- Table of Contents
- Title Page
- Table of Contents
- Introduction
- Definitions
- Risk Management
- Components
- Ethics
- Malpractice
- General Adherence Areas
- Difficulties Identifying Risk Areas
- Common Areas for Ethical Complaints/Malpractice Litigation
- Deficit Office Operations
- Sexual Misconduct
- Violation of Confidentiality
- Limits of Confidentiality
- Informed Consent
- Office Procedures
- Client Records
- Release of Records
- Privileged Communication
- Fee Collection Disputes
- Lack of Clinical Sophistication and Ongoing Consultation
- Improperly Conducted Treatment
- Client Loss Due to Evaluation
- Incorrect or Faulty Diagnosis
- Medical Clearance
- Causing Physical Damage
- Death of A Client
- Bodily Injury
- Assault and Battery or Touching the Client
- Other
- Slander, Libel, or Defamation of Character
- Involuntary Treatment
- Failure to Warn
- Miscellaneous
- Ten Commandments of Applied Psychophysiology, Biofeedback
- (including Neurotherapy), and Behavior Medicine
- Specific Neurotherapy Applications: Part II
- Competence
- Supervision/Consultation
- Training Agencies
- Standard of Care
- Is Neurotherapy an Experimental Procedure?
- Informed Consent
- Being Sensitive
- FDA
- Being a Supervisor
- Advertising and Public Statements
- State Laws
- Medical and Other Consultation
- Responsibility
- Vendors
- Acceptance of Neurotherapy
- Legal Implications
- Changes in Brain States
- FDA Classification
- Defense
- Harm and Negative
- Responsible and Ethical Vendors
- Summary
- References
- Table 1 - Most Common Areas for Malpractice & Ethical Complaints
- Table 2 - Items From the Percival & Striefel Survey Which Respondents
- Found Controversial in Terms of Ethicalness
- Table 3 - Ten Samples of Controversial Ethical Items From the Percival and
- Striefel Survey of AAPB Members and Possible Ethical Position
- Figure 1 - Informed Consent Form
- Index
ETHICS AND RISK MANAGEMENT: PART I
Sebastian Striefel
Do you have written policies and procedures for your practice, including those related
to risk management? Have you had them reviewed by an external consultant? Do you use
consultation and supervision regularly? Are you careful to accurately document the
services you provide? Are you aware of the specific ethical concerns related to
neurotherapy? Do you know how an experimental procedure is likely to be defined by a
regulatory board? If you said no to any of these questions, you are probably at
greater risk than is necessary. This chapter will focus on some risk management areas that
seem to result in most ethical complaints and malpractice law suits. The chapter is by no
means comprehensive, since that would take a book by itself. If you address the areas
covered herein, you can avoid 95-99% plus of the ethical and legal problems that plague
providers today. The areas of concern may be different tomorrow; thus, ongoing education
is essential. Remember that the overall risk of having problems is very low for those
who continue their education, practice prudently and think and act preventively.
DEFINITIONS
Risk Management
The term "risk" refers to the probability of injury, damage or loss
(Guralnik, 1980). In the practice of biofeedback (including neurotherapy), behavior
medicine, and applied psychophysiology, it means the probability that some behavior will
result in injury to a client or that someone will file an ethics complaint or lawsuit
against a provider. A provider's behavior can result in damage to his/her reputation, loss
of income if clients no longer seek service or if a court finds a provider guilty of
negligence, loss of the right to practice if a licensing board finds one guilty of
unethical behavior, and loss of energy and emotional turmoil if one must defend ones self
against a complaint (Striefel, 1992b). Many more losses or injuries are possible. Some
dissatisfied clients have even killed mental health practitioners. These examples clarify
how important it is for providers to reduce their risk through skillful management.
Management is defined as carefully managing all aspects of treatment (Guralnik, 1980).
Thus, risk management means reducing the probability of damage, loss or injury by
carefully analyzing the ethical, regulatory and legal risks and managing all aspects of
one's professional activities to reduce these risks (Striefel, 1992b; 1992c; 1993).
Bennett, Bryant, VandenBos, and Greenwood (1990) have pointed out that most malpractice
suits arise from problems which practitioners could have avoided if they learned to
anticipate and recognize areas of concern. Similarly, most ethical complaints occur out of
ignorance rather than from deliberate acts. Ongoing education via reading chapters such as
this one, attending workshops and classes, and using frequent consultation and supervision
are all ways for learning to recognize and anticipate potential problem areas.
Components
A good set of written risk management policies and procedures is designed to:
1.Maximize client protection,
2.Minimize the probability of ethical complaints and litigation,
3.Encourage proactive quality control,
4.Minimize the probability of injury and dissatisfaction by clients and others
affected,
5.Maximize the probability of ethical and professional behavior by all staff, and
6.Minimize staff stress (Striefel, 1992b; 1995).
Risk management policies and procedures should cover all aspects of one's professional
practice; should adhere to the ethical principles of all relevant professional
associations, e.g., the Association of Applied Psychophysiology and Biofeedback (AAPB,
1990); should adhere to relevant state and federal laws; should be updated on an ongoing
basis; and should be reviewed by a competent external consultant. Consultation from an
attorney should be sought when an issue has legal components and/or implications. The
reader should be aware that this chapter is not intended to provide legal advice. For such
advice, readers should hire an attorney.
Ethics
Ethical principles are moral principles adopted by an association that provide rules
for how members are to behave (Corey, Corey, & Callanan, 1993; Striefel, 1995). Ethics
is concerned with identifying and doing what is right. Most professional associations
(e.g., AAPB) have ethical principles, provide training so their members can learn the
principles, and have a committee to investigate complaints about violations and to enforce
the rules. Those providing client services must take the time needed to learn what the
ethical principles are and how to implement them in daily practice. Remaining current and
competent in ethics, as in practice issues, is an ongoing task.
