instructor and lecturer on laparoscopic colectomy Astra-Zeneca: Speaker bureau; Takeda-Abbott: Speaker bureau Ethicon Endosurgery Canada: Unrestricted educational grant to Steinberg Bernstein Centre McGill University: Coinvestigator at Steinberg BerllStein Centre; Covidien Canada: Unrestricted educational groant to Steinberg Bernstein Centre McGill University: Coinvestigator at Steinberg Bernstein Centre AspenBio Pharma, Inc.: Compensation: Member of medical advisory board; Covidien: Grant funding for investigation into the impact of variability in gastrointestinal bypass procedures on surgical weight loss and diabetes improvement outcomes in a porcine animal model: Co-investigator; Sanofi-Aventis: Grant funding to assess the use of VTE chemoprophylaxis in commonly performed abdominal procedures and evaluate the impact of use on clinical outcomes: PI Accuray, Inc.: Flnancial compensation: Consultant, clinical applications Covidicn: Research support: Principle investigator; Olympus: Research equipment support: PrinCiple investigator Covidien: Speakers honorarium, consulting fee: Speaker for educational activities; EMS: Shares, consulting fee: Board member and consultant; Ethlcon Endo-Surgery: Speaker honorarium: Speaker for educational activities; Gore: Speaker for educational activities; Karl Storz: Travel sponsorship: Consultant; Olympus: Consulting fee, speaker honorarium: Consultant, speaker at educational activities Covidien: Speaker and advisory board Aloka: Consultant honorarium to teach lap. liver resection course: Consultant; Applied Medical: Consultant honorarium to teach lap. liver resection course: Course director; Covidien: Consultant honorarium to teach lap. liver resection course: Course director Agendia Corporation (maker of MammaPrint and TargetPrint Genomic Assays): Honorarium for speaking engagements: Speaker; Novartis Pharmaceuticals (maker of Femara): Honorarium for speaking engagements: Speaker Magnets-in-Me, Inc: Equity only: Founder Boston Scientific: Educational Grant; Covidien: Honorarium: Speaking and teaching; .. n~~~_. Gulthin Ergun, MD Liane S. Feldman, MD, FACS David R. Rum, MD, FACS PS07, P5106, SP08 Debra Freeman, MD Gerald M. Fried, MD, FACS 5POS PS104, PS26, 5C06 YE04, VE16, 5C13 Michel Gagner, MO, FACS, FRese Daniel P. Geisler, MD, FACS David A. Geller, MD, FACS 5C07 P542,P55{) I Jon M. Greif, DO, FACS P564 Michael R Harrison, MD, FACS Jeffrey W. Hazey, MD, FACS P565 __ ]... ~ __ 5C06 ~~ Disclosures/159 Full Name Disclosure Session Code Daithi J. Heffernan, MD B. Todd Heniford, MD, FACS Peter K. Henke, MD, FACS Alan J. Herline, MD, FACS Daniel M. Herron, MD FACS Pfizer: Speaker honorarium: Speaker for Linezotid Ethicon Endo-Surgery: Research grant: Investigator; Ethicon, Inc.: Research grant: Investigator; Pegasus: Research grant: Investigator; WL. Gore: Research grant: Investigator Sanofi: Monetary support for a research study: Pion grant Pathfinder Therapeutics fnc.: Stock: Founder Covidien: Fellowship grant: Fellowship director; Ethicon Endosurgery: Fellowship grant: Fellowship director; Hourglass Technology: Consulting fee: Consultant; W L Gore: .. __ C01]_sultingfee:J;.9n~_!J1tant Genentech: Payment for consulting on design of clinical trial: Consultant; Otsuka: Grant funding for clinical trial: Local site PI Ethicon Endosurgery: Grant: Consultant; Novare: Consultant; Olympus America: Grant: Consultant; USGI: Stock options: Advisory board Applied Medica!: Honorarium: Instructor; Ethicon Endosurgery: Honorarium: Instructor; Karl Storz Endoscopy: Honorarium: Instructor Microsulis: Consultant/research support; ValleyLab: Consultant/speaker/research