• ASBMR Policy on the Implementation and Management of Task Forces

     
     
     
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    The Society has developed specific policies for the creation and implementation of ASBMR task forces and joint task forces with other organizations. The policies are to ensure that all ASBMR task forces maintain the highest quality and ethical standards in regard to process and deliberation, and to manage or minimize any real or perceived conflicts of interest.

    1.       ASBMR Task Force Policies

    The following policies pertain to a task force created and administered solely by the ASBMR.


    1.a.         ASBMR Task Force Creation

      • A task force (rationale, objectives/charges, and timeline) may be proposed by any member, committee, or work group. Proposals are reviewed and approved by the ASBMR Executive Committee (EC).
      • As part of its deliberations, the EC may request that the ASBMR Professional Practices Committee or other committee review the task force proposal and make a recommendation regarding the establishment of the task force.


    1.b.         Task Force Co-Chairs

      • A recommendation to the EC for the establishment of a task force may include the names of individuals who should be considered to serve as co-chairs for the task force.
      • Upon EC’s approval of the establishment of the task force, the individuals recommended nominees for co-chair shall be contacted and asked to complete an ASBMR Conflict/Duality of Interest Disclosure Form and be vetted by the Ethics Advisory Committee (EAC). Only after EAC review of the nominees will the EC officially appoint an individual to serve as a task force co-chair.
      • The selected co-chairs must meet the applicable requirements of the Ethics Policy and Guidelines for the Leadership of the ASBMR as well as the following prerequisites:
        • Co-chair cannot currently be employed by industry or have been employed by industry in the past three years.
        • When possible, at least one co-chair should not have any industry conflicts.
        • Must have minimal conflicts with industry related to the task force initiative.
        • Must agree to not add any new conflicts until the task force work is completed or only with the review and approval of the EAC.
        • Must agree to decline offers from affected companies to speak about any and all published or related clinical task force materials on behalf of the company for three years.
      • In its review of potential co-chairs, the EAC shall consider each individual’s conflicts of interest while at the same time striving to balance the needs and integrity of the task force.
        • The EAC will carefully review each individual’s financial ties with industry and in its deliberations will consider such factors as promotional speaking, stock ownership, investments, advisory and consultative roles to industry and other funding received from business entities.
        • The EAC will consider leadership roles in other organizations to the extent that they might be real or perceived conflicts in relation to the task force’s deliberations.
        • In its review of disclosures, the EAC will consider five options for management of conflicts of interest:
          • No conflicts
          • Oversight management
          • Removal of conflict
          • Recusal from identified areas of discussion and votes
          • Unmanageable 


    1.c.         Task Force Members

      • Following the EC’s appointment, of the task force co-chairs, the co-chairs shall recommend members to serve on the task force.  All potential members must complete an ASBMR disclosure form and be vetted by the EAC before being reviewed for appointment by the EC.
      • The selected members must meet the following prerequisites:
        • Members cannot currently be employed by industry or have been employed by industry in the past three years.
        • Must agree to not add any new conflicts until the task force work is completed or only with the review and approval of the EAC.
        • Must agree to decline offers from affected companies to speak about any and all published or related clinical task force materials on behalf of the company for three years.
      • In its review of potential members, the EAC shall consider each individual’s conflicts of interest while at the same time striving to balance the needs and integrity of the task force.
        • The EAC will review disclosure forms with the general guideline of having less than 50 percent of task force members with “significant” conflicts.
        • The EAC will carefully review each individual’s financial ties with industry and in its deliberations will consider such factors as promotional speaking, stock ownership, investments, advisory and consultative roles to industry and other funding received from business entities.
        • The EAC will consider leadership roles in other organizations to the extent that they might be real or perceived conflicts in relation to the task force’s deliberations.
        • In its review of disclosures, the EAC will consider five options for management of conflicts of interest:
          • No conflicts
          • Oversight management
          • Removal of conflict
          • Recusal from identified areas of discussion and votes
          • Unmanageable
      • Once the task force is constituted, the completed disclosure summary is shared with all task force members and included in materials for each conference call and/or in-person meeting.


    1.d.         Ethicist and Independent Scientific Expert

      • Each ASBMR task force shall include a minimum of one ethicist and one independent scientific expert.
      • The ethicist and independent scientific expert are required to complete an ASBMR Disclosure Form for EAC review and approval prior to EC approval.
      • Individuals serving as a task force ethicist or independent scientific expert member must meet the following prerequisites:
        • Ethicists and independent scientific experts cannot currently be employed by industry or have been employed by industry in the past three years.
        • Must agree to not add any new conflicts until the task force work is completed or only with the review and approval of the EAC.


