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


                                                  Consent

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




    A long-established              legal principle             holds     that a                                      INFORMED                CONSENT
person     has a right not to have his body touched                             by
another.        If a physician            touches        any part         of the                            One       rapidly        changing             and      expanding            law
patient’s      body with or without                 instruments          during                         which      is currently         inflicting         a massive         impact       on
treatment-without                authority-he              may have com-                                medical       professional          liability       is informed         consent.
mitted      assault      and battery            for which         he may be                             Approximately             ten years ago, the Supreme                        Court
prosecuted          criminally         or sued         for damages           in a                       of the State of Kansas                in one of its opinions               coined
civil action.        Court     decisions         to this effect        go back                          the phrase        “informed           consent,”        which       is a facet of
beyond       the present         century.         Historically,        the law                          the newly          discovered           basic      human        right     termed
has always           required        that       the physician            obtain                         “the right         to know.            “The patient           must       now be
consent        of the patient              for treatment.             Further-                          given     an opportunity                to be informed              of matters
more, inasmuch             as all medical           procedures          may be                          which       are relevant            to the care             he is about            to
accompanied              by     risks,        the      law      has      always                         receive.      This means           explanation            of risks, alterna-
required           specific       consent          by      the      patient           to    all         tive     procedures,             and        other       related         matters,
operative         procedures.        The greater          the potential                                 including         the benefits             to be derived               and       the
risk, the greater             the duty        of the physician             to                           hazards        to    be      endured               if    the       patient        refuses           to
inform        the     patient       concerning          them,       so the                              undergo        the        recommended                      treatment.             The       pedi-
patient        can     decide       which       risks     he wants         to                           atrician      now         has a duty           to explain                to patients          and
assume.         The     patient      makes        the    final    decision                              parents       the     nature          and      risks           of procedures            which
about     whether         to take a chance             with    the treat-                               he feels are essential      to the health     and welfare                                       of
ment or operation              recommended            by the physician                                  the child.     He should         make      an entry      on                                   the
or risk the consequences.                                                                               medical    record     that    such    an explanation                                          was
    Generalities         concerning        consent      are difficult      to                           made,    and    how     the    child    (if old     enough                                      to
define    when        the involved         patients      are infants       or                           understand)            and      the        parent          responded.
minors,       who       may be incompetent                  and are not                                    Informed      consent   is a rule of law                                     which      adds
legally     empowered,               without            guardian           consent,          to         another     legal burden    to the practice                                    of medicine
make serious         decisions       regarding                    their bodies.        In               and as such results      in more    exposure                                    to liability.
such instances,        the parent,        next of                 kin, or guardian                      Because        the        doctrine            of        informed             consent         is of
is legally    required       to give consent.                        The physician                      recent   origin,    guidelines       have not yet been devel-
should     also      be aware           of the                     ever-increasing                      oped by court         decisions       or by statute;       but, they
numbers      of state       statutes      which                   empower          some                 are slowly       evolving       and should      be reported         in
classes       of      minors-or              minors          in     some         specific               medical     media.
situations-to             give     their      consent.                                                      Recommendations               for    the    “protection         of



