Synopsis of the RAMPART exception to informed consent for emergency research plan

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• Synopsis of the RAMPART exception to informed
  consent for emergency research plan
• and
• Current Timeline

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Foundational principles of the plan

• these are the underlying ethical purposes that we
  infer from the rules at 21 CFR 50.24. We use
  these as the goals to meet to define successful
  implementation. These principles are
• Understanding
• Respect
• Transparency

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Understanding

• the information we wish to obtain from community
  consultation is the variety of values and
  narratives of the people to whom we talk. The
  research to be conducted is the stimulus for the
  discussion, but the goal is for us to better
  understand them.

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Respect

• local investigators will demonstrate respect by
  going to community gatherings to make
  presentations, rather than by asking the
  community to come to us. The process is one of
  humility that emphasizes personal interaction.

5
Transparency

• public notification is about having nothing to
  hide. Adequacy is determined by the fullness of
  disclosure and the ease of accessibility rather
  than a head count of recipients or viewers.

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Community consultation

• recognizing that the draft 2006 FDA guidance
  defined communities as distinctly including both
  a geographic community and a disease/risk-specific
  community, our plan addresses these separately.

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Geographic CC

• Hub investigators will conduct presentations by
  seeking invitations to attend regularly scheduled
  meetings of community groups. These groups may
  include, but are not limited to religious
  groups, neighborhood groups, political groups,
  service organizations, business clubs, health
  organizations, parent-teacher organizations, etc.
  Attempts should be made to cover a diversity of
  groups, but it is not necessary to meet
  separately with every single possible sub-group
  of the community. At each hub-spoke complex,
  fifteen presentations or more are expected over a
  3 to 5 month period. Presentations will be
  designed to last sixty minutes, but shorter
  versions will be prepared for groups unable to
  commit that much of their agenda to this topic.
  Other trials have reported that going to existing
  organizations provides access to a bigger slice
  of the community than does holding special town
  hall style meetings sometimes used for this
  purpose. Additionally, the act of going to
  people where they meet is more respectful than
  having them come to us.

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Seizure Specific CC

• Patients with a risk of entry into the study
  higher than that of the general population, and
  patients that have previously experienced and
  survived status epilepticus will be consulted.
  These consultations will take place in focus
  groups involving both an investigator and a
  trained facilitator will be used. The
  seizure-specific community does not have to be
  geographically confined, so expertise will be
  leveraged by having focus groups of particular
  subsets of patients performed at different hubs,
  and then having all the focus group experiences
  collated and distributed to all sites. One hub
  will focus on children and parents recruited from
  a pediatric epilepsy clinic, another on survivors
  of status epilepticus, another on members of the
  epilepsy foundation, another on patients from an
  adult epilepsy clinic, and so on.

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Public notification

• Hub sites will coordinate local public
  notification efforts with their hospitals media
  relations office. The Clinical Coordinating
  Center will coordinate national efforts with the
  NINDS media relations office. Public service
  announcements, press releases, paid print and
  broadcast advertising, community access cable TV,
  postings in existing hospital publications and
  mailings, and other modalities will all be used
  to ensure transparency has been achieved in
  public notification. A web site will be also be
  used. It will be created nationally and will
  have the ability to show local content to those
  identified by locale.

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ER-EFIC Toolbox

• The Clinical Coordinating Center will provide a
  toolbox for these efforts. This includes
  pamphlets, advertising copy, and templates for
  IRB submissions, presentations, and reports on
  consultation and notification efforts. A
  high-production-quality series of video stimuli
  will be produced that can be used to make
  presentations more accessible to lay audiences.
  These feature a series of on the street
  interviews where members of the public
  colloquially ask questions about the nature of
  research, the trial, consent and why it is not
  possible, and how it is regulated. Short answers
  in simple language from experts are provided.
  These videos can also be strung together and used
  as broadcast or webcast public service
  announcements. A public web site is also part of
  the toolbox with opportunities for individual
  hubs to add site specific information for
  visitors to the site who identify themselves by
  location. The web site will serve primarily as a
  form of public notification, but will also have a
  link to a survey and open commentary box where by
  visitors can provide feedback.

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Local IRB review

• To ensure that efforts conducted in all the
  communities participating in the NETT all meet
  our standards for understanding, respect, and
  transparency, and to promote equity across
  communities, we strongly encourage adherence to
  this plan across all the sites. We encourage IRB
  to participate in community presentations at each
  site to help explain their role, and to
  experience the feedback obtained. Investigators
  will report on their experiences and findings to
  their IRB using standardized templates and these
  reports will be collected centrally within the
  NETT as well. It is clearly recognized, however,
  that IRB may alter or supplement the plan as
  deemed necessary for local conditions. To
  enhance communication on exception from consent
  plans within the network, a meeting of
  investigators and IRB representatives from the
  different sites will be convened early in the
  process to share opinions and promote consensus.

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Milestones

• The need to complete milestones in the exception
  to consent process to receive reimbursement
  payments provides incentives for efficient
  execution of these efforts. Anticipated
  milestones triggering payments will be discussed
  separately.

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Process research

• In an effort to better understand and continually
  improve our exception from informed consent for
  emergency research processes, ethicists with a
  special interest in this area will study strategy
  and implementation in the NETT. They will attend
  trainings and community consultations, and will
  ask to interview investigators and IRB chairs.
  This will be limited in RAMPART and more
  extensive in ProTECT. If possible, please
  cooperate in their efforts to learn what works,
  what does not, and how things can be done better.

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Timeline

• November initial IRB contact, letter template,
  identify EMS coordinator
• End of November IND submission, final protocol,
  complete CC PD plan, IRB template
• December IRB submissions begin, identify EMS
  required approvals
• End of December toolbox will include
  advertising copy, public web site, etc.

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Timeline

• January some centers begin CC PD, identify EMS
  training schedule, begin EMS train the trainers
• End of January RAMPART ER-EFIC conference for
  investigators and IRB members, toolbox will have
  video materials for CC PD and advertising, EMS
  training materials
• February onward High season for CC PD and EMS
  education, ongoing IRB and EMS approval processes

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Timeline

• Summer most centers expected to complete
  approval processes
• End of October current scheduled delivery of
  experimental drug (earlier delivery under
  negotiation)
• Study team training, data training, and phase II
  EMS training takes place just prior to opening
  enrollment

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Timeline

• End of 2008-2011
• Enrollment
• On-going EMS training
• On-going AE reporting
• One interim analysis at 350 subjects enrolled
• 2011
• Last patient in database lock
• Analysis
• Public notification again

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nett.umich.edu