Acceptance of CLSI Policies

* Red asterisks are for required information. This information will be kept on file at the CLSI Office.

(PhD, MD, PharmD, etc.)

Please provide your full work address.

(For example, QMS20 or MM23)

In accordance with CLSI’s “Standards Development Policies and Processes” document, and in order to participate on a CLSI committee, all CLSI volunteers are asked to review and to indicate that they understand and accept the attached CLSI policies. Volunteers will not be eligible to participate on any CLSI committee until this Acceptance is completed, signed, and returned to CLSI. This acceptance is an integral part of the official records of consensus document development and governance committees’ meetings and addresses the following core CLSI principles and practices: • Code of Ethics. • Constituency Selection. • Standards Development Participation. • Conflicts of Interest Disclosure. • Permission to Use. • Attestation. Take note that volunteers will be asked to sign and return a new “Acceptance of CLSI Policies” form at least every four years, and upon each new committee appointment and/or election to any new governance, standards development, or other volunteer activity on behalf of CLSI. Eligibility to assume such new or different roles in CLSI activities and/or to participate on any CLSI committee shall depend, in part, upon the return of such signed Acceptance.


I. CLSI’s Code of Ethics

CLSI Values*

I will abide by the fundamental values that guide the way CLSI operates; specifically, these are Inclusiveness, Excellence, Responsiveness, Integrity, and Teamwork.

Antitrust*

I will adhere to CLSI’s established policy and procedures to help ensure that the activities of CLSI will proceed without violation of antitrust laws.

Confidentiality*

I will maintain the confidentiality, privacy, and security of information entrusted to me in accordance with legal and ethical obligations. I will not, without appropriate written authorization, disclose to any third party any confidential information or document to which I obtain access by virtue of my volunteer board or committee service to CLSI. If I have any doubt about whether particular information or a particular document is confidential, I will not make disclosure unless I have first clarified the situation with appropriate CLSI officials or staff and obtained written authorization.

Intellectual Property*

I will respect CLSI’s copyright and other rights and interests in the works it publishes.

Standards Development Policies and Processes Document, and Laws Adherence*

I will abide by CLSI’s Standards Development Policies and Procedures. I will not knowingly violate any applicable laws or regulations.

CLSI's Interest*

I will not promote my personal interests at the expense of CLSI’s interests and/or the work being performed by CLSI when serving on any CLSI committee or board or contributing to any CLSI effort.

II. Conflict of Interest Disclosure

Conflict of interest (hereafter “conflict”) disclosure is intended to help ensure transparency and unbiased decision making by CLSI. The existence of an actual or potential conflict does not necessarily preclude board or committee service to CLSI. However, if an individual has an actual or potential conflict relating to a topic that is under discussion, the individual shall promptly identify such actual or potential conflict and explain the nature thereof. The presiding individual for the specific CLSI activity shall then determine, in his or her discretion, whether the individual’s actual or potential conflict should preclude participation in the activity, the discussion, and/or in voting on a given topic and the individual agrees to abide by that determination. Information on disclosed actual and potential conflicts will be kept on file at the CLSI office. In the spaces that follow (or on additional pages, if necessary), please provide the requested information when it is relevant to the field(s) of work in which you will be involved with CLSI. In determining your actual or potential conflicts, you should consider your relationships as well as those of your spouse/domestic partner, business partner, parent, child, and/or sibling (“related person(s)”) that give rise, or could give rise, to a conflict.

Part A: Financial Interests

In this section, please disclose each financial relationship that might reasonably be seen as a conflict of interest or potential conflict of interest. Disclosure does not necessarily mean that there is a conflict or that you will not be able to participate in specific projects. So, if in doubt, please err on the side of disclosure.

Consultancy Disclosure

Do you, or any related person, currently have, or have had within the last 12 months, a consultancy, advisory board (or similar) position, or any other relationship from which you or the related person has received more than $5,000? (Money received from an employer for salary, travel, or other costs associated with business responsibilities does not need to be included.)

If yes, please list the name(s) of the entity(ies) with which you or the related person held such position(s).

Honoraria Disclosure

Have you, or any related person, received any honoraria or fees (eg, lecture, speaker’s bureau, travel reimbursement) of more than $5,000 in the last 12 months?

If yes, please list the name of the entity(ies) from which such payment was received.

Expert Witness Disclosure

In the last 12 months, have you, or any related person, served as an expert witness for any individual or organization?

If yes, please list the name of the entity(ies) served.

Patent Disclosure

Have you, or any related person, received in the last 12 months, or expect to receive in the next 12 months, any patents, including pending patent applications?

If yes, please list the item or method which is covered by such patent(s).

Royalties Disclosure

Have you, or any related person, received in the last 12 months, or expect to receive in the next 12 months, any royalties?

If yes, please list the source of the royalty and describe the reason for such royalty payment.