Malpractice
Malpractice litigation requires that: a) a treatment relationship existed between the
service provider and another person, the client; b) the service provider's behavior was
below or deviated from the acceptable standards of care; c) that injury occurred to the
client; and d) that the cause of the injury was related to what the service provider did
or did not do (Striefel, 1989b). If a client can prove in court that all four components
of malpractice law existed, then they can seek financial compensation (Stromberg et al.,
1988). If the client was also negligent, if all four components cannot be proven, or if
the provider is immune from litigation for some reason (e.g., works for the federal
government), it is possible that no financial compensation will be awarded.
GENERAL ADHERENCE AREAS
In general terms, risk management requires those engaged in professional practice to
know and follow a) the ethical principles of all professional associations to which they
belong; e.g., AAPB (1995); b) all relevant state and federal laws; and c) the standards of
professional practice relevant to what one does. Biofeedback and behavior medicine are not
specific professional disciplines, but rather are treatments provided by members of many
disciplines. Thus, it is not possible to provide one list of risks and/or solutions that
fit all disciplines using the procedures. Since biofeedback and behavior medicine services
are delivered by providers from a multitude of disciplines, the ethical principles, laws,
and standards of practice that must be followed, include a component that is common to all
biofeedback and behavior medicine service providers and a component that is unique to the
provider's specific discipline. Part I of this chapter will, for the most part, focus on
those aspects common to most biofeedback (including Neurotherapy), behavior medicine, and
applied psychophysiology practitioners. Part II will focus on specific neurotherapy
issues.
DIFFICULTIES IDENTIFYING RISK AREAS
When an ethics complaint or malpractice suit is filed, it is often difficult to decide
if the complaint is related primarily to the practitioner's biofeedback or behavior
medicine activities or the activities common to the practitioner's discipline, e.g.,
nursing. If one were to look only at the complaints filed with a specific group, e.g.,
AAPB's Ethics Committee, one would have an under-representation of complaints related to
activities by practitioners who provide biofeedback services. On the other hand, if one
looks at all complaints filed against members of disciplines where biofeedback service is
common, one might have a too broad range of risk areas. As such, the reader is cautioned
to use common sense and judgement in applying the content of this chapter to one's own
professional activities.
COMMON AREAS FOR ETHICAL COMPLAINTS
AND MALPRACTICE LITIGATION
Different authors (e.g., Pope, & Vetter, 1992; Roswell, 1989; Zuckerman &
Guyett, 1991) have listed different, but overlapping, areas in which the filing of ethical
complaints and malpractice litigation is common for psychologists. For practical purposes,
these areas of concern apply to practitioners engaged in applied psychophysiology,
biofeedback, and behavior medicine and can be divided into four major areas, each with
subparts (see Table1). The four areas are, a) deficient office operations and records, b)
lack of clinical sophistication and ongoing consultation, c) causing physical damage, and
d) other (Zuckerman & Guyett, 1991).
Table 1 appears about here
Deficient Office Operations and Records
One should take great care in setting up the policies and procedures for operating
one's office and for dealing with client records. The key to good practice is for each
practitioner to always behave responsibly, in all professional activities; to practice
only in areas where one is competent, as demonstrated by training and experience (AAPB,
1995; Striefel, 1990c; 1995); and to show respect for all with whom one comes in contact
in one's professional activities (Striefel, 1995). A provider should not try to be all
things to all people, i.e., try to serve everyone who is referred. Rather, a provider
should learn through self-analysis, feedback from clients, client outcome data, and
supervision and consultation both one's limits and one's areas of competence. It can be
difficult for a provider to behave responsibly and refer a client elsewhere when the
client's problem is outside one's area of competence and one needs more income to make
ends meet. Yet, from a risk management and ethical standpoint, that is precisely what a
provider should do, because it is unethical not to refer in such a situation. The only
other immediate possibility is to arrange for close supervision, if and only if, such
supervision will allow the provider to provide services at least at the minimal level of
acceptable practice. Specific areas in which providers have difficulties follow.
Sexual Misconduct
In a recent survey of AAPB members, Percival and Striefel (1994) reported that 5% of
those who responded had engaged in some type of sexual activity with clients. A few even
deceived themselves into believing that such behavior is ethical. Such findings are very
surprising in view of the large number of articles written which clearly point out that sexual
contact is unethical, causes damage to clients, and is the leading cause for malpractice
litigation (Percival & Striefel, 1994; Pope, & Vetter, 1992; Striefel, 1989a;
1995; Zuckerman & Guyett, 1991). In addition, virtually every professional health care
association's ethical principles specify that sexual contact with clients (and more
recently former clients) is unethical. In several states, sexual contact with current or
former clients is a felony punishable by imprisonment (Corey, Corey, & Callanan, 1993;
Striefel 1989a; 1995).
The "bottom line" is that, sexual contact with clients is unethical under
all circumstances. There are no exceptions. In addition, sexual contact with former
clients is extremely risky behavior that can result in the loss of one's license to
practice, one's BCIA Certification, one's reputation and self-esteem, and many dollars.
Each provider should learn to identify behaviors that can result in a breakdown of
professional boundaries, such as dwelling on or excessive emotional responses to sexual
attraction, non-erotic contact, and socialization with clients (Striefel, 1989b).
Practitioners should seek professional consultation or therapy at the first signs that the
professional boundaries are being breached or that a dual relationship has begun. Pope,
Sonne, and Holyroyd (1993) and Striefel (1989a) have provided information on sexual
attraction and feelings and what to do in such situations.
Violation of Confidentiality
Confidentiality is essential to all therapeutic relationships in biofeedback (including
Neurotherapy), applied psychophysiology, and behavior medicine. Clients find it difficult
to enter meaningful treatment if they cannot trust that what they say will remain
confidential.
Limits of confidentiality. Professionals have an ethical
obligation, and often a legal obligation to protect the confidentiality of all those they
serve, including, clients, students/trainees, and research subjects. Most people like to
talk about what they are doing, partially as a stress reducer, partially to socialize, and
sometimes because they are excited about what they are doing. Unfortunately, this natural
behavior of talking often results in violations of confidentiality.
