Research Compliance Office
Consent Form Workshop
Kristin B. Frazier
HRPP Education Specialist
Research Compliance Office
January 24, 2008
Topics
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Consent Process
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Waivers and Alterations of Consent
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Oral consent, telephone screening, online consent, consent by
mail
Recruitment Methods
Obtaining Consent
Consent Form Templates
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Children
Managing your consent forms
Short form consent process
CIRB
Other Issues
Research Compliance Office
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Consent Process
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Remember, it’s an ongoing process…not a one
time event (e.g. sign the consent form)
Valued Qualities (know your audience)
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Communication – tone, vocabulary and level of
discussion during the consent process
Timing – some need time to consult with others and
gather their own information
Understanding – one understands when the reasons,
motivations and expectations are discussed and
grasped
Research Compliance Office
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Consent Process
eProtocol Application – section 13
 Consent Background
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Describe the consent process (e.g. when and where
consent will be obtained and by whom)
Address potential issues of coercion and undue
influence
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Give participants time to consider participation (let them take
the consent form home, especially if a complex study)
Make clear the distinction between research and treatment
and that refusal to participant will not effect treatment,
especially when the treating MD is the investigator
Research Compliance Office
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Consent Process - Children
If your protocol includes
children and the children
reach adulthood (18 years
old) while still participating
in the research, you must
consent these individuals
for their continuing
participation in the
research or request a
waiver of consent from the
IRB
Research Compliance Office
Assent is required
for children
between 7 and 17
years of age
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Waivers and Alterations of
Informed Consent
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Waiver of Informed Consent
Waiver of Documentation of Informed Consent
Alteration of Informed Consent
Research Compliance Office
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Consent – Waiver of Consent
Basic Elements of Informed Consent
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Research statement: purpose, procedures
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Reasonably foreseeable risks or
discomforts
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Reasonably expected benefits to
participants or others
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Appropriate alternatives
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Extent of confidentiality or privacy
protections
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Compensation or treatment for research
related injury
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Contact information
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Voluntary participation statement
Research Compliance Office
Most often used for
retrospective record
reviews and other studies
when it is impracticable (not
just inconvenient)
to obtain consent before
conducting research
Not allowed on FDA
regulated research (drug and
device studies)
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Waiver of Documentation of
Informed Consent
Criteria for IRB Approval
 Risks minimized, research
design sound
 Risks reasonable with regard to
benefits
 Subject selection equitable
 Informed consent from subject
or LAR
 Informed consent documented
 Plan for monitoring data, when
appropriate
 Plan for privacy/confidentiality,
when appropriate
Telephone screen
In response to advertisement
All elements of consent in
phone screen
Full consent process with
documentation (signature)
required before study procedures
begin
Also used for survey or
questionnaire studies that are
low risk (oral consent process)
A signature is never obtained
Research Compliance Office
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Alternations of Informed Consent
Basic Elements of Informed
Consent
Research statement: purpose,
procedures
Reasonably foreseeable risks or
discomforts
Reasonably expected benefits to
participants or others
Appropriate alternatives
Extent of confidentiality or privacy
protections
Compensation or treatment for
research related injury
Contact information
Voluntary participation statement
Alteration of Informed Consent
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Can be used for deception in
behavioral studies
Used less frequently in
medical studies
Not allowed in FDA-regulated
research (device or drug
safety/efficacy trials) except for
Emergency Use or Planned
Emergency Research
Research Compliance Office
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Waiver and Alternations of
Informed Consent
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To grant an alteration or waiver of consent, the IRB must
find that:
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The research in its entirety involves no more than minimal
risk
The alternation or waiver of consent will not adversely affect
participant rights and welfare
Research could not practicably be carried out without alteration
or waiver
Whenever appropriate, participants are provided with additional
information after participation
Research Compliance Office
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Waiver of Documentation of
Informed Consent
To grant a waiver of documentation of consent, the IRB
must find:
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The research presents no more than minimal risk and
involves procedures for which written consent is not
normally required outside of research context
or
That a signature on the consent would be the only link to
participation and the principal risk to the participant would
be breach of confidentiality (Not allowed by the FDA)
Research Compliance Office
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Identifying Participants
How are you getting participants?
