**National Ethics Teleconference**

***Informed Consent Policy Revision***

**January 29, 2003**

**and**

**February 10, 2003 (repeated)**

**INTRODUCTION**

**Kenneth Berkowitz, MD:**

Good day everyone. This is Ken Berkowitz. I am the Chief of the Ethics
Consultation Service at the VHA National Center for Ethics in Health
Care and a physician at the VA NY Harbor Healthcare system. I am very
pleased to welcome you all to today\'s National Ethics Teleconference.
By sponsoring this series of calls, the Center provides an opportunity
for regular education and open discussion of important VHA ethics
issues. Each call features an educational presentation on an interesting
ethics topic followed by an open, moderated discussion of that topic.
After the discussion, we reserve the last few minutes of each call for
our \'from the field section\'. This will be your opportunity to speak
up and let us know what is on your mind regarding ethics related topics
other than the focus of today\'s call.

First, a few announcements:

-   Today's (2/10/03) call is being repeated due to the overwhelming
    interest in the 1/29/03 call. We have set the dates for the 2003
    National Ethics Teleconference calls. The schedule is posted on our
    Web site and was distributed electronically. Please let staff in
    your facility know about each of these upcoming educational
    opportunities.

-   Beginning with the January call, the name of the series has been
    changed from Ethics Hotline Calls to National Ethics
    Teleconferences. In addition, the calls will now be 1 hour in
    length. These changes were made to accommodate requirements
    necessary to offer CME credits to our call participants. This
    opportunity starts with today\'s call, and we are pleased to offer 1
    hour of CME credit to physicians, nurses and social workers
    participating on today's call. To fill you in on the details of the
    process required to obtain CME credit lets head to Birmingham
    Alabama. We have on the line one of our colleagues from EES, Bob
    Smith, a National EES program manager. Bob, could you walk the
    listeners through the process?

    **Robert Smith, Ed. D., EES:**

    Thank you Ken. Let me review the Registration and Evaluation
    Instructions:

You must register and evaluate the course to receive a certificate.
Please print these instructions and keep them in front of you.

Go to the EES Librix Evaluation Website:
[http://vaww.ees.aac.va.gov](http://www.ees-learning.net/)

1\. If you have been to this site before, you will enter your
\"Username\" (first four letters of your last name, and the last four
numbers of your SSN) and \"Password\" (last four numbers of your SSN,
and the first four letters of your last name). Click Login

2\. If you have not registered on the site before, the log on page will
reappear with a new link, "To Enroll Click Here\" below the Login boxes
to create an account on the EES server.

After you create an account, now you must return to the LOGIN screen
where you will enter the \"Username\" (first four letters of your last
name, and the last four numbers of your SSN) and \"Password\" (last four
numbers of your SSN, and the first four letters of your last name). Once
access is allowed, you must build your personal profile by clicking on
"My Profile."

Click on the \"My Catalog\" link on the left-hand side bar.

Click on "Ethics"

Click on "January 03 Hotline Call"

Click on the \"Sign Me Up\" link on the top right of screen

The following statement will appear: The item, 'January 03 Hotline
Call\', has been added to your resource list.

Click on the \"View My Resources\" button

Click on "January 03 Hotline Call" link to complete the evaluation and
to obtain a certificate. There are 18 questions to be answered and a
19th that is available for you to enter subjective comments. If you
chose not to enter subjective comments the computer will tell you that
you have left one question blank. Just go ahead and hit "ok" and your
evaluation will be evaluated. You will be returned to the home page of
the course.

Clink on "Evaluation" again and it will bring you to the certificate
page. Choose the certificate for you specialty and print it. Information
about course completion is only maintained in the EES database. If you
wish to have it entered into TEMPO or Synquest you should use your local
systems.

If you have problems with this site email <librixhelp@starmountain.com>\
or call (866) 247-0770.

**Dr. Berkowitz:**

Thank you so much Bob and all your colleagues at EES. The information on
obtaining CEUs for this call was also attached as a file to the
announcement and reminder for the call and will be included in the
follow-up e-mail for this call.

[Ground Rules:]{.underline} As we proceed with today\'s discussion of
the newly revised VHA Handbook on Informed Consent, I need to briefly
review the overall ground rules for the National Ethics Teleconferences:

-   We ask that when you talk, you please begin by telling us your name,
    location and title so that we continue to get to know each other
    better. During the call, please minimize background noise and PLEASE
    do not put the call on hold.

-   Due to the interactive nature of these calls, and the fact that at
    times we deal with sensitive issues, we think it is important to
    make two final points:

-   First, It is not the specific role of the National Center for Ethics
    in Health Care to report policy violations. However, please remember
    that there are many participants on the line. You are speaking in an
    open forum and ultimately you are responsible for your own words,
    and

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-   Lastly, please remember that these Ethics Teleconference calls are
    not an appropriate place to discuss specific cases or confidential
    information. If, during the discussions we hear people providing
    such information we may interrupt and ask them to make their
    comments more general.

**PRESENTATION**

**Dr. Berkowitz:**

Today\'s presentation will cover the ethical grounding for informed
consent in health care, highlight policy changes, explain how to apply
the new policy in clinical practice and offer resources for further
education or policy clarification. To begin today\'s presentation I
would like to head to Washington DC, VA headquarters and call on Leland
Saunders. Leland works in communications for the Center. He has a master
degree in bioethics and an undergraduate background in philosophy.
Leland, start us off.