There are only a few situations in which a provider can ethically and/or legally
violate a client's right to confidentiality. The general rules are: a) when more harm is
likely to occur to the client or others if client confidentiality is not breached, e.g.,
when a client is suicidal or intends to harm others (legal duty to warn and protect in
some state laws), b) when breaking confidentiality is required by law, e.g. every state
requires health care professionals and others to report suspected and/or actual child
abuse and neglect, c) when the client, although informed, still engages in behavior that
requires breaking confidentiality, e.g., does not pay his/her bill; thus requiring the use
of a collection agency or uses his/her mental condition as a legal defense, and d) when a
provider’s right to protect him/ herself becomes relevant because the client
initiates legal or ethical action against a provider (Striefel, 1995).
Informed Consent. Clients should be informed about the limits of
confidentiality, conditions under which a provider will breach confidentiality, according
to informed consent procedures, early in treatment--preferably before or during the first
session. By being informed, a client has a choice of what s/he chooses to reveal or not
reveal that could result in confidentiality being violated.
Informed consent requires that: a) the client has all of the information a reasonable
person would want about the advantages and disadvantages of the proposed activity (e.g.,
treatment, assessment, collection procedures) and possible alternatives; b) the client
gives his/her consent voluntarily without coercion; and c) the client is competent to give
consent (Striefel, 1989b; 1995). For minors and others with questionable competence, it is
important to get informed consent from a parent, guardian, or advocate. Informed consent
should be ongoing, because it provides an opportunity to increase collaboration with the
client (Bongar, 1991), and should cover all aspects of treatment, not just the limits of
confidentiality. Informed consent should be obtained for assessments, diagnosis, treatment
and changes in treatment procedures, touching, applying biofeedback sensors, release of
information, fees, billing, and the use of collection agencies (Striefel, 1990a). The
informed consent process reduces risk for a provider only if all three requirements of the
informed consent process are met for each client. Informed consent should be documented in
writing. See Striefel's articles for specific details (Striefel, 1990a; 1995). Figure 1
includes a sample informed consent form which readers may copy and/or adapt.
Figure 1 appears about here
Office Procedures. It is important that care be taken in all
aspects of office operations to assure that client confidentiality is protected. All
employees, as a condition of employment, should be educated about the importance of
confidentiality, and should sign an informed consent statement agreeing to protect client
confidentiality in all of their activities. They should also sign an agreement to follow
the ethical principles of AAPB and those of other relevant professional groups.
Client last names should not be called out in a waiting room. Instead, some other
procedure that protects client confidentiality should be used; for example, when clients
arrive, a receptionist can attend to what the client looks like and thus match the
client’s face with his or her name. When it is the client’s turn for service,
the receptionist can go to the client and say something like, "Please come with
me." Having clients sign in on a common log on which the names of other clients are
visible is a violation of confidentiality. Having them sign a card on which there are no
other names is not.
It is also important that clients not be able to overhear telephone calls, verbal
messages, or what goes on in the treatment rooms, especially if names or other identifiers
are used. Offices can be soundproofed or White Noise used. Staff can be trained to hand
other staff written messages and not to use client last names when speaking on the phone.
Some readers may see such attention to detail as "overdoing it", but failure
to attend to detail has cost many a professional his reputation, his license, and many
dollars. Proactive behavior is less stressful than reactive behavior.
Client Records. Client records need to be protected to prevent
breaches of confidentiality. As such, a provider should have access only to the records of
his/her own clients and not to those of other providers. In addition, client records
should be kept in a locked records room or locked files that are not accessible to
unauthorized personnel, e.g., janitors. Records should not be left face up on a desk where
another client or office visitor can read them, nor should the screen of a computer be
readable by individuals who have "no need to know". Having a computer face away
from the direction of client flow in an office can make a big difference in protecting
confidentiality. Computerized client information should be kept on floppy discs that can
be locked up or the computer should be lockable to control for unauthorized access.
Consultants and other agency staff should have access to identifiable client information
only if there is a bona fide "need to know"; in other words, when they are
actively involved in the treatment of the client. In 1993, the American Psychological
Association published a document called, Record Keeping Guideline which is very
useful to providers of health care services (APA, 1993a).
Release of Records
Client information should not be released to other agencies or professionals without a
signed release of information form (Striefel, 1989b). The form needs to include some very
specific information (see Zuckerman & Guyett, 1991), and the requirements for informed
consent should be met. Similarly, a professional should not ask for identifiable client
information from another agency without having "in hand" a client-signed release
of information form. Do not let some power figure intimidate you into violating a client's
right to confidentiality just because s/he is in a hurry and did not take time to get a
release of information. Why increase the probability of someone taking action against you
just to satisfy someone else? Tactfulness and educating other professionals about your
adherence to ethical guidelines can maximize the probability of power figures continuing
to make referrals to you. Work out the process before it becomes an issue.
Privileged Communication
Privileged communication is a legal responsibility, specified in state law, which
precludes a professional from releasing confidential client information in any legal
proceeding without client consent (Corey et al., 1993; Striefel, 1989b; 1995). The client,
not the therapist, owns the right to release or not release certain information. Not all
professionals are protected by a privileged communication statute. Know your state law and
whether your activities are covered by a privileged communication law, and know what the
exceptions are. Lawyers, physicians, clergy, and psychologists are typically covered by
such laws, usually within the state licensing laws for their disciplines. Other health
care service providers, such as social workers, may also be covered.
The exceptions to privileged communication vary from state to state, but typically
include: a) when conducting an activity for the court, b) when the client has initiated a
lawsuit against the therapist, c) in a civil action wherein the client introduces his
mental or physical status as part of his case, d) when the client is a minor (e.g., sexual
abuse), and e) when the client gives permission (Striefel, 1989b; 1995). When in doubt,
do not give it out (Striefel, 1989b; 1995).
Fee Collection Disputes
Fee collection disputes result in the filing of many ethical complaints and lawsuits
against providers (Zuckerman & Guyett, 1991). Whenever possible, determine a client's
ability to pay before initiating services (Bennett et al., 1990), i.e., be sure the client
understands and agrees to your fees. Doing so will prevent later frustration when a client
cannot afford to pay your fee. It is also important to obtain informed consent concerning
your fees, billing practices (e.g., third-party billing), and collection procedures, so
clients can decide before receiving services if they want to enter services under the
conditions you have specified.
