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Informed Consent

What do patients and physical therapists need to know?

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For the patient, informed consent can be defined as the process of authorizing medical treatment after discussing the nature of the treatment, including indications, risks and benefits.1 For physical therapists, informed consent should begin with reporting initial evaluation findings, proposed plan of care and prognosis of treatment. Also, informed consent may include discussing the benefits, risks, alternatives and potential outcomes for a specific manual treatment, modality or therapeutic exercise regimen. The goal is to provide the patient with enough information to make an "intelligent" autonomous decision.1 Informed consent is the foundation of safe, ethical medical care. In this discussion, we will explore the different ethical and legal aspects of informed consent as it relates to clinical practice and research. Then we will briefly explore the aspects of informed consent with individuals who have special circumstances.

Clinical Practice

Especially in physical therapy practice, informed consent should be an ongoing process as new interventions are introduced in each phase of rehabilitation. As clinics and rehabilitation facilities become busier, clinicians may forget to talk to patients about their revised plan of care. Ethical concerns can arise if patients are not completely informed about their treatment.

Fortunately, legal claims for lack of informed consent are small. A study by CNA/HPSO, a large insurer of physical therapists, looked at physical therapy claims (total 1,464) from Dec. 1, 1993, through March 31, 2006, and found that claims for uniformed consent were less than 1 percent (a total of 2) of all claims.2 The low incidence of claims seems to reflect both the strong ethical values of our profession and the respect physical therapists have for patient autonomy and informed consent.

Despite these low incidences, all clinicians should always be prepared to discuss the details when introducing new interventions or when changes in treatment are made. A study by Everett et al (2005), examined subjects' (N=25) understanding and satisfaction with the informed consent process.1 They found that the primary concern with subjects was the amount of information provided. Subjects wanted more information on the procedure, potential risk, benefits and alternatives. Suggestions included additional sources of education, including a video of the procedure and informing patient's family members.1 For physical therapists, these findings support the idea that informed consent begins the day of the evaluation and ends when the patient is discharged.

The principles behind informed consent may have different interpretations among physical therapy clinicians. This is why organizations such as The World Confederation of Physical Therapy have created guidelines for clinicians to follow. In June 2007, The World Confederation of Physical Therapy updated their "Declaration of Principles" for informed consent. Their expectation for the physical therapist is to provide a competent adult with the following information:

• Description of the intervention/treatment to be provided;

• A clear explanation of the risks that may be associated with the therapy;

• Expected benefits from the therapy and anticipated timeframes;

• Anticipated costs and reasonable alternatives to the recommended therapy.3

These guidelines provide a common language for clinicians to follow when dealing with patients and informed consent. In the clinic, the ethics of informed consent should always reflect the needs of the patient. Patient expectations and what is communicated by the clinician can become an ethical concern if the patient is not given all the needed information. This is why informed consent should be an ongoing process, especially when new interventions are introduced or the plan of care is changed.

Understanding Negligence

Lack of informed consent may be considered professional negligence.4 Professional negligence can be considered a breach of duty by the clinician. Below are some qualifications for professional negligence.4,5

• A duty of care was owed the patient by the clinician; 

• That duty of care was breached by clinician failure to conform to the relevant standard of medical care;

• The breach of the standard of care must be shown by expert testimony, or in the case of obvious errors, the negligent act speaks for itself without additional testimony;

• The breach of duty caused a direct injury or was the proximate cause of an injury to the patient.

The legal issue surrounding informed consent and professional negligence has caused many states to enforce this issue to ensure patients completely understand. Each case is unique; however, landmark cases such as Schloendorff v. The Society of the New York Hospital (1914), Tarasoff v. Regents of the University of California (1976), and Catalano v. Moreland (2002) have changed the standards of informed consent.6 Cases such as these are enforcing the high ethical standards that are needed when providing information and ultimately protecting the patient.

Research Involvement

Even researchers have specific standards of informed consent for subjects being recruited for clinical trials. Informed consent for subjects must include the purpose of the research, procedure, risk and benefits. These standards were first established in 1974 when the National Research Act was signed into law.7 This law created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. In 1976, the commission created the Belmont Report, which is arguably one of the most important guidelines ever developed in human subject research. It summarizes the basic ethical research principles of respect, beneficence and justice.7 Below we will use these principles as they relate to informed consent.

Respect. Informed consent in the research setting should always be designed with subject autonomy in mind. Probably the most important aspect is making sure the subject understands what is written or told. Words can influence a subject's decision, especially if they are hoping the intervention will have a therapeutic benefit. A recent study by Weinfurt et al (2008), illustrates this point. They studied the expectation of benefit response in oncology subjects (N=45) who were undergoing early phase oncology trials.8 The subjects were randomized into three different groups with corresponding interviews.