**Leland Saunders, MA:**

Thank you Dr. Berkowitz. Informed consent is widely regarded as a
cornerstone of health care ethics and clinical care. Understanding the
ethical principles that provide the basis of informed consent is
essential for understanding the practice and process of informed consent
in the clinical setting. The key ethical concepts of informed consent
are patient self-determination, otherwise known as patient autonomy,
beneficence, and non-maleficence. These ethical principles require a
practitioner to promote the welfare of his or her patient, reduce risk,
and support autonomous patient choice. These principles also ensure that
a practitioner will act in a patient's best interests, while recognizing
that that the choice of which goods to pursue is always the patient's.
In practice, these various strands of ethical principles tie together to
form a model of shared decision making.

**Dr. Berkowitz:**

That's right Leland in fact VHA is very committed to providing a health
environment that respects patients and protects their right to informed
participation in health care decision making. The informed consent
policy is the formalization of this commitment into a process that
ensures shared decision making between patient and practitioner. Now we
know that some practitioners view informed consent as a legal
requirement that is, at best, a waste of time, and at worst,
bureaucratic interference with patient care, but I think this view
really neglects how important ethical principles are as an essential
component of quality patient care. The revised Handbook was signed by
the Under Secretary of Health on January 29, 2003. We believe that the
new Handbook better translates these ethical principles into patient
care. Leland, could you just go over the major changes in the policy?

**Mr. Saunders:**

Certainly Dr. Berkowitz, as you know policy is not really developed in a
vacuum, but there are several steps that we take to ensure that policies
are adequate to the needs of the VA. The first step in this process is
discussing ethical issues of timely importance with the VA leadership
then we form a working group from affected stakeholder VA officers to
draft a policy outline. The Center then conducts and extensive review of
the ethical issues and related statutory requirements. We then draft the
policy and sent it to VA field staff for comments. We take all those
comments and revise the policy based on that feedback. We submit the
policy to a very strict concurrence process which required us to meet
individually with affected stakeholders and VA offices We obtain
concurrence on the policy from all affected offices and then we submit
that policy for approval to the Under Secretary for Health.

**Dr. Berkowitz:**

Thanks Leland. Now, can you describe the major changes that have taken
place in the informed consent policy?

**Mr. Saunders:**

The major change in this policy is that it has been revised in format
and structure to clarify and facilitate the informed consent process.
Special emphasis has been given to the process of informed consent,
including the issues of determining decision-making capacity, informing
the patient, promoting voluntary decision-making, and documenting the
process. Attention has also been given to outline the process of
informed consent for patients who lack decision-making capacity, both
patients who have surrogates and those who do not. Lastly, special
emphasis was given to consent in special situations such as medical
emergencies.

**Dr. Berkowitz:**

When I looked through the policy revision, Leland, some of the specific
changes that I noticed were that:

-   the definition section was expanded to clarify confusing terms,

-   there's been a whole new section added on decision making capacity
    and assessing it,

-   there are new documentation requirements to show how facilities are
    to attempt to locate the appropriate surrogate if there is none
    readily available,

-   there is an explicit statement on how to proceed if there are more
    than one potential surrogate in the same category,

-   there are explicit statements on mechanisms that surrogates must use
    in their decision making process and suggestions for the team on
    what to do if it doesn't seem that the surrogate is following those
    procedures,

-   there is a requirement for explicit, periodic review by the team and
    a patient advocate if there is no surrogate other than the care
    team,

-   their is an option when obtaining informed consent over the
    telephone not to audio tape it; there is an alternative process
    involving witnesses,

-   there's a new section on obtaining informed consent in
    telemedicine/telehealth, and

-   there are changes in the list of procedures that require signature
    consent in appendix A

So Leland, maybe you could start by walking us through the general
informed consent process as it is laid out in the new policy?

**Mr. Saunders:**

Certainly Ken. In the revised policy, the first step for the
practitioner is to determine if the patient has decision-making
capacity. Decision-making capacity for health care decisions has four
major components: understanding, appreciating, formulating and
communicating. As I noted before, one of the major changes in this
policy is the emphasis placed on decision-making capacity. In order to
ensure shared decision making it is essential to determine whether the
patient can participate in the decision-making process as it relates to
a specific proposed treatment or procedure.

**Dr. Berkowitz:**

Does this mean that a practitioner will have to formally assess
decision-making capacity whenever we propose a treatment or procedure to
a patient?

**Mr. Saunders:**

Not at all. In fact, the policy states that most patients can be
presumed to have decision-making capacity. No formal assessment of
decision-making capacity has to be undertaken unless the practitioner
suspects that the patient lacks decision-making capacity for a
particular health care decision, and then the practitioner should
undertake the appropriate clinical evaluation to determine if the
patient does indeed lack decision-making capacity. The only exception to
this rule are patients who lack decision-making capacity as a matter of
law, that is, minors under state law, and patients who have been ruled
incompetent by a court of proper jurisdiction.

**Dr. Berkowitz**:

So, if a patient lacks decision-making capacity as a matter of law, then
the practitioner does not need to perform any assessment of their
decision-making capacity?

**Mr. Saunders:**

Not quite. Even patients who lack decision-making capacity as a matter
of law may be able to make a specific health care decision. For example,
a practitioner may find that a patient who is a minor under state law
does have the capacity to make an informed decision concerning his or
her own health care. It is also possible for a practitioner to have a
patient who has been ruled incompetent by a court of law, but whom the
practitioner believes to have decision-making capacity regarding a
specific treatment or procedure. In these cases, the practitioner must
discuss this with the patient's legal guardian and seek advice from the
local ethics program and/or Regional Counsel.