    1.e.         ASBMR Task Force Interactions with Industry

      • At the discretion of the task force co-chairs, written information may be requested from industry. Any information received must note whether the data are published or unpublished.
      • Task force members must decline offers from affected companies to speak about any and all published or related task force materials on behalf of the Company for three years.
      • The ethicist or independent scientific expert shall be kept apprised of any interactions the members have with industry as it relates to the work of the task force and such interaction shall be pursued only with the approval of the task force.


    1.f.          ASBMR Task Force Output

      • Any written task force materials must include all task force member disclosures.
      • Written materials must include a statement describing ASBMR policy regarding conflicts and how the society manages conflicts. The statement must include the roles of the EAC, ethicist, independent scientist, task force co-chairs and members.
      • Written materials are reviewed and approved by the Professional Practice Committee or another committee or individuals appointed by the EC.
      • In general, an ASBMR Task Force recommendations/output  must be supported by a majority of the Task Force members without conflicts in order to be considered by the Professional Practice Committee, Executive Committee, or other assigned oversight Committee.  In the absence of  such support, Task Force recommendations/output can be considered by, and can be approved by, any such Committee, in its discretion, only if a majority of such Committee members without conflicts approves such a proposed action.
      • Written manuscripts submitted to the JBMR are peer-reviewed.
      • Any written output or recommendation produced by an ASBMR task force remains the sole property of ASBMR regardless of its acceptance as an official Society statement or position, or its acceptance in JBMR, and may not be submitted to any other organization or journal for publication, including but not limited to press releases, position papers or statements, and online websites,  without the express written consent of ASBMR.


     2.       Joint Task Force with Another Organization Administered by ASBMR

    The following policies pertain to a task force ASBMR jointly creates with one or more organizations and for which ASBMR provides the administrative support.


    2.a.         Joint Task Force Creation

      • Joint task forces are considered when it is appropriate and mutually beneficial for one or more organizations to work together. 
      • A task force (rationale, objectives/charges, and timeline) may be proposed by any individual or organization. Proposals are reviewed and approved by the Executive Committee (EC) and by the leadership of each participating organization.
      • As part of its deliberations, the EC may request that the Professional Practice Committee or other ASBMR committee review the task force proposal and make a recommendation regarding the establishment of the task force.
      • A written agreement is established between the organizations to consider task force expenses, administration, conflict of interest management, and dissemination of outcomes. The agreement between participating organizations must be ratified before task force work begins and must include how the task force report, manuscripts or other output will be disseminated.  This will include identifying the “primary” journal, which will own the copyright, joint authorship acknowledgement, delayed or simultaneous publications in all participating journals, and alternative publication (e.g. white paper on participating society websites) if journal publication is denied by one or all journals.


    2.b.         Joint Task Force Co-Chairs

      • A recommendation to the EC for the establishment of a task force shall include the names of individuals who should be considered to serve as co-chairs for the task force.
      • Upon the approval of the EC and participating organizations of the task force, the nominees for co-chair shall complete an ASBMR Disclosure Form and be vetted by the Ethics Advisory Committee (EAC). Only after EAC review of the nominees will the EC and participating organizations officially appoint an individual to serve as a task force co-chair.
      • In its review of co-chair nominees, the EAC will request individuals to complete the ASBMR Disclosure Form. The selected co-chairs must meet the following prerequisites:
        • Co-chair cannot currently be employed by industry or have been employed by industry in the past three years.
        • When possible, at least one co-chair should not have any industry conflicts.
        • Must have minimal conflicts with industry related to the task force initiative.
        • Must agree to not add any new conflicts until the task force work is completed or only with the review and approval of the EAC.
        • Must agree to decline offers from affected companies to speak about any and all published or related clinical task force materials on behalf of the company for three years.
      • In its review of potential co-chairs, the EAC shall consider each individual’s conflicts of interest while at the same time striving to balance the needs and integrity of the task force.
        • The EAC will carefully review each individual’s financial ties with industry and in its deliberations will consider such factors as promotional speaking, stock ownership, investments, advisory and consultative roles to industry and other funding received from business entities.
        • The EAC will consider leadership roles in other organizations to the extent that they might be real or perceived conflicts in relation to the task force’s deliberations.
        • In its review of disclosures, the EAC will consider five options for management of conflicts of interest:
          • No conflicts
          • Oversight management
          • Removal of conflict
          • Recusal from identified areas of discussion and votes
          • Unmanageable


