VHA Handbook 1200.05

1. VHA Handbook 1200.05 October 15, 2010 Version Guidance

2. VHA Handbook 1200.05VHA Office of Research & Development (ORD) ORD is responsible for 1200.05 content Interpreting 1200.05 Answering questions about 1200.05 Email address for unencrypted questions VHACO120005Q@va.gov 2 If your question is sensitive and needs to be encrypted, please see contact PRIDE staff directly (see last slide for contact information) Kevin Nellis Kevin.Nellis@va.gov Marian Serge Marian.Serge@va.gov Lynn Cates Lynn.Cates@va.gov Karen Jeans Charlotte.Jeans@va.gov If your question is sensitive and needs to be encrypted, please see contact PRIDE staff directly (see last slide for contact information) Kevin Nellis Kevin.Nellis@va.gov Marian Serge Marian.Serge@va.gov Lynn Cates Lynn.Cates@va.gov Karen Jeans Charlotte.Jeans@va.gov

3. 3 VHA Handbook 1200.05Purpose of This Guidance Cover some (not all) new content Point out issues that have created confusion in the past Ensure 1200.05 is interpreted consistently Answer questions The purpose of this presentation is to discuss some of the updated content in the new version of the VHA Handbook 1200.05. We will not have time to cover every change, but we want to point out some important new policy and clarify issues that have led to compliance issues in the past. Our goal is to ensure consistent interpretation of ORD policy. The purpose of this presentation is to discuss some of the updated content in the new version of the VHA Handbook 1200.05. We will not have time to cover every change, but we want to point out some important new policy and clarify issues that have led to compliance issues in the past. Our goal is to ensure consistent interpretation of ORD policy.

4. 4 VHA Handbook 1200.05What to Expect October 15, 2010 version of 1200.05 is longer Includes more content (e.g., Training, International, Children) More explanations and notes More Paragraphs More definitions More regulatory citations No appendices The new version of VHA Handbook 1200.05 is longer It is about 100 pages in length The text is a lot longer, because we have Incorporated requirements that were published outside of the old 1200.05 (e.g., training, international and children�s research requirements) Provided more explanations, regulatory citations, and notes to ensure consistent interpretation of this policy It has been divided into 65 paragraphs to help you find relevant information more easily The handbook has over 80 definitions to facilitate easy reference and will help make sure we are all on the same page The appendices of the old version have been incorporated into relevant paragraphs of the new Handbook, so there is no chance they can be lost The new version of VHA Handbook 1200.05 is longer It is about 100 pages in length The text is a lot longer, because we have Incorporated requirements that were published outside of the old 1200.05 (e.g., training, international and children�s research requirements) Provided more explanations, regulatory citations, and notes to ensure consistent interpretation of this policy It has been divided into 65 paragraphs to help you find relevant information more easily The handbook has over 80 definitions to facilitate easy reference and will help make sure we are all on the same page The appendices of the old version have been incorporated into relevant paragraphs of the new Handbook, so there is no chance they can be lost

5. 5 VA Facility Director* ResponsibilitiesGeneral Responsibilities, Paragraph 5 Signs Federalwide Assurance (FWA) Establishes IRB of record Fosters institutional culture that supports the ethical conduct of all research Ensures adequate resources for local HRPP Ensures the IRB functions independently Is available to all IRB members Ensures subject outreach The VA Facility Director = The Institutional Official (IO) VA Facility Director General Responsibilities, Paragraph 5 (i.e., responsibilities of all Facility Directors of VA�s that conduct human research) The VA Facility Director is the Institutional Official (IO) of the VA Human Research Protection Program (HRPP) He/she serves as the signatory authority for the Federal Wide Assurance (FWA) and must ensure their local facility�s IRB of record is established in accordance with the requirements of VHA Handbook 1200.05 He/she fosters an institutional culture that supports the ethical conduct of all research involving human subjects and ensures their facility has an adequate Human Research Protection Program (HRPP) He/she ensures that the IRB functions independently and he/she is directly available to all IRB members if they have any concerns about the IRB, particularly coercion or undue influence He/she ensures local requirements for a �Research Subject Outreach Program� are met and that recruiting documents, flyers, and advertisements for non-VA research are not posted within or on the premises of a VA facilityVA Facility Director General Responsibilities, Paragraph 5 (i.e., responsibilities of all Facility Directors of VA�s that conduct human research) The VA Facility Director is the Institutional Official (IO) of the VA Human Research Protection Program (HRPP) He/she serves as the signatory authority for the Federal Wide Assurance (FWA) and must ensure their local facility�s IRB of record is established in accordance with the requirements of VHA Handbook 1200.05 He/she fosters an institutional culture that supports the ethical conduct of all research involving human subjects and ensures their facility has an adequate Human Research Protection Program (HRPP) He/she ensures that the IRB functions independently and he/she is directly available to all IRB members if they have any concerns about the IRB, particularly coercion or undue influence He/she ensures local requirements for a �Research Subject Outreach Program� are met and that recruiting documents, flyers, and advertisements for non-VA research are not posted within or on the premises of a VA facility

6. 6 VA Facility Director ResponsibilitiesParagraphs 6-8 Responsibilities based on when the IRB of record is: VA facility�s internal IRB (Paragraph 6) External IRB such as another VA�s or affiliate�s (Paragraph 7) VA Central IRB (Paragraph 8) VA Facility Director Responsibilities, Paragraphs 6-8 Additional VA Facility Director responsibilities vary depending on the type of IRB(s) that are used by the VA Facility. These specific responsibilities are described in Paragraph 6-8. VA Facility Director Responsibilities, Paragraphs 6-8 Additional VA Facility Director responsibilities vary depending on the type of IRB(s) that are used by the VA Facility. These specific responsibilities are described in Paragraph 6-8.

7. Investigator Responsibilities Paragraph 9 New Paragraph, but few new requirements Purpose � to help investigators understand their responsibilities for VA human research 7