Stock Disclosure

In the last 12 months, have you, or any related person, owned or been a beneficiary of stock (including options, but excluding mutual funds) valued at more than $5,000, or other equity interest of more than one percent (1%) of the shares of a corporation.

If yes, please list the name of the entity(ies).

Gift Disclosure

In the last 12 months, have you, or any related person, received any items, gifts, or benefits of substantial value (eg, free trips, accommodations, sports tickets, appliances, electronic devices) valued at $5,000 or more, in the aggregate, from any one commercial or noncommercial entity or related entities?

If yes, please list the name of the entity(ies).

Relationship Disclosure

Do you, or any related person, have any other relevant financial interests or other relationships that could pose an actual or potential conflict of interest with your work at CLSI that are not listed above?

If yes, please list the name of the entity(ies).

Part B: Leadership in Other Associations

Leadership History

At present, or within the past 12 months, have you, or any related person, held a leadership position (eg, officer, director, and/or chair of a committee or other subdivision) with another clinical laboratory, medical, or pharmaceutical-related association, OR do you know that you, or any related person, will hold such a position in the next 12 months?

If yes, please list the name of the entity(ies) and the applicable position(s).

Part C: Disclosure of Conflicts

Conflict of Interest

If a matter arises during a topic discussion with respect to which you, or any related person, may have (or reasonably be perceived to have) an actual or potential conflict of interest, you will disclose the nature of the conflict when the matter arises. Unless permitted to do so by the presiding individual (or other CLSI official), you agree not to participate in any discussion or vote relating to such matter and topic.

III. Permission to Use

• By voluntarily joining, or by accepting an appointment to, a CLSI committee or board, and by participating in that committee’s or board’s programs, sessions, collaborations, and/or meetings (individually and collectively “Program(s)”), and/or other Programs arranged or conducted by CLSI, I grant CLSI permission to use the data and information (individually and collectively, “Information”) that I contribute to CLSI as a participant in such Program(s), along with Information provided by other Program participants, for the purpose of discussing, analyzing, and evaluating such Information as part of CLSI’s Standards Development Process (the “Process”). • I understand that CLSI may create works (the “Work(s)”) that are the result of the Process in which I and others may voluntarily participate, that such Works are based upon the Process and Information derived from multiple sources, and that such Works belong exclusively to CLSI. I understand and agree that participants in the Process do not own or control any rights in or to the Works by virtue of participating in the Process or the Programs or by virtue of CLSI synthesizing the Information into the Works. • I reserve those rights and interests, if any, belonging to me (or my employer, if applicable) to Information contributed by me to the Process subject to CLSI’s right to use and synthesize such Information as set out above. • Without limiting the generality of the above, CLSI agrees that it will not reproduce any specific expression of Information furnished by me in the form submitted by me (eg, a chart, graph, illustration, or text) in a Work without my approval, which approval will not be unreasonably withheld by me so as to frustrate the Process or the purpose of the Process. • I represent that I have the right and authority to grant this permission and to participate in the CLSI Program(s) and the Process and that the Information provided by me is, to the best of my knowledge, accurate and does not infringe upon the rights of any other party. • I understand and agree that CLSI has the exclusive right to publish, reproduce, and distribute, the Works throughout the world in all media and platforms whether known now or hereafter developed and I will not copy, adapt, translate, or otherwise reproduce by any means (eg, electronic, file sharing, mechanical, photocopying, recording, or otherwise), any Work without prior written permission from CLSI.

Please type your initials to confirm the above.

IV. Standards Development Participation

Participation

I affirm that I have reviewed the Essential Job Duties and Skills and Abilities for CLSI Committee Participants (https://clsi.org/media/duydpnqu/essential-job-duties-and-skills-and-abilities.pdf ), and I agree to perform the duties and to fulfill the responsibilities which correspond to the role, if any, that is assigned to me by CLSI as part of the Process. I acknowledge the time commitment associated with Process participation and I represent that I have adequate time available to participate in the Process.

Attestation

I attest that I have read and I understand this Acceptance of CLSI Policies, and each of its components. I further attest that I have made the required disclosures to the best of my knowledge, and recognize that I have a continuing responsibility to disclose all actual or potential conflicts of interest that might bias, or that might reasonably be perceived as biasing, any action that I might take or any statement that I might make in connection with my board or committee service to CLSI. I attest that I will promptly inform CLSI of any changes in actual or potential conflicts of interest while I serve on a CLSI committee or other leadership body or otherwise participate in any CLSI Program or the Standards Development Process. I recognize that if I fail to make the disclosures set forth above or to honor my ethical and other commitments as set forth herein, I shall be subject to removal from the body of CLSI on which I serve without any further proceedings, and I will forfeit any eligibility for indemnification pursuant to the bylaws of CLSI or otherwise. If I have any questions about this form or its component parts, I will raise those questions with the Chief Executive Officer of CLSI.

Typing your name below will serve as your electronic signature.


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