support Allergan: Surgical proctoring; Covidien: PI for research; Ethicon Endo Surgery: Surgical proctoring Regenerex, LLC: Medical director/CEO Covidien Healthcare: Research grant: Principle investigator Covidien: Honorarium: Speaker I consultant; Ethicon Endo inc: Honorarium: Consultant; New Wave Surgical: Nothing: Advisory board Ethicon Endosurgery: Consultant Founder, Surgical Safety Institute: No salary: Founder Textbook editor, Principles and Practice of Gedatric Surgery: Royalties: Editor Genomic Health: Stockholder Ethicon Endo-Surgery: Research grant: Investigator; Ethicon, Inc: Research grant: Investigator; WL. Gore: Research frant: Investigator SF04 PS74, VE06, VE21 PG25 SC07 VE04 Peter Higgins, MD, PhD, MSc (CRDSA) Santiago Horgan, MD Steven R. Hunt, MD, FACS David A. iannitti, MD, FACS Sayeed Ikramuddin, MD, FACS S~zanne PSI7 PS25, YE04 SC07 PS42, YE06 PSIOI, VE04 PS92 VE04, VE09 VE12, VE23 T. Ildstad, MD, FACS William B. Inabnet, MD, FACS Brian P. Jacob, MD, fACS Moises Jacobs, MD FACS Richard C. Karl, MD, FACS Mark R. Katlic, MD, FACS Francine R. Kaufman, MD John S. Kennedy, MD, FACS Kent W. Kercher, MD, FACS PS2S PS99 PS45 PS64 PS05,PS23 PS08 PS79, SC04 PS44 PS73,PSI06 PS81 DPS Health: Spouse's company; Medtronic Diabetes: Full-time employee: Chief medical officer PS10l Badrinath R. Konety, MB, BS, FACS Abbott Molecular Diagnostics: Honorarium: Speaker; Spectrum pharmaceuticals: Clinical trial: Site investigator James R. Korndorffer, MD, FACS Robert S. Krouse, MD, FACS Thomas M. Krummel, MD, FACS Ronald O. Kruzel, CST, MA Covidien: Research grant: Consultant; Stryker: Unrestricted educational grant Novartis Pharmaceutical: Payment for consulting services on prospective trial: Steering committee member/consultant Lung Port (pending): Ownership interest: SAB; PEAK Surgical: Ownership interest: SAB; Visible Productions: Ownership interest: SAB; Wir:-g-Tec: ownership interest: SAB Employed by the NBSTSA: Compensation in the form of salary: The NBSTSA sponsors credentials in surgical technology and surgical assisting that are not exclusive to these professional areas. Davol, WL Gore: Speaker bureau Applied Medical: Honorarium: Teaching laparoscopic colorectal surgery; Covidien: Honorarium: Teaching Iaparo3copic colorectal surgery. Karl A. LeBlanc, MD, FACS Kirk A. Ludwig, MD, FACS Alan B. Lumsden, MD, FACS Douglas W. Lundy, MD, FACS Michael J. Mack, MD Peter W. Marcello, MD, FACS Jeffrey M. Marks, MD, FACS John H. Marks, MD, FACS PS05 SC07 BSCI, VNUS Medical, WL Gore, Abbott: Consultant; BSC!, WL Gore, Medtronic: Speakers PS97 bureau; Hatch Medical, Northpoint Domain: Stock shareholder; Medtronic: Spouse is employee Synthes Orthopaedics: Nothing: Unpajd consultant Edwards Ufesciences: Travel expenses for steering committee meetings: Consultant; Medtronic: Consultant fee: Consultant Applied Medical: Honoraria: Speaking; Covidien: Honoraria: Speaking; Ethicon: Honoraria: Speaking; Olympus: Honoraria: Consultant PGl7 PS24 PG22, PS36, SC07 Covidien: Honoraria: Consultant; Neoguicfe: Honoraria: Advisory board; Olympus: Honoraria: SC06, VE22, Consultant; WL Gore: Honoraria: Consultant; Apollo Endosurgery: Honoraria: Advisory board SFl6 Covidien: Consultant fee; Honoraria: Consultant; Speakers bureau; Glaxo Smith Kline: Honoraria: Speakers bureau; Richard Wolf: Consultant fee; Honoraria: Consultant; speakers bureau; Stryker Endoscopy: Honoraria: Speakers bureau; SurgiQuest: Honoraria: Scientific advisory board; Zassi: Consultant fee: Consultant Ethicon Endo-Surgery: Consultant Atrium Medical: Consulting; WL Gore: Contracted research Ethicon & Ethicon Endosurgery Education grant Ethicon