**Dr. Berkowitz:**

Okay, so let's shift a little bit now and say that our patient has
decision-making capacity. What is the next step?

**Mr. Saunders:**

Next, the practitioner must undertake the informed consent process,
which I will briefly outline here.

A large part of the informed consent process is providing information.
Since most patients a practitioner sees do not have the benefit of a
medical education, the information a practitioner provides a patient is
a crucial component of the patient's decision-making process. The
question many practitioners have is: how much information does a patient
need in order to make decisions regarding his or her own health care?
The standard adopted by VHA is that the practitioner must provide
information to the patient that a patient in similar circumstances would
reasonably want to know. That probably sounds a little vague, so I will
unpack the specific informational requirements that are entailed.

First, the practitioner must describe the recommended treatment or
procedure in language that is understandable to the patient. If it is
necessary, a translator must be provided to achieve this purpose. The
practitioner must give a clear and concise explanation of the patient's
condition or diagnosis that relate to the recommended treatment or
procedure. The practitioner must describe the name, nature and details
of the recommended treatment or procedure, and indications for that
course of action including the likelihood of success of the recommended
treatment or procedure for that particular patient. The practitioner
must describe the expected benefits and known risks associated with the
recommended treatment or procedure, including problems that might occur
during recuperation. Risks of minor seriousness do not have to be
disclosed unless they commonly occur, and risks that are extremely
unlikely do not have to be disclosed unless the patient requests that
information or such risks may result in death or permanent disability.
The practitioner must also describe reasonable alternative treatments
and procedures, and explain why the recommended treatment is thought to
be more beneficial to the patient than the alternatives. Expected
benefits and known risks associated with the alternative treatments and
procedures must also be described. The patient must be told any
responsibilities that patient will have, such as taking medication at
home or changing own dressings. The patient must also be told if the
treatment is novel or unorthodox. The practitioner must identify by name
and profession the practitioner who has primary responsibility for the
patient's care, and the names and professions of any other individuals
responsible for authorizing or performing the treatment or procedure
under consideration.

The practitioner must also make certain that the patient understands all
of the information provided. This can be done by asking the patient to
describe the recommended treatment in the patient's own words. Lastly,
the patient should be encouraged to ask questions.

After all of this informing, the patient must make a decision regarding
the proposed treatment or procedure. The revised informed consent policy
stresses the importance of voluntary decision-making on the part of the
patient, so a practitioner must convey to that the patient is free to
choose among any recommended treatments and procedures, including no
treatment, or to revoke prior consent, without prejudice to the
patient's access to future health care or other benefits.

**Dr. Berkowitz:**

Well Leland, the informed consent discussion is always a significant
discussion and in many ways, it is the cornerstone of true informed
consent. How does the practitioner document informed consent in the
patient's record?

**Mr. Saunders:**

There are two different documentation requirements based on whether or
not the proposed treatment or procedure requires signature consent.

Even if a treatment or procedure is low risk and within broadly accepted
standards of medical practice, it requires the patient's consent, even
if it does not require signature consent. Still, documentation in the
patient record must be sufficient to serve as a basis to plan patient
care, support diagnoses, and warrant treatment. If a treatment or
procedure produces significant discomfort or risk it requires signature
consent, and all of the following must be documented in the patient
record. The practitioner must document their assessment of the patient's
decision-making capacity, the names of all practitioners immediately
responsible for the performance, and if applicable, the supervision of
the treatment or procedure, such as the resident physician and the
attending, a brief description of the recommended treatment or
procedure, a statement that all relevant aspects of the treatment have
been discussed with the patient in language the patient could understand
and that the patient indicated comprehension, a statement that the
patient had an opportunity to ask questions, a statement that the
practitioner refrained from using coercion, the date and time the
discussion took place and whether the patient consented to treatment. Of
course, the note must be signed. The patient must also sign the consent
form, and the patient's and practitioner's signatures must be witnessed
by any adult third party. If the patient signs with an "X", it must be
witnessed by two adult witnesses. The witnesses' role is merely to
attest to the fact that the patient is signing the form. The witnesses'
signature does not imply any other involvement in the process or
endorsement of the decision. The signed form is then filed in the
patient's record, and the patient must be offered a copy of the
completed form.

**Dr. Berkowitz:**

There is such a major difference in documentation requirements for the
practitioner between procedures that do not require signature consent
and those that do. Leland can you elaborate on the difference between
types of procedures that do and do not require signature informed
consent?

**Mr. Saunders:**

A treatment or procedure does not require signature consent if it
considered to be low risk and within broadly accepted standards of
medical practice, such as the administration of most drugs or the
performance of a minor procedure like a routine x-ray or blood drawing.
A treatment or procedure does require signature consent if any of the
following apply: it involves the use of sedation, anesthesia, or
narcotic analgesia, it can be reasonably expected to produce significant
discomfort to the patient, it can be reasonably expected to have a
significant risk of complication or morbidity, it requires an injection
of any substance into a joint space or body cavity (including any
non-vascular space), it involves testing for HIV or is included in
Appendix A. Appendix A of the policy includes a list of treatments and
procedures that always require signature consent. This is not a complete
list and any treatment or procedure that meets any of the six criteria
already mentioned requires signature consent.

**Dr. Berkowitz:**

That's a good overview of the usual informed consent process. How does
this process change if the patient lacks decision-making capacity?