    2.c.         Joint Task Force Members

      • Prior to EC appointment, the task force co-chairs shall recommend members to serve on the task force.  All potential members must complete an ASBMR Disclosure Form and be vetted by the EAC.
      • The selected members must meet the following prerequisites:
        • Members cannot currently be employed by industry or have been employed by industry in the past three years.
        • Must agree to not add any new conflicts until the task force work is completed or only with the review and approval of the EAC.
        • Must agree to decline offers from affected companies to speak about any and all published or related clinical task force materials on behalf of the company for three years.
        • In its review of potential members, the EAC shall consider each individual’s conflicts of interest while at the same time striving to balance the needs and integrity of the task force.
          • The EAC will review disclosure forms with the general guideline of having less than 50 percent of task force members with “significant” conflicts.
          • The EAC will carefully review each individual’s financial ties with industry and in its deliberations will consider such factors as promotional speaking, stock ownership, investments, advisory and consultative roles to industry and other funding received from business entities.
          • The EAC will consider leadership roles in other organizations to the extent that they might be real or perceived conflicts in relation to the task force’s deliberations.
          • In its review of disclosures, the EAC will consider five options for management of conflicts of interest:
            • No conflicts
            • Oversight management
            • Removal of conflict
            • Recusal from identified areas of discussion and votes
            • Unmanageable
        • Once the task force is constituted, the completed disclosure summary is shared with all task force members and included in materials for each conference call and/or in-person meeting.


    2.d.         Ethicist and Independent Scientific Expert

      • Each joint task force shall include a minimum of one ethicist and one independent scientific expert.
      • The ethicist and independent scientific expert are required to complete an ASBMR Disclosure Form for EAC review and approval prior to the approval of EC and other organizations.
      • Individuals serving as a task force ethicist or independent scientific expert member must meet the following prerequisites:
        • Ethicists and independent scientific experts cannot currently be employed by industry or have been employed by industry in the past three years.
        • Must agree to not add any new conflicts until the task force work is completed or only with the review and approval of the EAC.


    2.e.         Joint Task Force Interactions with Industry

      • At the discretion of the task force co-chairs, written information may be requested from industry. Any information received must note whether the data are published or unpublished.
      • Task force members must decline offers from affected companies to speak about any and all published or related task force materials on behalf of the Company for three years.
      • The ethicist or independent scientific expert shall be kept apprised of any interactions the members have with industry as it relates to the work of the task force.


    2.f.          Joint Task Force Output

      • Any written task force materials must include all task force member disclosures.
      • Written materials must include a statement describing ASBMR policy regarding conflicts and how the society manages conflicts. The statement must include the roles of the EAC, ethicist, independent scientist, task force co-chairs and members.
      • Written materials are reviewed by the Professional Practice Committee or other committee or individuals appointed by the EC and participating organizations.
      • Written manuscripts submitted to the JBMR or other publications are peer-reviewed.
      • Any written output or recommendation produced by a joint task force remains the sole property of ASBMR regardless of its acceptance as an official Society statement or position, or its acceptance in JBMR, and may not be submitted to any other organization or journal for publication, including but not limited to press releases, position papers or statements, and online websites, unless otherwise agreed upon in writing with other participating organizations.
      • In general, an ASBMR Joint Task Force recommendations/output must be supported by a majority of the ASBMR Task Force members without conflicts in order to be considered by the ASBMR Professional Practice Committee, Executive Committee, or other assigned oversight Committee.  In the absence of such support, a Task Force recommendations/output can be considered by, and can be approved by, any such ASBMR Committee, in its discretion, only if a majority of such ASBMR Committee members without conflicts approves such a proposed action.

    2.g.         Joint Task Force Timeline
      • The task force timeline must be approved by all participating organizations.
      • The timeline will include “check in” points when each participating organization will have the opportunity to review the task force’s work to date and reaffirm its continued support and involvement in the task force. 


    3.      
    Managing Conflicts of Interest on Joint Task Forces and Guideline Groups Managed by Other Organizations

    The following policies pertain to joint task forces or guideline groups ASBMR joins that are managed by other organizations.


    3.a.         Review of Other Organization’s Conflict of Interest Policy and Disclosure Form

      • The organization providing the administration for the task force or guideline group will provide its standing conflict of interest policy (and disclosure form) to ASBMR. Their conflict of interest policy and practice will be reviewed by the EAC to determine its alignment with ASBMR policy and practice, and the EAC will provide a recommendation to the EC. Only after the EAC policy review is complete shall the EC appoint a member to serve on the task force or guideline group. The ASBMR appointed member to the task force shall adhere to the policies outlined in 2.c.


    3.b.
             Use of ASBMR Task Force Policies When Other Organization Has No Policies

      • If the organization providing administration for the task force or guideline group has no conflict of interest policy, the organization will be asked to agree to adhere to the ASBMR task force policies 2.b., 2.c., 2.d., 2.e., 2.f. for ethical standards for task force chairs and members and use of the ASBMR disclosure form.  All task force members will be required to complete the ASBMR disclosure form and will be vetted by the EAC.