Informed Consent Form (ICF) &

Health Insurance Portability and Accountability Act (HIPAA)

Human Subject Protection OfficeUConn Health Center

Monika Haugstetter, MHA, RN, MSN

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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 – 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:• 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)

• 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:

– 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 study2. Statement that Subject/Legally Authorized

Representative receive a copy of ICF3. Place for role, printed name, signature, & date

for subject and individual obtaining ICF4. Timing of consent – not required but good

practice 5. Remove or add lines as needed

- 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 ???