**Mr. Saunders:**

Well, then the practitioner needs to make a couple of determinations.
First, the practitioner needs to determine if the patient is likely to
recover decision-making capacity. If the practitioner determines that
the patient will recover decision-making capacity, then the practitioner
needs to wait for the patient to regain that capacity before undertaking
the informed consent process, unless waiting will adversely affect the
patient's condition. If waiting will harm the patient, or if the
practitioner believes that the patient will not regain decision-making
capacity, an authorized surrogate must be sought. Second, if the
determination that the patient lacks decision-making capacity is based
on a diagnosis of mental illness, a psychiatrist or licensed
psychologist must be consulted in order to ensure that the underlying
cause of the lack of decision-making capacity is being adequately
addressed. Still, the practitioner who will perform the specific
treatment or procedure must make the final determination of whether the
patient has decision-making capacity for a particular treatment or
procedure.

**Dr. Berkowitz:**

Leland, as many of our listeners know decision-making capacity is a
complex topic that is closely interrelated with the informed consent
process. As you know the National Ethics Committee issued a report on
this topic that was reviewed in a prior Ethics Hotline Call. That report
is available on our Web site and we will include the link in the
follow-up e-mail to this call.

But, to shift gears, you mentioned an authorized surrogate. Could you
describe the process for identifying an appropriate surrogate
decision-maker for a patient who can not make decisions for himself or
herself?

**Mr. Saunders:**

If a patient is determined to lack decision-making capacity and not
likely to regain it, a surrogate must always be sought. First, the
practitioner must make a reasonable inquiry as to the availability and
authority of an advance directive naming a health care agent. If no
health care agent is authorized and available to make health care
decisions for the patient, the practitioner and staff must make a
reasonable inquiry as the availability of other possible surrogates in
the following order of priority: health care agent\--which is the same
thing as the health care proxy, legal or special guardian, next-of-kin,
and close friend. There is also a priority list among the next-of-kin.
Next-of-kin surrogates have priority in the following order: spouse,
child, parent, sibling, grandparent, and grandchild.

Also, something that is new is this policy is that all facilities are
required to have a procedure in place for identifying surrogates,
including, if necessary, examining personal effects, medical records,
and other VA records such as benefits and pension records.

Once a surrogate is identified, an attempt to contact that person by
telephone must be made within 24 hours of determination that the patient
lacks decision-making capacity. If a particular surrogate is unavailable
or unwilling to serve as a surrogate, the next surrogate in the priority
order must be sought. The practitioner must document the process and
outcome of efforts to identify a surrogate.

**Dr. Berkowitz:**

Once the available authorized surrogate is identified how does the
informed consent process proceed?

**Mr. Saunders:**

The informed consent process is pretty much the same. As outlined in the
policy, a surrogate generally assumes the same authority and
responsibilities as the patient in the informed consent process.
However, there are a few additional safeguards to ensure the welfare of
the patient. First, if possible, the practitioner must try to explain to
the patient the treatment or procedure to which the surrogate consented.
Then the practitioner must document, in addition to the already stated
requirements, the surrogate's name, relationship to patient, authority
to act as surrogate, and how the consent was obtained.

**Dr. Berkowitz:**

Once you identify a surrogate, how are they supposed to make decisions
for the patient?

**Mr. Saunders:**

The surrogate's decision must be based on a substituted judgement, or,
if the patient's values or wishes are unknown, on the patient's best
interests. Substituted judgement is the optimal standard to be used by a
surrogate because it leads to a decision based on what the patient would
have wanted if he/she were able to express their wishes. If the
patient's specific values or wishes are unknown, the surrogate and
health care team must decide the treatment course based on what is in
the patient's best interests. That is, what intervention is most likely
to produce the optimal outcome for the patient?

**Dr. Berkowitz**[:]{.underline}

Leland, how is the surrogate suppose to sign if they are not physically
present on site?

**Mr. Saunders:**

The policy has provisions for obtaining surrogate consent by mail, fax
or telephone. One very significant change in the new version of the
handbook is the easing of the prior requirement to audiotape all
telephone consent conversations. The new Handbook makes audiotaping
optional. Alternatively, the telephone consent conversation may be
witnessed by a second VA employee who must document this in the medical
record.

**Dr. Berkowitz:**

Sometimes getting consent from surrogates raises other concerns.
Occasionally the surrogate appears to be acting against the patient's
wishes or best interests. Issues also can become even more complicated
when there is more than one surrogate in the same group of the
hierarchy. For example, if the patient has several children. Does the
revised policy give guidance on how a practitioner should handle cases
where surrogates conflict or surrogates are clearly not acting in accord
with the patient's known wishes or best interests?

**Mr. Saunders:**

I think you have hit on something that is very important to
practitioners when working with surrogates. The hope is that all
surrogates will act as advocates for the patient, and represent the
patient's point of view, but when a practitioner believes the surrogate
to be clearly acting contrary to the patient's values and wishes or the
patient's best interests, the practitioner must notify the Chief of
Staff, or designee, and consult with the local ethics program and/or
Regional Counsel before implementing the surrogate's decision.

When conflict arises between surrogates of the same priority level, let
us use your example of say, a patient with three adult children. The
practitioner must make a reasonable effort to reach consensus. If
consensus can not be reached, the practitioner should chose the
surrogate best able to speak for the patient. Perhaps one of the
children lived with the patient or was better able to relate the
patient's values. The practitioner must document the reasons for
choosing that individual. If the choice is not obvious or a significant
conflict arises, the practitioner must consult with the local ethics
program and/or Regional Counsel.

