Informed Consent and Informed Refusal in Dentistry

By DIANNE GLASSCOE WATTERSON, RDH, BS, MBA

Dental professionals know the importance of mitigating liability through good

recordkeeping, good communication, and providing only the most excellent care.
However, some offices fall short in the area of consent. In our increasingly litigious
society, understanding and implementing informed consent is more important than ever.

What is informed consent?

Informed consent is a process whereby a patient voluntarily agrees to proposed treatment after a
discussion of advantages, disadvantages, risks, and alternatives. All states require that patients
provide informed consent before dental treatment is commenced.

The concept of informed consent evolved from battery, which is the unauthorized touching of
another person. A landmark case from New York in 1914 laid the foundation for informed
consent, stating: Every human being of adult years and sound mind has a right to determine
what shall be done with his own body; a surgeon who performs an operation without his patients
consent commits an assault, for which he is liable in damages. (Schoendorff vs. Society of NY
Hospital; 211 N.Y. 215; 1914)

Before informed consent became a standard part of the information process, patients could be
subjected to treatments of a medical or dental nature to which they did not give permission.
Many legal cases exist where patients were subjected to various forms of treatment that resulted
in damaging, disfiguring, or otherwise detrimental outcomes, all without the patients
permission.

The informed consent discussion

The purpose of informed consent is to assure that the patient has a full understanding of proposed
treatment and can make a relevant health-care decision based on the information provided by the
health-care professional. Many health-care professionals see the process as burdensome and
time-consuming. However, according to the CNA HealthPro Risk Management Program, The
informed consent discussion represents the first step in managing the patients expectations for
treatment outcomes and reducing the possibility of a misunderstanding. Patients are less likely
to file a lawsuit if they are fully informed about risks and possible outcomes.

There are several components of the informed consent discussion. They are:

1. The nature of the proposed treatment, including necessity, prognosis, time element, and cost.
2. Viable alternatives to the proposed treatment, including what a specialist might offer or the
choice of no treatment.
3. What are the foreseeable risks, including things likely to occur and risks of no treatment?

When obtaining informed consent, the dental professional should:

1. Use language that is easily understandable.

2. Provide opportunities for patient questions, such as What more would you like to
know? or What are your concerns?

3. Assess patient understanding by stating, If I have not explained the proposed dentistry
clearly or if you have difficulty understanding, please tell me so we can discuss anything
you do not understand.

Types of informed consent

Informed consent can be written, recorded, or verbal. Since informed consent is a process, it
requires a verbal discussion regardless of whether there is a written form involved. Some states
require written consent forms for certain procedures, such as surgical or endodontic procedures.
Most risk management companies recommend written consent forms for extensive dental
procedures, such as full-mouth reconstructions.

The consent to treat a minor (unless emancipated) must be signed by the parent or legal guardian.
A dentist may choose to use a blanket consent form that grants permission for the dentist or
hygienist to provide restorative and preventive care for any and all dental conditions presented
by my child as a patient in the practice. All written consent forms (see Table 1)should be dated
and signed by the patient (or guardian/parent for minors), dentist, and a witness (usually another
staff member).

If the practice is using digital records only, there are two ways to obtain the patients (or
guardians) signature for the patient record. One way is to use a signature pad, which is a device
that allows the patients signature to be transferred digitally into the record. The other way is for
a hard copy document to be signed by the patient, and then that document is scanned into the
patient record.

If a written consent document is not used, the patients verbal consent should be documented in
the patient chart. Here is an example of documentation of verbal consent: Discussed the
diagnosis of ______; purpose, description, benefits, and risks of the proposed treatment;
alternative treatment options; the prognosis of no treatment; and costs. The patient asked
questions and demonstrates that he understands all information presented during the discussion.
Informed consent was obtained for the attached treatment plan.

Oral consents may be satisfactory for routine procedures that you expect the patient to know
about, such as a dental examination. Most risk management professionals recommend using
written consent documents for all treatment procedures that are invasive or present a high risk.

There is another concept called implied consent. A patient may imply consent by his actions.
For example, a patient presents with a toothache, is examined, and is informed radiographs are
needed. The patient allows the radiographs to be taken without any objections. In this case,
consent is implied by the actions or nonactions of the patient. The key elements are that the
patient was aware of the problem and made no objection when the treatment began.

Implied consent is also applicable during emergencies. During a true emergency, a health-care
provider can render services without the consent of the patient. Most courts classify an
emergency as a situation when care must be rendered at once to protect the life or health of the
patient. At such times, consent is implied by law. There are two test questions that the courts
apply:

1. Would consent have been given if the patient was able to grant consent

2. Would a reasonable person in the same situation have granted consent? Good Samaritan laws
exist in all states and imply consent to treat at the scene in emergency situations.

Another form of consent that is acceptable is telephone consent. However, to be valid, it has to
contain all the elements that constitute a valid consent and should be properly documented. For
example, if a neighbor or friend brings a minor to his dental appointment, the parent or guardian
should be contacted by phone and told that a third party is listening on an extension. The parent
should be told of needed treatment, including all the information that would be required for a
valid consent. The consent discussion should be documented in the patient chart and signed by
the one who obtained the consent and countersigned by the listening third party. Then a follow-
up letter should be sent to the parent/guardian that contains all the information related to the
dental care and the parents response.