It is important for service providers to know the laws of their state concerning
billing, bill collection, insurance, and paying or receiving referral fees. Knowing
relevant Federal Trade Commission, Medicare, Medicaid, and specific insurance company
regulations is also important. Billing procedures that do not comply with the law can
result in prosecution for fraud (Harrison & King, 1993). Letting a client accumulate
large unpaid bills and then putting on pressure to collect is very high risk behavior
(APA, 1993b). It has been said that this is almost a sure way of having the client file an
ethical complaint or malpractice suit against the provider. Establish procedures that do
not let clients accumulate large bills for services, and follow them carefully. It might
be useful to have an attorney and another practitioner review those procedures for
possible problem areas.
Honesty in diagnosis, billing, insurance reimbursement, and other aspects of practice
is essential. Dishonesty, such as signing as a provider when one was a supervisor, billing
insurance companies for client "no shows", or changing the diagnosis to collect
from third-party payers, may be fraud and subject to heavy fines and/or criminal
prosecution. Billing clients directly for "no shows" may be acceptable pending
any agreements you may have with the insurance company that allows you to bill the client
directly. Fraud is grounds for the loss of one's professional license, BCIA Certification
and membership in AAPB. In addition, failure to be honest when using experimental
procedures can result in problems. At least a dozen individuals doing neurotherapy have
had difficulty with state licensing boards around issues of how they described the
services and potential benefits of the EEG services provided (Striefel, 1997). Because
many health care providers and members of licensing boards have varying definitions of
what is considered experimental or verified by the research literature, it is important to
use caution when using controversial procedures. AAPB’s Board in September 1997
established a committee to evaluate the issues related to clinical efficacy in biofeedback
to help practitioners deal more effectively with such issues.
It is also helpful to try to educate other professionals about the utility and support
for the procedures you use. Doing so can help reduce problems. If in doubt, consult with a
knowledgeable expert before making claims that might be considered problematic by other
professionals (Clayton & Bongar, 1994). Learn and use the appropriate codes for
biofeedback and other client service billings. Small (1991) has written an excellent book
related to collection of third-party payments.
If a client does not pay her/his bill, a provider should not stop services abruptly.
Proceeding with caution in trying to negotiate a payment schedule is appropriate. A
provider should take care in ending services because payments are not being made, to
assure that the client does not file an abandonment charge against the provider (Arnold
Conner, 1994). A client still in need of services at termination should be so informed,
should be given the names of several referral sources, a follow-up reminder of options
should be sent, and all these steps should be carefully documented in the client's file.
Many providers are now accepting credit cards for service payments, as a way to assure
a positive cash flow and for avoiding fee disputes.
Lack of Clinical Sophistication and Ongoing Consultation
Ongoing education, supervision, and consultation are becoming more and more critical to
professional survival (Striefel, 1990b). It is almost impossible for the typical
practitioner to keep current on all the literature; therefore, it is useful to attend
periodic workshops, belong to professional groups (such as AAPB), and one's state
association (e.g., biofeedback chapter), and to use ongoing supervision as methods of
maintaining and enhancing one's professional skills. Providers are ethically required to
become and remain competent in all areas in which they practice. Each time a provider
tries to provide services in an area in which he/she is not competent, he/she is behaving
unethically and is taking unnecessary risks (Clayton & Bongar, 1994).
Improperly Conducted Treatment
Improperly conducted treatment is likely to occur when: a provider is not aware of the
treatment(s) of choice for a particular problem; fails to obtain informed consent,
especially for experimental procedures; delivers incompetent service because of
incompetence, fatigue, or personal problems; practices in an area not appropriate for
one's license (e.g. providing services in an area belonging to a medical doctor [M.D.]
when one is not an M.D.); a provider does not have a backup or emergency procedure in
place; and when a provider makes an inappropriate referral or termination.
Practitioners should practice only in those areas in which they are competent by
training and/or experience (Clayton & Bongar, 1994). An acceptable alternative is when
one has sufficient supervision and/or consultation available for dealing with any
situation that arises. The supervisor should be on site, so potential problems can be
avoided or their impact reduced. One should not agree to provide supervision outside one's
own areas of competence (Striefel, 1990b).
Client Loss Due to Evaluation
Zuckerman and Guyett (1991) reported client loss due to an evaluation is the cause for
about 11.8 percent of professional liability claims against psychologists. Such claims may
account for either higher or lower percentages of claims against applied psychophysiology,
biofeedback, and behavior medicine practitioners.
Biofeedback, applied psychophysiology, and behavior medicine practitioners are often
called upon to conduct an evaluation and/ or provide treatment to clients who have
suffered injuries on-the-job or in other accidents. Failure to identify an injury that a
client insists s/he has suffered can result in the client not obtaining secondary
benefits, e.g., worker's compensation. It can also result in a negligence lawsuit.
Dissatisfied clients often initiate action against their service providers (Bennett et
al., 1990). As such, it is essential, from a risk management viewpoint, to seek
consultation whenever one conducts a difficult evaluation or where the "stakes"
are high for a client (Clayton & Bongar, 1994). Working with clients of another
culture, without appropriate training or supervision, can also be problematic.
Incorrect or Faulty Diagnosis
Misdiagnosis has been defined by Stromberg et al., (1988, p 453) as a "failure to
recognize the patient's condition and to carry out proper measures before harm
occurs." As such, preventing a misdiagnosis implies that: a) one should not operate
outside of one's area of competence, b) one should seek consultation and/or make a
referral elsewhere when in doubt, c) one should be sensitive to situations in which a
client is not making progress or seems to be getting worse, and d) one should take
corrective action if a misdiagnosis has occurred. In accepting referrals from others where
a diagnosis has already been made, it is important for the provider to verify that the
diagnosis is accurate. This verification can involve additional assessments by other
professionals, if the assessments are outside the boundary of acceptable practice for
one's own discipline. Blindly accepting another provider's diagnosis without reviewing it
for accuracy may be negligence. Lawsuits for improper diagnosis are more common in
medicine than in mental health (Stromberg et al., 1988). Applied psychophysiology,
biofeedback, and behavior medicine often fall somewhere inbetween physical medicine and
psychotherapy, depending on ones discipline. One's ability to diagnose should be equal to
that of other competently trained providers, if one wishes to avoid claims of malpractice.