**Dr. Berkowitz:**

Well, now we have gone over an overview of the informed consent process
for patients who have decision-making capacity and patients that lack
decision-making capacity and have a surrogate. What is the process for
patients who lack decision-making capacity and there's no available or
identifiable surrogate?

**Mr. Saunders:**

Well, the practitioner always has the option of contacting Regional
Counsel for assistance in obtaining a guardian for health care
decisions, but a practitioner can also use an in-house method for
obtaining consent. This in-house process is different for procedures
that do not require signature consent and those that do and has
additional safeguards for treatments and procedures of most significance
or high risk. For procedures that do not require signature consent the
practitioner must, just like any other surrogate, use substituted
judgment when the patient's wishes are known, or best interests when the
patient's wishes and values are not known to make a treatment decision.
If the practitioner is not sure that the treatment is consistent with
the patient's wishes, the practitioner must consult the local ethics
program and/or Regional Counsel. For patients without surrogates, the
new policy requires that a patient advocate outside the primary
treatment team review the treatment plan every 6 months

When there is no surrogate, for each procedure that requires signature
consent, the practitioner must also obtain a signed and dated
concurrence from the Chief of Service or designee.

**Dr. Berkowitz:**

You said there were additional safeguards for the most significant or
highest risk treatments and procedures. What did you mean?

**Mr. Saunders:**

When considering the withholding and/or withdrawal of life-sustaining
treatment for patients who lack decision-making capacity and have no
surrogate, the practitioner must first discuss the option with the
treatment team, and sign and date a progress note in the medical record
recommending the withholding and/or withdrawal of life-sustaining
treatment. That recommendation must be reviewed by a multi-disciplinary
committee appointed by the facility director, which can be the local
ethics committee. The committee must use substituted judgment or the
patient's best interests to evaluate the decision to withhold and/or
withdrawal life-sustaining treatment. To the extent possible, the
committee must also seek input from representatives of the patient's
cultural, ethnic, or religious group. The committee must then submit a
written report to the Chief of Staff that describes its findings and
recommendations. The Chief of Staff, or designee, must either approve or
disapprove of the committee's recommendation, and document that decision
in the medical record. The Facility Director must then concur or not
concur with the decision to withhold and/or withdrawal life-sustaining
treatment, or request review by Regional Counsel. The withholding and/or
withdrawal of life-sustaining treatment can only be undertaken with the
concurrence of the Facility Director.

**Dr. Berkowitz:**

So now we have gone over the process of informed consent for patients
who have decision-making capacity, those that lack decision-making
capacity and have a surrogate, and those that lack decision-making
capacity and do not have a surrogate. When are the other situations
special situations where informed consent applies?

**Mr. Saunders**:

Well, the last category is broadly called consent in special situations.
This includes medical emergencies, unusual or extremely hazardous
treatments, forced administration of psychotropic medications, release
of evidentiary information, testing for HIV, consent to participate in
research, and consent for telemedicine and/or telehealth.

**Dr. Berkowitz:**

Can you very briefly describe the process for some of those situations?

**Mr. Saunders:**

Certainly. Let us start with medical emergencies. A medical emergency
exists when immediate medical care is necessary to preserve life or
avert serious impairment of the health of the patient or others, the
patient is unable to consent, and no surrogate is immediately available
to provide consent. In these situations the patient's consent is implied
by law, and the practitioner can provide necessary medical care.
However, even after the treatment is begun, reasonable attempts must be
made to contact the patient's surrogate as promptly as possible, and the
patient's previously stated wishes must be followed if they are learned.
The practitioner must also sign and date a progress note in the medical
record documenting the patient's inability to provide consent, imminent
danger to the patient, the decision and rationale to undertake a
particular treatment, and attempts to identify and contact a surrogate.
Because this represents a significant departure from our usual standard
of collaborative decision making, the chief of staff or equivalent must
be made aware of when this occurs, and must sign and date the VA
authorized consent form whenever treatment is provided under the
emergency exception even if the signature occurs after the treatment or
procedure is completed.

**Dr. Berkowitz:**

Leland does this policy cover consent for research?

**Mr. Saunders:**

No, this handbook does not address consent for research which is covered
in separate policy Manual M-3 Part I Chapter 9 or superseding
regulations or policies.

**Dr. Berkowitz:**

But, testing for HIV is included in this handbook.

**Mr. Saunders:**

Yes, the handbook includes specific requirements for written consent for
HIV testing including specifics of accompanying pre and post-test
counseling.

**Dr. Berkowitz:**

I noticed a new section on informed consent for telemedicine and/or
telehealth.

**Mr. Saunders:**

Sure Ken let me review it. Telemedicine is defined as the electronic
communications and information technology used to provide and support
health care when distance separates the participants. Telemedicine
includes the remote monitoring of physiological data and video visits,
but it does not include the use of the telephone for direct audio
consultation between practitioners and patients or surrogates. The
process of obtaining informed consent for telemedicine is the same for
specific treatments or procedures as if they were face-to-face, except
that additional information must be provided to the patient such as the
likely difference between receiving care delivered via telemedicine and
face-to-face care, the benefits and risks of using telemedicine rather
than face-to-face care in the patient's situation, whether the use of
telemedicine for a particular treatment or procedure would generally be
considered novel or unorthodox, and that patient's are free to use
treatments and procedures that do not involve the use of telemedicine.

