session ii: the informed consent process: an …jayvant heera, md, mfpm pfizer clinical development,...
TRANSCRIPT
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SESSION II: The Informed Consent Process: An Interactive Discussion
Jane Perlmutter, Patient Advocate
March 10, 2015
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Session II Objectives ! Solicit feedback on proposed recommendations for
ensuring a more effective informed consent process to achieve enhanced research participant understanding ! Solicit feedback on the utility of the proposed
informed consent checklist ! Discuss roadblocks to implementation and steps
that can be taken to overcome them
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Proposed Recommendations for the Informed Consent Process: Who, How, When, Where
Jayvant Heera, MD, MFPM
Pfizer Clinical Development, Groton, Connecticut
March 10, 2015
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Background
Ensuring respect for
persons
The Informed Consent
Process is important
What do we need to do to improve
the process?
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Proposed Recommendations
Defining the Process
Key Elements of the Informed Consent Process
Informed Consent Checklist
*Does not cover specialized situations
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Defining the Process ! Ongoing, interactive conversation between participant and
research staff
! Document is part of the process but not the primary mechanism for consenting participants
! Process continues after the document is signed § Throughout course of trial, staff should continuously
follow-up with participants to assure ongoing consent
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Who should be involved in the process?
Potential Research
Participant
Family, friends, witness,
LAR
Persons obtaining Consent
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When is the informed consent process conducted? ! Before the research participant undergoes any research
related procedures
! If possible, document can be provided to the participant ahead of time
! At a time when the potential participant can focus on the process
! Ongoing throughout the trial, particularly when there are significant new findings
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Where is the Informed Consent Process Conducted? ! When possible, in a nonthreatening, safe setting that
reduces any feeling of coercion
! In the best possible location to protect a participant’s privacy
! Specifically: § Try to avoid
• waiting rooms • or locations where a participant is not fully dressed
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How is participant understanding facilitated?
! Use consent document as an outline
! Interactive discussion with participant
! If possible, a multimedia approach, such as tablets or internet access with visual aids, study calendars
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Facilitate Understanding
Understanding the distinction
between research and treatment
Consenter awareness of
participant anxiety and/or
cognitive overload
Consenter awareness of participant’s education, culture and
learning style
Avoid jargon when consenting
Presenting information in
layers
Offering additional
educational materials and/or
referrals
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How is understanding evaluated?
! Participant should explain in their own words what they understand about the study
! Teach-back method
! Ask participant open-ended questions
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How is informed consent documented? ! Participant must sign and date the ICD
! Assure that optional areas have been signed, as needed
! Consenter signs and dates the consent document
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Informed Consent Checklist ! Tool that may be used to document the consent process for
each participant
! Can be reviewed before the process begins to serve as a reminder of what the process entails
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(✔) I have considered: Notes:
A private, nonthreatening place to hold the informed consent discussion
Inclusion of family/friends in the informed consent discussion, as desired by the research participant
The research participant’s individual needs and geared my discussion to match them • Language facility • Education level • Health literacy • Interest in learning as much as possible • Comfort with numbers/probabilities
Providing the research participant with ample time to review the informed consent document and ask questions as needed
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(✔) The following items have been described to the research participant: Notes:
• Purpose of the research
• Research procedures, including those that are experimental, rela7ve to visits required for standard care
• Dura7on of par7cipa7on
• Reasonably foreseeable risks/discomforts
• Benefits to par7cipants and others
• Compensa7on for research-‐related injury
• Addi7onal costs to the subject for par7cipa7on, compared to standard of care
• Voluntary nature of par7cipa7on
• Available alterna7ve treatments
• Whom to contact with ques7ons/concerns
• Number of trial par7cipants (if required)
• Reasons for termina7ng par7cipa7on by research team (if required)
• Consequences of subject withdrawal (if required)
• Statement that par7cipants will be updated throughout the process (if required)
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(✔) I have: Notes:
Answered all of the research participant’s questions before the document is signed
Evaluated the research participant’s understanding of the information discussed
Provided the research participant with a signed copy of the informed consent document, and a copy of the detailed reference section
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Informed Consent Process Work Group ! Jane Perlmutter (Patient Advocate)
! Jayvant Heera (Pfizer, Inc.)
! Hallie Kassan (North Shore-LIJ Health System)
! Steve Mikita (Patient Advocate)
! Linda Morgan (Patient Advocate)
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CONNECT WITH CTTI www.ctti-clinicaltrials.org
Thank you.
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Panel Discussion ! Helen Donnelly
§ Clinical Research Nurse, Pulmonary and Critical Care Medicine, Northwestern University
! Linda Neuhauser § Clinical Professor, Community Health and Human Development,
University of California - Berkeley
! Kevin Prohaska § Office of Good Clinical Practice, Food & Drug Administration