Informed Consents by zhi83591

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									Informed Consents
and HIPAA
Authorization Follow-
Up for VA Research
Shawn Axe
Laura Gibson
October 27, 2010
Today’s Agenda

   VA Informed Consents
      Required injury and cost language
      Implementation Date
      Amendments/Continuing Review
   HIPAA Action Plan Follow-up
      Continuing Review process
      Completion timeline
VA Informed Consents

   Required injury and cost language
                Informed Consent
                        Research injury language
                         VA must provide necessary medical treatment for
                          subjects injured as a result of research participation
                          unless the injury is due to noncompliance by a subject
                          with study procedures or the research is conducted for
                          VA under a contract with an individual or a non-VA
                          institution
                           Updated consent template coming soon
                           Revise open and enrolling studies at the time of continuing
                            review

                           Compensation & Treatment for Injury: (Always include #2)
                           1. You (will/will not) receive payment for taking part in this study (include details and
                              any conditions of payment).
                           2. The VA medical facilities shall provide necessary medical treatment to a research
                              subject injured as a result of participation in a research project approved by a VA
                              Research and Development Committee and conducted under the supervision of one
From VA ICS Template:         or more VA employees. This does not apply to: (1) treatment for injuries due to
                              noncompliance by a subject with study procedures; or (2) research conducted for VA
                              under a contract with an individual or a non-VA institution.
                           3. Financial compensation for research-related injuries is not available. However, by
                              signing this form, you do not give up your legal rights to seek such compensation
                              through the courts.
                           Do not include the IUPUI IRB template consent verbiage when it conflicts with
                              statements in #2 above.
VA Informed Consents

   Research subject cost language
                Informed Consent
                       Cost language
                         Charges will not be made for medical services furnished as
                         part of an approved VA research project
                         Updated consent template coming soon
                         Revise open and enrolling studies at the time of continuing
                         review
                             Research Subject Costs:
                             Each of the following items should be included if applicable: (Number 4 is
                             always applicable.)
                                 1. List any additional costs to the subject that may result from participation in the study.
                                    If not applicable, then use this statement:
                                 2. There will be no costs to you for any of the treatment or testing done as part of this research
                                    study. Eligibility for medical care at a VA Medical Center is based upon the usual VA
                                    eligibility policy and is not guaranteed by participation in a research study.
                                 3. The study is sponsored by        .
From VA ICS Template:            4. You will not be required to pay for medical care or services received as a participant in a VA
                                    research project except as follows:
                                       Some veterans are required to pay co-payments for medical
                                       care and services provided by the VA. These co-payment requirements
                                       will continue to apply to medical care and services provided by VA that
                                       are not part of this study.
                             Do not include the IUPUI IRB template consent verbiage when it conflicts with
                             statements in #2 & #4 above.
VA Informed Consents

   Genetic information statement
              Informed consent
                  Genetic information statement
                     GINA law
                     ICS template excerpt:

                         GENETIC INFORMATION
                         If the study involves genetic testing or the tracking of a
                         particular disease or disorder in an individual’s family,
                         insert the following statement:
From VA ICS Template
                         This research follows the Genetic Information
                         Nondiscrimination Act (GINA), a federal law which generally
                         makes it illegal for health insurance companies, group health
                         plans, and most employers to request the genetic information
                         we get from this research and discriminate against you based
                         on your genetic information.
VA Informed Consents

   Legally authorized representatives
              Informed consent
                  Legally Authorized Representative (LAR)
                   signatures
                     IRB must make a determination in writing of
                      each of several criteria before it can approve the
                      inclusion of incompetent subjects or subjects
                      with impaired decision-making capacity
                     At continuing review, remove the line for LAR
                      unless surrogate consent procedure approved by
                      IRB

                         Inclusion of a signature line for the Legally
                         Authorized Representative (LAR) should ONLY
From VA ICS Template:
                         be used when the use of surrogate consent has
                         been approved by the IRB.
VA Informed Consents
   Implementation
      Who:
        • Any research study open to enrollment
          with an informed consent statement, or
          studies closed to enrollment but who
          intend to reconsent subjects
      When:
        • Now, at continuing reviews or amendment
          submission when the informed consent is
          affected
        • OR, by specific amendment if not
          corrected by May, 2011
VA Informed Consents

   Implementation
       How
        • Continuing review – changes are required
          for studies with a consent form that are
          open to enrollment or that are closed to
          enrollment but will be re-consenting
          subjects
        • Amendment – if the informed consent
          statement is submitted as a result of a
          separate change, these changes should
          be included
VA Informed Consents

   Implementation
       How:
        • If the consent document has not been
          corrected by May, 2011:
           • Submit an amendment to update the consent
             with regard to the outlined changes
           • Minor amendment
                       Informed consent reminder
                          IRB policy
                              Non-English-speaking participants
                                  • Consent interview and document must be in language understandable
                                     to the subject
                                         • Current policy allows for translator; does not require translated
                                           written document = non-compliant
                                  • Solution: Short form consent
                                         • Coming soon!