**Dr. Berkowitz:** Is written consent required for all telemedicine?

**Mr. Saunders:**

No, but if delivering the care by telemedicine can reasonably be
expected to produce significant discomfort or risk then signature
consent should be obtained. In addition, the policy requires signature
consent for all uses of home telehealth.

**Dr. Berkowitz:**

Leland, home telehealth is a very good example of a treatment that is
often provided as a series. Other examples include dialysis and
chemotherapy. Do we need to get signature consent for each episode of
care in a series?

**Mr. Saunders:**

No, this is generally not necessary unless, there is a significant
deviation of the treatment plan to which the patient consented to as a
series, or if the patient's condition or diagnosis changes in a way that
would have altered the original informed consent discussion.

**Dr. Berkowitz:**

Leland, once you get your signature consent, how long is it good for?
For example, for an elective operation, does the patient need to consent
that same day?

**Mr. Saunders:**

No, a properly executed VA authorized consent form is valid for a period
of 30 calendar days if no significant changes occur.

**Dr. Berkowitz:**

Thank you for that overview Leland. We have really covered an awful lot
of ground. It is important to note that the limited timeframe of this
call does not allow us to cover all the details of the revised informed
consent policy, and that we have only gotten through some of the major
points. The National Center for Ethics in Health Care is planning
additional educational opportunities that all of you are encouraged to
participate in to get a fuller understanding of the revised policy. The
Center is planning a live satellite broadcast for Thursday, February 27
at 1:00pm ET. The satellite will review the major changes and features
of the revised Handbook. The live broadcast can be videotaped, by each
medical facility for future use. I would also like to mention other
resources that available. First, the policy is available on our Web site
at vaww.va.gov/vhaethics. If you have specific questions about the
policy or its implementation, we encourage you can address them to your
local ethics committee at all of your facilities. Of course, our
Center's Consultation Service is always available to help support your
local ethics resources.

That leaves us still some time for open discussion of today's call. I
know that we covered a lot of ground it is a lot to digest, but we would
like to hear from you. So please identify yourself, your facility and
let us know what your questions are.

**MODERATED DISCUSSION -- January 29, 2003**

**Susan Gilbert, QM, Portland, OR VAMC:**

What I did not hear you discuss today were the new requirements from the
National Center on patient safety before surgical informed consent.

**Dr. Berkowitz:**

That's very important Susan, and I know that involves making sure that
the Surgery is performed on the correct side of the body and on the
correct patient. Do you have a reference to that policy? If not, I will
get it and I will make sure to include that into the follow-up e-mail
for this call. Excellent point.

**Ms. Gilbert:**

The reference is VHA Directive, 2002-070.

**Hope Lee, AA/COS, Mountain Home, TN:**

I wanted to know if the consent for HIV testing for patients who lack
decision making ability, VHA Directive 2002-048 has it been incorporated
into this handbook?

**Dr. Berkowitz:**

The treatment of the specific procedures and requirements for informed
consent for HIV testing is in this VHA Handbook 1004.1. They
specifically cover the procedures for obtaining informed consent as well
as the procedures for pre- and post test counseling and I believe that
everything is in accord with the directive that you mentioned.

**Ms. Lee:**

OK! What we were wondering here at the Mountain Home is that so much
information on HIV and the special testing and also for Hepatitis B;
would it be appropriate to pull this information out into a separate
memo rather then leaving it all in the consent policy were it can
sometimes get buried.

**Ellen Fox, MD, Director, National Center for Ethics in Health Care:**

We have been working with officers in Headquarters around some of those
issues and VHA has issued some information letters and memos recently
regarding HIV. We do reference the HIV policy in the new informed
consent policy. There is no additional information beyond what is
covered in our new informed consent policy. In some of the other
documents it is more detailed, but as Ken mentioned they are all in
accordance with each other.

**Suzanne Cottle, Social Worker, Palo Alto, CA:**

I have a question. The process for obtaining the DNR does not require
the steps outlined in you informed consent Policy. Do you think it
should?

**Dr. Berkowitz:**

Specifically, what are you referring to?

**Ms. Cottle:**

Having to do with people\'s understanding. How it is presented to either
the patient and/or family.

**Dr. Berkowitz:**

Well as you know DNR is covered by its own separate policy.

**Ms. Cottle:**

I realize that.

**Dr. Berkowitz:**

The spirit of policy is that all decision making for health care
decisions should be collaborative. Whether for informed consent or DNR,
the discussion should follow the same general tone of assessing capacity
assuring an adequate exchange of information, good comprehension and
appropriate environment for the patient to make a free choice. So, I
think that the ethical underpinning is the same for decision making
weather it is for a treatment or for a procedure or in fact to forego a
procedure of treatment such as the during the DNR process.

**Dr. Fox:**

I would add to that we are in the process of revising the DNR policy. We
did issue an interim revision. The new policy is going to be a much
broader policy addressing ethical issues and end of life care. Not only
DNR orders, but also life sustaining treatment issues in general. I
think you will see more parallel there, in terms of specific language
the DNR policy currently is rather old. It does not reflect the latest
language.

**Ms. Cottle:**

Do you know when that might be coming out?

**Dr. Fox:**

Right now, we are recruiting for a vacancy in the policy area of our
office. As soon as that person is hired, that will be their first
assignment.

**Dr. Berkowitz:**

But I do think it is safe to say, and correct me if I am wrong, if
people have concerns about the existing policy or suggestions for
incorporation into the future policy on DNR or end of life, please send
them along to our Center at VHA Ethics on the Outlook system. Identify
them as a suggestion that you think that should be considered for that
policy revision and we will make sure they get included in the process.

