• Breaking News

    Friday, January 23, 2015

    You want to do what?!?! The importance of informed consent in treatment





    By Gail  A. Edelsohn, MD, MSPH





    We come across ads in print, on television
    and on the Internet for medications and therapies that promise to make your child
    do his homework without a screaming match, behave better and generally restore
    harmony to home life. Not so easy, taking a medication raises a host of
    questions:  How long does the therapy
    take? Should I as the parent sign off on this? What about the possible serious
    side effects, such as significant weight gain, thoughts about suicide, risk of
    diabetes or a life-threatening condition?








    Parents and legal guardians make
    decisions about psychosocial therapy and medication treatment for children and
    adolescents every day. But who should give permission and sign informed
    consent?  What should parents, advocates,
    guardians be looking for or consider before signing informed consent? Is
    signing a form enough?  What about the child
    or teen - do they have a voice regarding their own treatment?


    What is Informed Consent?


    Psychiatric informed consent
    involves a parent or legal guardian giving
    permission
    for his/her child to undergo evaluation and treatment.  It is a
    process which partly involves receiving sufficient relevant information about
    the condition, prognosis, risks and benefits of treatment to be given and other
    types of treatment available. Informed consent is NOT simply a signed and dated
    form. Parents and guardian should expect informed consent to include:




      The purpose of the treatment


    • To address a specific condition or diagnosis?



    • To lessen symptoms?



    •  To change behaviors?


      The effects of treatment


    • How will you know if it is working?



    •  How long till you see an effect?


      Risks of treatment


    • Side effects of medications



    • Consequences of psychosocial treatment (e.g., therapy
      can be emotionally difficult)


      Risks of NO treatment


    • Will symptoms improve over time without
      treatment?



    • Will things get worse or lead to other
      consequences? (e.g., Untreated individuals are more likely to use substances,
      get into legal trouble)


      What alternative treatments are available?
      


    For medication


    • Is it FDA approved for this age and condition?
      (i.e., prescribed FDA on label)



    • If it is prescribed off-label, why?



    • Are there any FDA warnings about the medication
      and what do they mean?



    • What is the plan for stopping or phasing out the
      medication?









         Parents and legal guardians are
    asked to give legal permission or informed consent for treatment.
     If a child is in foster care, it may be the
    parent or it may be child welfare service or court that can give consent.
      Where a child is living (home, out of home
    placement) does not tell you who the legal guardian is.
      In some states an adolescent may give
    informed consent for psychiatric treatment depending on the state’s legislation
    about mental health procedures. Ideally the parents/guardians and the child
    should be involved in treatment decision making.



    Children also have a voice in
    this process.  Children and youth should
    be involved in giving assent.  Assent involves providing the child or teen
    with information about the therapy or medication in terms appropriate to their
    age and stage of development. The assent process should include opportunities
    for the child/adolescent to ask questions and have their concerns addressed.






    Gail A.
    Edelsohn, MD, MSPH, is senior medical officer with Community Care Behavioral
    Health, clinical professor of psychiatry and human behavior,  Jefferson
    Medical College, and clinical professor of psychiatry and behavioral science,
    Temple University School of Medicine.

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