VA Response:As stated under Directive 0005, ¶ 5.a.(10), VA will afford whistleblower protections to employees who have a reasonable belief of scientific integrity concerns, including but not limited to, the protections described in 5 U.S.C. 2302, which specifically prohibit threatening, taking, or not taking personnel actions against an employee (or applicant for employment) who discloses information reasonably believed to be a violation of law, rule, or regulation or to represent gross mismanagement, waste of public funds, abuse of authority, or substantial and specific danger to public health or safety. These employee protections are sufficient for VA because VA does not award research grants to individuals who are not VA employees. Consequently, no changes were made to the Directive.
Comment Summary:VA employees should have the right to review, approve, and comment on the final version of any proposed publication that significantly relies on their research, identifies them as an author or contributor, or purports to represent their scientific opinion. Procedures should be established for handling differing scientific opinions and ensuring that these opinions are included in the final versions of scientific documents.
VA Response:VA has amended Directive 0005, ¶ 5.e.(1), to clarify that VA employees who conduct research independently determine the content of publications that report on their research findings. The primary author of such publications is responsible for interpreting the findings and ensuring the accuracy of the findings reported. Disputes may be referred to the study sponsor, the VHA Office of Research and Development, or ORO, depending upon the nature of the dispute. Publications of findings from VA research are submitted to peer reviewed journals, and the peer review process ensures that differing opinions on the interpretation of findings are considered. Consequently, no changes were made to the Directive.
Comment Summary:The Directive should not state that “every aspect of VA research * * * is governed by specific regulations, policies and guidelines” since not every aspect of VA research can be governed by regulations, policies, or guidelines.
VA Response:VA has amended Directive 0005, ¶ 5.b., to state that “VA policy provides an ethical and accountable framework in the form of specific regulations, policies, and guidelines that establish VA's research priorities, funding mechanisms, administration, conduct, and oversight.”
Comment Summary:Protections related to research safety should also extend to research staff.
VA Response:VA has amended Directive 0005, ¶ 5.b.(4), so that it explicitly includes research safety protections for research staff.
Comment Summary:The Directive should clarify whether VA's policy is to ensure the privacy and confidentiality of research data and research-related information.
VA Response:VA has amended Directive 0005, ¶ 5.b.(5), so that it specifically includes ensuring the privacy and confidentiality of research data as well as research-related information.
Comment Summary:VA needs to demonstrate how it will make VA research findings and the products of VA research available to the public.
VA Response:As stated under Directive 0005, ¶¶ 5.e.(1) and 5.e.(2), VA will convey research findings to the public in a timely, accurate, and comprehensive manner. VA is currently developing formal policies to promote the sharing of VA research findings to the public. Consequently, no changes were made to the Directive.
Comment Summary:VA should replace the Association for the Accreditation of Human Research Protection Programs (AAHRPP) with Alion Science and Technology Corporation and clarify requirements relative to the accreditation of VA facility human research protection programs.
VA Response:VA is currently reviewing its accreditation requirements and in the interim has removed AAHRPP's name from the Directive.
D. Public Communications (Directive 0005, ¶ 6)
Comment Summary:The phrase requiring “appropriate coordination” byresearch investigators in speaking to the media is too ambiguous.
VA Response:VA has deleted the word “appropriate” from Directive 0005 ¶ 6.a. to eliminate the ambiguity and ensure consistency with ¶ 6.a.(7).
Comment Summary:The policy should explicitly state that scientists have the right to express their own views so long as the appropriate disclaimers are made. Public affairs officials should not interfere with this right.
VA Response:VA has amended the note in Directive 0005, ¶ 6.a.(5), to state that VA scientists and other VA employees may express their personal views to the media provided that they specify that they are speaking in their private capacity and not speaking on behalf of VA.
E.Use of Federal Advisory Committees (Directive 0005, ¶ 7)
Comment Summary:The Directive should reduce conflicts of interest among, employees, reviewers, and members of Federal advisory committees.
VA Response:VA is currently developing conflict of interest requirements specifically applicable to research. Consequently, no changes were made to the Directive.
F. Professional Development (Directive 0005, ¶ 8)
Comment Summary:VA scientists should be required to disclose conflicts of interest if they participate in scientific societies or sit on their boards.
VA Response:VA has amended the note in Directive 0005, ¶ 8.a.(4), to clarify that participation in professional societies is encouraged, to the extent permitted by law and in accordance with the Standards of Professional Conduct for Employees of the Executive Branch.
Comment Summary:VA should have regular training in scientific integrity for all of its employees.
VA Response:As stated under Directive 0005, ¶ 8.c., VA researchers are required to complete training at 2-year intervals in multiple areas, including data integrity, ethics, privacy, and human research protections, as well as training in specific content areas relevant to their research. Consequently, no changes were made to the Directive.
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. John R. Gingrich, Chief of Staff, Department of Veterans Affairs, approved this document on November 5, 2012, for publication.
Dated: November 5, 2012.
Robert C. McFetridge,
Director, Regulation Policy and Management, Office of the General Counsel, Department of Veterans Affairs.