**Dr. Fox:**

Absolutely Ken, thank you. Also the process that Leland described
earlier in terms of sending out drafts to the field, we will be
repeating that process again with regards to end of life.

**Dr. Berkowitz:**

Any other questions on what we talked about or the informed consent
policy revision?

**St. Louis, VA:**

I have one question about the mental illness. Dr. Klein asked me to ask
does that include dementia or is it a specific diagnosis? We are a
little unclear about this.

**Dr. Berkowitz:**

Well, again I think I can comment on the intent. If there is a patient
who has obvious progressive, long standing dementia and it is clearly
understood that there is no possible reversible component. I do not
think that we need to burden our mental health colleagues with assessing
capacity. But if the lack of capacity is based on the presence of mental
illness, generally, we do feel that is very important to involve mental
health practitioners and professionals in the process, to make sure that
there is not some way to treat that underline disease, to help the
patient regain their decision making capacity. If the dementia is acute
or if they are not sure what the cause of it is, then you still might
want to involve a psychologist or a psychiatrist in that process. But I
do not think it is required because of specific diagnoses. It is
required more because of a particular clinical situation that a patient
is in.

**Paul Schneider, MD Los Angeles, CA:**

Regarding patient's who lack decision making capacity and who have no
established surrogate\--some of whom are conserved because of mental
illness. It sounds like the new policy is largely similar, or the same
as the old policy. That is, that you could get informed consent for an
elective medical procedure by doing a special two-physician consent. One
being the attending and the other being say, the service line director
or equivalent, is that correct?

**Dr. Berkowitz:**

That is partially a legal question and I do not really want to go out on
a limb to offer an answer to that right off the top of my head. There
are some distinctions between conservator and guardian and distinctions
from state to state as to what authority those people have. I do not
want to say something on-line that is wrong. If any one else feels
comfortable answering, they can. And if not, Paul I will ask you to put
that in an electronic e-mail to me or to us at the Center at VHA Ethics
so that we can try to clarify your question.

**Dr. Fox**[:]{.underline}

Dr. Berkowitz, I may have understood the question differently, I think
you were referring to a case were there is no legal guardian is that
correct?

**Dr. Schneider:**

Well no, actually I meant to generalize it in that I am referring to
cases were the person is mentally ill. There may or may not be a legal
Guardian in California, where I live. Many of the legal guardianships,
or as we call them conservatorships, are only for mental health purposes
and for purposes of decisions for whether to hospitalize someone in a
psychiatric ward or not, and specifically do not address medical
decision making at all. If we want to follow California law when we want
to get approval for, say, doing a peg-tube for such a patient, we go to
mental health court and get a judge's opinion. Now that is for someone
who is conserved, for someone who is not conserved, you know we could
see about doing it using the VA's in-house mechanism. But, it is a very
touchy area so I just wanted to see if the new set of guidelines was
going to change much from were it had been in the past.

**Dr. Berkowitz:**

I think Paul, what I will ask you to do is to read through the new
policy and see if some of the new language helps clarify the questions
that are in your mind. And if not, then by all means get to us and we
will see if we can work through it with you.

**Isabel Moriarty, LCSW, GLAHCS, CA:**

I have a DNR related question. We are trying to revise our local DNR
policy right now and one of the issues which were/are confronting is the
notion of a pre hospital DNR orders which the California Medical
Association in conjunction with the Emergency Medical Service has
written or developed a form for a patient to have a pre hospital DNR.
The question is whether encouraging patients to make use of that would
be consistent with VA policy and because it is a state thing instead of
a Federal thing and if not, is there some other approach we can use
dealing with this problem.

**Dr. Berkowitz:**

Ms. Moriarty, you have your finger right on the pulse of an electric
issue in the VA right now. We have seven current consultations in our
Center from facilities that are struggling with the same question you
asked. Out of hospital DNR is a controversial topic right now. We feel
that it is an ethically justified practice, perhaps an ethical
imperative. When subjected to a legal analysis additional questions have
been raised within the VA system. Our office is working with the office
of General Counsel and with other involved parties within the system to
try to clarify the issues. Unfortunately, there is no current policy on
out of hospital DNR in the VA at the national level. We are also working
to remedy the issue. It is very high up on our list of priorities. We
know it is a big concern to many people in the field. And we look
forward to getting back to you. If you could just send me an e-mail to
remind me, I will put you on the list of people to keep up to date on
the latest. I will send you a memo on things that we have already
accomplished.

**Ms. Moriarty:**

That would be great.

**George Kelly, Chaplain, East Orange, NJ:**

New Jersey changed its law a couple of year ago so that we can provide
to Home Base Primary Care patients a DNR and a note that is posted on
their refrigerator so that if they have to be transported to another
hospital it will be accepted and they will not be resuscitated.

**Dr. Berkowitz:**

George, please keep in mind\--and I understand exactly where you are
coming from\--those are State laws, and if you also want to send me an
e-mail, we'll get to you on the correct thinking of that within the VA.

Well, as usual, we did not expect to conclude this discussion in the
time allotted and unfortunately, we are out of time for today\'s
discussion. We do make provisions to continue our discussions in an
electronic form on our Web board which can be accessed through the VA
National Center for Ethics in Health Care Web site. We also post on our
Web site a very detailed summary of each National Ethics Teleconference.
So, please visit our Web site to review or continue today\'s discussion.

