The Process of Informed Consent
Amy Blakeslee, BS, CIP, CCRP
HIC Lead Coordinator
Yale University
School of Medicine
July 1, 2016
What is the HIC?
Institutional Review Board (Called HICHuman 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 subject’s
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 out—no changes
of ANY type without HIC approval
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• Written/signed consent may be
waived under certain
circumstances—this 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 participant’s
involvement
• Description of procedures (***In
LAY terms***--see handout)
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Elements-Required (cont’d)
• 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 (cont’d)
• Confidentiality Section
• In Case of Injury
• Whom to contact with questions
• Voluntary Participation—free 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 relative—what would you
like them to know if THEY were the
participant
•
Don’t 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 nonverbal 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 eg7-12, 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 version—can
be a ‘short form’
• Consent should be obtained by someone
fluent in the participant’s language.
• This should NOT be a family member
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Non-English (cont’d)
• 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, participant’s assent
should also be obtained—may 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
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