AAO-NHS-Ethical-Rules-for-Otolaryngologists-1996

Chapter 1: Informed consent
THE ETHICS COMMITTEE OF THE AMERICAN ACADEMY OF OTOLARYNGOLOGY-HEAD AND NECK SURGERY,
Alexandria, Virginia
The principle of informed consentis subject to multiple
interpretations. From the standpoint of medical ethics,
informed consent can be defined as “‘an autonomous
authorization by a patient or subject.”' A legal definition
considers the “rules that prescribe behaviors for phy-
sicians in their interactions with patients and provide for
penalties, under given circumstances, if physicians de-
viate from those expectations.”” From both the moral
and legal viewpoints, informed consent must consider
the clinical setting and the importance of the interper-
sonal process “whereby physicians (and often other
bealth care professionals) interact with patients to select
an appropriate course of medical care.”
In this chapter we are concerned with informed
consent from all three aspects—moral, legal, and clini-
cal—with particular attention to clinical considerations.
Regardless of the approach, however, a discussion of
this subject requires an understanding of the component
acts that result in informed consent.
The process of informed consent involves the inter-
play of four elements: (1) disclosure and (2) compre-
hension, the informational components; and (3) com-
petence and (4) voluntary choice, the consent compo-
nents. Before considering these elements in detail, let us
review three case studies that illustrate the significance
of informed consent in the doctor/patient relationship.
CASE STUDIES
Case 1. As you read this case, keep in mind the following
questions:
« How should the otolaryngologist respond when the pa-
tient places the burden of choice on him?
« Should the otolaryngologist use therapeutic privilege in
this case?
‘This material is based on The Ethical Ophthalmologisi: A Primer; by
the Ethics Committee of the American Academy of Ophthalmology
© 1993 American Academy of Ophthalmology, Inc., 655 Beach
Street, San Francisco, CA 94109,
Modified by Julian H. Groff, MD, from the original text of Samuel
Packer, MD. us it appeared in The Ethical Ophthalmologist: A
Primer.
Reprint requests: Michael D. Maves, MD, MBA, Executive Vice-
President, American Academy of Otolaryngology—Head and Neck
Surgery, Inc., 1 Prince St., Alexandria, VA 22314,
Otolaryngol Head Neck Surg 1996;115:179-85.
23/1/74823
A 67-year-old retired concert violinist, Mrs. Beasley, comes
10 Dr. Reed with the symptom of decreased hearing. Exami-
nation reveals presbycusis with a 30-dB air-bone gap, prob-
ably caused by otosclerosis.
Dr. Reed discusses the risks, benefits, alternatives, and
procedures for stapes surgery and then asks whether Mrs.
Beasley has any questions. She replies that she has none and
will leave it to the doctor to decide whether surgery would be
best for her. Dr. Reed tells Mrs. Beasley she will hear better
after surgery, gives her literature regarding the procedure, and
sends her to the booking secretary to be scheduled for surgery.
Discussion. The otolaryngologist’s obligation s to tell the
patient that stapes surgery is an elective procedure. Therefore
the doctor must explain the condition as fully as possible and
answer any questions she. may have. In brief, his responsibility
is to educate her to the point at which she feels comfortable
in making the decision for herself. The otolaryngologist might
explain the difference between informed consent in this situ-
ation and in an emergency, where the physician must exercise
therapeutic privilege to act in the patient’s best interests. He
could also suggest that she take a little more time to decide,
perhaps read the Hterature he has provided and discuss the
matter with her family; then she can return to review her
decision with the doctor. He might also tell her that the more
she understands before surgery, the less anxious she will be
about the procedure. He should not tell the patient she will hear
better after the operation. This suggests a guaranteed good
result.
ally, we should recognize that, although rare, there are
paticnts who do not want to know details of the procedure and
who prefer to have the surgeon make the decision. If this
appears to be the case after the physician’s best cfforts to
educate the patient, the physician might wisely attempt to
engage a relative or friend in the process. Instruction of a
concerned cohort on the issues of the proposed surgery might
provide an informed surrogate who could assist in educating
the patient and in helping her to reach a decision.
questions:
® Is there truly informed consent in this case, without
persuasion or coercion?
« Is the patient able to comprehend the nature of his
condition and the planned treatment?
« Is he competent to give consent, and is the consent
voluntary?
A T4-year-old man recently emigrated from China and
speaks only Chinese. He visits the otolaryngologist because
his hearing has been slowly decreasing, making it difficult for
him to hear. He conveys this information to the otolaryngolo-
179

180 ETHICS COMMITTEE OF THE AAO-HNS
gist through an interpreter. The examination reveals presby-
cusis with a 30-dB air-bone gap. The remainder of the ex-
amination is unremarkable.
The otolaryngologist concludes that the hearing loss is the
result of otosclerosis and that the patient would benefit from
stapes surgery. These conclusions are relayed to the patient
through the interpreter, and surgery
is recommended.
The patient is given informational brochures and an in-
formed consent form printed in English, listing all known
complications from stapes surgery with clear definitions of
cach complication. The paticnt is told to bring the signed
consent form when reporiing for surgery and to ask any
questions he may have about the procedure to the otolaryn-
gologist’s assistant.
The otolaryngologist then has the assistant review preop-
erative clearance procedures and outpatient surgery logistics
with the patient.
The patient has uneventful surgery.
Discussion. This is an unusual case that requires special
care to ensure the patient’s complete understanding of the
nature of his otologic condition and the procedures planned to
restore his hearing. Obviously, an interpreter is essential. If
available, a family member conversant in English might be
asked to join the discussion so that questions arising after the
patient leaves the office can be adequately addressed or
referred to the otolaryngologist. Such special circumstances
clearly require a greater time commitment than usual; how-
ever, it is essential that all patients fully understand their
conditions and planned treatments if they are to give an
informed consent.
In this case study the otolaryngologist may have abrogated
her responsibility to the patient by providing information on
otosclerosis and stapes surgery written in English. Moreover,
requiring the patient to return with the signed consent form at
the time of surgery, without knowing whether anyone had been
available to assist the paticnt in translating or understanding
the form, was negligent. Further, requesting the patient to
defer other questions until he reported for surgery ignored the
probable emotionally charged state of the patient before sur-
gery—especially a patient who does not speak the language of
his caregivers. Having a relative or friend present at surgery
to help communicate with the patient was a worthwhile
possibility not considered by the otolaryngologist.
From the information presented, it appears that the patient
was not truly informed, did not fully comprehend the issues
surrounding his care, and was not able to make a voluntary
choice regarding surgery. To the extent that this inference is
accurate, we may conclude that the otolaryngologist failed her
patient with respect to the informed consent process, not only
morally and clinically but possibly from a legal standpoint as
well.
question:
* Has the HMO doctor or physician violated any of the
elements of informed consent?
A 58-year-old taxi driver consults his HMO otolaryngolo-
gist because he feels drowsy during the day. The cause of the
Otolaryngology -
Head and Neck Surgery
September 1996
problem is determined to be sleep apnea; otherwise, the taxi
driver is in excellent health. The otolaryngologist advises
uvulopalatoplasty and briefly discusses the risks and benefits
of surgery. All of the patient’s questions are answered fully,
and surgery is scheduled on an outpatient basis. When the
Ppatient reports for surgery some weeks later, he finds that the
surgery will be performed by the HMO otolaryngologist
scheduled for that week.
Discussion. Although the otolaryngologist answered “all
the patient’s questions fully,” a truly informed consent was not
obtained in this case. It is reasonable for the patient to want
to know who will be performing the surgery, and the oto-
Jaryngologist should have volunteered the information without
expecting the patient to ask. .
Armangements (contracts) between patients and insurance
companies, HMOs, and so forth are sometimes written such
that the patient may elect to give up the right to choose the
physician. When the patient has so elected, a signed covenant
between the patient and physician takes on increased com-
plexity.
ANALYSIS OF PRINCIPLES
Backgrounds
Many argue that informed consent came to medicine
from the law; others contend that it has a moral foun-
dation embedded in medicine. Without entering this
debate, we will take a brief look at the moral and legal
background of informed consent.
Moral background. The ethical principles most fre-
quently associated with the practice of medicine are
autonomy, beneficence, nonmaleficence, and justice.
Truth-telling is also an cssential ethical rule. The prin-
ciple of autonomy—the right of a patient to make
decisions without external constraints—provides the
moral basis of informed consent.
The role of beneficence in informed consent may
seem contradictory if informed consent is viewed from
only a legal perspective. However, the very basis of
medical care requires that the physician-patient rela-
tionship be one of confidence and trust. Once this
relationship is accepted, the need for beneficence is
easily understood. If a physician does not have the best
interests of his or her patient in mind, no legal require-
ments will ensure achievement of the complex condi-
tions necessary for informed consent to occur.®
Finally, the principle of justice must be incorporated
into informed consent. The truth-telling or disclosure
aspects of justice are discussed in the chapter ““Patient
Rights and Surrogacy.” Here, we consider the principle
of justice in its broader sense.
Traditionally, justice has received the least attention
in discussions of the basis of informed consent. How-
ever, this ethical principle becomes increasingly rel-
evant as issues of access to health care and selection of

