Consent

Task Force on Pediatric Research, Informed Consent, and Medical Ethics

414 PEDIATRICS Vol. 57 No. 3 March 1976

Consent

Rowine H. Brown, M.D., author for the Task Force

A long-established legal principle holds that a person has a right not to have his body touched by another. If a physician touches any part of the patient’s body with or without instruments during treatment-without authority-he may have com-mitted assault and battery for which he may be prosecuted criminally or sued for damages in a civil action. Court decisions to this effect go back beyond the present century. Historically, the law has always required that the physician obtain consent of the patient for treatment. Further-more, inasmuch as all medical procedures may be accompanied by risks, the law has always

required specific consent by the patient to all

operative procedures. The greater the potential risk, the greater the duty of the physician to inform the patient concerning them, so the patient can decide which risks he wants to assume. The patient makes the final decision about whether to take a chance with the treat-ment or operation recommended by the physician or risk the consequences.

Generalities concerning consent are difficult to define when the involved patients are infants or minors, who may be incompetent and are not

legally empowered, without guardian consent, to

make serious decisions regarding their bodies. In such instances, the parent, next of kin, or guardian is legally required to give consent. The physician should also be aware of the ever-increasing numbers of state statutes which empower some

classes of minors-or minors in some specific situations-to give their consent.

INFORMED CONSENT

One rapidly changing and expanding law which is currently inflicting a massive impact on medical professional liability is informed consent. Approximately ten years ago, the Supreme Court of the State of Kansas in one of its opinions coined the phrase “informed consent,” which is a facet of the newly discovered basic human right termed “the right to know. “ The patient must now be given an opportunity to be informed of matters which are relevant to the care he is about to receive. This means explanation of risks, alterna-tive procedures, and other related matters, including the benefits to be derived and the

hazards to be endured if the patient refuses to

undergo the recommended treatment. The

pedi-atrician now has a duty to explain to patients and parents the nature and risks of procedures which

he feels are essential to the health and welfare of the child. He should make an entry on the medical record that such an explanation was made, and how the child (if old enough to

understand) and the parent responded.

Informed consent is a rule of law which adds another legal burden to the practice of medicine and as such results in more exposure to liability.

Because the doctrine of informed consent is of

recent origin, guidelines have not yet been devel-oped by court decisions or by statute; but, they are slowly evolving and should be reported in medical media.

Recommendations for the “protection of

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AMERICAN

ACADEMY

OF PEDIATRICS

human subjects” are being considered by the Department of Health, Education, and Welfare. Its proposed guidelines recommend that no research be conducted without informed consent, and that consent committees be established to monitor this requirement.

Consent forms have been developed and are in use in many private offices and hospitals. When a multitude of specific forms have been devised, searching for the correct form and getting it properly signed and witnessed become burden-some and outside the realistic function of the physician. Regardless of any inconvenience or annoyance, the correct consent must be obtained. Titling a form “informed consent form” and having it signed and even witnessed, does not always indicate to the judge and/or jury that “informed consent” was actually obtained. Signa-lures on such a document may carry little legal weight when the significance of the document is challenged in court. Therefore, a dated entry on the medical record is good defensive evidence.

MINORS

As a general rule, treatment of a minor requires the consent of the parent or guardian, except in an emergency when immediate treatment is imperative and delay would involve serious risk to the life or limb of the patient. In such an

emergency situation, a minor may usually give his

own consent. The rule of thumb in applying for parental consent is the feasibility of obtaining such consent, weighed against the necessity of urgent treatment for the child. The physician is the sole judge of this. Documentation about the state of the emergency must be available; and the physician should enter appropriate justification for his decision on the medical record. A concur-ring opinion by a second physician would be beneficial.

Minors in need of treatment who are married, pregnant, or emancipated (which here means living on their own) may give valid consent for their medical or surgical care under some

statutes. These minors may also consent to treat-ment for their children.

