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HIPAA Enhancements to IRB Submissions. John M. Falletta, MD Chairman, Institutional Review Board Duke University Health System Durham, NC. HIPAA Health Insurance Portability and Accountability Act Protected Health Information (PHI) Individually identifiable health information.

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hipaa enhancements to irb submissions
HIPAA Enhancements to IRB Submissions

John M. Falletta, MD

Chairman, Institutional Review Board

Duke University Health System

Durham, NC

slide2
HIPAAHealth Insurance Portability and Accountability Act

Protected Health Information (PHI)

Individually identifiable health information

slide3
Treatment, Payment, or Operations (TPO)

Education and Quality Improvement are Operations

hipaa and research
HIPAA and Research

HIPAA mandates that a privacy board ensure institutional compliance with HIPAA. For research involving humans receiving care at DUHS, this function is fulfilled by the IRB.

definition of research
Definition of "Research”

A systematic investigation designed to develop or contribute to generalizable knowledge. 45 CFR 46.102 (d)

definition of human subject
Definition of "Human Subject”

A living individual about whom an

investigator...conducting research obtains

(1) data through intervention or interaction

with the individual, or (2) identifiable

private information. 45 CFR 46.102(f)

definition of human subject operational change due to hipaa
Definition of "Human Subject”Operational Change due to HIPAA

An living individual about whom an

investigator...conducting research obtains

(1) data through intervention or interaction

with the individual, or (2) identifiable

private information.

research using decedent phi
Research Using Decedent PHI

No longer “exempt from IRB review”

Now covered as any other PHI

IRB must be notified of research plans

- Implementation requires response

- IRB may require evidence of death of the subject

items to exclude for deidentification
Names

Address

Zip code *

Dates except year

Telephone numbers

Fax numbers

Electronic mail addresses

Social security numbers

Medical Record Numbers

Health plan beneficiary numbers

Account numbers

Items to Exclude for Deidentification
items to exclude for deidentification cont
Certificate/license number

Vehicle identifiers and serial numbers

Web Universal Resource Locators (URLs)

Internet Protocol (IP) address numbers

Biometric identifiers

Full face photographic images

Any other unique identifying number, characteristic or code

Items to Exclude for Deidentification (cont.)
anonymization versus hipaa deidentification
AnonymizationversusHIPAA Deidentification

The only setting where approval of IRB anonymization (unlinking) does not also confer approval of HIPAA deidentification is when the anonymized (unlinked) data contain dates (more specific than the year) of events, or full ZIP code or age of a subject over 90.

hipaa deidentification versus anonymization
HIPAA DeidentificationversusAnonymization

The only setting where approval of HIPAA deidentification does not also confer approval of IRB anonymization (unlinking) is where a code with a key linking back to the subject is retained with the deidentified data without special provisions approved by the IRB.

protocol
Protocol

Methods for Subject Accrual

  • Identifying Potential Subjects
  • Recruitment

Methods for Protecting

  • Privacy of Subject
  • Confidentiality of Data

Consent Form

methods for subject accrual
Methods for Subject Accrual

Identifying Potential Subjects

(Reviews Preparatory to Research, Pre-Screening, Case Finding)

Notification of IRB via letter or protocol description

Request IRB waiver or alteration of consent

methods for subject accrual cont
Methods for Subject Accrual (cont.)

Notification of IRB of plans for identifying potential subjects

  • Letter or protocol description to include specific information needed to prepare research protocol and/or identify potential subjects
  • Implementation requires response
  • Limitation - No PHI may be removed from DUHS
methods for subject accrual cont1
Methods for Subject Accrual (cont.)

Implication - Notification of IRB (cont.)

Useful for screening prior to protocol development to determine whether research is feasible.

slide17

Methods for Subject Accrual (cont.)

Request IRB Waiver or Alteration of Consent in order to identify potential subjects

  • Protocol description justifying waiver or alteration
  • Description of PHI needed
  • Evidence that risks will be minimal
  • Evidence that research is impractical without waiver for access to PHI
implications waiver or alteration of consent
Implications - Waiver or Alteration of Consent
  • Use to contact individuals who have left covered entity
  • Use if sponsor requires pre-screening logs
  • IRB needs to know if sponsor gets PHI from pre-screening
  • Identification removal requirement implies contract modifications with sponsor
slide19

Implications - Waiver or Alteration of Consent (cont.)

Note: May use/disclose data as described in IRB protocol.

