Difference between revisions of "Committee Procedures"

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==Organizational Structure==
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<font color="red">NOTICE: These instructions are accessible on the QIBA Wiki as a historical reference only! Independent Profile Authoring Groups are required to oversee the various developmental stages from Draft to Public Comment to Consensus based on the current QUIC endorsement criteria, found HERE:</font> https://qibawiki.rsna.org/images/9/95/QUIC-Review-Criteria-for-New-Profiles-FINAL-v23SEPT2023.pdf.
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* '''Steering Committee''' is established by RSNA
 
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** Responsible for managing the strategic direction, processes and inftrastructure for QIBA and overall oversight of the QIBA activities and committees.
 
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* '''Modality Committees''' are established by the Steering Committee
 
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** Responsible for coordinating modality areas of QIBA, and to formalize (i.e., vote, on) decisions when needed.
 
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* '''Technical Committees''' are established by the Modality Committee
 
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** Responsible for selecting biomarkers, drafting Profiles and protocols, and coordinating groundwork.
 
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** '''Groundwork Committees''' are established by the Technical Committee as needed to carry out specific groundwork projects.
 
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** '''Authoring Groups''' are established by a Technical Committee as needed to write Profiles and/or protocols.
 
  
  
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==Committee Membership==
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==Meeting Procedures==
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* '''Steering Committee''' members are appointed by the RSNA.
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The goal is group consensus and the input and endorsement of imaging community stakeholders on major decisions.
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* '''Modality Committee''' members can be self-nominated, but must have participated in at least 50% of teleconferences during the previous 12 months. Retention of modality committee membership will require participation in at least 50% of teleconferences. Participation in teleconferences will be assessed on a rolling basis every 6 months. New members can be added to Modlality Committees every 6 months based on their participation in a tleast 50% of TC calls during the previous 12 months. The minimum level of teleconference participation is established by the Steering Committee and can be changed by the Steering Committee if it sees fit to do so.
 
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* '''Technical, Groundwork and Authoring Committees''' are "open" committees
 
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** '''"Open" committees''' are open to anyone with a relevant interest.
 
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** '''Committee Co-Chairs''' can direct RSNA staff to add names to the roster.
 
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** '''Groundwork Groups''' and '''Authoring Committees''' are typically volunteer subsets of their parent Technical Committee
 
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* '''Rosters''' for each Technical Committee are posted on the Wiki.
 
  
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* When participation at a given meeting is not open to all committee members, (e.g., it takes place at an '''“invitation-only” face-to-face event and remote access is not provided for the committee meeting'''), that meeting '''will not be considered an official meeting''' of that committee.  No official decisions will be made and attendance will not count toward or against voting privileges.
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** The chair will need to ensure that attendance records are captured and submitted to the Profile Authoring Group members.
  
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==Decision Making==
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A record of committee decisions and rationale is necessary to be effective and learn.  
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* Goal: group consensus and imaging community input and endorsement on major decisions.
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* ''Profile Authoring Group scribe'' records minutes (call summaries) for meetings 
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* Recorded vote required for procedural decisions
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* ''Chairs'' are strongly encouraged to support Profile Authoring Group scribes by reviewing/correcting the draft minutes circulated 
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** Key group decisions, such as public dissemination of documents, are subject to approval by Modality Committees
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* ''Profile Authoring Group Chairs'' maintain '''[[Committees|rosters of the members of each committee]]''' and their participation.  Those details are used to determine which members currently have '''[[Voting Privileges]]'''
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** Majority of participating members passes
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** ''Members'' who believe their attendance record is in error should contact Profile Authoring Group Chairs.
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** Negative votes must be discussed
 
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* For recorded votes:
 
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** Meeting attendee names and vote outcome will be recorded in minutes.
 
  
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==Voting==
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Most committee work doesn't need a vote.  At the discretion of committee chairs and members, however, decisions can be put to a vote during meetings.  This also facilitates recording key decisions in the minutes.
  
