Transcript Informed Consent Form (ICF) & Health Insurance Portability

Informed Consent Form (ICF) &
Health Insurance Portability
and Accountability Act (HIPAA)
Human Subject Protection Office
UConn Health Center
Monika Haugstetter, MHA, RN, MSN
HSPO Website
http://resadm.uchc.edu/hspo/index.html
(bookmark to your desktop)
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Informed Consent Process
• Described in details in IRB application
– Special provisions
• Informed Consent Form (ICF)
• HIPAA Authorization
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Informed Consent Process
Essentials
• Individual consenting must complete CITI
training within last 3 yrs
• Current valid ICF signed & dated & copy
provided to subject
• Certificate of Confidentiality
– Allows investigators to refuse disclosing individually
identifiable research information in any legal
proceedings unless…
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Informed Consent Process
Essentials
• Storage (in accordance with ICF content &
protocol)
– Several options
• E.g. research records separate from ICF
• Revision
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Review carefully for content & accuracy
Requires submission for modification
Links to protocol
Requires re-consenting subjects
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Informed Consent Form (ICF)
Essentials
Formatting document:
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1” margin for stamps & scanning
Font size – 12, easily readable font
Clear section headings
Sufficient white space
Utilization of tables/charts/pictures to
communicate a point
• Version number in the footer (change when
revised)
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ICF Essentials
• Complete ICF:
– PI, PI Phone Number, All Co-Investigator(s), Title of
Research Study, Expected Duration of Subject’s
Participation, IRB Number, Name of Research
Participants (consistency)
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Provide IRB number on continuation
Include version of ICF
Avoid redundancy (read documents)
State risks clearly (bullets, tables, headings)
NO HIPAA elements in ICF - separate form
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ICF Essentials
• Use consistently person/tense – no use of 1st
person
• Include all required elements
• Be attentive to coercion/undue influence
issues
• Apply IRB version of pregnancy language (if
applicable)
• Subjects initials on each page optional
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ICF Required Elements –
Checklist
• Always use ICF checklist
• Checklist contains:
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All regulatory requirements
When elements required
Reminders (format, use of language, etc)
Requirements for genetic research
Additional requirements for specific funding/oversight
agencies (VA, FDA, PHS)
• Sponsor’s ICF may differ – check with UCHC
template for required elements & acceptable
language
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ICF Required Elements
Basic 8 elements of ICF
• Statement - research, purposes, expected duration
procedures to be followed, experimental procedures
• Reasonably foreseeable risks
• Benefits to subjects
• Disclosure of alternative procedures
• Maintenance of confidentiality of subject records
• Research w/ more than minimal risk - compensation &
whether any treatments available if injury occurs
• Contacts to answer questions re research & subjects'
rights
• Participation voluntary - no penalty or loss of benefits &
subjects may discontinue at any time
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ICF Required Elements
Additional elements when appropriate
• Unforeseeable risks (embryo or fetus if pregnancy
possible)
• Circumstances of subjects’ termination
• Additional costs to subjects
• Consequences of a subject's decision to withdraw (none)
• If new findings developed, subject appropriately informed
• Approximate number of subjects involved
• Disclosure about payments & financial gains
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ICF Highlights
• Use appropriately “injury language”
– e.g. “The sponsor will pay for your injuries unless
your injury resulted from your failure to follow the
directions”
– Injury language consistent with fully executed
contract
• When describing risks, provide numbers
– e.g. risk of seizure is rare (1 in 1,000)
• For complex ICF delineate essentials on 1st or
separate summary page
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ICF Highlights
• Use lay language/explanation when possible/
appropriate (be mindful of technical/medical
terminology)
– E.g. angina pectoris (chest pain resulting in insufficient
blood to the heart)
• Specifics on specimen storage
• No use of exculpatory language
– NOT acceptable: You will not share any financial gains
from the marketing of this study
– Acceptable: The sponsor does not intend for you to
share any financial gains if this product becomes
marketable
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Signature Section of ICF
1. Statement of consent to participate in the study
2. Statement that Subject/Legally Authorized
Representative receive a copy of ICF
3. Place for role, printed name, signature, & date
for subject and individual obtaining ICF
4. Timing of consent – not required but good
practice
5. Remove or add lines as needed
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e.g. If no LAR – remove LAR signature line
e.g. If child involved, a line for parent/s permission
and child assent
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Who Signs & Dates Consent Form?
• Subjects or
• Parents/children (think of assent)
• Legally Authorized Representative (LAR) (make
sure to provide proper documentation)
– Legal Guardians
– Court-appointed conservators
– Individuals with power of attorney/health care
representatives
• Next-of-kin not acceptable unless prior
designation
• AND – research staff obtaining consent
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Assent
• Knowledgeable agreement to participate in
research
• Subjects older than 12
– Subjects & parents sign ICF
• Subject 7-12 of age
– Therapeutic trial – parents/guardians sign ICF;
subjects do not have to
– Not Therapeutic trial – parents sign ICF; subjects sign
assent statement
• Subject younger than 7
– Parents/guardian sign ICF; subjects sign nothing
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ICF Considerations
• Need for ICF to be in subjects’ medical record?
• Practices ensuring use of most current ICF?
• What to do when revised ICF is pending
approval and subject’s visit is scheduled?
• Need for translation of ICF?
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ICF Considerations
• Separate ICF for optional sub-study components
(opt-outs)?
– All new studies per UCHC policy
– Sponsor template needs revision?
• Need for ICF for participation in
registry/repository studies
– Storage of information/specimen for future research
• Can a 8th or 5th grader understand the form?
• What will happen to data & specimens after
study closure?
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Upcoming Session
ICF & HIPAA waivers
• Partial waivers
• Request for Waiver of the Requirement to Consent
Subject or Alteration of Consent Elements
• Request for Waiver of the Requirement to Consent
Subject for Planned Emergency Research
• Request for Waiver of the Requirement to Document
the Consent of Subjects
• Information Sheet/ Written Summary if
documentation of consent waived
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Contact Information
• IRB support
– Patty Gneiting (exempt/expedited) x4849
– Pam Colwell (panel 1 & 3) x1019
– Donna Horne (panel 2 & 3) x4851
– Marcy Chasse (outgoing approvals) x8729
• HSPO
– Deb Gibb x3054
– Judy Gaffney x7555
– Monika Haugstetter x8802
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??? QUESTIONS ???
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