  • Other use requires IRB approval
  • Verbal consent allowed with IRB approval
slide20

Methods for Subject Accrual

Recruitment

  • Ads (content, style and placement/ publication)
  • Word of mouth
  • Contact potential subjects who know PI
    • Describe location and procedure
  • Contact of potential subjects who are “strangers” (such as Other People’s Patients)
    • Describe location and procedure
procedure for contacting other people s patients
Procedure for Contacting Other People’s Patients
  • Obtain permission of the patient’s physician
  • Provide IRB-approved study information (brief) to patient’s physician or other caregiver known to the patient
  • Caregiver provides patient with introduction to the study and the name of the investigator (staff member) who will contact the patient
  • Investigator (staff member) contacts the patient about the study
methods for protecting privacy of subjects
Methods for Protecting Privacy of Subjects

Privacy - the right to be left alone

- the right to control personal information even after disclosing it

How will you minimize the risk of invasion of the subject’s privacy?

methods for protecting confidentiality of data
Methods for Protecting Confidentiality of Data

How will you minimize the risk of inappropriate disclosure of PHI?

general requirements for informed consent 45 cfr part 46 116
General Requirements for Informed Consent (45 CFR Part 46.116)

Legally effective informed consent shall:

1. Be obtained from the subject or the subject's legally authorized representative;

2. Be in a language understandable to the subject or the representative;

general requirements for informed consent 45 cfr part 46 116 cont
General Requirements for Informed Consent (45 CFR Part 46.116) (cont.)

3. Be obtained under circumstances that provide the subject with the opportunity to consider whether or not to participate, and that minimize coercion influences;

4. Not include language through which subject is made to waive any of his legal rights or which releases the investigator, sponsor or institution from liability for negligence.

slide26

Basic Elements of Informed Consent 45 CFR Part 46.116 (A)(cont.)

1. Statement that study involves research; explanation of purpose(s) and expected duration of participation; description of procedures and identification of experimental procedures.

2. Description of risks or discomforts to subject.

basic elements of informed consent 45 cfr part 46 116 a cont
Basic Elements of Informed Consent 45 CFR Part 46.116 (A)(cont.)

3. Description of benefits to subject or to others.

4. Disclosure of alternative procedures, if appropriate.

5. Description of the extent to which confidentiality will be maintained.

basic elements of informed consent 45 cfr part 46 116 a cont1
Basic Elements of Informed Consent 45 CFR Part 46.116 (A)(cont.)

6. For research involving more than minimal risk, explanation as to whether compensation and medical treatments are available if injury occurs.

7. Explanation of whom to contact if questions arise about the research or the subjects' rights or whom to contact if research-related injury occurs.

basic elements of informed consent 45 cfr part 46 116 a cont2
Basic Elements of Informed Consent 45 CFR Part 46.116 (A)(cont.)

8. Statement that participation is voluntary, that refusal to participate involves no penalty or loss of benefits, and that subject may discontinue at any time.

additional elements of informed consent 45 cfr part 46 116 b
Additional Elements of Informed Consent 45 CFR Part 46.116 (B)

When required by the IRB, one or more of the following elements shall be provided to each subject:

1. Statement that procedure may involve unforeseeable risks;

2. Description of circumstances under which subject's participation may be terminated by the investigator without subject's consent;

additional elements of informed consent 45 cfr part 46 116 b cont
Additional Elements of Informed Consent 45 CFR Part 46.116 (B)(cont.)

3. Additional costs to subject resulting from participation in research;

4. Consequences of subject's decision to withdraw from research;

5. Statement that significant new findings developed during research which may relate to subject's willingness to continue will be provided to subject;

6. Approximate number of subjects involved in study.

consent form
Consent Form

All of the following information will be needed in each consent form.

consent form1
Consent Form

For early withdrawal from the study:

If you agree to be in this study, you are free to change your mind. At any time you may withdraw your consent to be in this study and for us to use your data. If you withdraw from the study, you will continue to have access to health care at Duke.

consent form2
Consent Form

For early withdrawal from the study (cont.):

If you do decide to withdraw, we ask that you contact Dr. [PI] in writing and let [him/her] know that you are withdrawing from the study. [His/her] mailing address is [address]. At that time we will ask your permission to continue using all information about you that has already been collected as part of the study prior to your withdrawal.

consent form3
Consent Form

Statement of Consent:

You will be given a signed copy of this consent form.

or

“I have been told that I will be given a signed copy of this consent form.”

consent form4
Consent Form

Confidentiality:

Study records that identify you will be kept confidential as required by law. You will not be identified by name in the study records. Your records will be assigned a unique code number. The key to the code will be kept in a locked file in Dr. [PI]’s office.

consent form5
Consent Form

Who will have access to study records and to whom information may be disclosed:

Your records may be reviewed in order to meet federal or state regulations. Reviewers may include …, …, … and the Duke University Health System Institutional Review Board.

consent form6
Consent Form

Expiration date or event for the retention of records:

The study results will be retained in your research record for at least six years or until after the study is completed, whichever is longer. At that time either the research information not already in your medical record will be destroyed or information identifying you will be removed from such study results at DUHS. Any research information in your medical record will be kept indefinitely.