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the treating physician are introduced into the manage-
ment of a patient’s medical problem. What should we as
physicians tell the patient in this regard during the
informed consent discussion? Do we describe the dif-
ferent forms of distributive justice (i.e., according to
need, according to merit, by lottery, or other)? Or should
physicians abjure these responsibilities and say that we
are agents of the patient and not of society? Clearly,
physicians have been viewed as inappropriate to make
decisions related to allocation of major resources of
society.” Should we, then, refuse to participate in the
larger social debate or to express an opinion on this
issue? When matters of allocation are related to care,
can the physician obtain a truly informed consent with-
out communicating these issues to patients?
Whether health care resources are being allocated
nationally or locally, the principle of justice leads to a
more critical analysis. In assessing a health care plan, we
might look at it from the viewpoint of John Rawls” veil
of ignorance, that is, the decision makers would not
know how or whether they would be affected by the
decision (and thus would act as if they were behind a
veil). For example, the Oregon Health Care Plan would
pass a more critical ethical analysis if it were as likely
to have been implemented for senators and congressmen
as for welfare recipients. The fact that it was known a
priori to be a plan for the poor designed by those who
are not poor creates a less than ideal method for an
ethical allocation of resources.
Legal background. The legal basis for informed
consent rests in the physician’s moral obligation to fully
inform the patient. When this obligation is abrogated
(e.g., when an undisclosed risk is discovered or occurs),
the patient may have a claim in “tort law.” A tort is an
injury to one’s person or property that is intentionally or
negligently inflicted by another and that is measured in
terms of, and compensated by, monetary damages.’ (The
“injury”” may be the performance of a procedure itself,
with a positive outcome, but for which the patient was
not fully informed.) The legal causes of action arising
from insufficient or no informed consent are negligence
and battery. Under negligence theory, “. . . ‘careless’
action or omissions” (that is, failure to disclose adequate
information related to treatment) are the source of
liability, whereas battery . . . is an intentional and
legally unpermitted physical contact with . . . another
person” (that is, treatment and/or surgery after failure to
obtain any consent).
In most states, five conditions are necessary to sub-
stantiate an informed-consent claim: (1) the physician
has the duty to provide information a reasonable person
would find material as part of the professional duty of
due care; (2) the physician breaches the duty; (3) there
ETHICS COMMITTEE OF THE AAO-HNS 181
is an injury that makes the patient worse off (either in
financially measurable terms or by violating the pa-
tient’s right to privacy) than if the procedure had not
been performed; (4) the injury is the materialization of
an undisclosed risk or possible outcome; and (5) had the
patient been informed of the potential outcome or risk,
even if none occurs, he or she (or a reasonable person)
would not have consented.®
Clinical background. The moral and legal aspects of
informed consent have received the most public and
professional attention, but it is the relationship between
the patient and physician in the clinical setting that sets
the stage for informed consent. The communication
skills of the physician play a critical role in whether
informed consent can be given by the patient. Nonverbal
clues may be more important than carefully worded
explanations of risks and benefits in how the patient
perceives the proposed procedure. Whether the patient
feels comfortable asking questions and requesting more
information will depend largely on how he or she
believes the doctor will respond to such requests. A
physician who takes the time to inquire into the social,
vocational, and recreational aspects of a patient’s life
not only will create a better relationship with that patient
but also may uncover previously unknown factors that
affect informed consent.
Ultimately, it is not the signed form that is the essence
of informed consent; it is the character and quality of the
conversations that the physician has with the patient.
Elements of Informed Consent
Competence. In the context of informed consent,
competence refers only to the patient’s capacity to
reason and to make an autonomous decision based on
discussions with the physician. It does not refer to the
patient’s ability to perform some other task nor does it
allude to the treating physician’s professional qualifi-
cations. In this sense, competence relates only to the
patient and is limited or relative, “. . . a continuum
concept.”” A court, for example, may judge a person
incompetent to manage his or her financial affairs but
capable of making decisions concerning his or her
health care. Competence to consent is specific to what
is being asked of the patient.
In the clinical setting, responsibility for determining
whether the patient is able to give informed consent falls
to the physician. The physician must ascertain whether
the patient can understand the information presented
and must evaluate the patient’s ability to reason, to
weigh risks and benefits, and to decide issues related to
his or her health care. These assessments are not always
easy or possible. Occasionally, the task goes beyond the
skills of the treating physician and requires consultation

182 ETHICS COMMITTIEE OF THE AAO-HNS
with other health professionals, such as a primary care
physician or a psychiatrist.
Disclosure. The nature of disclosure as it relates to
informed consent has matured through case law and
reflects changing patterns. in society. What was appro-
priate for a physician to tell a patient in the days of
Hippocrates may have little relevance to complex medi-
cal situations—and medical decision making—encoun~
tered today.
The term informed consent came into use in the
1950s, when the duty to disclose became a legal re-
quirement. Subsequent series of legal cases spelled out
the elements of disclosure: risks, benefits, procedure,
and alternatives. Considerable argument ensued con-
cerning the point of view to be taken in determining the
content of an informed-consent discussion. Should the
practitioner give the patient only information that is the
nerm in his or her community—the so-called profes-
sional standard? Or should the physician tell the indi-
vidual what a “‘reasonable” patient would want to
know? Over the years, the professional standard (com-
munity standard of practice) has given way to patient
standards (reasonable-patient standard).
The greatest problem associated with implementation
of the reasonable-patient standard is ascertaining what
information is relevant for a particular patient. During a
lawsuit the patient might state that certain information
withheld by the physician might have changed his or her
mind concerning a health care decision. Thus a subjec-
tive patient standard, although ideal, can be onerous or
impractical. K
In most cases discussion with the patient should
include the following: (1) what is to be done; (2)
anticipated benefits, their probabilities, and their ex-
pected consequences for the patient; (3) the significant
and/or frequent risks involved and their probabilities;
and (4) all reasonable alternatives, whether performed
by the surgeon or not.
Finally, in deciding what information to give a pa-
tient, the physician must assume that he or she is talking
to a “reasonable” person and then ask the patient
whether more information would be helpful. Once
again, good communication skills on the part of the
physician are essential for a meaningful dialogue to
occur, one in which the patient can communicate freely
his or her fears, concerns, and questions.
Comprehension. Comprehension is an extension of
competence: whereas competence is required before
disclosure, comprehension is assessed after disclosure.
Tdeally, comprehension should be an ongoing process to
be assessed throughout the disclosure process so that
explanations can be adjusted to fit the informational
needs of the patient.
Ofolaryngology -
September 1996
Comprehension is another concept that has a con-
tinuum or relative nature. Failure of comprehension
relates to a patient’s inadequate understanding, unsub-
stantiated knowledge, or forgetting of information. The
relevant measure of comprehension, however, is
whether a particular individual has an adequate, or
threshold, understanding compared with a “‘reasonable
patient” under similar circumstances. ““Adequate” un-
derstanding does not presume brilliance or total recall
on the part of the patient, nor does it assume that patients
even have to understand the information in any pro-
found sense.
Assessments of a patient’s comprehension and com-
parisons with a “reasonable-patient” standard are ob-
viously subjective judgments on the part of the physi-
cian, However, if the dialogue between the patient and
physician involves a conscientious effort to evaluate the
patient’s comprehension, as well as to inform the pa-
tient, the physician has fulfilled his or her ethical re-
sponsibility in regard to these aspects of informed
consent.
Voluntariness. Once the information provided has
been understood, the patient must be permitted to make
an autonomous decision free of external constraints, if
a valid informed consent is to be given. We are all aware
of the blatant examples of coercion and manipulation
used in the Nazi medical experiments. However, the
subtleties of persuasion in the typical medical encounter
related to informed consent are more difficult to detect
and control; paralinguistic attempts to influence deci-
sions are beyond legislation. The moral physician, who
acts in the best interests of the patient, however, need
have no concerns with this issue because there will be
no attempt to influence the patient’s decision.
Issues Related to Informed Consent
Therapeutic privilege. Management of medical in-
formation is an important duty of the physician. As part
of this responsibility, the physician must decide, on
occasion, whether revealing such information is in the
best interest of the patient. Because withholding infor-
mation from a patient compromises the patient’s au-
tonomy, decisions not to disclose must be made only
after careful balancing of philosophic principles or
consideration of the requirements of specific medical
indications. The latter instance is easier to explain.
In emergencies, the time required for full disclosure
could jeopardize the patient’s health. For this reason,
under the law, informed consent is frequently not re-
quired in such situations. When the release of informa-
tion has been judged to pose a threat to the public health
and welfare, such information may be withheld. More
comunon, however, is the situation in which the patient

