[Federal Register Volume 77, Number 217 (Thursday, November 8, 2012)]
[Notices]
[Pages 67063-67065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-27326]


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DEPARTMENT OF VETERANS AFFAIRS


VA Directive 0005 on Scientific Integrity

AGENCY: Office of Policy and Planning, Department of Veterans Affairs.

ACTION: Notice.

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SUMMARY: This Federal Register notice announces the adoption of the 
Department of Veterans Affairs (VA) Directive 0005 on Scientific 
Integrity and responds to public comments about the draft version of 
this Directive, which was originally announced in the Federal Register 
on April 9, 2012 (77 FR 21158).

FOR FURTHER INFORMATION CONTACT: Billy E. Jones, M.D., Senior Advisor 
to the Assistant Secretary for Policy and Planning (008), Department of 
Veterans Affairs, at 202-461-5762. (This is not a toll-free number.)

SUPPLEMENTARY INFORMATION:

Background

    The Presidential Memorandum on Scientific Integrity and the Office 
of Science and Technology Policy's 2010 guidance memorandum on 
scientific integrity call for ensuring the highest level of integrity 
in all aspects of the Executive Branch's involvement with scientific 
and technological processes.

VA Policy on Scientific Integrity

    VA Directive 0005 on Scientific Integrity, adopted on July 10, 
2012, is available on the VA Publications Web site at http://www1.va.gov/vapubs/. Directive 0005 establishes VA policies that:
     Foster a culture of transparency, integrity, and ethical 
behavior in the development and application of scientific and 
technological findings in VA;
     Protect the development, application, and dissemination of 
scientific and technological information from political or commercial 
influence;
     Prohibit suppression or alteration of scientific and 
technological findings for political purposes;
     Afford whistleblower protections to employees who have 
scientific integrity concerns;
     Uphold professional and Governmental standards for the 
conduct for research;
     Promote free flow and exchange of scientific and 
technological information;
     Ensure that clinical care, health care operations, and 
public health decisions are informed by scientific data and analysis;
     Uphold the independence, transparency, and diversity of 
Scientific Advisory Committees; and
     Encourage full participation of employees in scientific 
and professional activities.

Public Comments on VA Draft Policy on Scientific Integrity

    VA adopted Directive 0005 on Scientific Integrity after carefully 
reviewing and considering public comments that were received on the 
draft version of this Directive, which was announced in the Federal 
Register on April 9, 2012 (77 FR 21158). All of the public comments 
have been grouped together by the paragraph of the Directive that they 
address, and VA has organized our discussion of the comments 
accordingly. All comments are available for public inspection between 
the hours of 8 a.m. and 4:30 p.m. in the Office of Regulation Policy 
and Management, Department of Veterans Affairs, 810 Vermont Avenue NW., 
Room 1063B, Washington, DC 20420. Call (202) 461-4902 for an 
appointment.

Comments

A. Purpose, Responsibilities, and Definitions (VA Directive 0005, ]] 1-
3)

    Comment Summary: The Directive should apply to all VA employees, 
including VA scientists, managers, supervisors, visiting scientists, 
political appointees. The Directive should also apply to VA 
contractors.
    VA Response: VA has amended the note in Directive 0005, ] 1, so 
that it clarifies that the Directive applies to all VA employees, 
thereby including all VA scientists, managers, supervisors, visiting 
scientists, and political appointees. All VA contracts are managed by 
VA employees. VA may share this Directive with the agency's contractors 
and may incorporate the policies in this Directive in applicable future 
contracts or when renewing existing contracts.
    Comment Summary: The Directive should clearly define what 
constitutes a conflict of interest to strengthen disclosure of and 
reduce conflict of interest among, employees, and reviewers. Conflict 
of interest policies should apply to research staff as well as research 
investigators.
    VA Response: As stated under Directive 0005, ] 5.a.(3), VA is 
currently developing conflict of interest requirements specifically 
applicable to research. These requirements will define what constitutes 
a research conflict of interest and who is required to follow VA's 
conflict of interest

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requirements. Consequently, no changes were made to the Directive.
    Comment Summary: VA should improve transparency by publicly 
reporting information on individuals who meet with top agency 
officials.
    VA Response: This comment addresses an issue that is beyond the 
scope of VA Directive 0005. Consequently, no changes were made to the 
Directive.

B. Core Principles (VA Directive 0005, ] 4)

    Comment Summary: It is not clear what constitutes ``inappropriate 
influence.'' The definition of ``inappropriate influence'' should be 
more explicit.
    VA Response: VA has amended Directive 0005, ] 4.b.(3), so that it 
explicitly state's that scientific data and analyses will be protected 
from political and commercial influence. The term ``inappropriate 
influence'' has been removed.

C. Foundations of Scientific Integrity (VA Directive 0005, ] 5)

    Comment Summary: The Directive should provide clear and specific 
guidelines relating to the enforcement, reporting, and investigation of 
allegations related to scientific integrity violations. Uncensored 
details of cases should be provided to the VA's Office of Inspector 
General (OIG), the Office of Government Ethics, and Congress. VA should 
create an online portal where all documents related to scientific 
integrity may be found. VA should have a Department-wide procedure for 
reporting and investigating allegations related to scientific integrity 
violations.
    VA Response: VA has amended Directive 0005, ] 5.a.(8), so that it 
discusses the Veterans Health Administration's (VHA) Office of Research 
Oversight's statutory authority, under 38 U.S.C. 7307, to investigate 
and enforce compliance with VA requirements for the conduct of 
research, including research misconduct and other forms of research 
impropriety. VHA's Office of Research Oversight (ORO) operates 
independently of all VA entities that fund research and may suspend VA 
research where warranted. All VHA Directives and Handbooks related to 
scientific integrity, including the procedures for reporting 
allegations to ORO and the standards for ORO's investigation and 
enforcement activities and may be found on the ORO Web site at http://www.va.gov/oro/. The ORO Web site provides guidance on filing a 
complaint and includes a telephone hotline for persons who wish to 
remain anonymous. In accordance with statutory requirements, ORO 
reports all of its activities, investigations, and findings to the 
Committees on Veterans' Affairs of the United States Senate and House 
of Representatives. ORO regularly exchanges information with OIG, 
including summaries of all compliance cases and copies of all 
compliance reports.
    Comment Summary: Whistleblower protections should be strengthened 
to prohibit individuals from recommending or taking a personnel action 
as a means of censoring or discriminating against an employee or grant 
applicant because the employee or grant applicant discloses, or is 
about to disclose, information that he or she believes is evidence of 
illegality.
    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'' 
by

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research 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.

Signing Authority

    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.
[FR Doc. 2012-27326 Filed 11-7-12; 8:45 am]
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