Donate for the Cryptome archive of files from June 1996 to the present

8 February 2012

Ethical Guidance for Pandemic Influenza


[Federal Register Volume 77, Number 26 (Wednesday, February 8, 2012)]
[Notices]
[Pages 6625-6626]
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 
Administration

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.,

[[Page 6626]]

Washington DC, 20420, Telephone: (202) 461-4020 (this is not a toll-
free number).

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 
H1N1 pandemic.
    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 
Guidance?
    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 
decisions?
    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 
document at: 
http://www.ethics.va.gov/activities/pandemic_influenza_preparedness.asp. 
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]
BILLING CODE P