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would not wish to know certain particulars regarding his
or her health. Such situations test the physician’s com-
‘munication skills, judgment, and diplomacy. The courts
have viewed therapeutic privilege as appropriate when
information would be hazardous to the patient’s health,
interfere with treatment, or be psychologically damag-
ing. Again, because withholding information abrogates
a patient’s rights, the therapeutic privilege should be
invoked only after careful reflection.
Treatment refusals. A patient is expressing his or her
autonomy when he or she chooses not to have treatment.
Physicians must respect this right, even though the
patient is making a choice that differs from that of the
physician. Such acquiescence by the physician pre-
sumes that the patient has been fully informed (educated
to the best of our ability), understands the information
given, and is competent.
Situations in which a patient totally refuses treatment
are fortunately rare. When they do occur, they create a
conflict between the principles of autonomy and benefi-
cence, the patient’s right to choose, and the physician’s
obligation to the welfare of the patient. If additional
efforts to convince the patient are ineffective, the pa-
tient’s decision prevails.
The U.S. Supreme Court has ruled that a competent
person has the right to refuse treatment for himself or
herself, including the Jehovah’s Witness who elects not
to accept a blood transfusion. Refusal of treatment be-
comes more complex when the decision is that of a
surrogate for an incompetent paticnt or when there may
be reasons to challenge the legal competence of the
patient. Even more difficult are cases of special circum-
stances; for example, the case of a pregnant Jehovah’s
Witness where a blood transfusion is required to save
both the mother and the unborn child. Has the mother
the right to refuse treatment for the fetus? Does it de-
pend on the age of the fetus? There are no easy answers.
Research. The ethical principles underlying in-
formed consent as it relates 10 research stem largely
from deliberations at the Nuremberg trials after World
War I1. In brief, these principles acknowledge the right
of human subjects to be fully informed regarding the
nature and purpose of the research study and to under-
stand that participation is voluntary and without con-
straints.
Some authors have stressed the importance of the
physician as protector of patient rights in research. H. K.
Beecher, for example, “criticized rigid codes and ap-
pealed to the virtuous physician as the appropriate
standard for ensuring that informed consent will be
obtained.”® Although there is no argument that ethical
physicians are essential to execute the requisites of
human research, abuses of subjects in even the recent
past have emphasized the need for regulations to ensure
informed consent. One example of the more blatant
abuses is the withholding of treatment from 400 men
diagnosed with syphilis in the 1930s to assess the natural
course of the disease during the next 40 years (the
Tuskeegee incident). This study ended with public dis-
closure in the 1970s. Another example is the infection of
750 mentally retarded children with hepatitis virus in the
1950s to test the efficacy of an experimental vaccine. A
third example is the injection of live cancer cells into 22
elderly patients to study immune response. The last
example was authorized by a New York hospital in
1963.
In 1966 the U.S. Public Health Service (PHS), which
includes the National Institutes of Health (NIH), drafted
a policy defining the rights of human subjects and made
informed consent a condition of NIH and other PHS
funding for research. In 1981 the Food and Drug Ad-
‘ministration (FDA) adopted a series of regulations cov-
ering the human testing of drugs, medical devices, and
other products that requite FDA approval. These regu-
lations contain the elements of informed consent and
include the following:
1. A statement that the program is a research study,
with an explanation of its purposes, the cxpected
duration of subject involvement, and a description
of the procedures involved, including identifica-
tion of experimental procedures as such.
2. Description of risks and discomforts that are “rea-
sonably foreseeable.”
3. Description of possible benefits to subjects and
others.
4. Disclosure of appropriate alternative treatments, if
any.
5. A statement describing the extent of confidential-
ity of records generated.
6. Explanation of whether compensation or treat-
ment will be available if injuries occur.
7. A note as to whom to contact with questions or
reports of injuries.
8. Astatement as to the voluntary nature of participa-
tion and the subject’s right to withdraw at any
time.
The regulations also list six optional elements of
information to be included if appropriate:
1. A statement that unforeseen risks may arise.
2. Description of circumstances in which subjects’
participation may be terminated without their
consent.
3. Anote as to any costs to the subjects as the result
of participation.
4. Description of the consequences of premature
withdrawal.

vide examples
5. A statement that subjects will be informed of any
findings that may affect their willingness to con-
tinue.
6. Notation of the number of subjects to be involved
in the research.”
As a general guide, Appendixes A through C pro-
of possible consent forms from
which appropriately specific consent forms can be de-
veloped.
REFERENCES
1
N
@
©
©
10.
su
Faden RR, Beauchamp TL. A history and theory of informed
consent. New York: Oxford Universiy Press, 19863
Appelbaum PS, Lidz CW, Meisel A. Informed consent—legal
theory and clinical practice. New York: Oxford University Press,
1987:3.
Pellegrino ED, Thomasma DC. For the patient’s good. The
restoration of beneficence in health care. New York: Oxford
University Press, 1988:149.
Veatch RM. Physician and cost containment: the ethical conflict.
Hastings Center Report 199 1:March-April:461-82.
consent. New York: Oxford University Press, 1986:23.
Appelbaum PS, Lidz CW, Meisel A. Informed consent—legal
theory and clinical practice. New York: Oxford University Press,
1987:224-5.
Rozovsky FA. Consent to treatment. Boston: Little Brown and
Co, 1990:743-52.
The following are samples and are not intended to be
itable for any particular practice. Prepare your in-
formed consent forms based on consultation with your
insurance carrier and/or your attorney.
APPENDIX A: LONG CONSENT FORM™
Consent to Treatment
1. 1, (patient’s name) of (place of residence), do
hereby give my consent to the performance of
(name of medical, surgical, or diagnostic proce-
dure). [ understand that the procedure will involve
(explanation of the procedure). 1 have made my
decision voluntarily and freely.
2. Tunderstand that there are certain risks associated
with this procedure, including (Zist of risks), and I
freely assume these risks. [ also understand that
there are possible benefits associated with this
procedure, including (list of benefits). However, I
understand that there is no certainty that I will
achieve these benefits and no guarantee or assur-
ances have been made to me regarding the out-
come of this procedure.
3. The reasonable alternative(s) to this procedure
Ofolaryngology
September 1996
have been explained to me, including (list of
reasonable alternatives, if any exist).
4. Any questions I have had regarding this procedure
have been answered to my satisfaction.
5. In authorizing my physician, Dr. (name of doctor)
to perform this procedure, I understand that he or
she will be assisted by other health professionals
of the (name of the health facility) and such others
as he or she considers necessary in my care. [ agree
to their participation in my care.
6. To attest my consent to this procedure, I hereby
affix my signature to this authorization for
treatment.
7 —
__ Signature of patient.
8. Signature of witness.
9 __
O Date and time.
Additional inclusions appropriate for a long consent
form would be:
1. I understand that during the course of the proce-
dure, unforeseen conditions may arise that neces-
sitate procedures different from those contem-
plated. I therefore consent to the performance
of additional treatment(s) (procedure(s) which
Dr.______ or his or her associates or
assistants may consider necessary.
2. 1 further consent to the administration of such
anesthetics and/or blood transfusions as may be
considered necessary. I recognize there are always
risks to life and health associated with anesthesia
and blood transfusion, and such risks have been
fully explained to me.
3. Any organs or tissues surgically removed may
be examined and retained by.
for medical, scientific, or educational purposes,
and such tissues or parts may be disposed of in
accordance with customary practices.
4. A place for an interpreter to sign.
APPENDIX B: SHORT CONSENT FORM™
Consent to Treatment
1. I, (patient’s name), of (place of residence), do
hereby agree to the performance of (name of
procedure) by my doctor, Dr. (name of physician),
and such others as he or she considers necessary.
2. The mature and consequences of the procedure
have been explained to me. I understand that it will
involve (brief explanation of the procedure).
3. The risks and benefits of this procedurc have been
explained to me. I also understand that there are
certain medical and surgical alternatives to this
procedure, and I have been given information
regarding other medically or surgically feasible
forms of care.

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Volume 115 Number 3
4. 1 hereby frecly and voluntarily give my signed
authorization for this procedure.
5. Signature of patient.
6. Signature of witness.
7. Date and time.
APPENDIX C: CONSENT CHECKLIST FORM™
Consent fo Treatment: Certification Document
1, (physician’s name), MD, informed (patient’s name)
of the following information.
[Check the following where appropriate.]
O Nature and purpose of procedure:
(specify procedure).
O Probable risks and probable benefits of pro-
O Receiving analgesics but mentally capable of giv-
ing consent.
O Receiving analgesics and. mentally incapable of
giving consent.
O Mentally incapable of giving consent due to
other factors: and an authoriza-
tion was obtained from_________, who
was permitted to give consent on behalf of the
patient.
O Interpreter assisted in securing consent of patient:
(specify name of interpreter).
O Family who assisted in securing consent of
patient: (specify names of fam-
ily members).
cedure: . Names of those present during the consent pro-
O Reasonable treatment options (if any exist): cess_____
.
_ and their probable risks and 1 certify that the consent process described above
probable benefits: . occurred as stated.
O The risks of foregoing treatment, including:
Date Time Signature of caregiver
NOTE: The failure to complete the consent process
properly constitutes sufficient basis for revoking medi
cal staff privileges or otherwise taking appropriate dis-
ciplinary. procedures.
O An explanation of what the patient should antici-
pate after the procedure in terms of pain, discom-
fort, disability, and disfigurement.
O Answers to all questions posed by the patient using
language the patient could understand.
Condition of patient at time of consent process:
O Lucid and coherent.
BOUND VOLUMES AVAILABLE TO SUBSCRIBERS
Bound volumes of Otolaryngology—Head and Neck Surgery are available to subscribers
(only) for the 1996 issues from the Publisher, at an individual cost of $81.50 ($106.47 for
Canadian, $99.50 for international subscribers) for Vols. 114 (January-June) and 115
(July-December). Shipping charges are included. Each bound volume contains subject
and author indexes, and all advertising is removed. Copics are shipped within 60 days
after publication of the last issue in the volume. The binding is durable blue buckram with
the JOURNAL name, volume number, and year stamped in gold on the spine. Payment must
accompany all orders.
Contact Mosby—Year Book, Inc., Subscription Services, 11830 Westline Industrial
Drive, St. Louis, MO 63146-3318, USA; phone (800)453-4351 or (314)453-4351.
Subscriptions must be in force to qualify. Bound volumes are not available in place
of a regular JOURNAL subscription.

