The Process of Informed Consent

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The Process of Informed Consent

• Amy Blakeslee, BS, CIP, CCRP
• HIC Lead Coordinator
• Yale University
• School of Medicine

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What is the HIC?

• Institutional Review Board (Called HIC-Human
  Investigation Committee at Yale)
• Committee whose primary responsibility is to
  protect the rights and welfare of human research
  participants.
• Governed by Federal Regulations (OHRP and FDA)
• Also by Belmont Report (Ethical Principles of
  Justice, Beneficence and Respect for Persons)

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What is Informed Consent?

• Example of Ethical Principle of Respect for
  Persons
• Not a document, but a process
• Starts at initial contact (e.g. recruitment)

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• Continues through study participation
• an informed participant is better able to adhere
  to the protocol and therefore provide evaluable
  data
• research staff members are obligated to share any
  new information related to subjects
  participation (i.e. newly identified side
  effects, etc)

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• Informed Consent
• The Document

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• All subjects must receive a copy of the ICF
  document for their records
• Many participants will refer back to it or take
  it to show to a loved one
• USE THE CORRECT (HIC approved!) VERSION
• NO crossing out/white outno changes of ANY type
  without HIC approval

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• Written/signed consent may be waived under
  certain circumstancesthis must be approved by
  HIC on a case-by-case basis
• Investigators must keep a copy of the signed
  consent document for their records (in a secure
  location)

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Elements-Required by Federal Regulations and HIC
policy (see Yale template handout)

• Involves research
• Explain purpose of research
• Expected duration of participants involvement
• Description of procedures (In LAY
  terms--see handout)

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Elements-Required (contd)

• Differentiate between experimental and standard
  procedures
• Description of Risks/Discomforts
• Description of Benefits (Does NOT include
  Payments to Subjects)
• Disclose Alternatives

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Elements-Required (contd)

• Confidentiality Section
• In Case of Injury
• Whom to contact with questions
• Voluntary Participationfree to withdraw at ANY
  time

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Industry sponsored research

• Sponsors usually provide a template to be used
  however the HIC must approve the final version
  and it must follow the HIC guidelines
• This is not a contract between the participant
  and the company-both the document and process are
  meant to inform participants

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• Informed Consent
• The Process

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• Handing a participant the consent document and
  asking them to read and ask questions is NOT
  Informed Consent
• Verify participant knows diagnosis before
  proceeding with process (If a treatment study)

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Should be a discussion which covers what is
contained in the document

• Try to keep it short (people will tune out at a
  certain point)
• Tailor presentation to audience. You may want to
  think about your most unsophisticated
  relativewhat would you like them to know if THEY
  were the participant
• Dont assume people know jargon/acronyms

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• Participants should be given ample time to
  consider options, ask questions and be allowed to
  take the information home to consider options
• Pay attention to verbal and non-verbal cues both
  by YOU and by the person

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Verify person understands information presented

• Consider giving a quiz after explaining study
  and before participant signs

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Consent Addendums

• Very useful when new information has been
  identified
• Used to provide currently enrolled subjects about
  new information (side effects, etc)
• The Committees seem to be moving toward requiring
  an addendum
• HIC has developed a template, available on our
  website

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• Special Populations

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Minors

• Under 18 cannot sign Consent form (Unless
  pregnant female consenting for research related
  to pregnancy or on fetus OR under 18 parent
  consenting for research on child)
• Minors sign an assent form (should have separate
  assents for different age ranges eg-7-12, 13-17)
• Parents sign permission form
• Child declining participation trumps parent
  agreeing unless HIC determines child assent not
  required

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Non-English

• According to regulations, the document MUST be in
  a language understandable to the participant and
  must contain the same elements as English
  versioncan be a short form
• Consent should be obtained by someone fluent in
  the participants language.
• This should NOT be a family member

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Non-English (contd)

• Finalize the English version before having it
  translated.
• Talk to the translator.
• All translators listed on the HIC website must
  meet certain criteria.

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Decisionally Impaired

• May be cognitively impaired, unconscious,
  mentally disabled, temporarily impaired
• Informed Consent discussion should happen with
  next of kin/surrogate OR legally authorized
  representative
• When possible, participants assent should also
  be obtainedmay be after the research related
  activities have occurred in the case of
  participants who are temporarily impaired

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• And now a word about HIPAA.

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• HIPAA RAF (Research Authorization Form) IS NOT a
  consent form
• authorization to use and release Protected Health
  Information for research purposes records to
  those entities listed on the RAF
• Consider using a Compound consent form which
  incorporates HIPAA language into consent form

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Questions?

• HIC website http//info.med.yale.edu/hic/
• OHRP website http//www.hhs.gov/ohrp/
• FDA website
• http//www.fda.gov/
• HIC 785-4688