The Informed Consent and the Informed Consent Process

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The Informed Consent and the Informed Consent
Process
Andrea D. Buchmeier, CCRCUniversity of Colorado
Cancer Center
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ICH Definition

• A process by which a subject voluntarily
  confirms his or her willingness to participate in
  a particular trial, after having been informed of
  all aspects of the trial that are relevant to the
  subjects decision to participate. Informed
  consent is documented by means of a written,
  signed and dated informed consent form.
• ICH Guidelines

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Objectives

• To learn and understand the process of obtaining
  written informed consent.
• To recognize an approved and valid informed
  consent form.
• Identify the 8 essential elements of the ICF

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The Informed Consent Process

• Number 1 RULE
• The Informed Consent Process takes place PRIOR to
  ANY subject involvement!
• Potential subjects are identified.
• Informed Consent should be obtained by a person
  who is qualified knows the protocol, completed
  institutional requirements.

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• The study will be described to the subject.
• Relatives or friends who are in clinic with the
  subject should be included in the discussion.
• Give an opportunity for the subject/family to ask
  questions.
• The consent should be provided in a language the
  patient understands.

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• After the potential study subject has had the
  study explained, and all questions have been
  answered, the subject should be allowed time to
  review the written consent alone or with
  family/friends.
• Before the subject is asked to sign a consent
  form, the investigator or coordinator should
  assess understanding of the major elements of the
  study.

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• When subject understanding is assured, the
  patient is asked to initial each page of the
  form, and sign and date where indicated.

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• The following people should sign and date the
  consent form
• The study subject
• Qualified person providing the information
• The principal investigator or sub-investigator
• Witness (optional)
• All signatures should be dated by the person who
  is signing.
• Fully Executed copies should go to the patient,
  the study chart, and the medical record (with
  visible patient identification)

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• The informed consent form must be approved by the
  local IRB (CoMIRB or WIRB if applicable) as well
  as other entities involved (HRRC and VA if
  applicable).
• To enroll VA patients the study must be open
  and approved through the VA AND COMIRB. At this
  time, WIRB approved protocols are not allowed to
  be opened at the VA.
• A separate VA consent is used for all VA
  patients.

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• Any alterations to the informed consent, or other
  forms, must be approved by the IRB before they
  can be presented to study subjects.
• To help ensure that study personnel are using
  the correct forms, all informed consents include
  the approval date, the version number, and the
  expiration date.

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Documentation

• Written documentation of the informed consent
  process should be completed immediately.
• This documentation should include
• Subject Name
• Diagnosis
• Protocol title
• Any translation and/or special issues
• Time
• Consent Process

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Remember

• No study-specific procedures, tests, or
  questionnaires may be performed until the subject
  has completed the informed consent process!!!

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• The Informed Consent Process is ongoing.
• At every visit, the study team should inform the
  subject of the visit events and the subject
  should be given the opportunity to ask questions.

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Eight required elements of an informed consent

• Purpose
• Risks
• Benefits
• Alternative treatments
• Confidentiality
• Injury compensation
• Invitation for questions
• Voluntary participation

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Questions???
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What does a valid and properly executed Consent
look like?
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What is wrong with this consent??

• Identify 8 elements of this consent that are
  wrong.

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• Valid for use through date is after the approval
  date
• Edits by Nancy on page 1
• No subject initials on page 2
• Pg. 3 Nancy edits
• Pg. 4 more Nancy additions/cross outs
• Pg. 5 third question not checked, more edits by
  Nancy
• Pg 6 consent dates conflict, No investigator
  signature but signature line is dated-by Nancy?
  More edits!!!
• Pg. 7 no initials

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What is wrong with this consent?

• No IRB stamp of approval
• Pg. 2-missint subject initials, cross out by
  Carrie Coordinator
• Pg. 4-missing!
• Pg. 6-compensation changed
• Pg. 8-edits by someone??
• Pg. 9-no date by subject signature, no subject
  initials
• No consent checklist

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When do you re-consent
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When do you re-consent

• When in doubt, fill it out!
• Changes in safety information
• Changes in procedures
• Change in PI
• Anything else?

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Questions???Thank you!