C. Karen Jeans, PhD Soundia A. Duche, MA, MS ORPP&E (formerly PRIDE)

1. PART 2: The Revised Common Rule, Proposed VHA Directive 1200.05, and the IRB - Focus on Significant Changes C. Karen Jeans, PhD Soundia A. Duche, MA, MS ORPP&E (formerly PRIDE) Dial in: (213) 929-4212 Access Code: 870-113-815 Slides in “Handout” Tab December 18, 2018

2. Overview Dial in: (213) 929-4212 Access Code: 870-113-815 Slides in “Handout” Tab • Provide a Status Update on the Revised Common Rule and VHA Directive 1200.05 • VA Research on January 21, 2019 • Review the remaining significant changes in the Revised Rule, Proposed VHA Directive 1200.05 and its effect on the IRB • IRB Membership, Functions, and Review of Research (Part 1) • Exempt Research (Part 1) • IRB Review of Research (Part 1) • Informed Consent and HIPAA (Part 1) • Vulnerable Populations (Part 2) • Definition (Part 2) • Respond to unanswered questions from the November 29th cyberseminar

3. Dial in: (213) 929-4212 Access Code: 870-113-815 Slides in “Handout” Tab Status of the Revised Common Rule 1st six month delay to July 19, 2018 ANPRM 2nd six month delay to January 21, 2019 Original effective/ compliance date Effective date – Three burden-reducing provisions Final Rule revising the Common Rule NPRM Compliance date – 2018 Common Rule Cooperative research provision (single IRB) – compliance date remains January 20, 2020.

4. Dial in: (213) 929-4212 Access Code: 870-113-815 Slides in “Handout” Tab Status of VHA Handbook 1200.05 • Will be issued as VHA Directive 1200.05 • ORD's goal is to harmonize as much as possible VA's implementation of the revised Common Rule with other Federal Agencies and Departments, but there will be some VA specific requirements. • Incorporates VHA Directive 1058.06, “Research Conducted by Employees of VHA Program Offices” • Directive 1200.05 is in the final stages of concurrence • All Program Offices have concurred • VHA Office of General Counsel has concurred • Office of Labor Management Relations (Union) is final step in the concurrence process prior to signature and publication

5. Two Common Rules, Which Applies? OR IRBs will be operating under both the 2018 and pre-2018 requirements for the foreseeable future

6. Must Comply with 2018 Requirements ORD Policy Decision: Studies with a final IRB approval date on or after January 21, 2019 must comply with the revised Common Rule, even if the convened board review generating an approval with modifications was conducted before January 21, 2019.

7. IRB Approval on/after January 21, 2019 = 2018 Requirements Final, unconditional approval or exemption determination on or after January 21, 2019 • Convened Board – on/after January 21, 2019 • Expedited review – Reviewer signs off on/after January 21, 2019 • Exempt studies – IRB determined study to be exempt on/after January 21, 2019

8. Compliance Date with the 2018 Requirements Q1: Does the date of 1/21/2019 for compliance with the 2018 Requirements apply to final approval by the IRB or by the R&D Committee? Q2: Isn’t the IRB approval date for a study the date that the convened IRB Votes to approve the study and not the date of the designated review? That is the way most IRBs function and the study (if approved) is approved for a time period from the date of the convened meeting. This simplifies the tracking of expiration dates as well. Form my reading of the Handbook, the IRB determines in their SOPs how they want to address this. Is this a misinterpretation?

9. Revised Common Rule/2018 Requirements and Proposed Changes in VHA Directive 1200.05: Significant Changes

10. Vulnerable Populations

11. Pregnant Women

12. In Vitro Fertilization Research

13. Fetal and Human Stem Cells

14. Research Involving Children

15. Individuals with Impaired Decision – Making Capacity

16. Research Involving Prisoners

17. Definitions

18. Definitions

19. Outstanding Questions from Part 1 (11/29/2018 Cyberseminar)

20. IRBs of Record

21. IRB of Record Q3: Will their be a list of academic IRBs that are already approved by ORD on January 21, 2019? How can we get academic IRBs that are not on this list to be added to the ORD list? Q4: Will all current IRBs of Record be required to request inclusion on the list? Q5: You mentioned that 4 new IRBs are being considered as an external IRB for VA – Are any commercial IRBs?