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==Committee Functions==
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* ''Chairs'' accept motions, seconds, discussion, and then call for a vote
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** At its simplest, the ''Chair'' asks for objections, then asks for abstentions, and "Profile Authoring Group scribe'' notes those names.  The rest of those present with voting privileges can safely be assumed to have voted in favor.
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* ''Members'' who have '''[[Voting Privileges]]''' count towards quorum and may vote.
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* ''Chairs'' resolve negative votes and large numbers of abstentions per the '''[[Committee Procedures#Consensus Process|consensus process]]'''
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** details of the resolution discussion in the minutes are desirable
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* ''Profile Authoring Group scribe'' records the motion, the tally of those against/abstaining/in-favor, and the details of negative votes in the minutes.
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** If attendance, eligibility and quorum cannot be determined during the meeting, vote results will be ratified after the call and entered into the minutes by the ''Profile Authoring Group scribe''.
  
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*'''Steering Committee:'''
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==Email Ballot==
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**Manage Relationships and Optimize Communications
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Substantive decisions, such as whether a Profile is advanced to the next stage, are put to ballot. This allows more deliberation on the subject material than a vote in committee.
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***Create a collaborative, multidisciplinary environment that fosters communication among imaging groups and other medical disciplines involved in the research, approval, and use of quantitative imaging biomarkers (QIBs)
 
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***Educate stakeholders about Profiles
 
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***Provide content and administrative support of web sites/ Wikis
 
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***Support face-to-face meetings
 
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**Determine and Manage Process
 
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***Develop ways of working, organizing, etc. across the various entities.
 
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***Utilize principles from imaging science to undertand clinical image information content and utility.
 
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***Adopt a statistically rigorous framework for determining and reducing sources of variation.
 
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***Lay out a process for certification of compliance tot he Profile and how this relates to regulatory pathways.
 
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**Coordinate Quantitative Imaging Biomarker Evaluation
 
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***Evaluate clinical needs for biomarkers for each therapeutic area.
 
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***Develop and maintain public infrastructure for biomarker-specific data and associated metadata.
 
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***Oversee inputs and works-in-progress of teams; mantain scorecard.
 
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**Influence Regulatory Pathways
 
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***Clarify and optimize pathway for imaging biomarkers to become widely available.
 
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***Develop process guidance with regulatory agencies inclusive of drug development and patient care.
 
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***Plan and hold workshops with FDA.
 
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**Explore Self-funded Models to Maintain Forward Progress
 
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***Define what size adn scope of offort is sustainable and over what period of time.
 