Other sources (e.g., Schwartz, 1995) discuss the importance of a good history and
evaluation of the client in making an accurate diagnosis, so those factors will not be
discussed here.
Common areas of misdiagnosis that have resulted in lawsuits include client/patient
suicide, harm to third parties by the client after release from a hospital, and suits
alleging wrongful commitment to a mental health facility. Diagnoses that can be
problematic for those engaged in applied psychophysiology, biofeedback or behavior
medicine depends on the individual provider's discipline, years of experience, and
previous workups of the client and his or her problems. Accurate diagnosis is critical.
A misdiagnosis for the purposes of collecting from a third-party payor is both
unethical and is fraud. Great care should be taken to make an accurate diagnosis and to
diagnose only in areas appropriate to one's license, e.g., psychologists should make
diagnoses only in areas listed in the Diagnostic and Statistical Manual-Revised
(DSM-III-R, APA, 1987). Making a diagnosis in an area that falls in the jurisdiction of
another profession, e.g., diagnosing migraine headaches, if not a physician, can,
depending on state laws, result in charges of practicing medicine without a license.
Practitioners who are going to make a diagnosis should be competent in all of the
skills necessary for making an accurate diagnosis. When in doubt, consultation or referral
elsewhere are good risk management practices. Additional training can also be useful.
Medical Clearance. Applied psychophysiology, behavior medicine and
biofeedback providers who are not physicians need to understand and appreciate the role of
physicians, in terms of accurate diagnosis and appropriate treatment when physical
complaints are presented by clients. It is important that providers form a working
relationship with physicians. First, to assure accurate diagnosis when physical
complaints, such as headaches and pain, are the presenting symptoms. Obtaining medical
clearance helps assure that one does not provide an intervention, such as biofeedback,
when a medical intervention is the treatment of choice. For example, medical intervention
is called for when headaches are caused by a brain tumor. Providing neurotherapy because
one did not get medical clearance would be malpractice.
Second, in some situations, it is good practice to get medical clearance even when the
presenting problem seems to be psychological in nature. For example, acute anxiety attacks
can be caused by medication reactions. Third, some interventions, such as relaxation
training and biofeedback, can produce physiological changes that require medications to be
reduced or eliminated. Examples of such conditions include diabetes and hypertension. As
such, providers should coordinate and communicate regularly with appropriate physicians. A
good physical, including specific procedures, can help rule out medical causes for
problems that a provider in applied psychophysiology, biofeedback or behavior medicine
might be asked to treat. Getting a signed statement from the physician that says there is
no medical reason why a client cannot undergo a particular treatment can be most useful,
should later questions arise. A failure to consult, as needed, could lead to a legal
conclusion of negligence in a malpractice lawsuit (Clayton & Bongar, 1994). Document
all consultations in the client's file.
Causing Physical Damage
The probability of the following three issues causing risk management problems for an
applied psychophysiology, biofeedback or behavior medicine provider is dependent on the
provider's professional discipline. The occurrence of problems related to causing physical
damage can be largely avoided by being competent and by planning for how to avoid
difficulties. Again, consultation, supervision, and written policies and procedures are
critical.
Death of A Client
The death of a client is likely to be a risk for those service providers who operate
within the context of mental health and counseling services. It is also a risk for clients
who are experiencing extreme physical pain on an ongoing basis. It is important that
providers be aware of any duty to warn or protect laws that exist (Corey et al., 1993;
Striefel, 1995). These laws, often called the "Tarasoff Doctrine", generally
require certain mental health service providers, such as psychologists, to take specific
actions if they become aware of or suspect that a client is dangerous to self (suicidal)
or others. If a client commits suicide and someone thinks the provider could have
prevented it, then a lawsuit might be filed because of negligence. Those treating
hospitalized clients are at greater risk than those treating outpatients. Providers should
know the laws of their state and should seek consultation, including legal, when a
potentially dangerous situation arises. Be sure to establish a lawyer-client relationship
when consulting with a lawyer. If you do not, the lawyer could be required to testify
against you in court proceedings, because the privilege communications law in such cases
requires the establishment of a lawyer-client relationship. Stromberg et al., (1988)
provided some detailed and useful information on the topic that would help in making
decisions that could prevent death or injury. The death of a client due to suicide can
also be very traumatic for service providers. Bongar (1991) provides a consultation model
for reducing the likelihood of client suicide.
Bodily Injury
Applied psychophysiology and biofeedback providers should assure that their service
environment and the equipment they use are hazard-free. Frayed cords, uncalibrated
equipment, and line voltage equipment with defective optical isolators, could result in
client injury. Periodic inspection of one's work environment, equipment, electrodes, etc.,
by competent personnel can prevent problems from ever arising. Desai (1992, San Antonio)
suggested that all biofeedback equipment be checked for safety and calibration at least
once per year by someone like an electrical engineer. Doing so can prevent leakage,
electrode burns and other injury to clients. Computerized equipment should have power
surge protectors and optical isolators to prevent house current from accidentally reaching
a client through the equipment or electrodes. If a client is injured (e.g., complains of
burns from electrodes), they should be sent to a dermatologist for an exam and treatment,
if needed, probably at the provider's expense. A sincere apology is also helpful in
preventing further agitation by the client. Agitated clients often file lawsuits or
ethical complaints. If an injury occurs to a client, the provider should go into a
preventive or protective mode (Bennett et al., 1990) and seek legal counsel. Careful
documentation of the facts of the situation is also useful. In addition, other
documentation, e.g., maintenance records on equipment safety checks, can be useful in
counteracting accusations of negligence, assuming such service is received and recorded
regularly. In lawsuits involving equipment related injuries, it is very likely that the
equipment vendor will be named as a codefendant. Check to be sure that the vendor carries
product liability insurance, so that if the product was defective, you as a provider are
not held liable. A provider is responsible both for what they do and what they fail to do.
