informed consents and hipaa authorization follow-up for va research

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 soonRevise 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 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.

From VA ICS Template:


Research subject cost language

Informed Consent Cost language

Charges will not be made for medical services furnished as part of an approved VA research projectUpdated consent template coming soonRevise 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 .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.



Genetic information statement

Informed consent

Genetic information statement GINA law ICS template excerpt:

GENETIC INFORMATIONIf the study involves genetic testing or the tracking of a particular disease or disorder in an individual’s family, insert the following statement:

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.

From VA ICS Template


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 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


ImplementationHow

• 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


ImplementationHow:

• 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 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.

Excerpt from 1200.05

HIPAA authorization follow-up

ImplementationWhat

• 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) No interactions, ie: Completed, Withdrawn, Lost to follow up, Analysis Only, etc.

Section III: De-Identify Data or Return Data to VA. If not possible Justification must be provided

Total Active & Completed Subjects

Open to Enrollment Future Subjects/Interactions

Yes__

No__ If Yes, Section IV: Authorize with new VA HIPAA 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

ImplementationWhat

• 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 firstHow

• 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 AxeUnion 618

[email protected]

278-9211

informed consents and hipaa authorization follow-up for va research

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