AAO-NHS-Ethical-Rules-for-Otolaryngologists-1996

Chapter 2: Patient rights and surrogacy
Seeking medical advice can be a frightening experi-
ence for many individuals. Patients may envision dev-
astating conditions as the source of relatively minor
symptoms. Difficulties in comprehension become the
first signs of deafness; mild hoarseness indicates cancer.
Although the results of an examination may ease the
patient’s concerns, fear may linger that the physician
has not told the patient “the whole story,” in part
because the patient often does not fully comprehend the
physician’s explanation of the symptoms.
Dissatisfaction in this regard has led patients in-
creasingly to insist on a better understanding of
diagnoses and treatment when medical problems occur.
Tn a recent consumer poll conducted by the American
Academy of Ophthalmology,' respondents rated a
thorough explanation by the ophthalmologist as the
most important attribute of an eye care provider. In
response to these expressed needs, the health care
industry has moved to acknowledge and clarify the
rights of the patient. Hospitals now prominently dis-
play a patient bill of rights,” stipulating the individual’s
right to be informed, together with the right to refuse
treatment.
Whereas these steps have been welcomed by the
public at large, some paticnts fail to exercise such rights.
These are patients who, for a variety of reasons, are
unable to understand their medical conditions or to
make reasoned decisions regarding their own health
care. Many of these patients are fortunate to have
relatives, legal guardians, or empowered friends who
can act in their stead. However, ethical issues can arise
in such sitations when the attending physician has
reason to question whether the surrogate is acting in the
best interests of the patient.
‘This material is based on The Ethical Ophthalmologist: A Primer, by
the Ethics Committee of the American Academy of Ophthalmology,
© 1993 by the American Academy of Ophthalmology, Inc., 655
Beach Street, San Francisco, CA 94109,
Modified by Jay B. Farrior I1l, MD, from the original text of Susan
H. Day, MD.
President, American Academy of Otolaryngology-Head and Neck
Surgery, Inc., 1 Prince St., Alexandria, VA 22314.
23/1/74824
186
Consider these questions as you read the following
case study:
* Who is the patient?
* What actions are in the best interest of the patient?
* How might the attitudes and prejudices of the
family affect the outcome for the patient?
CASE STUDY
A pediatrician refers a 4-year-old boy to the otolaryngolo-
gist for treatment of bilateral chronic draining ears. Although
concems regarding mastoiditis have been cxpressed in the
past, the diagnosis was not made until after a recent computed
tomography (CT) scan was obtained. The child is accompa-
nied by both parents. The otolaryngologist notes that the father
is wearing a behind-the-ear hearing aid on the left ear and has
a moderate right-sided facial parcsi
The father explains that this is his first child. He is not
surprised about his son’s ear infections because he had ear
infections as a child. He underwent mastoid surgery at 3 years
of age himself, which left him with a complete hearing loss in
his right ear and unilateral facial paralysis. It took years to
recover any function. He has also lost most of the hearing in
his lcft ear despite numerous visits to doctors over the years;
nothing could be done about his hearing or his twisted face.
On evaluation of the father, the otolaryngologist finds a radical
mastoid cavity on the right. On the left, there is extensive
tympanosclerosis of the tympanic membrane. Hearing is at the
90-dB level by air conduction and 50 dB by bone.
Examination of the child reveals bilateral perforated ear-
drums, postauricular swelling, and induration. The audiogram
shows hearing at the 70-dB level, with bone conduction at 15
dB bilaterally. Review of the CT scan shows extensive soft
tissue density involving both the middle ear and mastoid
bilaterally with coalescence.
After reviewing the CT scan, the otolaryngologist recom-
mends bilateral mastoidectomy. The physician discusses his
recommendations with the family and explains that additional
surgery or a hearing aid may be needed to restore the child’s
hearing.
The father responds that he is totally opposed to surgery
because he says, “It did me no good and twisted my face.” He
adds that there are worse things in life than being deaf and that
he has had a full and productive live.
DISCUSSION OF THE CASE STUDY
The physician is obligated to respect the autonomy of
the patient, including the patient’s decision to reject
treatment. However, in this case, a question quickly

Otolaryngology -
Volume 115 Number 3
arises: Who is the patient—the child or the whole
family? In a strict sense the child alone is the patient, but
because he is obviously unable (o act on his own behalf,
the parents become the natural surrogates to decide for
the child whether to accept treatment.
If the otolaryngologist concludes that rejection of
surgery is not in the best interests of the patient, several
options may be pursued. One alternative is to continue
efforts to convince the parents that, with timely surgery
and amplification, the child’s hearing may be reasonably
expected to be nearly normal, the father’s unfortunate
experience notwithstanding; the care he received was,
by today’s standards, suboptimal. The ear, nose, and
throat surgeon must also acknowledge that risks are
present in any surgical intervention and that the outcome
cannot be predicted with absolute certainty.
At the other extreme of alternatives is the possibility
of legal action. The surgeon, as advocate for the patient,
could try to obtain a court order for surgery. If the court
concurs with the physician’s reccommendation, the court
would appropriate the responsibilities of surrogacy from
the parents. This alternative is not without conse-
quences, however, given the important role to be filled
by the parents in auditory rehabilitation of the child after
surgery (hearing aid fittings, assistive listening devices,
and frequent follow-up assessments).
Historic Review of Patients’ Rights Issues
The onus of ethical medical care has historically been
placed on the physician, as expressed in the golden rule,
“Always do what is in the best interest of your patient.”
The power of action here is given to the physician, not
to the patient. The Hippocratic Oath (Appendix 3A),
which outlines the proper and fitting performance of the
physician, does not even consider matters of appropriate
communication with the patient, apart from the single
issue of confidentiality.
Explanation for this paternalistic attitude of physi-
cians toward patients rests partly with the difficulty of
early lay populations to understand even the most fun-
damental aspects of health and hygiene, much less
issues related to their medical care. In addition, vestiges
of a primitive belief lingered within the medical com-
munity to the effect that shrouding the practice of
medicine in mystery contributed to the healing process.
The growth of literacy and general education during
the first half of the twentieth century largely changed the
character of patient populations in the Western World
and, hence, their relationship to health care providers.
The recent media and communications explosion fur-
ther contributed to the dissemination of medical infor-
mation—sometimes inaccuratc—among the general
population. The net effect has been a greater under-
standing of medical issues on the part of the average
person and an awareness that the individual shares in the
responsibility for his or her own health care.
In response to the increased demands and medical
sophistication of patients, the manner of practicing
medicine has also changed during the past half century.
Prominent among these changes is the increased com-
munication between physician and patient. Such infor-
‘mation helps the patient to understand the diagnosis and
proposed treatment or treatments and to comply with the
physician’s instructions. This knowledge also offers the
patient a basis for making choices regarding his or her
own health care.
Legislation has provided an additional impetus for
full disclosure to the patient. An example is the require-
ment for explicit discussions of indications, risks, and
alternatives to obtain an informed consent before sur-
gical and other procedures are undertaken.
Patients’ rights have become a key focus for various
advocacy groups in recent years. Although these om-
budsmen were created to serve the patient’s best inter-
ests on an ongoing basis, in practice they are often called
on only when the doctor-patient relationship is strained.
Patient Rights: General Considerations
The heightened awareness of individual rights, to-
gether with the proliferation of treatment choices and
legal regulations, has prompted most hospitals and
medical institutions to draft formal statements of pa-
tients” rights. These documents are distributed to in-
coming patients or are prominently displayed on the
premises. The statements declare that the rights apply
irrespective of the patient’s cultural, economic, educa-
tional, or religious background. The patient is further
granted the right to receive all relevant information on
his or her illness and treatment and to have this infor-
‘mation treated confidentially. The patient has the right
to be informed of the risks and benefits of proposed
courses of treatment and, should he or she so wish, to
refuse treatment to the extent permitted by law. Other
rights may also be detailed in the statements.
Experienced medical professionals may view thesc
lists as statements of the obvious at best or as cynical
public-relations efforts to help the patient “feel good”
about the institution. To the patient, however, such a
statement of rights may provide the stimulus and en-
couragement to pursue a better understanding of his or
her illness and to participate more fully in the decision-
making process of medical care. To the extent that this
is achieved, both the patient and physician benefit.
Patient rights have assumed even greater importance
in recent years as many issues facing the patient have

become literally life-and-death matters. Abortion is an
obvious example, but there are more: patient “self-
determination” (the right to refuse life support), living
wills, and durable powers of attorney, among others.
Both patient and physician rights have moved (o the
forefront of public concern in regard to testing for HIV
status and disclosure of test results.
Otolaryngologists may consider some patient rights
to be of little direct concern because a physician in this
specialty (except for colleagues performing head and
neck surgery) is unlikely to work frequently with ter-
minally ill patients. This, of course, is no longer the case.
An increasing number of patients secking medical carc
are infected with HIV or have AIDS. Other patients have
complications in association with potentially life-threat-
ening conditions such as diabetes, carcinoma, trauma,
and so forth. It is of interest to note that all hospitals by
federal law (the Patient Self-Determination Act) must
inform patients of their right to refuse life support in the
event of a sudden change in health status, regardless of
whether the patient is a liver-transplant candidate or is
scheduled for a tonsillectomy.
Patient Rights and Otolaryngology-Head and
Neck Surgery
The issue of patients’ rights within otolaryngology
relates directly to the same principles of ethical practice
that apply to all physicians: patient autonomy, physician
beneficence/nonmaleficence, and justice, including its
corollary, truth-telling.
Autonomy. The principle of autonomy signifies the
right of a patient to make personal choices regarding
medical care that the patient belicves are in his or her
own best interests. Implicit in this concept is the pa-
tient’s right to be informed of the nature of his or her
disease and of appropriate avenues of treatment, to-
gether with the authority to accept or reject recom-
mended therapy and to seek other opinions. Exercise of
these rights involves the requirement of informed con-
sent from the patient before initiation of medical, sur-
gical, or experimental procedures’ When patients are
judged to be incapable of making decisions about their
own medical care, a surrogate acts on the patient’s
behalf.
These rights place a burden on the otolaryngologist
beyond the responsibilities associated with his or her
medical expertise, specifically, the obligation to under-
stand, respect, and act in accord with the patient’s needs
and expectations. An understanding of these needs re-
quires the physician to listen carefully to what the
patient says and to recognize that all patients do not
share the same needs and hopes. The observation of
S.1. Hayakawa, ““A cow is not a cow is not a cow,” could
Otolaryngology -
September 1996
be accurately rephrased in this context: **A sinus patient
is not a sinus patient is not a sinus patient.” Similar
rhinologic findings may require different therapeutic
interventions, depending on the particular patient’s de-
sires, needs, and expectations.
Beneficence and nonmaileficence. This principle
is a charge to the physician to act first and foremost for
the well-being of the patient, and, above all, to do no
harm. This is a heavy responsibility. The physician can
give no unequivocal guarantee that a given procedure
will improve the patient’s condition or quality of life.
Nor can the physician be certain that surgery
or any
other procedure will not result in damaging complica-
tions.
‘What the physician can do is marshal all of his or her
professional training and experience to weigh the prob-
able benefits of an appropriate course of action against
its attendant risks and against the potential harm of no
therapeutic intervention. The physician can explain the
proposed procedures to the patient, the rationale for
their selection, the possible risks, and the expected
outcome. If competent and mature, the patient has the
right to reject the recommendation. If the physician
believes strongly that the patient’s decision is not in the
best interest of the patient, the physician must be certain
the patient fully understands the implications of denying
treatment. The physician may suggest that the patient
take some time to consider the recommendation and
perhaps discuss it with other family members or friends
before reaching a final decision. The physician may
encourage the patient to return to the office with close
relatives or trusted friends for further discussion of the
matter. Beyond these steps, further action by the phy-
sician is warranted only if the patient is not personally
competent to make a rational decision.’
Underlying all of these suggestions is the physician’s
obligation to act for the patient’s welfare as medical—
and human—skills, training, and experience enable him
or her to judge what is in the patient’s best interest.
Should unforeseen events or complications result from
treatment, the physician is obligated to do whatever is
possible medically to correct the complication. If the
initial procedures were appropriately selected and per-
formed, the physician’s charge “to do no harm” can be
justifiably qualified.
However, the principle of bencficence and nonma-
leficence cannot be qualified by the present tendencies
of some to view the practice of head and neck surgery
more as a business than as a profession. The temptation
to order an extra test or to perform surgery at an earlier
date than “may be necessary” may be rationalized as
doing no harm to the patient, especially if insurance will
pay for the procedures. However, in these instances the