414                PEDIATRICS              Vol.    57 No.          3 March        1976
human         subjects”          are being            considered             by the          to therapy,           even    for nonemergency     conditions
Department              of Health,          Education,          and Welfare.                 including         “nose-bobbing”       and removal   of disfig-
Its proposed               guidelines           recommend                 that       no      uring     lesions      (such as those of Von Recklinghaus-
research       be conducted               without       informed           consent,          en’s        disease).
and that          consent        committees             be established                to
monitor        this requirement.                                                                               STATUTORY                      LAW       REGARDING              MINORS
    Consent         forms have been developed                         and are in                  In recent            years        many         statutes          have        been
use in many private                  offices and hospitals.                 When         a   enacted         in which           the rights         of minors            to treat-
multitude          of specific           forms      have      been         devised,          ment      on their          consent        have been            specified.         This
searching          for the correct                form       and      getting          it    trend       will probably              continue.         For example,                the
properly         signed       and witnessed               become           burden-           legislatures            in 25 states            have       enacted           specific
some       and outside             the realistic           function           of the         statutes       which        permit        minors        over the age of 12
physician.          Regardless            of any inconvenience                        or     years       to give          their       consent         for treatment                 of
annoyance,           the correct          consent        must be obtained.                   venereal         disease       and/or        drug abuse.             Notification
Titling       a form          “informed             consent        form”           and       to their          parents        is not required.                  By statutory
having       it signed          and even           witnessed,            does       not      provisions,           at least        40 other         states        now      permit
always       indicate         to the judge               and/or         jury      that       medical         examination              and medical               treatment           of
“informed          consent”          was actually          obtained.           Signa-        “certain          categories          of minors           without           parental
lures on such a document                         may carry           little      legal       consent.”           In addition,           11 states        have        broadened
weight       when        the significance             of the document                   is   the rights            of minors           and      allow         them        to give
challenged           in court.        Therefore,          a dated         entry      on      consent          to obtain            contraceptive                services         and
the medical            record       is good defensive              evidence.                 devices,        without          parental        consent.            Many        court
                                                                                             decisions          have held that unmarried,                          “unemanci-
              MINORS
                                                                                             pated”         minors          may       obtain         abortions            without
    As a general    rule, treatment       of a minor      requires                           parental           consent.          These       last-mentioned                  court
the consent      of the parent      or guardian,        except                         in    decisions          and statutes             demonstrate              the judicial
an emergency           when     immediate         treatment                             is   and      legislative           trends         toward          freeing          under-
imperative     and delay would        involve    serious     risk                      to    standing         minors        to obtain         medical           assistance         on
the    life or limb       of the     patient.       In such                           an     their      own        and allowing              physicians             to provide
emergency            situation,        a minor        may     usually        give    his     assistance               without           fear         of a possible           malpractice
own consent.              The rule of thumb                 in applying             for      action           because     of lack of                          consent.  These                court
parental          consent        is the feasibility             of obtaining                 rulings           and legislative    acts                        also demonstrate                  the
such consent,               weighed        against       the necessity                of     flexibility              of   the          law          makers        when        there          is       a
urgent       treatment           for the child.          The physician                 is    specific      goal,      such       as eradication            of venereal
the sole judge              of this. Documentation                    about        the       disease    or drug abuse.
state of the emergency                   must be available;                and the               Considering           the diversity           of statutory        law in
physician            should      enter     appropriate            justification              the various         states,      the paucity          of appellate        and
for his decision             on the medical            record.       A concur-               supreme        court        decisions,        and     rapidly      evolving
ring opinion              by a second             physician          would           be      local changes,           a reasonable           safeguard        for physi-
beneficial.                                                                                  cians    in all elective             cases     would       be to get the
     Minors        in need of treatment                 who are married,                     written     consent         to surgery        or treatment        from any
pregnant,             or emancipated              (which         here        means           minor     13 years of age or older in addition                        to that
living      on their         own) may give valid                  consent           for      of the parent.
their       medical           or surgical           care        under          some              It has been suggested                 that consent         to research
statutes.       These        minors      may also consent                to treat-           procedures                should           be      obtained           from      all      children
ment for their children.                                                                     over the age of 7 years               (the earliest      age the law
     Some courts            have held that a minor’s                  consent          is    considers         that     a child       could    form      a specific
sufficient         if he is mature            enough          to understand                  intent).      It is also wise to include           a provision     that
the full significance                  of the contemplated                    treat-         the procedure            will be verbally        explained      to the
ment.        Age        is not       always       a true         criterion            of     minor and his wishes             respected.      His consent      form
maturity          or intelligence.           There        seems        to be no              may      assure     the parent       that a study         not specifi-
sound       justification          for denying           a minor            who        is    cally essential         to the child will be discontinued               if
mature         enough         to comprehend                the nature             and        the child exhibits           fear or resistance.
consequences              of the procedure            the right to accept                           No     reported             legal        cases      indicate      that         consent         of
or reject       treatment.          Court     rulings       have permitted                   both parents     is required                          prior to treating    a minor.
minors       of mature          judgment         to give their            consent            If a controversy       exists                       between    the parents      rela-



                                                                                                    AMERICAN                ACADEMY                    OF PEDIATRICS                             415
tive    to the      treatment,       the     physician        should        VICTOR         C. VAUGHAN,            III,     M.D.,   Chairman
attempt      to secure     the consent      of both.    When       the      (1975-1976)
parents     are separated       or divorced,        the physician           CHARLES          A. ALFORD,           JR.,     M.D.
should    obtain     the consent       of the parent      with the          ROWINE          HAYES        BROWN,          M.D.
legal   custody,      or one in loco parentis           (acting      as     MALCOLM             A.   HOLLIDAY,            M.D.
parent).                                                                    (1974-1975)
                                                                            AvRUM          L. KATCHER,      M.D.
             CONCLUSION
                                                                            CALVIN          C. J. SIA, M.D.
    Consent      must be obtained            prior     to the institu-      DAVID         SPARLING,    M.D.
tion of medical          or surgical        treatment.       Pediatri-      (1974-1975)
cians     should     keep    informed           concerning        court     Consultants
decisions       and statutes       relative        to consent         and   LEWIS      A. BARNESS,            M.D.
minors.                                                                     L. STANLEY       JAMES,          M.D.
TASK       FORCE       ON     PEDIATRIC       RESEARCH,      INFORMED       SAMUEL       L. KATZ,           M.D.
CONSENT          AND        MEDICAL       ETHICS                            SUMNER         J.   YAFFE,      M.D.
            HORACE           L. HODE5,       M.D.,    Chairman              Liaison        Representative
            (1974-1975)                                                     NORMAN           KRETCHMER,             M.D.




 416            CONSENT

								
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