Some informed consent documents contain language that attempts to hold the provider harmless
in the event the procedure does not go well. Such stated policies are called exculpatory terms
and have been deemed invalid in many court cases. Burton Pollack, DDS, JD, discusses
exculpatory statements in his book titled Law and Risk Management in Dental Practice
(Quintessence, 2002) and gives the following example: I accept this treatment with the
understanding that I will hold the doctor harmless for any negligence in the performance of the
treatment. Pollack posits that while people are able to bargain away their rights in dealing with
merchants, they cannot do so with health-care providers, as both parties are not in equal
bargaining position. Expressed differently, the statement is actually saying, Either you agree not
to sue me should I be guilty of negligence and you are injured as a result of my negligence, or I
will not provide the services you need.

Limitations of informed consent

It is important to understand that a properly executed informed consent does not protect against
claims of malpractice. If a patient feels she has been treated negligently, she must prove the four
elements of malpractice, which are:

1. The duty of the health-care provider to provide competent care.

2. There was a breach of the duty to provide competent care.
3. An injury occurred.
4. Her injury was a direct result of breach of the standard of care (called proximate cause).

Courts have held that informed consent is irrelevant on the question of malpractice.

Informed refusal
Informed refusal is a persons right to refuse all or a portion of the proposed treatment after the
recommended treatment, alternate treatment options, and the likely consequences of declining
treatment have been explained in language the patient understands. A patient who refuses to
follow the recommendations of the dental provider must be advised of the consequences of the
refusal. This is a hot topic today, given the trying economic times that many are facing with loss
of employment and benefits, including dental benefits. It is recommended to have a patient sign a
Refusal of Treatment form if he or she declines the treatment recommendation (see Table 2). If
a patient is referred to see a specialist and refuses the referral, the clinician should document the
refusal thoroughly in the patient chart and have the patient sign the chart or a separate form.

Patients have many reasons for declining a recommended treatment, such as inconvenience, fear,
denial, or inability to pay for services. If a disease condition is diagnosed and the patient refuses
treatment, the doctor may decide to dismiss the patient from the practice. That is the doctors
decision. Depending upon the circumstances, a doctor may not feel it is appropriate to dismiss
the patient and may choose to provide alternate treatment (as opposed to ideal) for the short term.
As long as the patient understands the ramifications of postponing treatment and the goals of
alternate treatment, liability risks are minimized. Sometimes, however, the best option is patient
dismissal. Thorough documentation cannot be overemphasized. Case decisions must be made on
a patient-by-patient basis.

A case in point could be a patient with a broken tooth. The diagnosis is tooth fracture, and the
doctor recommends restoration with a crown. After discussing the cost, the patient asks for other
less costly options. An alternate treatment could be a large composite restoration for the short
term. The patient is fully informed of the advantages, disadvantages, risks, and alternatives, and
opts for the composite restoration. The patient made an informed decision. Two months later, the
restoration fails. Is the doctor liable for malpractice? The answer is no, unless the patient can
satisfy all four elements of malpractice.

Conclusion

Informed consent is a communication process, not necessarily a document. According to experts

on malpractice litigation, keeping the lines of communication open with the patient is a vital
component in avoiding lawsuits. Studies demonstrate that patients who believe they have been
well informed regarding their condition and who have had their questions answered by members
of the dental team are more compliant with treatment recommendations. All clinicians should
view the informed consent process as an educational experience with the patient to discuss
needed treatment advantages, disadvantages, risks, and alternatives, and ensure such discussions
are well documented in the patient record. RDH
Table 1

Informed Consent Periodontal Scaling and Root Planing

I___________________________, have received information about the proposed treatment. I
have discussed my treatment with Dr.________________________ I understand that I have
periodontal (gum and/or bone) disease. The disease process has been explained to me and I
understand that it is caused by bacterial toxins (poisons) and my host response to these toxins. I
realize that this disease may be painless and without symptoms, but that usually symptoms such
as bleeding, swelling, or recession of gum tissue, loosened teeth, elongated teeth, bad breath, or
sensitivity and soreness may be noticed. Treatment of periodontal disease may include
periodontal scaling and root planing, either as a therapeutic procedure or preliminary to more
extensive treatment.

Periodontal scaling and root planing involves the removal of calculus, bacterial plaque, bacterial
toxins, diseased cementum (the outer covering of the root surface), and diseased tissue from the
inner lining of the crevice surrounding the teeth. The purpose of this procedure is to reduce some
of the causes of periodontal disease to a level more manageable by my individual immune
system. I understand that my own efforts with home care are just as important as my professional
treatment.

Consequences of doing nothing about my periodontal condition may be, but are not limited to:

Increased recession of gum tissue and exposure of root surfaces

Increased sensitivity to hot, cold, or sweets; this may require further treatment, may fade
with time, or may persist no matter what is done

Increasing tooth mobility (loose teeth)

Food may collect between teeth

Continued infection of the gums and other supporting structures

Loss of teeth

Spread of infection to other sites in the body

I understand the recommended treatment, the risks of such treatment, and any alternative
treatment and risks have been explained to me. I understand the fee(s) involved in the treatment
as well as consequences of doing nothing.