  
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*'''Modality Committees''' (Most of the this work is delegated to Technical Committees)
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A committee may initiate an email ballot on a document by approving a motion to do so (i.e. officially deciding the document is ready for ballot).  Alternatively, Chairs may initiate email ballots at their own discretion after assuring appropriate discussion and review by the committee, and if there are multiple chairs then a simple majority of the chairs must approve the action.
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**Based on the clinical context and needs, identify and prioritize biomarkers to pursue ("work item selection").
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***Propose
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* ''Chairs'' submit the ballot question and length of the ballot period to RSNA Staff
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***Evaluate
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** The ballot period may be specified by the particular procedure that calls for a ballot
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***Approve
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** The ballot period is generally not less than 14 days to allow adequate time to review the material and vote
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**For each selected biomarker:
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** If reviewing lengthy documents or collecting feedback within member organizations is involved 30 days is suggested for the ballot period
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***Profile development
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* ''Profile Authoring Group scribe'' emails the ballot to all members with '''[[Voting Privileges]]''' on the committee making the decision
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****Production
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* ''Profile Authoring Group scribe'' emails a notification of ineligibility to the rest of the members of the committee making the decision
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****UPICT protocol
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** Members who do not have Voting Privileges will thus be aware of the ballot and are still permitted to submit comments
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****Provisional goals
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** Members who believe their attendance record is in error can review of their attendance with the Profile Authoring Group scribe or Chairs, and if they are found to be eligible will be sent a ballot
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****Draft and Review text
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* ''Profile Authoring Group scribe'' compiles the ballot responses and comments for the Chairs
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****Collect and Resolve Public Comment
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** o At the discretion of the Chairs, comments submitted by non-voting members may be stricken
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***Real world validation ("Field-testing")
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* ''Chairs'' ratify the resulting tally and comments within a reasonable period of time (preferably in the next committee meeting) per the consensus process
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****Approve
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* ''Profile Authoring Group scribe'' records resolution results/rationale in the minutes
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****Trial implementation
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****Collectand Resolve feedback
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==Quorum==
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***Publication
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For a vote or ballot to be valid, at least 50% of those with voting privileges must have participated (by either voting in favor, objecting, or abstaining).
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****Prepare
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****Approve
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==Consensus Process==
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****Publish
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As a group setting standards on behalf of a community, the Profile Authoring Groups actively seek to pursue Consensus.
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**Reference Object(s) and Support Material(s) for Experimentation and Quality Control (QC)
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***Phantoms traceable to recognized physical standards
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* a vote/ballot passes with a quorum of votes and a majority of votes in favor, but
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***Digital Reference Objects (DRO)
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** a '''negative vote or votes should result in subsequent discussion''' to
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***Definition of comprehensive QC program, including data analysis and reporting requirements
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*** '''understand the reason''' for such (a) negative vote(s) and '''attempt to find a compromise or resolution'''; associated edits to the document under ballot do not typically require re-balloting
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**Identification of Technical Characteristics and Standards
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** a '''large number of abstentions''' may also warrant discussion; it may indicate many people have:
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***Assess intrinsic scanner variablity, minimum detectable change, and limits of quantification.
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*** misgivings
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***Identification and assessment of intra- and inter-reader bias and variance across scanners and centers.
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*** not been able to adequately evaluate the question
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**Clinical Performance Groundwork
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***Develop a process map detailing steps to meet regulatory and payer requirements.
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Participants concerned that a reasonable attempt at consensus has not been made should consider raising the issue with the chair(s) of the Profile Authoring Group.
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***Perform studies necessary if literature does not fully support the process map. These may be retrospective or prospective (e.g.,assessment of intra- and inter-reader sensitivity and specificity for specific clinical utility).
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**Clinical Efficacy Groundwork
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==Profile Authoring Group Leadership==
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***Characterize value in clinical trials
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*Profile Authoring Groups are encouraged to have 2 or 3 leaders who are preferably drawn from diverse backgrounds (Researchers, Clinicians, Physicists, Vendors, Regulators, etc.) 
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***Characterize value in clinical practice
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** If not possible, groups are permitted to have some concentration but should discuss plans to expand the breadth of stakeholder representation at least annually
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***Compare new biomarker and 'accepted-as-standard' method
 
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***Develop/ merge databases from trials in support of achieving statistical power
 
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**FDA Qualification
 
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***Request letter
 
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***Briefing document(s)
 
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***Full data package
 
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**Device Compliance
 
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***Determine compliabce testing methods
 
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****Acquisition
 
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****Post-procesing
 
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***Device version tracking
 
  
 
==See Also==
 
==See Also==
 
* [[Committees|QIBA Committees]]
 
* [[Committees|QIBA Committees]]

Latest revision as of 17:32, 19 January 2024

NOTICE: These instructions are accessible on the QIBA Wiki as a historical reference only! Independent Profile Authoring Groups are required to oversee the various developmental stages from Draft to Public Comment to Consensus based on the current QUIC endorsement criteria, found HERE: https://qibawiki.rsna.org/images/9/95/QUIC-Review-Criteria-for-New-Profiles-FINAL-v23SEPT2023.pdf.


Meeting Procedures

The goal is group consensus and the input and endorsement of imaging community stakeholders on major decisions.

  • When participation at a given meeting is not open to all committee members, (e.g., it takes place at an “invitation-only” face-to-face event and remote access is not provided for the committee meeting), that meeting will not be considered an official meeting of that committee. No official decisions will be made and attendance will not count toward or against voting privileges.
    • The chair will need to ensure that attendance records are captured and submitted to the Profile Authoring Group members.

A record of committee decisions and rationale is necessary to be effective and learn.

