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ICF & HIPAA waivers. Human Subject Protection Office UConn Health Center Monika Haugstetter, MHA, RN, MSN & HSPO/IRB Staff. Waivers. Partial waivers Request for Waiver of the Requirement to Consent Subject or Alteration of Consent Elements

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icf hipaa waivers

ICF & HIPAA waivers

Human Subject Protection Office

UConn Health Center

Monika Haugstetter, MHA, RN, MSN

&

HSPO/IRB Staff

waivers
Waivers
  • Partial waivers
  • Request for Waiver of the Requirement to Consent Subject or Alteration of Consent Elements
  • Request for Waiver of the Requirement to Document the Consent of Subjects
  • Request for Waiver of HIPAA Authorization
general guidelines
General Guidelines
  • Waiver not applicable in FDA regulated studies*
  • Waiver not acceptable for convenience reasons
  • Study must involve no more than minimal risk*

* Note: There are rare exceptions to these guidelines

waiver to consent form
Waiver to Consent Form

1.Indicate whether a waiver or alteration of consent is being requested

  • Partial Waiver
    • Phone Screening/Recruitment
  • Full Waiver of Consent
  • Alteration of Consent Elements
    • Description of alterations requested
waiver to consent form6
Waiver to Consent Form

2. Will the research involve greater than minimal risk? (Answer must be NO)

  • Partial Waiver
    • Solely to determine eligibility
  • Full Waiver of Consent
    • Ex. Chart Reviews
  • Alteration to Consent

Ex. Subjects initially intentionally misinformed for study purpose (not common)

waiver to consent form7
Waiver to Consent Form

3. Could the research be practicably carried out without the waiver or alteration? (Answer must be NO)

  • Partial Waiver
    • Ex. Impractical to require every caller to come for screening visit
  • Full Waiver of Consent
    • Ex. Chart Review (volume/people moved away/time constraint)
waiver to consent form8
Waiver to Consent Form

4. Will waiving/altering informed consent adversely affects subjects’ rights and welfare? (Answer must be NO)

  • Partial Waiver
    • Right to not answer questions or end phone call
    • Subjects fully consented if choose to participate
    • Forms of screen failures consist no names/numbers
  • Full Waiver of Consent
    • Confidentiality of data protected by codes, passwords, secured locations
waiver to consent form9
Waiver to Consent Form

5. Will pertinent information be provided to subjects later? (Yes/No)

  • Partial Consent
    • Informing person re meeting eligibility, full consenting visit, study requirements, etc.
  • Full Waiver of Consent
    • If not possible, explain reasons (ex. contact information not part of data)
waiver to document consent
Waiver to Document Consent
  • Build into IRB application (section 9)

OR

  • Use separate form
  • Consent process still occurs
  • Documentation waived
waiver to document consent12
Waiver to Document Consent

1st scenario:

  • ICF only link between subject & research due to potential harm if breach of confidentiality
  • Minimal risk criteria not applicable
  • Not applicable in FDA studies
  • ICF developed/IRB approved
waiver to document consent13
Waiver to Document Consent

1st scenario (cont):

  • ICF (written documentation) as source of information
  • No need to sign the ICF but subject has right to opt to do
  • Examples
    • Ex. doing blood draws of HIV+ subjects
    • Ex. research involving women abused by spouses
    • Ex. research on drug use / sales
waiver to document consent14
Waiver to Document Consent

2nd scenario:

  • No more than minimal risk of harm to subjects
  • No procedures that would require written consent outside of research context
  • IRB may require investigators to provide written summary
    • Ex. surveys/interviews
hipaa waiver
HIPAA Waiver
  • Used in conjunction w/ waiver for consent
  • Not practical to conduct research w/out waiver
hipaa waiver17
HIPAA Waiver

1. Use/disclosure of PHI involves no more than minimal risk to subject privacy

  • Risks reasonable in relation to benefits
  • List specific PHI/their sources collected
  • Partial Waiver
    • Recording of name & phone number only for eligible callers
hipaa waiver18
HIPAA Waiver

2. Plan to protect identifiers

  • Describe storage
  • Describe in details access (PI, study personnel, FDA, other government agencies, DSMB, etc.)
  • Partial Waiver
    • For ineligible persons, information shredded; for eligible persons (subjects), PHI maintained in secured/locked location
hipaa waiver19
HIPAA Waiver

3. Procedures to destroy data collected during study

  • Destroyed at earliest opportunity consistent with study design/protocol
  • Ex. Records kept for 3 yrs after study conclusion on site, then hardcopy shredded/electronic data erased
hipaa waiver20
HIPAA Waiver

4. Research not practicably conducted without waiver

  • Response similar to waiver of consent
  • Partial Waiver
    • Solely requested for phone screening
hipaa waiver21
HIPAA Waiver

5. Not practical to conduct research without access/use of PHI

  • Ex. Chart Review or Survey
  • Partial Waiver
    • Preliminary view of PHI necessary to determine eligibility (ex. phone screening)
hipaa waiver22
HIPAA Waiver

6. Why PHI obtained for this study is the minimum information needed to meet study objectives

  • Partial Waiver
    • Only pertinent information (inclusion/exclusion) asked
    • Name/phone number only for those eligible/ interested in enrollment
infrequent waivers
Infrequent Waivers

If you ever need one of these:

  • Request for Waiver of the Requirement to Consent Subject for Planned Emergency Research
  • Request for Waiver of the Requirement to Consent Subject or to Make Alteration to the Elements of Consent for Projects Conducted by or Subject to the Approval of State or Local Government Officials

Contact IRB staff!

contact information
Contact Information
  • IRB support
    • Patty Gneiting (exempt/expedited) x4849
    • Donna Horne (panel 2 & 3) x4851
    • Pam Colwell (panel 1 & 3) x1019
    • Marcy Chasse (outgoing approvals) x8729
  • HSPO
    • Deb Gibb x3054
    • Judy Gaffney x7555
    • Monika Haugstetter x8802