Endosurgery: Organization of surgical training course: Scientific consultant; Karl Storz: Royalties for patented instruments: Scientific consultant Cook Medical: Honoraria: Speaker; Maquet Medical: Honoraria: Speaker; Medtronic: Hcmnraria: Sneaker PSlO4, SCQ7 Da'l"rjd J. Maron, MD, FACS Brent D. Matthews, MD, FACS Robin S. McLeod, MD, FACS Paolo Miccoli, MD . PS7S, VE24 PS40, SC04, VE06 PS30, PS57, SF23 YEIO SC07 PG25 John R. T. Monson, MB, BCh, FACS Covidien: Consultancy Nicholas J. Morrissey, MD, FACS 160/0isc!osures Full Name Disclosure Session Code Kenric M. Murayama, MO, FACS Michael Murphy, MD Geo~ge Covidien: Honorarium: Proctor/speaker; Ethicon Endosurgery, Inc: Honorarium: Proctor Biomet, Inc.: PI, Phase I Clinical Trial; Medistern, Inc: Arteriocyte: Research'grant: Principle investigator; Depuy spine: Royalties: Inventor; Medtronic: Research gral!t: Principle investigator; Synthes: Research grant: Principle investigator SF20 PG25 PS62 Muschler, MD Matthew G. Mutch,' MD, FACS Applled Medical: Honoraria: Speaking; Covidien: Honoraria: Speaking; Ethicon: Honoraria: Speaking bureau PG22 rG20-~~ ___L~~.5t__ M-,--NapQ!itan.9J MJ!., YA~ __ " __f_fj~r,_Wy~th".s~heIing Plough, Met?;k, QJJJ1Q-N\cNe.i!; HQIlOrilJJa:.Consu!.tant, speaker's_ PSI5, PS66, PSI13 PSOI PS74,SP09 Ajay Nehra, MD, FACS Yuri W. Novitsky, MD GSK: Consultant; Pfizer: Consultant; Sanofi-Aventis: Consultant CR Bard: Consulting fee: Consultant; Covidien: Honorarium: Speaker; Ethicon, Inc: Consulting fee: Consultant; LifeCell: Honorarium: Speaker; WL Gore: Consulting fee: Consultant Patricia J. Numann, MD, FACS Donald Nuss, MD, FACS I receive a stipend from the American College of Surgeons as Director of the Fundamentals of Surgery Program Biomet Microfixation: Research grant for multicenter study. Honoraria for workshops in other countries. Royaltfes for pectus bar and metallic stabilizer per 10 year agreementApril 1998-April2008 Covidien Ltd.: Consulting fees: SCientific consultant; VNUS: Consulting fees: Scientific consultant Synapse Biomedical: Founder and board member: My university and myself developed this technology for these orphan applications under FDA HOE programs Smith and Nephew: Institutional research funding: Researcher; Stryker: Institutional research funding; Honoraria for educational speaking: Researcher, lecturer; Synthes: Institutional research funding: Researcher Medtronic Inc: Speaker honoraria: Speaker's bureau; WL Gore and Associates: Speaker honoraria: Speaker's bureau, consulting fees Boston Scientific: Research grant to university: Investigator; Rita Medical: Research grant to university: Investigator Torax Medical: Grant funding: Principle investigator Johnson & Johnson: Research grant support: PI Covidien: Consulting fee: Consultant Applied Medical: Honorarium: Speaker; Covidien: Honorarium: Fellowship; Ethicon: Honorarium: Consultant; Intuitive: Honorarium: Consultant Covidien: Honoraria: Teaching; immersion: Consulting fees: Consulting; Transenterix: Ownership interest: Advisory board member Atrium: Honoraria: Consultant; Covidien: Honoraria: Speaker, consultant; Ethicon, Inc.: HorlOraria: Speaker, consultant; UfeCell: Honoraria: Speaker, consultant; MTF: Honoraria: Consultant; WL Gore: Honoraria: Speaker, consultant Applied Medical: Research support, honoraria, stock options: Researcher, consultant, course faculty; Covidien: Honoraria: Course faculty; Ethicon Endo-Surgery: Honoraria: Course faculty PS79 PS65, ME212 Thomas F. O'Donnell, MD, FACS Raymond P. Onders; MD, FACS Greg M. Osgood, MD PS116 SP04 PS105 Himanshu J. Patel, MD, FACS Arjun Pennathur, MD, FACS Jeffrey H. Peters, MD, FACS