1. Ensuring Human Subject Protection A Guide for Those who Obtain Research Informed Consent Documents 10/15/20151

2. Informed Consent Documents (ICD) must be obtained correctly and completely in order to PROTECT not only the subjects involved, but also YOURSELF (you the obtainer of consent) and the research study in which you are involved 10/15/20152

3. Why is ICD Compliance so Important? The ORO (Office of Research Oversight) mandated regulation for FY 2009 and beyond The Research Compliance Team is mandated to audit EVERY new ICD signed by EVERY research subject for EVERY IRB approved and active study 10/15/20153

4. Clinical Informed Consent ≠ Research Informed Consent FY 2009 changes in clinical informed consent as described in VHA Handbook 1004.01 Informed Consent for Clinical Treatments and Procedures… Do Not Apply To Research Situations 10/15/20154

5. Clinical Informed Consent ≠ Research Informed Consent Research 1)Research Informed Consent must always contain the signature and date of the research subject. There are no instances where the investigators can choose specific oral consent without prior IRB Approval 2)Research Informed Consent may require a third party witness signature depending on local policy Clinical 1) Clinical Informed Consent for home tele-health may involve specific oral consent per revised VHA Handbook 1004.01 2)Clinical Informed Consent no longer requires a witness signature unless the patient signs with an X, or if there is telephone consent without an audiotape 10/15/20155

6. Serious Reporting Deficiencies Deficiencies requiring a 5-day Report to ORO by the Medical Center Director, ACOS/R, R&D and IRB Chair are: –Lack of ICD signed/dated by subject –Use of an unapproved, unstamped ICD –Initiation of study procedures prior to obtaining Informed Consent –Lack of approved HIPPA signed/dated by subject (as applicable) –Lack of consent obtainer signature/date –Lack of CPRS documentation of informed consent process Other Deficiencies found will be recorded in the ICD Audit Report, distributed to the IRB for determinations of remedial action and to the R&D Committee for review DON’T LET THIS BE YOU! 10/15/20156

7. What Exactly is Audited on the ICD? The following slides are to give you an idea of what the Compliance Team looks for during an ICD Audit: what you, the consent obtainers, must ensure is completed with each newly signed ICD in order to meet all federal and local regulations… 10/15/20157

8. Step #1 - Prior to Informed Consent Process Prior to initiating any study activities…set up a time in which the new subject comes in for the informed consent process and to sign the ICD Make sure that you have the most recent IRB approved and stamped document for the subject to sign Make sure the study HIPAA Form is officially approved and signed by the Privacy Officer Before informed consent is obtained, make certain that the subject meets Inclusion and Exclusion criteria for the study Consent obtainer completes the IDMC Form (do not give to subject) Subject signs the HIPAA Form, if applicable, prior to the consent process 10/15/20158

9. Step #2 - Informed Consent Process Legibly print subject name/date on the top of EACH page Read the ICD carefully with the subject and verify that the subject understands the research and is willing to participate Ask the subject if he/she has any questions that need to be answered 10/15/20159

10. Step #3 - Informed Consent Process At the end of the ICD document, have the Subject… Print/sign their name List Social Security Number List Time and Date Also, if applicable, check the box (fill in line) confirming the ICD was reviewed by a study team member 10/15/201510

11. Step #4 - Other Mandatory Signatures Person Obtaining Consent sign/date Have PI (if PI did not obtain consent) sign ICD within 24 hours 10/15/201511

12. Step #5 Provide the research subject/surrogate with a copy of the ICD and HIPAA Form before leaving Subject receives VHA R&D “Volunteering in Research” Pamphlet Send copies of the signed ICD/HIPAA Forms to: the IRB Office Medical Records scanning Research Pharmacy, if applicable Enter Research Study Initiation Note (RISN) into research subject’s CPRS chart with 24 hours, and have PI co-sign it within 5 days 10/15/201512

13. ICD and HIPAA Storage Investigators MUST retain the original signed HIPAA and informed consent documents in a secured location on VA property indefinitely until further direction from VA Central Office 10/15/201513

14. Lastly, remember… Sending a copy of the signed ICD/HIPAA to the IRB Office will ensure that the research subject name is added to the Database Listing of Subjects for the appropriate study (Always Use Privacy Sealed Envelopes) Scanning a copy of the ICD/HIPAA into the subject’s CPRS chart will ensure that other providers will understand the research study to determine the impact, if any, on other aspects of patient care 10/15/201514

15. To Recap…  Subject meet Inclusion/Exclusion criteria?  IDMC Form and HIPAA Form completed before ICD?  Consent obtained before initiation of any study activates?  Correct Version and date of ICD used?  ICD has IRB approval stamp?  Subject name/date at top of each ICD page?  Subject check box-ICD explained to them? By whom? (line filled in ?)  Subject sign/date/SSN/time last page?  Person Obtaining Consent Sign/date?  PI sign/date? (within 24 hours)  PO-approved HIPAA Form signed/dated by subject?  CPRS documentation of RISN/written progress note?  Copy ICD/HIPAA sent to IRB Office and scanned into CPRS? 10/15/201515

16. Best Wishes in Your Research Endeavors! If you have questions or need clarifications, Please contact the HRPP Office… 10/15/201516