RESEARCH COMPLIANCE

1. RESEARCH COMPLIANCE Agenda 1. No Destruction of local research documents after scanning 2. Training for shipping biological samples/specimens 3. Regulatory Audits 4. Investigational Drug changed to “Study Drug” in CPRS progress note templates: Research Consent & Contact and Research Reconsent 5. Informed Consent & HIPAA Waivers

2. Destruction of Local Research Documents After Scanning Is an investigator permitted to destroy the original VA Form 10-1086 signed and dated by the subject or the subject’s legally authorized representative after its scanned into CPRS?

3. Destruction of Local Research Documents After Scanning “…in concurrence with both ORD and ORO” NO!   A subject’s original signed and dated informed consent document cannot be destroyed after it has been scanned into the VHA health record. The subjects’ original signed and dated informed consent documents are investigator research records, not clinical records. Email communication from Bob Brooks, ORO June 18, 2010

4. Training for shipping biological samples/specimens • Initial training required for all research personnel that ship (SRS & R&D) Training offered: Mayo Clinic (free)http://www.mayomedicallaboratories.com/education/index.html?type=&topic=&format=&query=transportation&action=Search Safe-T-Pak (fee) http://www.saftpak.com NJ DOH (small fee-offsite) https://hazmatonline.phmsa.dot.gov/services/publication_documents/measure_up.pdf

5. Regulatory Audits All studies approved after 1/1/08 required • Follow the protocol history • Training records • (CITI, Info. Sec. 201 for R&D) • Inclusion/Exclusion criteria • Documentation of consent Recommended: regulatory file contain all submitted and received documents (all committees)

6. CPRS Progress Note Template Investigational Drug changed to “Study Drug” in Research Consent & Contact and Research Reconsent

7. Informed Consent & HIPAA Waivers • Waiver of Consent • Waiver of Documentation of Consent • Request for Waiver of HIPAA Authorization

8. Informed Consent Waivers What is a waiver of informed consent?

9. Waiver of Consent • The research involves no more than minimal risk to the subjects • The waiver or alteration will not adversely affect the rights and welfare of the subjects Can be granted by the IRB if:

10. Waiver of Consent The research could not practicably be carried out without the waiver or alteration

11. Waiver of Consent Whenever appropriate, the subjects must be provided with additional pertinent information after participation

12. Informed Consent & Documentation of Consent Waivers • If data is obtained about individuals without their consent and authorization, it is likely that a waiver is required • Just obtaining contact information prior to consent is a trigger for a waiver of informed consent and a waiver of HIPAA Authorization

13. Waiver of Documentation of Consent

14. Waiver of Documentation of Consent Criteria for IRB consideration 1. That the research presents no more than minimal risk of harm to subjects and Involves no procedures for which written consent is normally required outside of the research context

15. Waiver of Documentation of Consent Criteria for IRB consideration: 2. That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality

16. Waiver Of Documentation Of Consent Once a study has a waiver of documentation of consent… …how do the requirements differ from those for studies where a signed consent form is obtained? See next 2 slides for the answer

17. Waiver Of Documentation Of Consent Same: • Obtain informed consent (disclosure for informed decision, time to consider, no undue influence or coercion, no exculpatory language, etc.) • Include all basic and applicable additional elements of consent • Person obtaining consent must be the PI or be formally delegated • Progress note must be entered in CPRS

18. Waiver Of Documentation Of Consent Progress note must be entered in CPRS The IRB may consider waiving the progress note requirement when the research procedures do not require medical record entries • No inpatient visit • No outpatient visit • No clinical resources • The research intervention would not lead to physical or psychological adverse events

19. Waiver Of Documentation Of Consent Different: • IRB may require that a written statement be given to subjects • No signed consent form • No witness • No entry of consent form in CPRS • No IDMC Screening form • No HIPAA Authorization – Need HIPAA Waiver

20. Request for Waiver of HIPAA Authorization

21. HIPAA Waiver IRB may waive HIPAA when all 4 items are met • No more than minimal risk to privacy • Written plan to protect identifiers • Written plan to destroy identifiers. NOTE: All research records must be kept (not destroyed) until the release of VA regulations on retention of research records • Written assurance that PHI not re-used or disclosed except: • As required by law • For authorized oversight of research • With specific approval from IRB for other research

22. HIPAA Waiver 2. Research cannot practicably be done without waiver 3. Research cannot be done without PHI 4. Uses and disclosures of PHI must be limited to the minimum necessary to achieve the research purpose

23. RESEARCH COMPLIANCE Conclusion • Don’t destroy research records • Get shipping training if you ship • If there is a study, it will be audited • Study drug = the drug being studied—even if it is FDA approved • Request a waiver if your study will obtain information about subjects prior to consent (Consult Privacy Officer or RCOs )