I give permission for the use of local anesthetic and any anxiolytic and/or sedative medications
that may become necessary. The possible side effects of local anesthetics are prolonged or
permanent numbness of the lips, cheeks, or gums, rapid heart rate, allergic reactions, and
reactions with other drugs that I am taking.

If there are any problems, contact the dental office immediately.

Patient Signature _______________________________ Date _________

Hygienist or Doctor Signature ______________________ Date __________

Witness Signature _____________________________ Date __________

Table 2

Following is a sample form for the refusal of treatment for periodontal disease:

REFUSAL OF TREATMENT

Date _______________________

Patient Name ___________________________________

Treatment Recommended:

A diagnosis of periodontal disease has been presented to me on this date. The disease process and
possible ramifications for non treatment have been explained to me, and I understand the
consequences of not allowing this office to proceed with appropriate treatment.

Patient Signature _________________________________

Hygienist and/ or Doctor Signature __________________

Witness Signature _____________________________

Source : http://www.rdhmag.com/articles/print/volume-32/issue-9/features/informed-consent-and-
informed-refusal.html
 RESUME

Informed Consent

Informed consent adalah suatu proses dimana pasien secara sukarela setuju untuk
pengobatan yang diusulkan setelah diskusi tentang keuntungan, kerugian , risiko , dan alternatif.
Sebelum informed consent menjadi bagian standar dari proses informasi , pasien dapat
mengalami perlakuan yang bersifat medis yang mereka tidak memberikan izin . Banyak kasus
hukum ada di mana pasien mengalami berbagai bentuk pengobatan yang mengakibatkan
merugikan, merusak , menodai , atau sebaliknya , semua tanpa izin pasien. Tujuan informed
consent adalah untuk memastikan bahwa pasien memiliki pemahaman penuh pengobatan yang
diusulkan dan dapat membuat keputusan perawatan kesehatan yang relevan berdasarkan
informasi yang diberikan oleh profesional kesehatan. Informed consent dapat ditulis , direkam ,
atau verbal. Karena informed consent adalah suatu proses, memerlukan diskusi verbal terlepas
dari apakah ada bentuk tertulis yang terlibat.

Seperti yang terlihat contoh pada tabel 1 yaitu informed consent terdiri dari pernyatan
bahwa pasien mengerti penyait apa yang yang dia alami, penyebab yang mendasari penyakit
tersebut, akibat yang mungkin timbul dari penyakit tersebut, konsekuensi bila tidak dilakukan
pengobatan, mengerti pengobatan apa yang akan diberikan kepadanya kemudian memberikan
pernyataan bahwa dia menyetujui tindakan yang akan dilakukan kepadanya oleh dokter.
Kemudian informed consent berisi data pasien dan data dokter kemudian ditandatangani oleh
kedua belah pihak.

Informed penolakan

Informed penolakan adalah hak seseorang untuk menolak semua atau bagian dari suatu
pengobatan yang diusulkan setelah pengobatan yang dianjurkan , pilihan pengobatan alternatif ,
dan kemungkinan konsekuensi dari pengobatan menurun telah dijelaskan dalam bahasa pasien
mengerti . Seorang pasien yang menolak untuk mengikuti rekomendasi dari penyedia gigi harus
diberitahu tentang konsekuensi dari penolakan tersebut . Pasien memiliki banyak alasan untuk
menolak pengobatan direkomendasikan , seperti ketidaknyamanan , ketakutan , penolakan , atau
ketidakmampuan untuk membayar jasa .
 Jika kondisi penyakit didiagnosis dan pasien menolak pengobatan , dokter mungkin
memutuskan untuk mengabaikan pasien dari praktek . Tergantung pada keadaan , dokter
mungkin tidak merasa adalah tepat untuk mengabaikan pasien dan dapat memilih untuk
memberikan pengobatan alternatif ( sebagai lawan ideal) untuk jangka pendek . Selama pasien
mengerti konsekuensi dari menunda pengobatan dan tujuan pengobatan alternatif , risiko
kewajiban diminimalkan . Dokumentasi menyeluruh tidak bisa terlalu ditekankan. Keputusan
kasus harus dilakukan oleh pasien.

Contoh kasusnya bisa menjadi pasien dengan gigi patah pada table 2 . Diagnosis adalah
fraktur gigi , dan dokter menganjurkan restorasi dengan mahkota . Setelah membahas biaya ,
pasien meminta untuk pilihan lebih murah lainnya . Pengobatan alternatif bisa menjadi restorasi
komposit besar untuk jangka pendek . Pasien sepenuhnya diberitahu tentang keuntungan,
kerugian , risiko , dan alternatif , dan memilih untuk restorasi komposit . pada tabel 2 terdapat
data pasien dan dokter kemudian tanda tangan kedua belah pihak yang menyatakan bahwa pasien
menolak untuk diberikan terapi. Pasien membuat keputusan.