Assault and Battery or Touching the Client
Touching a client to attach electrodes or to check their pulse or breathing without
their permission can result in charges of assault and battery. It can also result in the
filing of ethical complaints of sexual misconduct. Such complaints have been filed against
biofeedback service providers. Before you touch a client, be sure you have informed
consent and that such touching falls within the confines of what is considered common
practice for biofeedback providers of the same discipline. The touch allowed for a
gynecologist (not without risk) doing an examination of a patient is very different from
that allowed for a social worker doing urinary incontinence biofeedback using an anal or
vaginal sensor, electrode or peritonometer. Knowing the standards of accepted practice and
adhering to them can prevent many problems. Showing a client how to insert a vaginal
sensor using diagrams can preclude the need to touch the client or otherwise invade their
sense of decency. Using a same-sex assistant with client permission can also be
appropriate in some cases. If you have physical contact of any type with a client, and it
was shown on public television to your family or colleagues, would you be embarrassed? If
so, it is probably inappropriate contact.
Although it should not need to be said, assault and battery of a client in the
traditional sense (i.e., an intentional physical or verbal attack or beating) is illegal,
unethical and unprofessional, so do not do it. It is important to remember that assault
and battery charges are for intentional, not negligent acts. As such, they are generally
not covered by professional liability insurance (Stromberg et al., 1988). All applied
psychophysiology, biofeedback, and behavior medicine service providers should seriously
consider carrying good professional liability insurance and should know what is covered.
AAPB and other professional associations have arranged with insurers to make such coverage
available to their membership. Often, liability insurance will not cover an individual if
an ethics complaint is filed that does not include a civil lawsuit. Know what your
insurance covers. Woody (1988) provides very useful information about legal liability
safeguards.
Other
Three other categories that place psychologists at risk were mentioned by Zuckerman and
Guyett (1991). These categories could also place some applied psychophysiology,
biofeedback, and behavior medicine providers at risk; thus, they follow. In addition,
there are many other situations that can place providers at risk; some of these will also
be mentioned. The reader should remember that risk management must remain flexible and
ongoing, since new areas of concern are always occurring.
Slander, Libel, or Defamation of Character
Defamation occurs when one harms another's reputation, so others in the community might
not want to deal or associate with the person. When this harm occurs because of written
statements, it is called libel. When it occurs because of verbal statements, it is called
slander. Providers should be careful not to make any false statements about a client or
another provider. Since good, ethical providers never violate a client's right to
confidentiality without justifiable cause, they in fact, do not make statements
about their clients to anyone, right? This should be a true statement; unfortunately that
is not always the case. Providers should be cautious about what they put in a client's
file, on an insurance claim, or release to other agencies. No careless labels should be
used, e.g., calling someone an alcoholic versus describing them as having difficulty in
controlling their use of alcoholic beverages, are two different things. Being sure that
the statements one makes (orally or in writing) are accurate, non-inflammatory, and kept
confidential is what is expected of the service provider.
Involuntary Treatment
Except for minors, it is very unlikely that applied psychophysiology and biofeedback
will be provided involuntarily. Obtaining informed consent precludes the possibility of
accusations of involuntary treatment, if the informed consent meets the requirements
previously specified (i.e., it's informed, voluntary, and the person is competent to give
consent). The failure of a client to protest about a form of treatment cannot be assumed
to be equal to having given informed consent. Since applied psychophysiology and
biofeedback involve the learning of voluntary self-regulation skills, it is unlikely that
treatment will be successful if the client does not participate.
Failure to Warn
The responsibility to warn an intended victim of possible harm is a part of the duty to
warn and protect laws that exist in some states. Providers should know what their state
law is and to what discipline(s) it applies. Any service provider could become aware of a
client's intent to injure or kill another person, although it is more likely for those
also providing mental health services. When in doubt, legal and collegial consultation
should be sought immediately, perhaps while the client is still in the office. As such, a
provider needs to know in advance (written policies and procedures) who they would contact
and how they would do so. Care must be taken to assure that the client does not catch the
provider unaware by picking up the telephone or walking into the space where the provider
is making the call. The best procedure may be to involve the client in the process.
Miscellaneous
Additional information on miscellaneous areas in which complaints have been filed
against service providers can be found by looking in the literature published by the
professional association for one's own discipline. Some references for psychologists, for
example, include: Pope and Vetter (1992); APA (1993b) and Bennett et al., (1990). See also
Striefel's (1995) chapter in Schwartz's (1995) book on biofeedback. Each of these
publications discusses areas in which complaints have been filed, problematic areas, or
provides lists of risk management activities. Bennett et al., (1990) list 31 areas that a
psychologist should have addressed to minimize risk. Many of the areas apply directly to
the 57% plus membership of AAPB whose primary discipline is psychology, but they also
apply to many other AAPB members, applied psychophysiologists and those engaged in the
practice of behavior medicine. Areas such as competency, consent to treatment, therapeutic
contact, interrupted therapy, and terminating treatment have been discussed by several
authors (APA, 1993; Bennett et al., 1991; Stromberg et al., 1988; Striefel, 1990c; 1992a;
Zuckerman & Guyett, 1991). Readers are referred to these sources for more information.
Percival and Striefel (1994) surveyed the membership of AAPB regarding many ethical
issues. Over 60% of the 536 respondents were unsure about whether 29 of the items (see
Table 2) were ethical or unethical. One should review items from this list that are
relevant to one's practice, so one can develop and use appropriate policies and
procedures. Readers should review the items included in that survey to assure that they
can recognize and deal with such situations appropriately. Table 3 provides some possible
solutions for 10 of the controversial items from the Percival and Striefel (1994) Survey.
Tables 2 & 3 appear about here
TEN COMMANDMENTS OF APPLIED PSYCHOPHYSIOLOGY,
BIOFEEDBACK (INCLUDING NEUROTHERAPY) AND BEHAVIOR MEDICINE
1. Thou shalt not practice applied psychophysiology, biofeedback or
behavior medicine without first and foremost protecting the welfare of those served.
2.Thou shalt avoid problematic dual relationships with clients.
3.Thou shalt not release client information without client permission.
4.Thou shalt not engage in treatment activities without obtaining informed consent from
client on all aspects of practice.