The authors found that wording of the questions about likelihood of benefits influenced expectations, and subjects who had high expectations demonstrated more optimism than understanding of the clinical trial.8 This supports the fact that informed consent needs to be honest and presented in a fair, logical manner. Respect is demonstrated through the process of informed consent, which ultimately allows the subject to make an autonomous decision.

Beneficence and Justice. Honest disclosure of information reflects the idea of doing what is good (beneficence) and fair (justice) for all subjects. Research with live subjects comes with very strict guidelines that ultimately protect subjects and ensure they receive some benefit. Past abuse of study subjects, such as in the Tuskegee Syphilis study of 1932, prompted swift action to protect human subjects. This resulted in the creation of guidelines such as the Belmont Report, which clearly explains the need for honesty and fairness for all subjects participating in studies.

Legal Aspects. The legality of not informing a research subject is also considered negligent and carries the same consequences as in the clinical setting.4,5 This is why Institutional Review Boards (IRB) and the NIH have established strict guidelines to ensure the safety of all subjects who participate in research. A more comprehensive discussion on this topic can be found at the NIH Office of Human Subject Research Website at http://ohsr.od.nih.gov/index.html

Special Circumstances

Informed consent for children and other vulnerable populations should be considered "special circumstances" and needs to be handled appropriately in order to ensure that patient autonomy is met.

Assent for a Child. Assent can be defined as the child's affirmative agreement to participate in research or clinical treatment.9 For clinical treatment, the American Academy of Pediatrics (1995) published a policy statement that defines assent as having the following key elements:9-10

• Helping the patient achieve a developmentally appropriate awareness of the nature of his or her condition and telling the patient what to expect with tests and treatment(s).

• Making a clinical assessment of the patient's understanding of the situation and the factors influencing how he or she is responding.

• Soliciting an expression of the patient's willingness to accept the proposed care.

These standards reinforce the need for patient autonomy at all levels. Physical therapy interventions for minors should include the elements mentioned above and should begin during the initial evaluation. Serious ethical concerns can arise if all parties are not properly informed. Informed consent is complete when the adult is present during the initial evaluation and follow-up reevaluations and all parties come to an agreement. This provides a medium for all parties to discuss the patient's plan of care and for the family to make an "intelligent" decision.

Assent for children in research is a very comprehensive subject that takes into account the child's assent, parental consent, principle of "minimal risk," selected intervention, etc. This topic is beyond the scope of this discussion. The reader is referred to more comprehensive references such as the CITI Collaborative Institutional Training Initiative (www.citiprogram.org), which covers the federal regulations for children involved in research.

Consent for Vulnerable Populations. Along with children, there are other patient populations considered vulnerable that have specific guidelines for clinical practice and research. Vulnerable populations include prisoners, pregnant women, fetuses, cognitively impaired subjects and other groups who might require special handing to ensure appropriate informed consent is reached.11 In 2009, The Department of Health and Human Services updated the Code of Federal Regulations (45 CFR 46): Protection of Human Subjects, which defines the federal policies for research.11 These regulations have become a standard in research and are commonly enforced by institutional IRBs. The overall purpose is to allow these populations to receive complete informed consent.

These guidelines should be mirrored in the clinical setting. Patients who are commonly seen in the clinical setting include the frail elderly, those cognitively impaired, children, the foreign-born and others. Every effort should be made to make sure these patients understand the initial evaluation, proposed plan of care and prognosis of treatment.

For example, at the first visit a foreign patient may need a translator, or an elderly patient may need a legal guardian present in order to clearly communicate the information.

Clinicians should consider these vulnerable populations as "special circumstances" and make sure every action is taken to ensure the patient is able to make an informed decision.

Ensuring Understanding

The most important goal is to provide patients with enough information in a way that allows them to make informed, autonomous decisions.1 With clinical practice and research, informed consent is based on collaborative communication between all parties involved, especially when dealing with vulnerable populations. Open and honest communication is the key for all clinicians and researchers.

References available at www.advanceweb.com/PT or by request.

Scott Cheatham is owner of the National Institute of Restorative Exercise in Torrance, CA. He received his doctor of physical therapy from Chapman University and is also a certified athletic trainer. He holds the PES, CSCS, NSCA-CPT and ACE-CPT, and Level I Club Coach certifications. Dr. Cheatham is a board-certified specialist in orthopedics (OCS). He has authored several chapters and articles on the topics of orthopedics, vestibular balance and health and fitness. Dr. Cheatham is currently pursuing his PhD in physical therapy.





     

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