VA Central IRB s3

May 2, 2012

SUMMARY OF MAJOR CHANGES IN LOCAL FACILITY MOU WITH VHA CENTRAL OFFICE

Change Old MOU Revised MOU New Added Local NonProfit The local NPC is now a Signatory Corporations (NPC) as a Authority and has been added Signatory Authority (Section N/A throughout the MOU in sections that E) discuss general responsibilities of all parties. In addition, a new section, Section E, addressing the specific responsibilities of the NPC has been added.

Added a provision about the The local Privacy Officer does not VA Central IRB Privacy and conduct a separate privacy review of Information Security Officers N/A studies overseen by the VA Central (ISOs) performing required IRB. However, the local ISO may privacy and information need to review some studies security reviews. (B.5) overseen by the VA Central IRB due to local project-specific information security issues. In those cases, the VA Central IRB ISO works with the local ISO to address the issues.

Added provision for Added to General Provision Section amending MOU (B.9) that MOU could be amended when N/A there is a change in one of the signatory officials

Added provisions for VA Two separate paragraphs were Central IRB to notify facilities added; one to address each issue. when signed copies of VA Central IRB meeting minutes are posted on SharePoint N/A and that a copy of the VHA Central Office HRPP annual review report would be provided to facilities. (C.10 and 11)

Added a paragraph about Added a paragraph about how use of and access to VA documents from VA Central IRB Central IRB SharePoint site. would be distributed through VA (C.16) N/A Central IRB SharePoint site and how

1 May 2, 2012

sites would be notified documents are available for review. Paragraph also includes who at the local site will be granted access

Added specific paragraphs A separate paragraph addressing regarding reporting to the each reporting responsibility was VA Central IRB and the local N/A added in Section D as local facility Privacy Officer and ISO any responsibilities. unauthorized use or disclosure of PHI or any violations of VA information security requirements in projects overseen by the VA Central IRB. (D.1.i)

Added a paragraph requiring The VA Central IRB will continue to local facility to communicate work with designated local site with local NPC staff N/A liaisons concerning site issues. No concerning maintaining NPC liaison is being appointed. validity of FWA. (D.3)

Included requirement for Added requirement to maintain maintaining scopes of N/A scopes of practice to paragraph on practice by local sites. (D.4) requirement to maintain training, credentialing, and privileging documentation.

Added records disposition Indicated that all records regarding instructions. (D.17) N/A VA Central IRB approved studies must be maintained in accordance with the VHA Records Control Schedule. Changes Changed MOU approval Approval period was three years Approval period is now five years. period (B.9) Also moved from termination provisions section to the General Provisions Section

Information on COI for IRB Reference was made to specific References only that SOPs will members and content of VA issues that the VA Central IRBs incorporate by inclusion or reference Central IRBs made less must cover and how COI of VA all VA and other federal specific and instead, citing Central IRB members would be requirements and that COI VA and federal handled. procedures will be in compliance requirements. (B.2) with criminal statutes and Executive Branch Employee standards.

2 May 2, 2012

Paragraph on providing There were several paragraphs These were all consolidated into one timely written notice to sites that separately addressed paragraph that references providing of IRB actions was expanded providing timely written notice to timely written notice to sites of IRB to consolidate other similar sites about various IRB actions, actions to include but not limited to references in the document i.e., continuing reviews and contingent approvals, requested to this one paragraph. (C.9) amendments. modifications, final approvals, and continuing reviews.

Paragraph on VA Central IRB Paragraph was very general on Provided more specificity, to include oversight of approved investigating reports of review of local RCO audit reports, projects was totally noncompliance, unanticipated and reporting requirements to ORO rewritten. (C.12) problems, and complaints in and other federal agencies. accordance with SOPS.

Provision on communicating Required VA Central IRB to only Requires VA Central IRB to exemption approvals to sites communicate approval to PI of communicate exemption approval was changed. (C.15) multisite study, who would then decisions to all potential communicate with sites. participating sites if known at time of approval.

Combined paragraphs on Had a separate paragraph on These two functions were combined human subjects research research determinations and in one paragraph. Also requires VA determinations and another, separated by other Central IRB to communicate engagement paragraphs, on engagement determinations to other determinations. (C.14) determinations. Also required PI participating sites if known, not just of multisite study to PI of multisite project site. communicate determinations with other participating sites.

Reformatted some Had some subparagraphs that did Re-ordered paragraphs and made paragraphs and made some not necessarily fall under the some previous subparagraphs into subparagraphs into full main paragraphs. full paragraphs to facilitate a more paragraphs. logical arrangement.

Expanded paragraph on Paragraph was very general and Provided more specificity to include local oversight mechanisms. just mentioned local audits and local RCO audits and well as audit (D.1.d) monitoring mechanisms. requests from the VA Central IRB.

Changed local comment Local sites were given 30 Local comment period has been period timeframe. (D.6) calendar days to provide local reduced to 15 calendar days. comments on initial approval by VA Central IRB of a PI/SC Application.

Changed paragraph about Stated that project could not be States that project cannot be when project could be started at a site until approved by initiated until it has been approved initiated at site. (D.7) both the VA Central IRB and the by the VA Central IRB and the

3 May 2, 2012

local R&D Committee. requirements of VHA Handbook 1200.01, as well as other VA and local requirements have been met.

Expanded paragraph Referenced only clinical records References all research project concerning providing VA and case files. records if required and includes but Central IRB access to local does not limit access to various records for oversight types of records kept by local sites purposes. (D.12) and study teams.

More clearly states One paragraph referenced site Now there are two separate responsibilities for annual responsibility to participate in paragraphs. One indicates that review of HRPP. (D.14) annual review of VHA Central facilities will cooperate with the VA Office HRPP. Central Office in its annual review of the VHA Central Office HRPP and the other paragraph indicates that the local site needs to include the VA Central IRB in its own HRPP annual review. Deletions Deleted paragraph about This was felt to be adequately requiring use of informed covered by indicating the VA consent unless waived. Central IRB would adhere to all N/A federal and VA requirements for the protection of human subjects and did not add anything to the document.

Deleted paragraphs on This was felt to be adequately continuing review, covered by indicating the VA amendments, and a Central IRB would adhere to all N/A duplicative paragraph on federal and VA requirements for review of local issues. the protection of human subjects and did not add anything to the document. The paragraph on local issues was duplicative.

Deleted paragraph on This was felt to be adequately requiring data safety covered by indicating the VA monitoring plan for studies Central IRB would adhere to all that were greater than federal and VA requirements for N/A minimal risk. the protection of human subjects and did not add anything to the document.

Deleted reference to VA This was one of the items in the Central IRB maintaining list MOU that was to be maintained

4 May 2, 2012 of approved projects on on public website. This was N/A website. never done and was eliminated.

Deleted requirement for This is a local study team and/or Local site must only provide local sites to notify VA PI/SC study team responsibility. procedures for coordinating Central IRB and PI of approval of project by other local multisite study of changes in committees if applicable. local team members, as well as other local committee approvals.

Deleted requirement to Required an individual be This requirement has been provide a final approval designated by the MCD the site eliminated and the MCD is now only decision within 10 days of to provide a final participation required to designate a liaison and notification of VA Central decision for the site within 10 an individual to provide initial IRB final approval of a days of receiving the final comments within 15 days of project at a site. approval of the project at the site notification. Can be the same from the VA Central IRB. person or two different local site staff members. Receipt of the final approval letter issue by the site to the investigator to begin a project will replace this requirement.