Walter J. Pories, MD, FACS Dana D. Portenier, MD Leela M. Prasad, MD, FACS Aurora D. Pryor, MD FACS Bruce Ramshaw, MO, FACS PG25 PS72 SP07 PS58, PS10l PS20, VE04 PG22 SF20, SC13, VF.23 PS05, PS23 Thomas E. Read, MD, FACS PG22, SC07 William O. Richards, MD, FACS Bard: Research grant: Principle investigator; Covidien: Research grant: Principle investigator; VE02 Covtdien: Travel and consultant fees: Consultant metabolic surgery scientific advisory board; Metacure: Research grant: Principle investigator Applied Medical: Honoraria: Speaker & instructor at laparoscopic course, Consultant; Covidien: Honoraria: Speaker & instructor at Japaroscopic course, consultant; Genzyme Biosurgery: Honoraria: Speaker; Trans1: Honoraria: Speaker & consultant Covidien: Consultant Lifecell: Honorarium: Consultantj speaker; Covidien: Honorarium: Consultantj speaker PG22, SC07 David E. Rivadeneira, MD, FACS, FASCRS Homero Rivas, MD, FACS Michael J. Rosen, MD, FACS SC13 PGI5, PS05, PS40, VEOS, VE22 PS25, VE02, VE04 Raul J. Rosenthal, MD, FACS Covidien: Honorarium/educational grant: Consultant/speaker; Ethicon Endosurgery: Honorarium/educational grant: Consultant/speaker; Karl Storz Endoscopy: Honorarium/ Educational grant: Consultant/speaker; Synovis: Honorarium/educational grant: Consultantf speaker Covidien: ConSUltant for proctoring: Consultant; Valentx: Stock options: Scientific advisory board Bard/Diwol: Honorarium: Presentation; Covidien: Grant support, honorarium: PrinCiple investigator, adviSOry board; Musculoskeletal Transplant Foundation/Ethicon: Honorarium: Advisory board, presentation; Serica: Honorarium: Advisory-board ArthroCare: Consulting fees: Scientific/research consultant Covidien: Educational support: Fellowship director Covidien: Speaker honoraria; Ethicon: Speaker honoraria; GI Dynamics: Consulting fees; NGM Biotech: Consulting fees; Roche: Research grant Mitchell S. Roslin, MD FACS J. Scott Roth, MD, FACS VE02 PS05 Soham Roy, MD, FACS, FAAP J. Peter Rubin, MD Francesco Rubino, MD PS29 PS37 PS58, PS101, VE04 Disclosures/161 Full Name Peter Sand, MD Disclosure Allergan: Honoraira: Advisor, lecturer, investigator; Astelias: Honoraria: Advisor, lecturer, investigator; Coloplast: Honoraria: Advisor; GSK: Honoraria: Advisor, lecturer; Pfizer: Honoraria: Advisor, lecturer, investigator; Watson: Honoraria: Advisor, lecturer, investigator Covidien: Speaker honoraria: Speaker Karl Storz: Coosulting fee: Consultant Merck: Honoraria: Consultant, speaker; Pfizer: Honoraria: Consultant, speaker; Schering: Honoraria: Consultant, speaker; Wyeth: Honoraria: Coilsultant, speaker Allergan Medical: HOflorariu_m: Proct()r /COI_lsyltant;_ Ethicoo Endosurgery:_ Honorariu_m: ---f'iroctor}c'onsultant;TFlo:-HollOTilr?illffi: proctor/co?osultallt-?? ..--.. .__ ...- . Session Code PSOl Juan M. Sarmiento, MD, FACS Richard M. Satava, MD, FACS Robert G. Sawyer, MD, FACS VEGg PS26, PS83 PS66, PS1l3 psa5 sea4, VEaS, VE23 D~iel J. Scott, MD, FACS Accelerated Technologies, Inc.: Honorarium: Consultant; Allergan: Honorarium: Educational course speaker; Covidien: Sponsored research: Investigator; Ethicon Endosurgery, Inc.: Licensing agreement, sponsored research: Co-inventor, investigator; Storz: Unrestricted educational grant: Center director BoShen, MD Vernon K. Sondak, MD, FACS David H. Song, MD, FACS Nathaniel J. Soper, MD, FACS Ocera Therapeutics: Research grant: Investigator; Prometheus Lab: Honorarium: Consultant; PS36 Salix: Research grant: Investigator; VCB: Honorarium, research grant: Investigator, consultant Schering-Plough Corporation: Honorarium: Speaker's bureau, advisory board/consultant Consultant for Biomet