Otolaryngology -
Volume 115 Number 3
interests of the patient obviously have been superseded
by those of the physician. Other ethical issues associated
with beneficence concern competence to perform a
particular procedure, delegation of services, and post-
operative care. These issues are considered elsewhere.
Truth-telling. The need for a careful, and sometimes
prolonged, discussion of diagnoses and proposed
courses of treatment has been stressed repeatedly in this
chapter. Only with such communication can a patient
make an informed decision about his or her own wel-
fare. The difficulty, of course, is that multiple truths
often exist in any given situation. The physician can
base his or her “truth” on only the accuracy of obser-
vations made and the depth of knowledge and experi-
ence gained during the course of training and clinical
experience. Without doubt, the “truth™ may change over
time, however subtly, as the physician grows in clinical
proficiency. Whatever the physician’s level of clinical
sophistication, however, the patient is owed the best
conception of truth that the physician possesses, even if
an answer must be “I don’t know™ or *‘nobody knows.”
At times these statements, too, are truths.
Truths may be told in many ways, and the manner of
telling the truth to a patient is perhaps as important as
the truth itself. Within otolaryngology, this fact is most
deeply felt when there has been acute hearing loss that
may or may not be reversible. Telling the truth about the
best management for glomus jugulare tumors must
acknowledge the differing opinions on dealing with this
entity. Explaining unanticipated cranial nerve loss and
the need to alter surgical strategy may be a real test of
how to tell the truth.
Surrogacy
Decisions regarding medical management must be
‘made for the patient who is too young to make a decision
legally and for those patients who lack judgmental
capabilities by reason of mental incompetence. Ideally,
a surrogate for the adult patient has been designated by
or for the patient before the need arises. When no such
selection has been made, the choice of a surrogate is
usually determined by state law. Alternatives are often
ranked on the basis of relationship to the patient and
proceed in descending order: guardian, spouse, adult
children, parents, siblings, adult grandchildren, and
close friends.
‘When the patient is a minor, parents are usually the
obvious choice as surrogate decision makers. Problems
arise, however, when the parents disagree, either with
each other or with the medical advice. This situation is
of particular concern when refusal of medical treatment
may result in life-threatening circumstances, as with
carcinoma, or hearing-threatening consequences pre-
ventable by proven treatment. In many cases refusal to
proceed with specific medical care is based on religious
or cultural beliefs. In the United States, legal proceed-
ings may be instituted against Jehovah’s Witness par-
ents who refuse blood transfusions for their child.
Similarly, surrogacy of Christian Science parents may
be legally appropriated if they refuse surgery for life-
threatening conditions such as rhabdomyosarcoma.
Elderly patients often have occasion to rely on a
surrogate for decisions regarding their medical care.
Selection of an appropriate and willing surrogate is
especially important in patients with upper aerodiges-
tive tract cancers to ensure a proper understanding of the
patient’s needs. Complete care may require consider-
able time and effort, and these needs may be neglected
if the patient and surrogate do not live in the same area.
In addition, the potential for abuse, or evasion, of the
surrogate’s role is perhaps greater in the case of elderly
patients than in the analogous parent-child relationship.
Special Circumstances Relating to Patient Rights
Research and clinical experiments. Patients par-
ticipating in research studies voluntarily share their
interests in appropriate care with the objectives of the
investigation. For this reason particular efforts must be
‘made to ensure that the patients understand their rights
as subjects of a study. Just as many hospitals commonly
adopt a patient’s bill of rights, institutions that routinely
perform research frequently display a statement of
rights for participants in clinical trials and experiments.
Suchdeclarations underscore the patient’s right to know
the purpose of the investigation, the procedures o be
followed, and the right to withdraw from participation
at any time.
These public displays of rights are designed to com-
plement special informed-consent statements, which
must be signed by patients before participation in a
study. The statements provide details of the experiment
and confirm the rights of the patient as a participating
subject. Ethical issues relating to these special in-
formed-consent statements and to clinical research are
discussed elsewhere in this text.
Patient’s rights and residency training. The issue of
residency training raises many ethical questions sur-
rounding patient rights. Is it truly in the best interest of
the patient to have a first-year resident perform ear,
nose, and throat surgery? Are additional tests, such as
clectrophysiologic testing or magnetic resonance imag-
ing scans, performed for the benefit of the patient or
because the resident desires a better understanding of a
clinical circumstance? What does the physician answer
when the patient asks how many surgical procedures he
or she has done?

190 ETHICS COMMITIEE OF THE AAO-HNS
As with clinical research, a residency training pro-
gram must accommodate the interests of both the patient
and the future of medical care. Without a residency
program, patients of even the next generation would
experience the gradual disappearance of otolaryngic and
other medical specialities. Design of an effective and
ethical residency training program, however, must en-
sure that patients’ interests are safeguarded. This means
that, together with organized instruction for the resident,
appropriate input is available from attending otolaryn-
gologists. Care must also be taken to ensure that ad-
equate supervision is present in special instances, such
as during invasive procedures. And finally, patients must
be made aware that their care is being provided by
residents.
Patients often express pride in being able to partici-
pate in the training of residents. As with subjects in
clinical trials, many of these patients realize that resi-
dency programs permit them to contribute—even with
their illnesses—to the advancement of medicine and the
better care of future generations. Apart from these
sentiments, delivery of the best possible care is often
Otolaryngology -
September 1996
fully attainable within the context of a residency training
program. But such care can be achieved only by a
willing resident, an honest, committed, competent, and
attentive staff, and a well-informed patient.
The resident gains not only the skills and knowledge
of an otolaryngologist from a sound training program
but also respect for patient autonomy, beneficence, and
truth-telling. In turn, the trained otolaryngologist can
often benefit from truths made evident by the resident’s
fresh perspective. The patient profits from the expertise,
concern, and respect of both the otolaryngologist and
resident.
REFERENCES
. Insights into primary eye care. Market research summary. San
Francisco: American Academy of Ophthalmology, 1989:7.
Monagle JF, Thomasma DC. Medical ethics, a guide for health
professionals. Rockville, Md.: Aspen Publications Tnc, 1988:317.
Code of ethics. Alexandria, Va.: American Academy of Otolaryn-
gology—Head and Neck Surgery Foundation, 1995
. Special report. Report and model legistation focus on treatment
decisions. Medical Ethics Adviser 6(6):70-3.
»
w
IS

Chapter 3: Delegation of authority
opemnon of a busy modern otolaryngology practice
does not permit a physician to perform all of the tasks
that may be required. For this reason, many practitioners
rely on a competent staff to run the office and delegate
certain technical duties to qualified assistants. In the
commercial world businesses and industries have vastly
increased production and profits by defining and del-
egating tasks and by streamlining the provision of goods
and services they sell to the public. Some physicians
believe that the efficiencies of business can be extended
to the practice of medicine with benefit to both the
public and the practice. This interest in efficiency raises
an important question: At what point does the delegation
of duties by the physician begin to erode the ethical
underpinnings of health care delivery?
The essence of medical ethics is to ensure that the best
interests of the patient are served. But who is to decide
what these interests are? In our society the answer has
been the individual patient, as illustrated by the concept
of informed consent. The individual physician, of
course, plays a critical role in the process by providing
the information and counsel on which the patient’s
decision is based.
In speaking of patients and physicians, however, we
must remember that they exist both as individuals and
as members of collectives: for patients the larger group
is the public; for physicians it is the profession. Ulti-
mately, the will of the collective public determines the
form of the collective profession. Thus decisions on best
interests may be made in terms of the individual patient
or in terms of the public as a group of actual or potential
patients. Unfortunately, the interests of individual pa-
tients may not always coincide with those of the public.
Likewise, the interests of the individual physician will
“This material is based on The Ethical Ophthalmologist: A Primer, by
the Ethics Committee of the American Academy of Ophthalmology,
Modified by Thomas P. Gonsoulin, MD, from the original text
of John
W. Lewis, MD.
Surgery, Inc., | Prince St., Alexandria, VA 22314
2301774825
not always coincide with the interests of the collective
profession.
The following case study describes a scenario that
may be the future of medicine if the public views it
favorably. This possibility poses a dilemma for the
patient as an individual and as a member of the public;
the prospect also raises questions of ethical responsi-
bility for the physician as an individual and as a member
of a profession. If medicine is perceived by the public
and the profession as only the efficient delivery of
information and technology, traditional practices may
be seen as inefficient and doomed by the market. Our
goals are to understand, define, and market the part of
medicine that might be neglected by the scenario below.
Consider these questions as you read the case study:
« Is there a limit to the tasks that an otolaryngologist
may ethically delegate to subordinates?
* If adequate patient care can be provided more
efficiently by supervised technicians than by oto-
laryngologists, does society have a duty to move in
this direction?
Does it make any difference to a patient what the
credentials of the provider are as long as the care
provided is competent?
Does competence include ethical behavior as well
as technical expertise?
CASE STUDY
Dr. Ross is an otolaryngologist and a fellow of the Acad-
emy. He has developed a large practice during the years. To sce
more patients, he has worked hard at organizing his office
efficiently and has developed what he calls “staged compe-
tence.” By this he means that a patient entering the practice
will meet a series of persons with increasing levels of com-
petence until the problem of the patient is solved. He employs
audiologists, nurse practitioners, and fellows to manage the
flow of patients. He is always available to answer any ques-
tions, but he routinely sees patients only after a history, a
problem-specific questionnaire, an audiogram or videostro-
boscopy, sinus x-ray films, or computed tomography scans
have been obtained. After Dr. Ross sees the patient, an
assistant writes out any prescriptions or instructions and
escorts the paticnt out of the examining room.
Dr. Ross is particularly proud of two aspects of his practice.
He has a collection of high-tech screening equipment, such as
audiometers including impedance instruments, computerized
guides to diagnosis, and a voice laboratory. He believes that
RL4]