5.Thou shalt not practice in areas where thou art not competent by training and/or
experience, unless appropriate supervision/consultation are available.
6.Thou shalt not practice without keeping good documentation and records.
7.Thou shalt not practice without emergency backup procedures.
8.Thou shalt not engage in libel or slander of clients or other professionals.
9.Thou shalt not allow physical harm to occur to clients or others.
10.Thou shalt not practice applied psychophysiology, biofeedback or behavior medicine
without adherence to the appropriate Ethical Principles and Standards of Conduct, e.g.,
the Ethical Principles of Applied Psychophysiology and Biofeedback.
SPECIFIC NEUROTHERAPY APPLICATIONS: PART II
Neurotherapy is relatively new as treatment approaches go; thus, providers need to give
more attention to risk management issues than might be necessary in more widely accepted
treatment procedures. Specific risk management, professional conduct and ethical
guidelines for neurotherapy have yet to be published. As such, prudent providers will
apply the risk management, professional conduct and ethical guidelines of their
professional discipline (if they have one), the professional associations to which they
belong, along with those of any group that licensed or certified them in any area of
health care practice. In addition, they will join relevant associations to access their
guidelines, continuing education offerings and general information about changes in the
practice environment. The guidelines for providing neurotherapy, as yet, are not that
different from those that exist for other areas of health care practice. However, the risk
for providers may be greater for several reasons, including:
1. Managed care is negatively impacting the income of many health care providers; thus,
a few are likely to engage in behaviors motivated by their desire to protect their income.
Such providers are likely to scrutinize the activities of other providers, especially
those engaged in newer treatment approaches like neurotherapy whose client flow is
increasing. Any deviation from the expected standard of care (as defined by that provider)
is likely to result in a report to a licensing board or ethics committee. Of course, some
reports will occur because a provider is deviating from the expected standard of care.
2. Neurotherapy providers may be so enthusiastic about the results that they are seeing
with clients that they fail to use good judgement in designing advertisements, e.g.,
making claims that may be difficult to support with published research literature.
3. New treatment approaches that have the possibility of generating large incomes,
attract some providers who are greedy and/or who are not sufficiently enough trained to
provide competent services. Unethical, unprofessional or negligent behavior by any
neurotherapy provider has the potential of negatively influencing all neurotherapy
providers. Neurotherapy providers must help educate and police the activities of other
neurotherapists to help assure competent services.
4. Newer treatment procedures are always resisted by those engaged in more traditional
treatments. In addition, providers engaged in those newer treatments are often held to a
higher standard of care, e.g., neurotherapy for treatment of attentional deficit disorders
is expected to have been shown in a double blind study, even if not appropriate or
possible to do (Lubar, 1993). In addition, some providers believe that neurotherapy should
be proved on the basis of the medical model, although that model does not seem appropriate
(Othmer & Othmer, 1995).
5. Some providers truly believe that neurotherapy is not a bona fide treatment and
become concerned about protecting the welfare of clients. As such, they may talk to or
write letters to neurotherapists or licensing boards to try to protect clients against
what they think is very experimental. They might be responding to their ethical
responsibility to help police their profession. Some of these individuals are amenable to
changing their position if given information, especially if it is made clear that clients
are informed that a procedure is experimental.
Several issues specific to neurotherapy to which providers should attend will be
discussed in the sections that follow.
Competence
Providers should be sure that they are competent in any area in which they intend to
serve clients. Attending one weekend or even week-long workshop is not sufficient for
making an individual competent to practice neurotherapy. To be competent means a
neurotherapist has the knowledge, skills and abilities needed to perform the tasks
relevant to neurotherapy and to understand when it is appropriate to provide neurotherapy
or refer a client elsewhere (Bennet et al., 1990). The neurotherapist should be able to
provide the service at least at the minimally acceptable level at which it is provided by
other competent neurotherapists. The amount of reading and training needed varies from
individual to individual, depending on several factors, e.g., the amount of knowledge and
experience one has in human physiology and health care treatment. Besides knowledge and
training, a new neurotherapy provider will want to arrange for peer review (Woody, 1988)
of advertisements, brochures, informed consent documents and of his/her evidence of
competence. Someone knowledgeable and competent in neurotherapy and in the standards
expected by ethics committees and licensing boards should conduct this peer review.
Supervision/Consultation
The new neurotherapy provider will also want to arrange for appropriate supervision
and/or consultation by a competent neurotherapy provider. This supervision/consultation
should continue until the provider is truly comfortable in providing a specific type of
neurotherapy. Lubar (1995) recommends a supervised internship of one to two years to
become competent. One should again seek supervision if one begins to treat different kinds
of problems, where one's competence is unclear or when problematic situations arise. In
fact, Clayton and Bongar (1994) recommend that professionals establish and maintain
ongoing consultation.
The purpose of supervision and consultation is to: assure that no injury occurs to the
client/patient, that the client's rights are protected, and to protect the provider by
increasing the probability that peers would agree that the provider was providing
neurotherapy services that at least meet the, as yet unestablished, minimum standard of
care. If the supervision or consultation is entered into as a professional activity, the
conversation may be a privileged communication, if covered by state law (Arnold Conner,
1994). As such, should a problem arise, the supervisor/consultant could not testify in
court against you without your permission.
Supervision may be a better risk management option than consultation, because a
supervisor takes on a shared legal liability for what does and what does not happen. The
supervisor is legally and ethically responsible for what happens to clients. As such,
supervisors are more likely to get into the details of what is and what is not being done
and what should or should not be done. Consultants may also take on legal liability,
depending on whether the agreement between the provider and consultant specifies that the
provider can reject the consultant's advice and, thus, retains full responsibility for
treatment or if the consultant provides direct client services (Clayton & Bongar,
1994). A lawyer should be consulted to clarify any legal liability issues concerning
consultations. Obtaining supervisor and consultation can decrease a provider's risk of
providing negligent services or of being confronted by a licensing board and not being
able to prove that he/she was competent before engaging in neurotherapy practice. The
least risk occurs when the supervisor/consultant is competent in the areas of services
provided, a formal written agreement exists between the provider and supervisor/consultant
(if not from same agency), and where the provider and supervisor/consultant both document
events in the client's record (Clayton & Bongar, 1994).
