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To Delegate, or Not To Delegate by HC1209170661

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									 Informed Consent: Process,
Document, and Waiver Criteria
Guiding Principles
   The Belmont Report – Respect For Persons
      People are autonomous agents and should be
       treated with respect
      Informed consent must be freely and voluntarily
       given
      Those of diminished capacity require additional
       protections
Informed Consent
What it is:
 Ongoing ‘process’ of communication and
  understanding
 Voluntary agreement between subject and
  investigator (absence of pressures/coercion)

What it isn’t:
 A piece of paper
 A one time conversation
Elements
 Statement that the study involves research
 Purpose
 Duration of participation
 Treatments/Procedures
     Probability for random assignment
     Aspects that are experimental

     Subject’s responsibilities

   Foreseeable risks/benefits
Elements (cont.)
 Alternative treatment(s)
 Compensation/treatment for injury
 Payment/expenses
 Confidentiality conditions
     Monitor, auditor, and REC access
     Subject’s identity not revealed in publications

   Notification of relevant/significant and
    (new) information
Elements (cont.)
 A statement that the particular treatment or
  procedure may involve risks to the subject
  (or to the embryo or fetus, if the subject is
  or may become pregnant) which are
  currently unforeseeable (when appropriate)
 Foreseeable reasons for termination
 Approximate sample size
 Voluntary nature of participation

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Elements (cont.)
 Consequences of discontinuing research
  participation (when appropriate)
 Contact person(s) for questions
     About the research
     About subjects’ rights

     In the event of research-related injury




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Informed Consent Document
   Written document that includes all applicable
    elements
       E.g., OHRA Consent Templates
 Readability and Comprehension
 Consent documents must be in language that
  is understandable to participants
 Must be approved by the IRB and/or local
  ethics board
Additional Considerations
 Parental/legal guardian permission for minors
 Minor assent
       affirmative agreement to participate in research
 Surrogate Consent
 Obtain consent from illiterate persons
 Use of a witness
 Use of a subject advocate
Documentation of
Informed Consent
   Valid IRB approved written consent form
   Signed and dated
       participant or legally authorized representative
       person who obtained informed consent
   Retain original signed/dated document for study
    file
   Provide subjects with a copy (unless waived by the
    IRB)
   Use Enrollment Log as additional documentation
When To Obtain Consent
   Prior to the start of any study procedures
   After sufficient time is allowed for participants to
    discuss with family, friends, and other physicians
   Throughout individual’s participation in the study
       Investigator is required to inform subject of
        relevant/significant (new) findings and to ensure that they
        are still willing to participate
       IRB or sponsor, may require that the subject sign an
        updated consent form
       For minors, when they reach the local age of majority
Who Can Obtain Consent
   Principle Investigator (PI) or Co-Investigator
       Qualified by training and experience
       Knowledgeable about informed consent process
       Knowledgeable about protocol
       Knowledgeable about local culture and their customs
   If others, persons must be approved by IRB
       PI to document, e.g., Delegation of Responsibility Log
   Responsibility of PI to ensure informed consent
    obtained and documented
Waiver of the Requirement to
Obtain Informed Consent
   Research involves no more than minimal risk to
    the subjects;
   Waiver or alteration will not adversely affect the
    rights and welfare of the subjects;
   Research could not practicably be carried out
    without the waiver or alteration;
   Whenever appropriate, the subjects will be
    provided with additional pertinent information
    after participation.
Waiver of the Requirement to
Document Informed Consent
Non-FDA regulated research that involves no more
than minimal risk:
 The only record linking subject/research would be
the consent and the principal risk would be harm
resulting from a breach of confidentiality
                          OR
 The research presents no more than minimal risk to
subjects and involves no procedures for which written
consent is normally required
Compliance Checklist
   Was informed consent obtained from each subject prior
    to the start of any study procedure(s)?
   Was an IRB approved consent form (IRB validation
    stamp in footer) used to consent each subject?
   Was the consent form used for each subject a copy of the
    most recently approved version (check valid dates)?
   Is the consent form on file for each subject the original
    signed and dated version (not a photocopy)?
   Are all pages of the consent form on file for each
    subject?
Compliance Checklist (cont.)
   Did all subjects receive a copy of their signed and dated
    consent form?
   Is there documentation to support that all subjects
    received a copy of their signed and dated consent form?
   Is subject identification (written or imprinted with
    hospital card) on all pages of the consent form?
   Did each subject sign and date the consent form for
    him/herself? (excluding IRB approved
    surrogate/parental consent)
Compliance Checklist (cont.)
   Did an IRB approved study representative obtain consent
    for all subjects?
   Did the IRB approved study representative obtaining
    consent sign and date for him/herself?
   Did the subject and study representative enter the same
    date on the consent form?
   Are all consent forms free of any handwritten
    changes/corrections (e.g. updated physician contact
    telephone number)?
Compliance Checklist (cont.)
   Are original copies of all IRB approved consent forms
    on file (maintain electronically or in study’s Regulatory
    Binder)?
   Is the number of subjects who have signed the consent
    form (i.e. enrolled) less than the target enrollment goal
    approved by the IRB?

								
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