Informed Consents and HIPAA Authorization Follow-Up for VA Research

1. Informed Consents and HIPAA Authorization Follow-Up for VA Research Shawn Axe Laura Gibson October 27, 2010

2. 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

3. VA Informed Consents • Required injury and cost language

4. 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) • You (will/will not) receive payment for taking part in this study (include details and any conditions of payment). • 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. • 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:

5. VA Informed Consents • Research subject cost language

6. 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.) • List any additional costs to the subject that may result from participation in the study.If not applicable, then use this statement: • 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. • The study is sponsored by . • 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. From VA ICS Template:

7. VA Informed Consents • Genetic information statement

8. 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:  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

9. VA Informed Consents • Legally authorized representatives

10. 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. From VA ICS Template:

11. 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

12. 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

13. 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

14. 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

16. 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

18. 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

19. 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

20. 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

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