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Clinic patients, tell then about the study at clinic visit
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Can be your patients or referrals to clinic for clinical care
 For former patients, you can send them a letter telling them about
the study – if interested contact you
Referrals for research (not for clinical care)
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Tell colleagues or send them letters letting them know about your study
Colleagues can give your contact information to the patients or with the
patients permission, give you the patient’s contact information
Colleagues can send their patients a letter about your study, interested
participants are instructed to call you
(All letters need prior IRB approval)
Advertisements
No cold calls and no passive consent!!
Research Compliance Office
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Obtaining Consent - Process
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Face-to-face – obtain signature from participant before beginning any
research related activity
Over the phone – send (mail or fax) consent to participant, then consent
process is conducted over the phone – signature is faxed or mailed back
(no research related activities can take place until signature received)
 Bifurcate the process – (screening consent and study consent)
Screening consent (oral consent/waiver of signature) for telephone
screening, then full study consent signed in face-to-face meeting if
qualifies for the study
Oral consent
 In person – man on the street research (hand out information sheet)
 Phone survey or questionnaire (waiver of signature)
On-line consent
 Secure computer system
 Completing online survey/questionnaire evidences agreement to
participate
 Waiver of documentation (no signature)
Research Compliance Office
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Managing Consent Forms –
eProtocol
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Consent Form Changes
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Track changes in consent and assent forms
Practice Tips:
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When protocol is approved, go to the approved
eProtocol and down load approved consent form
– accept the tracked changes and save on your
computer
When submitting a subsequent event, attach the
saved consent
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If new event includes changes to the consent, again track the new changes
Research Compliance Office
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Other Issues
CIRB (Central IRB)
 Start with CIRB approved consent forms, then add
Stanford required elements and HIPAA authorization
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Cancer research only, Phase I, II, III (children) and Phase
III (adults)
Short Form Consent
 Non-English speaking participants
 It is strongly recommended that the full English
consent be translated into the participants’ language
Research Compliance Office
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Short Form Consent
General Information
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A translated consent form will usually be requested if
the study targets persons who may not speak
English
Short form process is available and will be approved
by the IRB on a case-by-case basis, depending on
the complexity of the research, study duration and
whether or not it is a treatment study
Short form consents in 7 languages available
 Spanish, Russian, Chinese, Japanese, Korean,
Farsi and Vietnamese
Research Compliance Office
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Short Form Consent Process
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Interpreter/translator should explain the consent
process to participant and review the full English
consent, section by section, with the participant
Witness should witness the entire process (Witness
must be bilingual)
Give the short form consent to participant
Participant and witness sign short form consent
Person Obtaining Consent and witness sign English
consent
Research Compliance Office
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Tissue Banking Text
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Stanford consent form templates
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Reformatted
Revised tissue banking text
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For studies where specimens (blood/tissue) will be
collected - the consent must include either:
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A statement that left-over specimens will be destroyed at
the end of the study, or
Tissue banking text regarding any future use of the
specimens
This applies to optional specimen collections too,
whether noted in the main consent or in a separate
consent
Research Compliance Office
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AAHRPP Accreditation…
There're coming back
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Stanford HRPP received full accreditation in
March 2006
3 year accreditation period
Starting on the re-accreditation process
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Reviewing policies (HRPP)
Expect a site visit in September 2008
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Anticipate site visitors will want to interview
investigators and research personnel again
Research Compliance Office
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Contact Us
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Questions, concerns, comments or
suggestions
Feedback on IRB processes
Request IRB education
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Individualized
Small or large group presentations
Topic specific
Suggest topics for upcoming presentations
Research Compliance Office
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Contact Us
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Kristin Frazier, HRPP Education Specialist
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724-7141, [email protected]
Research Compliance website
http://humansubjects.stanford.edu/
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Look for notice of updates on website home page
Research Compliance Office
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