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

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Presentation on theme: "Informed Consent Form (ICF) & Health Insurance Portability and Accountability Act (HIPAA) Human Subject Protection Office UConn Health Center Monika Haugstetter,"— Presentation transcript:

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

2 2 HSPO Website (bookmark to your desktop)

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

4 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 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 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 7 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

8 8 ICF Essentials Use consistently person/tense – no use of 1 st 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 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 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 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 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 1 st or separate summary page

13 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 14 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 -e.g. If no LAR – remove LAR signature line -e.g. If child involved, a line for parent/s permission and child assent

15 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 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 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 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 8 th or 5 th grader understand the form? What will happen to data & specimens after study closure?

19 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 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 21 ??? QUESTIONS ???

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