Microfixation: Consultant fees for market analysis: Consultant Boston SCientific: Use of instruments: Scientific advisory board; Covidien: Instruments and funds: For resident education; EthicOfl Endosurgery: Research funding: For laboratory; Karl Storz: Equipment: For research; TransEnterix: Stock options: Scientific advisory board; USGI Medical: Use of instruments: Scientific advisory board Ethicon Endosurgery: Honorarium: Speaker; Genzyme Biosurgery: Honorarium: Coosultant Travanti Pharma: Provided iontopatches for the study Patent on Endoscopic Ligating Device: Royalty: Inventor PS64 PS1l5 Sea4, VEI4, SC!3 Scott R. Steele, MD, MCS Amalia J. Stefanou, MD Greg V. Stiegmann, MD, FACS Lee L. Swanstrom, MO, FACS PG22 SPl8 PSlaa Boston Scientific: Research support: Investigator/consultant; Ethicon Endosurgery: Research PSla4, PS3S, VEI4, VE23 and education grants: Investigator/consultant; Olympus Medical: Research support: Investigator/consultant; USGI: Research support: Investigator/consultant Apollo Endosurgery: Stock options: Advisory board; Covidien: Honorarium: Consultant; Intuitive Surgical, Inc.: Travel expenses: Consultant; Max Endoscopy: Stock options: Advisory board; Sanofi-Adventis: Honorarium: Consultant Educational grants from B-K Medical, Inc. and SonoSite, Inc.: Educational grants to Wright State Uoiversity Dept of Surgery: Wright State University Surgical Resident Ultrasound Course Director; Ultrasound instructor for GulfCoast Ultrasound Institute: Honoraria: GulfCoast Ultrasound Course instructor Allergan: Cash: Consultant; Covidien: Cash: Consultant; Novare: Cash: Consultant; Ethicon Endosurgery: Cash: Consultant Johnson & Johnson: Honorarium: director, thyroid course; Medtronic: Honorarium: Director, thyroid course Astellas: Research support: Investigator; Bristol-Myers Squibb: Research support: Investigator; Novartis: Research support, consulting fee: Investigator, consultant Elekta Oncology: Research grant: Pl; Varian Medical Systems, Palo Alto, CA: Research grany PI Boston Scientific: Honorarium for consultation/research: Consultant Covidien: Honoraria: Consultant; guest speaker Applied Medical: Honorarium: Speaker, course faculty; Covidien: Honorarium: preceptor; Ethicon Endosurgery: Honorarium: Speaker, course faculty Sanofi-Aventis: Research grant; Sanofi-Aventis: Speakers bureau Aicatel-Lucent: Salary support: Medical Director, Center for Connected Medicine; IBM: Salary support: Medical Director, Center for Connected Medicine; "Karl Storz: Equipment: Research support Sanofi: Grant support: PI Diagnocure: Hooorarium: Consultant Novartis: Speakers bureau; Schering Oncology: Speakers bureau Applied Medical: Honorarium: Speaker Davol: Consulting fees, Honoraria: Consultant, speaker American Medical Systems: Coosultant Colorado Orthopaedic and Surgical Hospital: Stockholder Covidien: : Consultant, research funding Cinemed: Fee: Speaker; Covidien: Fee: Speaker; Ethicon Endosurgery: Honoraria: Consultant PSla4 Mark A. Talamini, MD, FACS Kathryn M. Tchorz, MD, FACS sea3 Julio Amilcar Teixeira, MD, FACS David J. Terris, MD, FACS .lames R. Thistlewaite, MD Robert Timmerman, MD Thadeus L. Trus, MD Kent R. Van Sickle, MD H. David Vargas, MD, ~ACS Jean N. Vauthey, MD, FACS Andrew R. Watson, MD, FACS SC!3 ME3a5, PSll, VElO 5F24 PS72 sea6 Sea4 sea7 PS42 PS5a PS76, SF22, SF27, SP02 PG22, PSlQ3 PSS5 5eQ7 PS05 5PQ5 PS29 PS26,SCI3 PS25 Sharon M. Weber, MD, fACS Martin R. Weiser, MD, FACS Richard L White, MD, FACS Mark H. Whiteford, MD, FACS Stephen D. \Vohlgemuth, t.m, FACS Carson Wong, MD, FReSC, FACS David A Wong, MD, MSc, FRCSC Andrew S. Wright, MD, FACS Natan Zundel, MD, FACS