1. Informed Consent Form (ICF) & Health Insurance Portability and Accountability Act (HIPAA)
Human Subject Protection Office
UConn Health Center
Monika Haugstetter, MHA, RN, MSN

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HSPO Website
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3. Informed Consent Process
Described in details in IRB application
Special provisions
Informed Consent Form (ICF)
HIPAA Authorization

4. 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…

5. 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

6. 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)

7. ICF Essentials Complete ICF: Provide IRB number on continuation
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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. Signature Section of ICF
Statement of consent to participate in the study
Statement that Subject/Legally Authorized Representative receive a copy of ICF
Place for role, printed name, signature, & date for subject and individual obtaining ICF
Timing of consent – not required but good practice
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

15. 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

16. 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

17. 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?

18. 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?

19. 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

20. 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

21. ??? QUESTIONS ???