these modalitics enhance the expertise of his practice and
make it less likely that any mistakes will be made. The second
cause of Dr. Ross’ pride is a personnel innovation: he has
moved one of his physician assistants to the reception and
telephone area to manage incoming calls, questions, and new
patients so that they are seen in the most efficient and logical
manner. In this way emergency patients can be cvaluated and
seen immediately, and other patients can be fitted into the
schedule as time and conditions allow.
Dr. Ross is of the opinion that his practice makes optimal
use of his time while giving his patients maximum attention
to their particular problems and concerns. He has not yet
extended his system to surgery but is seriously considering the
move.
DISCUSSION
Delegation of authority in the provision of patient
services allowsa practitioner to see more patients but
dilutes the individual patient’s contact with the physi-
cian. Balancing these opposing values has always been
a concern. The overriding concern in this regard must
always be whether the welfare of the individual patient
is being served by the particular practice arrangement in
question. The interests of the public in professional
services, on the other hand, are more global and center
on the competence, cost, and availability of the services.
Whether Dr. Ross® system of staged competence is an
advance in the provision of services or is ethically
questionable must be measured in terms of its effect on
patient care and expectations in both the individual case
and in the broader public sense.
Those aspects of ear, nose, and throat care within the
unique competence of the otolaryngologist may not be
delegated. But how do we identify those aspects that
require unique competence? There is no question that
Dr. Ross is ultimately responsible for the quality of the
care provided by his practice. Nor is there doubt that he
is uniquely qualified within that facility to determine
what is competent in terms of otolaryngic practice
because he is the only otolaryngologist aboard. We may
wonder whether it is within the acceptable practice of
otolaryngology to spend one’s time teaching, supervis-
ing, and checking on the quality of services, without
actually providing any of the services personally? This
managerial approach to medicine may be viewed as an
attempt to increase the output of the otolaryngologist
purely for monetary gain, or it may be seen as the most
efficient use of the otolaryngologist’s precious training
and talent. The ultimate test, again, is patient welfare
and acceptance.
If a patient leaving the. office has received services
from the “system” as good as those he or she would
have received had Dr. Ross provided them personally,
Otolaryngology ~
Seplomber 1996
access and cost might tip the balance of public opinion
in support of Dr. Ross’ approach. Any system that can
provide adequate services widely and inexpensively
will find broad acceptance among the public. The defi-
nition of “adequate,” of course, is the problem—and
probably a political one. Ultimately, the public will have
to decide, and will decide, what sort of medical care it
desires.
In brief, Dr. Ross may have breached the canons of
professional ethics if hé has delegated aspects of his care
that fall within the unique competence of the ear, nose,
and throat specialist, or if his manner of practice com-
promises the quality of service offered to the patient.
Judgment of the latter issue may depend on whose
perspective we take, that of the individual patient or that
of the public at large. Another ethical issue involves Dr.
Ross’ motivation for introducing ““staged competence.”
‘Was personal gain placed ahead of the patients’ best
interests? Dr. Ross must examine his motives for his
atypical behavior, and we must examine our motives in
questioning them.
The Case for Delegation
There is a saying in the Marine Corps, “You can
delegate authority, but you can’t delegate responsi-
bility.” With some modification and elaboration, this
statement is a fair summary of the ethical circum-
stances surrounding delegation of authority in a medi-
cal practice.
Delegation of authority is not only efficient but often
mandatory. It would be impossible for a single person
to perform all of the diagnostic and therapeutic tasks
required in the care of a patient, even if the physician
devoted the entire practice to the needs of one
individual. In the strictest sense delegation of authority
is implicit in the very information on which diagnostic
and therapeutic decisions are made because this in-
formation comes largely from outside the physician.
‘Whether one chooses to diagnose and treat on the basis
of traditional allopathic principles or on the basis of
new-age nuclear imaging, the patient is being managed
according to guidelines probably not original with the
physician. Nonetheless, the physician is still respon-
sible for picking and choosing among competing
theories, paradigms, and schools of thought for the
good of the patient. Another example is the physician
or surgeon who routinely uses drugs and devices, such
as stapes prostheses and tracheotomy tubes, which
would be almost impossible to manufacture within the
practice. In a sense manufacture of the drug or device
has been delegated to an outsider, but the physician

Otolaryngology -
Volume 115 Number 3
is still responsible for the choice of the producer and
the product.
Ona different scale are the daily problems ofa private
practice. Tt would be highly impractical for a busy
physician to answer every phone call, although one
could argue that the most competent person in a practice
should do the telephone triage. In addition to public
relations, the telephone receptionist performs an impor-
tant medical function; it is this person who generally
determines when and how the patient will be seen by the
physician, possibly affecting the outcome of the physi-
cian’s therapy. These considerations are obvious but are
50 common as to be almost invisible. Without doubt, the
phy: n delegates a great deal of authority to the
telephone receptionist, but the physician must be re-
sponsible for the actions of the agent.
Referrals to Outside Physicians and Laboratories
Any practice will have occasion to send patients and
specimens to a technician or laboratory for information
or services that cannot be provided on site. The physi-
cian in these instances is, in effect, delegating the
authority to perform the tasks necessary to obtain the
desired information or accomplish the requested ser-
vice. The outside laboratory or service no doubt has its
own professional and ethical obligations to the patient,
but the physician still carries the ongoing responsibility
for the referral and for the welfare of the patient.
When a physician refers the patient to a medical
consultant, the physician’s responsibility probably ends
with due diligence in the referral; the physician’s ex-
pertise cannot extend to all matters. On the other hand,
when the physician refers to a party not under personal
control whose competence is at a level below that of the
physician, responsibilities may shift. For example, a
physician may arrange for a patient from a distant town
to be seen by a local family practitioner or surgeon for
the limited purpose ofremoving sutures or packing after
an operation. If the service is competent and is the best,
or only, means of caring for the patient, there should be
little complaint. However, the referring physician still
bears responsibility—certainly for the decision to refer
and for the referral itself.
A Pragmatic View of the Medical Practice
It is possible to think of a medical practice as simply
a process for treating patients. Under the best of cir-
cumstances, persons with problems flow in one end of
the practice, and pleased persons flow out the other. We
can imagine the process as a “black box” without
considering what goes on inside. From the outside,
whether we are clients, patients, government, or third-
ETHICS COMMITIEE OF THE AAO-HNS 193
party payers, our concern is that the box provides the
service promised or expected, is readily available, and
has a reasonable cost. We do not care about the internal
machinery.
Obviously, nothing harmful or degrading can be done
to the patients as they flow through the box because, by
definition, the box would not be meeting its commit-
ment to provide the services we desire.
This model may be disturbing because it seems to
ignore much of what we have been taught is basic to the
practice of medicine, such as the laying on of hands,
doctor-patient relationship, compassion, confidentiality,
and so forth. The point is that the nature of the required
“product” determines the nature of the internal process.
What is the product that the public expects from the
medical profession? Will adequate care mean imper-
sonal delivery of technically competent services, or will
the public demand a personal relationship with a phy-
sician? The public will define “adequate care” politi-
cally or in the market, after weighing considerations of
competence, cost, and availability.
In the present atmosphere of a growing public de-
mand for more efficient health care, the black box
approach to practice may appear very attractive to the
public, provided the box can deliver the services prom-
ised and expeoted in a timely fashion and at an accept-
able cost.
An Assessment of the Super-tech Practice
It is possible to misread some of the above discussion
as an endorsement of Dr. Ross’ unorthodox style of
practice. Although his efficiencies and ideas are fasci-
nating, large questions remain. If medicine is simply the
delivery of technical expertise, it is likely that some
combination of computerized systems, operated by low-
wage technicians, could provide acceptable services at
an even lower cost than Dr. Ross can. A computer can
quote scripture infinitely more accurately than the most
dedicated priest. But most of us would agree that there
is more to being a priest than cracking wafers neatly and
quoting scripture. However, it would be a foolish priest
who did not make use of modern technology that would
allow more time for his or her pastoral work.
Medicine might similarly benefit if we physicians
delegated a larger part of our duties to technicians to
discharge our primary obligation, that of protecting the
interests of our patients. The danger, of course, is the
possibility of overemphasizing the technical aspects of
our profession at the expense of philosophic and moral
considerations. The temptation is great to neglect the
best interests of the individual patient while focusing on
the interests of the practice itself. When interests of the

