Informed Consents
and HIPAA
Authorization FollowUp 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
From VA ICS Template:
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
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.)
From VA ICS Template:
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
.
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
From VA ICS Template:
Inclusion of a signature line for the Legally
Authorized Representative (LAR) should ONLY
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

Excerpt from 1200.05
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
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 legallyauthorized 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 legallyauthorized representative, in addition to a copy of the signed short form.
HIPAA authorization followup

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-01
IRB-02
IRB-04
IRB STUDY NUMBER:
DOCUMENT DATE:
IRB-05
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.:
Contact Information:
Name:
Phone:
E-Mail:
Address:
Fax:
Phone:
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)
Interactions Continue,
No continued interactions
Inactive VA Subjects (Total)
No interactions, ie: Completed,
Withdrawn, Lost to follow up, Analysis
Only, etc.
ACTION:
Section IV: Re-Authorize,
Immediately Submit new VA HIPAA to IRB
Section III: De-Identify Data or Return Data to VA. If not
possible Justification must be provided
Section III: De-Identify Data or Return Data to VA. If not
possible Justification must be provided
Total Active & Completed Subjects
Yes__
No__
If Yes, Section IV: Authorize with new VA HIPAA
Open to Enrollment
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 followup

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 followup

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