                           Written Consent Document (Short Form). A shortened written consent
                           document stating that the elements of informed consent required by this appendix
                           and 38 CFR 16.116 have been presented orally to the subject or the subject's
                           legally-authorized representative. When this method is used, there must be a
Excerpt from 1200.05       witness to the oral presentation. This process includes the following:
                           (a) The IRB must approve a written summary of what is to be said to the subject or
                           the subject’s legally-authorized representative.
                           (b) Only the short form is to be signed by the subject or the subject's legally-
                           authorized representative.
                           (c) The witness must sign both the short form and a copy of the summary. The
                           person actually obtaining the consent must sign a copy of the summary. The
                           original short form and summary must be filed, as required.
                           (d) A copy of the summary must be given to the subject or the subject’s legally-
                           authorized representative, in addition to a copy of the signed short form.
HIPAA authorization follow-
up
   Implementation
       What
        • ORO requires that progress in regards to
          the authorization action plans be reported
          to the IRB
       Who
        • Any research study that, as part of the
          authorization action plan, required action:
           • Re-authorization
           • Re-contact with subjects
                          IUPUI/CLARIAN INSTITUTIONAL REVIEW BOARD (IRB) REVIEW
                                          VA-Specific Authorization Action Plan

Reviewing IRB (please choose one):                                                           IRB STUDY NUMBER:
  IRB-01     IRB-02       IRB-04          IRB-05                                             DOCUMENT DATE:

Please type only in the gray boxes. To mark a box as checked, double-click the box, select “checked”, and click “OK”.
                                            SECTION I: INVESTIGATOR INFORMATION
Principal Investigator:                                                                      Department:
                                             (Last, First, Middle Initial)
Building/Room No.:                                                     Phone:                  E-Mail:
Contact Information:
Name:                                    Address:                                              Phone:
                                         Fax:                                                  E-Mail:
Project Title:
Sponsor/Funding Agency:                                                             Sponsor No.

                                                    SECTION II: STUDY INFORMATION
A. This study includes (check all that apply):
Submit the VA Research Data Privacy & Security Assessment (Appendix C)

        Personal Health Information (PHI) or Individually Identifiable Private Information (IPII)
        Storage of PHI (paper or electronic) outside of the VA facility or firewall (“off-site data”)
        Access, release, or disclosure of PHI or IIPI to non-VA associates (VA employees or Without Compensation WOC)
        None of the above. This form is complete. Proceed to Section V for Submission Instructions.

B. Number of VA subjects and required action:
Active VA Subjects (Total)                                                      ACTION:
  Interactions Continue,                                                        Section IV: Re-Authorize,
                                                                                Immediately Submit new VA HIPAA to IRB
   No continued interactions                                                    Section III: De-Identify Data or Return Data to VA. If not
                                                                                possible Justification must be provided
Inactive VA Subjects (Total)                                                    Section III: De-Identify Data or Return Data to VA. If not
No interactions, ie: Completed,                                                 possible Justification must be provided
Withdrawn, Lost to follow up, Analysis
Only, etc.

Total Active & Completed Subjects

Open to Enrollment                        Yes__                 No__    If Yes, Section IV: Authorize with new VA HIPAA
Future Subjects/Interactions                                            Immediately Submit new VA HIPAA to IRB
*VA Authorization for Release of Health Information for Research.
The updated Authorization must be immediately utilized for any new VA research participants

C. Current Continuing Review
   Approved Date:                         Expiration Date:
HIPAA authorization follow-
up
   Implementation
       What
        • ORO requires that progress in regards to
          the authorization action plans be reported
          to the IRB
       Who
        • Any research study that, as part of the
          authorization action plan, required action:
           • Re-authorization
           • Re-contact with subjects
HIPAA authorization follow-
up
   Implementation
       When
        • Submit at continuing review, or by
          December 31, 2010 whichever comes
          first
       How
        • Follow-up forms distributed
        • Send as attachment to continuing review;
          or
        • Send as general information item
Going forward
   Authorizations
      Submit follow-up to original action plans if required
   ICS
      Bring consents into compliance during continuing
       review or amendment if consent affected
      Use new consent template for any new subject
   Continuing reviews
      Make updates to consent
   Amendments
      Make updates to consent if affected by other
       change(s)
      Or, submit separate amendment to make changes if
       not otherwise corrected by May, 2011
Questions?

         Shawn Axe
           Union 618
        saxe@iupui.edu
           278-9211

								
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