194 ETHICS COMMITIEE OF THE AAO-HNS
practice supersede those of the patient, the practice
becomes indistinguishable from a business.
Businesses and Professions
Professions differ from businesses in several respects.
Professions are collectives of individuals who provide
services to the public under state regulations that ensure
the public will not be exploited when it is most vulner-
able. Businesses are private enterprises that exist pri-
marily to make a profit for the owners. Professionals
‘may make money and businesses may occasionally put
the customer first, but these are not the controlling goals.
‘When push comes to shove, a business must make
money, and a professional must put the interests of the
client (patient) above his or her own—by definition.
When Dr. Ross expands (o the point of using non-
professional employees to care for patients rather than
to help him respond to the patients’ needs, he is in effect
becoming the licensing agent for the providers of the
services. Licensing of medical practitioners has been a
state function and should be so until the state, and not
Dr. Ross, decides otherwise. What Dr. Ross is doing by
allowing lay technicians to treat patients under his
protocol and responsibility is substituting his evaluation
of employee competence for the licensing procedure
and exchanging his protocol for the standards of care
and curriculum of the profession, while putting himself
in the position of the collective profession itself.
Tt may be that in the future diagnosis and therapy can
be performed by persons making the minimum wage
using computerized protocols generated by a few highly
competent and ultimately responsible physicians serv-
ing as a board of editors for the protocol. That may even
be the best way to meet the requirements of competence,
access, and cost control that will be required. If the
practice of medicine is only the application of informa-
tion and technology to the diseases of people, then that
is likely the future of medicine, and Dr. Ross is leading
the parade to the future. However, if medicine is actually
a profession, an oath, to place the interests of the ill
above the self-interests of the practitioner, there will
always be a need for those to give disinterested advice
and comfort.
It is possible that the organization put together by Dr.
Ross will be able to care for the patients efficiently,
competently, and caringly. It is unlikely that any single
practitioner would provide the range and volume of
September 1996
services that such a practice could. There is a corre-
sponding concern that large practices require consistent
levels of income to.support the massive organization.
Some might worry that patients would be exploited to
meet overhead. However, such concerns are not unique
to large practices. Even solo practitioners may be
tempted by wealth, fame, or tenure. As is often true in
ethical questions, intent is more important than event or
content. A solo practitioner may be greedy and unethi-
cal, whereas a treatment factory may be operated in the
belief that such is the best way to ensure the best service
to the public. The public will decide.
A Look Toward the Future
Just as technologies in medicine may be expected to
expand and diversify over time, so too will practice
patterns transform themselves, ‘whether in response to
the desires and needs of individual patients or in re-
sponse to those of the public. Solo general practitioners
are now being replaced by multispecialty group prac-
tices. Even within specialties such as otolaryngology—
head and neck surgery, few practitioners still perform
the full spectrum of disciplines encompassed by the
specialty.
Delegation of authority, already inherent in our pro-
fession, will be used to a progressively greater extent,
both to prevent overloading the physician and to in-
crease the efficiency of the practice in order to meet the
cost requirements of the public, third-party payers, and
the government. These changes will inevitably reduce
the time and attention that a physician can give to a
patient. For some period into the future, a spectrum of
choices may be available to the patient: personal care
and attention from a patient-selected physician at one
extreme and impersonal technical delivery of standard-
ized therapy at the other. As in merchandising, the public
will have to choose and will have to pay for its choice.
Certainly, arrangements for health care delivery will
change in the future. What will not change is the fact that
as physicians and professionals, we hold our collective
privilege because we are perceived to have a collective
dedication to the welfare of our patients over our own
self-interests. It is not ensured that we can maintain our
privilege even though we have the public’s confidence
in our pledge, but it is certain that our privilege will
disappear once we lose that confidence.

Chapter 4: Research
owlaryngologists participate in many forms of re-
search, ranging from laboratory studies in animal mod-
els to human clinical trials of new otolaryngic drugs and
procedures. Even the practicing otolaryngologist who
denies active involvement in research has occasion to
evaluate emerging surgical techniques, new medica-
tions, and novel diagnostic methods as part of his or her
daily activities.
Although the design and scope of these research
projects may vary, they all share the common purpose
of contributing to the general body of scientific knowl-
edge, with the ultimate objective of better care for the
ear, nose, and throat patient. Benefits may also accrue to
the researcher and to the subjects of research studies.
ating patients are treated by the latest methods
and with the newest medications, often without charge.
The research otolaryngologist may gain by added ex-
perience, prestige in the scientific community, enhanced
career opportunities, and financial support in the form of
grants for further research.
Although few would argue against the potential ben-
efits and vital importance of research, serious problems
may be encountered in such pursuits, not because of
medical errors but because of a failure to understand
correlative issues unique to research. Formal otolaryn-
gic training rarely includes didactic instruction in re-
search methods or in related ethical concerns. This
chapter is designed to address the ethical issues that are
part of successful research.
Please consider these questions as you read the fol-
lowing case study:
* What are the similarities and differences between
conduct of research and performance of direct
patient care?
‘This material is based on The Ethical Ophthalmologist: A Primer, by
the Ethics Committee.of the American Academy of Ophthalmology,
Modified by David J. Terris, MD, from the original text of Susan H.
Day, MD.
Surgery, Inc., 1 Prince St., Alexandria, VA 22314,
23/1/74826
* How might the individual motives or concerns of
the patient, the junior researcher, and the senior
otolaryngologist influence the outcome of this
clinical trial? Could the design of the research
project be altered to reduce these biases?
« What impact might errors in the research program
have on patient care?
‘CASE STUDY
An elderly woman comes fo an otolaryngic clini
that the ringing in her ears can be improved. She
by a second-year resident. She was told elsewhere that she has
a moderately severe sensorineural hearing loss and that her
tinnitus was the result of this loss. The patient is cager to
undergo any treatment if it offers the hope of improving her
tinnitus.
The resident examines the patient and obtains an audio-
gram, which confirms the hearing loss and presumptive cause
of her tinnitus. Although aware that no recommended form of
treatment is available for this condition, the resident recalls a
recent presentation at which a senior otolaryngologist sug-
gested the use of a specific oral medication for such patients.
The resident contacts the otolaryngologist to obtain more
information.
The senior otolaryngologist has been very encouraged by
results obtained in several patients treated with the medication.
In fact, one of the patients was so pleased that, through her
business connections, she secured a mention of the treatment
in a local news release. The otolaryngologist delights in the
resident’s interest and offers the opportunity to participate in
the ongoing research project. The resident, who has already
begun pursuing a fellowship in otology, readily accepts the
offer.
The resident also learns that interest in the new treatment
has grown to the extent that the price of stock in the medi-
cation’s manufacturer has begun to rise. This information is
conveyed to a well-to-do friend who is in search of promising
financial investments.
The resident discusses what is known about the new treat-
ment with the patient, who enthusiastically volunteers to
participate in the research program. As a rescarch subject the
patient will now receive free medical care for her condition.
DISCUSSION OF THE CASE STUDY
This case illustrates a major force that drives many
research endeavors: the patient with a problem for
which present solutions are limited or nonexistent. One
could argue that the appropriate role of a supportive
195

otolaryngologist is to acknowledge the disease entity
and to help the patient deal realistically with the limi-
tations placed on her by the discase. Further assistance
could be offered in terms of tinnitus maskers, resources
for impaired persons, and education as to the natural
history of the specific disease process.
The researcher, on the other hand, is a bit of a dreamer
and is not content to accept the status quo, thinking and
hoping that amelioration or even a cure might be found.
Although commendable, optimism and cnthusiasm ex-
pressed by the resident in this case pose a potential
problem in the accurate evaluation of the proposed
treatment, particularly because the resident probably
lacks the skills to design and conduct a controlled study
of the oral medication. Without such skills, the resident
may disregard the clear biases of both the patient and the
investigators.
The understandable desire, and even desperation, of
the patient to regain any part of her lost hearing and
resolution of the tinnitus may result in a subjective
improvement after treatment with the experimental
medication, even though her measured auditory acuity
may not have changed. Because the resident noted a
hearing loss during the initial examination, it is even
possible that testing after treatment may appear to reveal
improved acuity. The free care provided to the patient
may also influence her subjective report of the outcome.
For peripheral reasons, the resident and senior oto-
laryngologist have vested interests in the success of the
experimental medication, interests which may influence
the accuracy of observations and the interpretation of
results. The otolaryngologist has already obtained “‘en-
couraging™ results in other patients, and publicity on
even one apparent success is a validation that is hard to
ignore, particularly if this practice has noticeably in-
creased in volume. The resident, of course, is eager to
please the senior otolaryngologist and senses that suc-
cess in this research project can do no harm to the
resident’s prospects in pursuit of a fellowship or other
career advancement. In addition, the resident may feel
a responsibility for the advice given to the friend inter-
ested in investments.
In brief, the outcome of the experimental treatment in
this case, successful or not, will be suspect because the
resident has failed to control for the biases of both the
patient and investigators and has disregarded the rigor-
ous requirements of a research study. A basic examina-
tion and simple audiogram are not sufficient observa-
tions for evaluation of the efficacy of the medication. If
improvement is observed, how did it develop and how
long will it persist? If the treatment fails, was the dosage
adequate, or was this particular patient uniquely refrac-
tory to the treatment?
Otolaryngology -
September 1996
Research studies are generally collaborative efforts
that require the expertise of various individuals in
diverse disciplines to design and conduct a meaningful
program and to evaluate results. In this instance, the
resident (and the senior otolaryngologist) erred in not
consulting with others in the clinic more experienced in
research before undertaking even a limited trial of the
experimental medication. Were this done, the resident,
no doubt, would have been advised to perform a more
intensive initial assessment of the patient’s status and to
schedule repeated examinations according to a specific,
predetermined protocol during and after the course of
treatment. Evaluations by two different physicians
would have been recommended to control for interob-
server variation. The patient would have been counseled
that the medication was experimental with only little
preliminary evidence to suggest that it might help; she
would have been informed of all possibilities including
the possibility that her condition might not improve.
Finally, the resident would have been advised to review
available information on safety of the medication and to
monitor the patient during treatment to reduce the risk
of adverse reactions.
For a truly meaningful evaluation of the medication,
multiple patients with sensorineural hearing loss and
tinnitus would have to be included in the study—half to
receive the experimental preparation and half to receive
a placebo, an inactive sugar pill, to control for both
patient and physician biases. Ideally, the study would be
double-blind, that is, neither the patient nor the exam-
ining otolaryngologist would know whether the patient
had received active medication.
These suggestions are technical considerations over-
looked in the treatment of the patient and in the evalu-
ation of the experimental medication. The greater error
was the failure of the resident to recognize and deal with
the ethical issues of the case. The resident confused a
responsibility for the welfare of the patient with con-
cerns for the advancement of science. The resident also
allowed personal interests and those of the senior oto-
laryngologist to threaten the validity of the study, thus
failing ethical obligations both to the patient and to
science.
The Scientific Process
The fundamental ethical issue in research is the
obligation to conduct an investigation competently and
accurately. Also required is the ability to approach the
question or problem at hand with the “innocence of a
little child,” as proposed by the biologist Thomas Henry
Huxley more than a century ago.' In reality, total free-
dom from bias is not possible because each of us carries

