8 February 2012
Ethical Guidance for Pandemic Influenza
[Federal Register Volume 77, Number 26 (Wednesday, February 8, 2012)]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-2777]
DEPARTMENT OF VETERANS AFFAIRS
Meeting the Challenge of Pandemic Influenza: Ethical Guidance for
Leaders and Health Care Professionals in the Veterans Health
AGENCY: Department of Veterans Affairs.
ACTION: Notice and Request for Comments.
SUMMARY: The Department of Veterans Affairs (VA) through its National
Center for Ethics in Health Care (NCEHC) invites interested parties to
comment on a guidance document entitled ``Meeting the Challenge of
Pandemic Influenza: Ethical Guidance for Leaders and Health Care
Professionals in the Veterans Health Administration.'' (Guidance). VA
is committed to an open and engaged stakeholder process and welcomes
input on how to improve the Guidance and integrate key ethical concepts
into ongoing emergency response planning in VA.
DATES: Comments must be received by VA on or before April 9, 2012.
ADDRESSES: Written comments may be submitted through
http://www.Regulations.gov; by mail or hand delivery to the Director,
Regulations Management (02REG), Department of Veterans Affairs, 810
Vermont Avenue NW., Room 1068, Washington, DC 20420; or by fax to (202)
273-9026. Comments should indicate that they are submitted in response
to ``Meeting the Challenge of Pandemic Influenza: Ethical Guidance for
Leaders and Health Care Professionals in the Veterans Health
Administration.'' Copies of comments received will be available for
public inspection in the Office of Regulation Policy and Management,
Room 1063B, between the hours of 8:00 a.m. and 4:30 p.m., Monday
through Friday (except holidays). Please call (202) 461-4902 (this is
not a toll-free number) for an appointment. In addition, during the
comment period, comments may be viewed online through the Federal
Docket Management System at http://www.Regulations.gov.
FOR FURTHER INFORMATION CONTACT: Virginia A. Sharpe, Medical Ethicist,
Veterans Health Administration, National Center for Ethics in Health
Care, (10P6), 810 Vermont Avenue NW.,
Washington DC, 20420, Telephone: (202) 461-4020 (this is not a toll-
SUPPLEMENTARY INFORMATION: In November 2005, the White House released
the National Strategy for Pandemic Influenza to guide preparedness and
response to an influenza pandemic, with the intent of (1) stopping,
slowing or otherwise limiting the spread of a pandemic to the United
States; (2) limiting the domestic spread of a pandemic, and mitigating
disease, suffering and death; and (3) sustaining infrastructure and
mitigating impact to the economy and the functioning of society.'' The
strategy is organized around 3 pillars: Preparedness & Communication,
Surveillance & Detection, and Response & Containment. These pillars
have been used to prepare for multiple influenza threats, such as H5N1
avian influenza. It also guided the government's response to the 2009
In the National Strategy, the White House identified Federal
responsibilities for the development of guidance and response planning
during a severe flu pandemic, including guidance for the allocation of
scarce health and medical resources. As part of this task, VA's
National Center for Ethics in Health Care developed a Guidance document
to provide a framework for decision making in VHA about three major
ethical challenges related to a severe pandemic influenza. Those
challenges are: (1) How can health care providers and the institution
as a whole meet the obligation to provide care during an infectious
disease outbreak? Specifically, what steps can the institution take to
minimize risk to health care workers, so that they can continue coming
to work to assist in patient care? (2) How can decision makers
ethically allocate scarce resources? Specifically what steps are needed
to ensure that decision making is transparent, reasonable, and fair?
(3) How can decision makers take steps to limit the spread of disease
but at the same time ensure the least restrictions on individual
liberties? As the largest health care system in the United States, VA
elected to address these difficult issues to ensure that VA is prepared
to respond thoughtfully and consistently to severe and widespread
health crises. For each of these challenges, the Guidance presents
ethical principles and national guidance for VHA. The expectation is
that VA leadership and health care professionals will use this
information in pandemic workforce, communications, and patient care
planning and response.
The Guidance has received feedback from VA clinicians and
administrators as well as experts outside of VA. Because the Guidance
document is anticipated to affect patients, their families, staff, and
the VA community as a whole, the NCEHC is inviting Veterans, members of
the general public and interested parties from relevant Federal, State,
and professional bodies to provide feedback through written comments.
The goal of this Notice is to ensure that people who may be directly
affected during a severe influenza pandemic have an opportunity to
contribute to the development of ethical concepts and processes that
will guide VA emergency planning. VA is aware that there are no perfect
approaches to managing a catastrophe, but we still believe that with
forward thinking and incorporation of broad public input and lessons
learned from the 2009 H1N1 pandemic, we can develop the best possible,
most scientifically- and ethically-informed approaches. We believe this
approach, led by VA, stands the best chance of developing a sound model
to serve as framework for other public and private healthcare
organizations on a national scale and beyond.
Comments are invited in response to the following:
1. Does the Guidance include the range of ethical issues relevant
to pandemic influenza planning and response that are of concern to you?
Are there other issues that you would like to see addressed in the VA
2. Does the Guidance support the needs of Veterans with regard to
fair treatment during a public health crisis?
3. Does the Guidance support the needs of health care workers with
regard to fair treatment during a public health crisis?
4. The Guidance presents a team process for allocation of scarce
lifesaving resources based on illness severity, the likelihood of
benefiting from treatment, and resource availability. Apart from
maintaining accountability for an established decision process, the
rationale for a team-based approach is to allow individual health care
providers to maintain their focus treating individual patients. Do you
think that this is a good and fair approach to making these difficult
5. Do you think that the key ethical concepts presented in the
Guidance for pandemic influenza planning and response can also be used
in VA's planning for other highly contagious illnesses? If so, are
there important differences that we should keep in mind?
Any other comments/observations regarding the Guidance are welcome.
Availability: Persons with access to the Internet may obtain the
Alternatively, the guidance may be obtained by mail
by calling NCEHC at (202) 501-0364 (this is not a toll-free number).
Dated: February 2, 2012.
Robert C. McFetridge,
Director, Regulation Policy & Management, Office of the General Counsel
Department of Veterans Affairs.
[FR Doc. 2012-2777 Filed 2-7-12; 8:45 am]
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