Some courts have held that a minor’s consent is sufficient if he is mature enough to understand the full significance of the contemplated treat-ment. Age is not always a true criterion of

maturity or intelligence. There seems to be no sound justification for denying a minor who is

mature enough to comprehend the nature and consequences of the procedure the right to accept or reject treatment. Court rulings have permitted

minors of mature judgment to give their consent

to therapy, even for nonemergency conditions including “nose-bobbing” and removal of

disfig-uring lesions (such as those of Von

Recklinghaus-en’s disease).

STATUTORY LAW REGARDING MINORS

In recent years many statutes have been enacted in which the rights of minors to treat-ment on their consent have been specified. This trend will probably continue. For example, the legislatures in 25 states have enacted specific

statutes which permit minors over the age of 12 years to give their consent for treatment of venereal disease and/or drug abuse. Notification to their parents is not required. By statutory

provisions, at least 40 other states now permit medical examination and medical treatment of “certain categories of minors without parental consent.” In addition, 11 states have broadened the rights of minors and allow them to give consent to obtain contraceptive services and devices, without parental consent. Many court decisions have held that unmarried, “unemanci-pated” minors may obtain abortions without parental consent. These last-mentioned court decisions and statutes demonstrate the judicial and legislative trends toward freeing under-standing minors to obtain medical assistance on their own and allowing physicians to provide

assistance without fear of a possible malpractice

action because of lack of consent. These court rulings and legislative acts also demonstrate the

flexibility of the law makers when there is a specific goal, such as eradication of venereal disease or drug abuse.

Considering the diversity of statutory law in the various states, the paucity of appellate and supreme court decisions, and rapidly evolving local changes, a reasonable safeguard for physi-cians in all elective cases would be to get the written consent to surgery or treatment from any minor 13 years of age or older in addition to that of the parent.

It has been suggested that consent to research

procedures should be obtained from all children

over the age of 7 years (the earliest age the law considers that a child could form a specific intent). It is also wise to include a provision that the procedure will be verbally explained to the minor and his wishes respected. His consent form

may assure the parent that a study not specifi-cally essential to the child will be discontinued if the child exhibits fear or resistance.

No reported legal cases indicate that consent of

both parents is required prior to treating a minor. If a controversy exists between the parents

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416 CONSENT

tive to the treatment, the physician should attempt to secure the consent of both. When the parents are separated or divorced, the physician should obtain the consent of the parent with the legal custody, or one in loco parentis (acting as

parent).

CONCLUSION

Consent must be obtained prior to the institu-tion of medical or surgical treatment. Pediatri-cians should keep informed concerning court decisions and statutes relative to consent and minors.

TASK FORCE ON PEDIATRIC RESEARCH, INFORMED

CONSENT AND MEDICAL ETHICS

HORACE L. HODE5, M.D., Chairman

(1974-1975)

VICTOR C. VAUGHAN, III, M.D., Chairman

(1975-1976)

CHARLES A. ALFORD, JR., M.D.

ROWINE HAYES BROWN, M.D.

MALCOLM A. HOLLIDAY, M.D.

(1974-1975)

AvRUM L. KATCHER, M.D.

CALVIN C.

J.

DAVID SPARLING, M.D.

(1974-1975)

Consultants

LEWIS A. BARNESS, M.D. L. STANLEY JAMES, M.D.

SAMUEL L. KATZ, M.D.

SUMNER

J.

Liaison Representative

NORMAN KRETCHMER, M.D.

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1976;57;414

Pediatrics

Kretchmer

Lewis A. Barness, L. Stanley James, Samuel L. Katz, Sumner J. Yaffe and Norman

Hayes Brown, Malcolm A. Holliday, Avrum L. Katcher, Calvin C. J. Sia, David Sparling,

Rowine H. Brown, Horace L. Hodes, Victor C. Vaughan III, Charles A. Alford, Jr., Rowine

Consent

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1976;57;414

Pediatrics

Kretchmer

Lewis A. Barness, L. Stanley James, Samuel L. Katz, Sumner J. Yaffe and Norman

Hayes Brown, Malcolm A. Holliday, Avrum L. Katcher, Calvin C. J. Sia, David Sparling,

Rowine H. Brown, Horace L. Hodes, Victor C. Vaughan III, Charles A. Alford, Jr., Rowine

Consent

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