Otolaryngology —
Volume 115 Number 3
expectations that inevitably influence what we observe.
Nonetheless, such biases must be acknowledged and, to
the extent possible, excluded by means of the project’s
design.
The conclusions of an investigation may be defective
for any of several reasons, Despite the best cfforts,
errors may occur under certain circumstances and may
influence the outcome of a research project. When
recognized, acknowledgment of the error must be com-
municated promptly, openly, and completely.
Erroneous results as the consequence of fraud, on the
other hand, constitute the most serious and fundamental
“sin” against the scientific process. The consequences
of deliberate fabrication of data reach far beyond the
disruption of scientific progress in a particular area.
Negative judgments are inevitably made, which reflect
on all researchers and the scientific process. Within
medical fields, fraud also carries the potential for dam-
age to patients if treatment is rendered as the conse-
quence of fraudulent research.
Communication and Reporting
Another ethical issue associated with research relates
to communication, both in the initiation of research
projects and in the reporting of results on conclusion of
the investigations. Although virtually every researcher
readily acknowledges the importance of an open ex-
change of information, fewer, no doubt, are aware of the
ethical concerns regarding the manner, timing, and tar-
gets of scientific communication. An example of these
concerns is the customary obligation of researchers to
communicate the details of a proposed project to gov-
ernmental and/or institutional bodies before the study
may even begin. Moreover, the obligation may pertain
even when these groups are not the responsible funding
agencies. Studies involving laboratory animals or hu-
man patients are generally subject to the scrutiny of
review boards to confirm the soundness of the experi-
mental design and the validity of the research objective,
as well as (o protect the interests of the human or animal
subjects. For human patients a special signed informed-
consent statement is required to ensure that the subject
fully understands the experimental nature and attendant
risks of the medical procedures to be performed.
On conclusion of an investigation, the researcher
bears an ethical responsibility to report the data and
results within appropriate avenues of communication.
Although the temptation to contact the public media
directly when promising preliminary results are present,
the more correct and responsible approach is to present
such information at recognized meetings of peers or (o
publish the results in a scientific journal refereed by
other knowledgeable investigators in the field. By fol-
lowing this peer-review process, the researcher main-
tains his or her own identity as the originator of the
information or idea, yet effectively protects the public
from misuse of the material and avoids promulgation of
flawed data and conclusions within the scientific com-
munity.
Conflict of Interest
Researchers must be continually alert to the inevi-
table pressure generated when a financial benefit may
result as a consequence of the outcome of a given
experiment or study. The promise of potential monetary
rewards may influence the strongest of wills and purest
of minds in the objective conduct of research. The
obvious solution, of course, is for the researcher to
withdraw from participation in any project in which
personal financial gain is a possibility, but such a simple
choice is not always possible. Remuneration may not be
an issue at the inception of a project, and subsequent
withdrawal could be a disservice to the team involved
in the research effort. In such instances, the researcher
should communicate openly with colleagues and sub-
jects in the study regarding the potential conflict of
interest, so that they may assist in avoiding bias.
Contlicts of interest do not arise solely out of the
possibility of financial rewards. Results of experiments
that appear to contradict earlier promising findings can
be difficult for a researcher to accept, particularly if the
initial reports were received with acclaim from the
scientific community. In such cases, the researcher
should seek the assistance of colleagues with no vested
interest in the results for a repetition of the studies to
obtain a definitive explanation of the discrepancy.
Allocation of Credit
“Giving credit where credit is due” is a critical
maxim in research and an issue that tests the ethical
sensibilities of most researchers at one time or another.”
Apart from simple faimess, appropriate credit for con-
tributions to a research project may be linked to ap-
pointments and job security. The problem becomes even
more complex when an investigation involves multiple
disciplines, which is often the case. Rarely does a single
dividual generate all of the ideas that underlie the
initiation and performance of a research study.
One of the most common sources of negative feelings
is the simple act of listing coauthors on reports of
investigations: Whose name should come first? Who
should be included? How much work is necessary to
ensure inclusion? Should the order be based on position
irrespective of the extent of participation in the project,
that is, department head, senior attending physician,
fellow, resident, PhD, nurses, and so forth?

There is no simple answer to this problem, but frank
discussion among the contributors is essential because
each author often has his or her own perspective on
relative contributions. Helpful, too, is the fact that often
more than one publication results from a research
project, and it is possible to alter the sequence of authors
among the different reports, depending on their specific
content and audience.
PATIENT CARE AND RESEARCH
Ethics of Research on Human Subjects
The purpose of otolaryngologic research is to prevent
the onset of disease of the upper aerodigestive tract, to
improve treatment methods, and to gain a better under-
standing of the function of the head and neck. Each of
these goals implies a gap in our knowledge that remains
to be filled. Thus patients participating in a research
study are treated by physicians who acknowledge that
the optimal form of treatment is still unknown. Some
would argue that this practice is in itself unethical
because the treatment may not benefit the patient.
The fact, of course, is that there is no optimal form of
treatment for every patient, and there is no guarantee
that every treatment or procedure will produce a suc-
cessful result. In this sense, an element of experimen-
tation is implicit in the treatment of every patient. For
this reason, even with treatment by recommended pro-
cedures and with known safe and effective medications,
the prudent physician monitors the patient and is pre-
pared with backup alternative measures in case of
failure or untoward incidents.
The same approach is applicable in research studies,
but here the requirements for protection of participating
patients are more rigorous than those for treatment by
recommended methods in the clinic. In the case of
medications, laboratory studies and animal testing pre-
cede any investigation in human beings to obtain a
preliminary measure of activity and safety.’ Studies in
normal human volunteers generally follow to confirm
safety and activity. Only then is the experimental prepa-
ration tested in patients to determine its efficacy and
safety in the treatment of a specific condition.
Initial clinical trials often compare experimental
preparations with the currently recommended treatment,
and the study is generally *“open-label,” that is, both the
physician and patient know which treatment is being
used. If after an appropriate period, response to the
experimental medication is not equivalent or superior to
the standard preparation, the study is terminated, and the
patient is switched to the standard treatment. In placebo-
controlled, double-blind studies, where neither the phy-
sician nor the patient knows whether active drug is being
used, the study may be interrupted and the code broken
Otolaryngology -
September 1996
if patients fail to show positive responses. Nonrespond-
ing patients who are found to have received placebo
immediately begin receiving treatment with the experi-
mental or recommended medication.
Both for the validity of the study and for the protec-
tion of participating subjects, an intensive and compre-
hensive workup is required on each patient before
commencement of treatment. Thereafter, throughout
and after the study, careful monitoring is used to deter-
mine response to treatment and to detect any adverse
events.
In reference to the ethics of clinical trials, Friedman
et al.* take the view that *. . . properly designed and
conducted clinical trials are ethical. A well-designed
trial can answer important public health questions with-
out impairing the welfare of individuals. There may, at
times, be conflicts between a physician’s perception of
what is good for his patient, and the needs of the trial.
In such instances, the needs of the subject must pre-
dominate.™
Informed Consent
Participation in a research project requires the patient
to sign a special informed-consent statement. The pur-
pose of the document, which is based on principles
established as the result of the Nuremberg trials after
‘World War 11, is to ensure that the subject understands
fully the purpose of the study, the medical procedures to
be performed, and their attendant risks.
In many instances, the consent form will even de-
scribe in great detail concerns relating to medications or
procedures that are part of a “routine” head and neck
examination.
Another purpose of the statement is to confirm that
the patient has volunteered to participate freely and
without coercion and that the patient is aware that he or
she may elect at any time during the course of the
experiment to withdraw from further participation. If the
treatments are to be randomized or administered in a
double-blind manner, the patient must understand the
purpose of the experimental design. Finally, any finan-
cial interests of the investigators must be disclosed.
Who Pays?
Funding of research projects is provided by a variety
of government, public, and private sources. When fed-
eral and institutional funds are involved, research pro-
tocols and personnel commonly undergo careful peer
review before support is granted. Thereafter, the inves-
tigator is generally permitted to pursue the research
without interference, so long as the performance is in
accord with the protocols that have been agreed upon.
Similar procedures may be followed when commer-

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