ICF & HIPAA waivers Human Subject Protection Office UConn Health Center Monika Haugstetter, MHA, RN, MSN & HSPO/IRB Staff

2 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

3 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

Request for Waiver of the Requirement to Consent Subject or Alteration of Consent Elements

5 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

6 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)

7 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)

8 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

9 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)

Request for Waiver of the Requirement to Document the Consent of Subjects

11 Waiver to Document Consent Build into IRB application (section 9) OR Use separate form Consent process still occurs Documentation waived

12 Waiver to Document Consent 1 st 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

13 Waiver to Document Consent 1 st 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

14 Waiver to Document Consent 2 nd 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

Request for Waiver of HIPAA Authorization

16 HIPAA Waiver Used in conjunction w/ waiver for consent Not practical to conduct research w/out waiver

17 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

18 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

19 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

20 HIPAA Waiver 4. Research not practicably conducted without waiver –Response similar to waiver of consent –Partial Waiver Solely requested for phone screening

21 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)

22 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

23 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!

24 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