22. Privacy Officer/ISO Review

23. ISO/PO Review Q6: Please clarify ISO and PO review role. Is their review still required for new VA protocols submitted to the IRB? Q7: Do the PO and ISO still have to fill out the Department of Veterans Affairs Checklist for reviewing Privacy, Confidentiality, and Information Security in Research? Q8: Is PO and ISO input required for exemptions requiring limited IRB review to ensure there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of their data?

24. IRB Approval and Limited IRB Review • Addition of new approval criteria specific to limited IRB review for certain types of activities eligible for exemption (38 CFR 111(a)(8)) • Limited IRB Review requirements: IRB does not have to ensure that all of the 111 approval criteria are met • 4 instances when limited IRB review is required: • Exempt Category 2(iii) and Exempt Category 3(i)(c): Ensuring that adequate provisions exist to protect the privacy of subjects and to maintain the confidentiality of their data. • Exempt Category 7: Determine broad consent was obtained in accordance with the requirements; broad consent is appropriately documented or documentation is waived; and if a change is made for research purposes in the way the identifiable info or specimens are stored, there are adequate provisions to protect the privacy of subjects and maintain the confidentiality of their data. • Exempt Category 8: Determine that the research is within the scope of the broad consent and that adequate provisions exist to protect the privacy of subjects and maintain the confidentiality of their data.

25. Limited IRB Review Q9: Do you have suggestions on what a limited IRB review form should look like? What specific questions need to be answered – (especially if we are transitioning an expedited project to exempt – like a simple chart review study)?

26. Broad Consent

27. Broad Consent Q10: Please define Broad Consent Q11: Can facilities decide NOT to adopt Broad Consent as long as it is documented in their SOPs? Q12: For VA-approved research, can Broad consent be used for the collection of samples/info for research purposes? Q13: If Broad Consent is combined with a traditional ICF, does the Broad Consent need its own signature block for the participant to sign (separate from the signature block for the traditional ICF)?

28. General Requirements for Informed Consent

29. Informed Consent Q14: Will there be clarification re. what needs to go in the key information section for informed consent under the revised common rule? Preamble to the Final Rule suggests that the key information would include the following: • The fact that consent is being sought for research and that participation is voluntary; • The purposes of the research, the expected duration of the prospective subject’s participation, and the procedures to be followed in the research; • The reasonably foreseeable risks or discomforts to the prospective subject; • The benefits to the prospective subject or to others that may reasonably be expected from the research; and • Appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the prospective subject.

30. HIPAA Authorizations

31. Informed Consent and HIPAA Q15: For all practical cases, it doesn’t matter for the vast majority of research studies whether the informed consent form and HIPAA Authorization Form are combined or not – they are usually handled as a group of documents requiring signatures in different places.

32. Collaborative Research Q16: The proposed 1200.05 has removed the language that states collaborative research involving non-VA institutions may not be undertaken without a signed written agreement that addresses such issues as the responsibilities of each party concerning ownership and reuse of data. Does this requirement for collaborative studies no longer exist? Or will this requirement be included in another handbook or directive?

33. Policy Q17: If revised 1200.05 contradicts another handbook (e.g. 1200.12 – Data Repository Handbook) – which handbook do we follow?

34. Resources

35. Important Links • Final Rule for the Delay (published June 19, 2018) • Revised Common Rule (published January 19, 2017) • Pages 7259 to 7274 contain the Text of the Final Rule • Current Common Rule • VHA Handbook 1200.05 • ORD Policies and Guidance Documents

36. ORD/ORO Cyberseminars on the Revised Common Rule

37. ORD/ORO Recorded Trainings on the Revision of the Common Rule Series Cyberseminars conducted by ORD and ORO as part of the Revised Common Rule series can be found on the PRIDE cyberseminar webpage: https://www.research.va.gov/pride/cyberseminars/default.cfm

38. Questions?