I will be sending a follow up email for this call that will include the
links to the appropriate web addresses for the call summary, the
webboard discussion, the CME credits, and the references referred to.

**MODERATED DISCUSSION -- February 10, 2003**

**Jan Torell, SA/Operations Office, Puget Sound HCS:**

I have some questions. The first is regarding paragraph 4c., where it
defines the practitioners and the residents who can obtain informed
consent. Is there any provision for a physicians assistant or nurse
practitioner who works with the licensed independent practitioner.

**Dr. Berkowitz:**

Again the spirit of the policy is that practitioners who are privileged
and who can themselves do the procedure are the individuals getting the
informed consent.

**Ms. Torell:**

I was noting in that paragraph that the term practitioner includes
medical and dental residents, regardless of whether they have been
granted clinical privileges. The resident may not actually be doing the
procedure but they may obtain the consent. Is that right?

**Dr. Berkowitz:**

If the resident is involved in the procedure you would expect that
he/she would be familiar with the procedure, who could answer questions
about it, and in general someone who is privileged. Can you tell me
where you are in the policy?

**Ms. Torell:**

I am on page 2, 4c.

**Dr. Berkowitz:**

I can't find where you are. If you can cut and paste it into an e-mail
message to me at VHA Ethics we'll try to get an answer to what you are
getting at.

**Ms. Torell**:

Another question. Paragragh 6c(1) dealing with how long the consent is
good for. After 30 days the implication is that the practitioner needs
to do another or updated progress note. Do they need to do another
informed consent form?

**Dr. Berkowitz:**

The signed consent form is valid for 30 days and after 30 days you would
have to get a new form.

**Charlotte Skinner, Lead Medical Clerk, Prescott AZ:**

Does the practitioner and the patient's signature both have to be dated
and timed?

**Dr. Berkowitz:**

As long as the date and time of the documentation reflects when the
discussion took place, and when the consent occurred it is ok that there
be one date and time and both signatures.

**Gerry Hayes, MD, ACOS Education, Washington DC:**

Some questions about where signature consent is not required. Let's take
the example of taking blood or getting a chest x-ray---What
documentation is required.

**Dr. Berkowitz:**

That documentation should be enough to support or show that the patient
generally consents to their overall treatment. Those are procedures that
result in minimal discomfort and risk that are consider routine care of
the patient. Any general documentation that shows that you talked to the
patient, they understood what is going on, is cooperative and agreeable
with the treatment.

**Dr. Hayes:**

So documentation that you are sending the patient would imply that you
discussed it with them if they show up?

**Dr. Berkowitz:**

It could. It is certainly documentation that the patient went for a
chest x-ray. That is all that is intended to be necessary for the most
routine treatment and procedures.

**Dr. Hayes:**

How about medications?

**Dr. Berkowitz:**

Well, with documentation, it's is always "the more the better."
Documentation might be that you are prescribing medication to the
patient for his hypertension, that they understand its purpose and the
side effects, risks, benefits and alternatives. Some medications carry
additional or specific risks that are greater than for other medication,
such as coumadin. You might want to document there that you went over
the specific risks associated with that medication. For example the risk
of bleeding and when they should contact you if they see something.

**Dr. Hayes:**

In the case of routine medication, here in Primary Care, a pharmacist
discusses all new prescriptions before they are filled. Would that be
considered adequate documentation?

**Dr. Berkowitz:**

I believe that that would be fine.

**Narain Srinivas, MD Radiology, Salem VA:**

I am a radiologist and right now we take informed consent for all
procedures with radiographic contrast including CTs, and IVPs. According
to the new handbook we probably won't need the written part of the
consent. But documenting it in a progress note will probably take more
time and break the continuity of our work. Would it be ok if we continue
with the informed consent and not go with the change?

**Dr. Berkowitz:**

You can certainly, at any time, require yourself to be more stringent
than the national policy as long as it is not onerous for the patient.
The new policy is more liberal than the old policy in that it only
requires signature consent for radiographic contrast material for
patients who are high risk for allergic reactions, and other risks such
as renal failure. There is some latitude there. If you feel that
liberalizing the consent process is going to cause more problems than it
will help, you feel more comfortable getting signature consent for all
IV contrast, or you have a many patients in your population that are at
high risk and you are doing the screening anyway, you may choose to
continue the current practice.

**CONCLUSION**

**Dr. Berkowitz:**

I would like to thank everyone who has worked hard on the conception,
planning and implementation of this call. It is never a trivial task and
I appreciate everyone\'s efforts, especially Leland Saunders and Bob
Smith for today\'s presentation and other members of the NCE and EES
staff who support these calls.

-   [NEXT CALL]{.underline}: Will be on Tuesday, February 25, 2003 from
    12:00 to 1:00 Eastern Time. The topic will be preparing for the pt
    rights and organization ethics portion of a JCAHO survey (The RI
    standards). Please look to the website and to your outlook email for
    details and announcements.

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-   I will be sending out a follow-up e-mail for this call with the
    e-mail addresses and links that you can use to access the NCEHC, the
    summary of this call and the electronic webboard discussion, the
    instructions for obtaining CME credits, and the references that I
    mentioned.

-   Please let us know if you or someone you know should be receiving
    the announcements for these calls and did not.

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-   Please let us know if you have suggestions for topics for future
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-   Again, our e-mail address is: <vhaethics@hq.med.va.gov>.

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-   Thanks you and have a great day!