  • Profile Authoring Group scribe records minutes (call summaries) for meetings
  • Chairs are strongly encouraged to support Profile Authoring Group scribes by reviewing/correcting the draft minutes circulated
  • Profile Authoring Group Chairs maintain rosters of the members of each committee and their participation. Those details are used to determine which members currently have Voting Privileges
    • Members who believe their attendance record is in error should contact Profile Authoring Group Chairs.

Voting

Most committee work doesn't need a vote. At the discretion of committee chairs and members, however, decisions can be put to a vote during meetings. This also facilitates recording key decisions in the minutes.

  • Chairs accept motions, seconds, discussion, and then call for a vote
    • At its simplest, the Chair asks for objections, then asks for abstentions, and "Profile Authoring Group scribe notes those names. The rest of those present with voting privileges can safely be assumed to have voted in favor.
  • Members who have Voting Privileges count towards quorum and may vote.
  • Chairs resolve negative votes and large numbers of abstentions per the consensus process
    • details of the resolution discussion in the minutes are desirable
  • Profile Authoring Group scribe records the motion, the tally of those against/abstaining/in-favor, and the details of negative votes in the minutes.
    • If attendance, eligibility and quorum cannot be determined during the meeting, vote results will be ratified after the call and entered into the minutes by the Profile Authoring Group scribe.

Email Ballot

Substantive decisions, such as whether a Profile is advanced to the next stage, are put to ballot. This allows more deliberation on the subject material than a vote in committee.

A committee may initiate an email ballot on a document by approving a motion to do so (i.e. officially deciding the document is ready for ballot). Alternatively, Chairs may initiate email ballots at their own discretion after assuring appropriate discussion and review by the committee, and if there are multiple chairs then a simple majority of the chairs must approve the action.

  • Chairs submit the ballot question and length of the ballot period to RSNA Staff
    • The ballot period may be specified by the particular procedure that calls for a ballot
    • The ballot period is generally not less than 14 days to allow adequate time to review the material and vote
    • If reviewing lengthy documents or collecting feedback within member organizations is involved 30 days is suggested for the ballot period
  • Profile Authoring Group scribe emails the ballot to all members with Voting Privileges on the committee making the decision
  • Profile Authoring Group scribe emails a notification of ineligibility to the rest of the members of the committee making the decision
    • Members who do not have Voting Privileges will thus be aware of the ballot and are still permitted to submit comments
    • Members who believe their attendance record is in error can review of their attendance with the Profile Authoring Group scribe or Chairs, and if they are found to be eligible will be sent a ballot
  • Profile Authoring Group scribe compiles the ballot responses and comments for the Chairs
    • o At the discretion of the Chairs, comments submitted by non-voting members may be stricken
  • Chairs ratify the resulting tally and comments within a reasonable period of time (preferably in the next committee meeting) per the consensus process
  • Profile Authoring Group scribe records resolution results/rationale in the minutes

Quorum

For a vote or ballot to be valid, at least 50% of those with voting privileges must have participated (by either voting in favor, objecting, or abstaining).

Consensus Process

As a group setting standards on behalf of a community, the Profile Authoring Groups actively seek to pursue Consensus.

  • a vote/ballot passes with a quorum of votes and a majority of votes in favor, but
    • a negative vote or votes should result in subsequent discussion to
      • understand the reason for such (a) negative vote(s) and attempt to find a compromise or resolution; associated edits to the document under ballot do not typically require re-balloting
    • a large number of abstentions may also warrant discussion; it may indicate many people have:
      • misgivings
      • not been able to adequately evaluate the question

Participants concerned that a reasonable attempt at consensus has not been made should consider raising the issue with the chair(s) of the Profile Authoring Group.

Profile Authoring Group Leadership

  • Profile Authoring Groups are encouraged to have 2 or 3 leaders who are preferably drawn from diverse backgrounds (Researchers, Clinicians, Physicists, Vendors, Regulators, etc.)
    • If not possible, groups are permitted to have some concentration but should discuss plans to expand the breadth of stakeholder representation at least annually

See Also

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