Training Agencies
Equipment vendors and other agencies that provide training in neurotherapy should make
clear to all trainees that a weekend or even week-long training session is probably not
sufficient for making one competent to practice neurotherapy without supervision or
consultation. Even those with previous experience in providing neurotherapy who are
learning a new application may need supervision or consultation to assure that the
services provided are competent. Trainees who take seriously the need for competence
before providing direct client services can help protect clients and enhance the
reputation of neurotherapy.
Standard of Care
Standards of care are guidelines for delivery of service in a specific discipline or
area of practice. Defining the standard of care is generally left to the field/discipline
itself (Schwartz, 1982). Not all standards of care are written; thus they are subject to
interpretation by the group in a decision making role, e.g., a licensing board, an ethics
committee, a court. The standard of care most directly relevant to neurotherapy providers
currently are those in preparation by the Association of Applied Psychophysiology and
Biofeedback. Such guidelines will provide useful information on what is expected of
providers in delivering biofeedback services to clients and is likely to be the standard
against which one's behavior would be measured, if a lawsuit were filed against a
neurotherapy provider. A prudent neurotherapist will know and abide by all relevant
standards. New standards in neurotherapy may wellbecome available as groups certifying
neurothrapists (e.e., The Academy of Certified Neurotherapists) address the issues of
ethics and standards.
Standards of care are usually conservative. This is because they are designed to
protect the best interests of those served and to prevent the undue restriction of having
laws passed because a profession or group of practitioners (e.g., neurotherapists) do
not police the activities of their members (Arnold Conner, 1994). Legislators or the
courts tend to intervene when they believe that the best interests of the public are not
being served, because the standards of care do not adequately safeguard the public.
A second standard of care against which the practices of a provider are likely to be
measured is that of the provider's professional discipline, e.g., the American
Psychological Association's Specialty Guidelines for the Delivery of Services
(1981). Neurotherapists should be aware of all relevant standards of care for areas in
which they provide services and should abide by those standards. Standards of care possess
no legal authority, but are often recognized by regulatory and legal groups (Woody, 1988).
In addition, if providers do not possess the knowledge and skills of other practitioners
or exercise the minimally accepted diligence in the application of these skills, they can
be sued for malpractice if a client is injured (Arnold Conner, 1994).
Providers are expected to conduct their practice like a reasonable, ordinary and
prudent peer in the same type of practice would (Woody, 1988). The question to remember is
"What would a reasonable, competent, prudent provider do if faced with the same
situation that I have encountered?" This is the other standard of care against
which a neurotherapist's activities will be measured, i.e., the standards of other
practitioners of neurotherapy. The law expects all health care providers to be
prudent/cautious (Woody, 1988).
If a practitioner professes to be a specialist and is involved in a malpractice
lawsuit, the court will look for a national standard of care for that specialty. Not
belonging to the association that set the standard is irrelevant. The standard may still
be applied by the court. Degrees, licenses, certifications, telephone book ads, brochures,
etc., can all be used as evidence that one professes to be a specialist. Specialists are
held to a higher standard of care; thus it is best to be prudent in what one claims and
how one advertises.
A degree from a "diploma mill" not accredited by an agency approved by the
U.S. Department of Education can be problematic for a provider who does not possess skills
equivalent to those of practitioners from accredited degree programs. The standard used
will likely be that of the accredited programs; thus, "diploma mill" degrees
increase a provider's risk. Similarly, possession of a certification from The Academy of
Certified Neurotherapists, especially if "grandfathered," i.e., without passing
a test, means a provider should be sure that she/ he possesses the skills and competence
implied by that certification, because if problems arise he/she will be expected to have
those skills.
Is Neurotherapy an Experimental Procedure?
The answer to this question is not simple because it depends on who you ask, to which
application of neurotherapy you are referring and to contextual factors. Yet, in most
situations it is best to develop and carry out your practice, policies and procedures on
the premise that neurotherapy as an experimental procedure. But you say, "What about
the experimental evidence that neurotherapy is effective with Attention Deficit
Disorders?" or the fact that AAPB's clinical efficacy document considers EEG
biofeedback to be a non-experimental procedure for attention deficit and hyperactivity
diagnoses (Shellenberger et al., 1994)? These points are all right; but, in practice one
must deal with reality. Reality in this context suggests clearly that until a procedure
like neurotherapy is accepted and used by most providers, those that use it are subject to
charges, spuriously or otherwise, that they are using an experimental procedure. Dealing
even with a spurious charge (e.g., a nuisance lawsuit) can cost up to $50,000, lost time,
energy and reputation (Woody, 1988). At minimum, it is important to inform clients that
some professionals consider a treatment procedure for a specific problem to be
experimental, even if one personally believes it is not experimental. In such cases, a
reasonable body of literature or a published statement by a professional association
should exist. For example, AAPB considers neurotherapy to be an accepted and verified
treatment procedure for attention deficit and hyperactivity disorders, as listed in
Shellenberger, Amar, Schneider, and Turner (1994). It is, to date, the only such listed
neurotherapy procedure. In addition, the largest body of published literature exists for
neurotherapy with attention deficit disorders and attention deficit hyperactivity
disorders.
If no professional association specifies in published form that neurotherapy is no
longer experimental for treating a specific problem, then supporting the argument that
neurotherapy is an accepted treatment for that problem depends on the published research
literature. Sufficient publications are needed in refereed journals in all areas of
neurotherapy. In-house publications by an equipment vendor or training agency are not
sufficient.
In reality, neurotherapy will clearly move from being an experimental to a
non-experimental procedure when more providers are using neurotherapy than are using the
previous treatment of choice, e.g., medication. The process may occur more rapidly when
third-party payers start paying for specific neurotherapy procedures regularly. To get
third-party payers to pay regularly will require that they be educated on the utility of
neurotherapy based on research data and/or on consumer demand for the service. The
neurotherapy procedures used must be cost efficient, since the bottom line for third-party
payors is saving money. It is unclear how much or what kind of data is enough for
third-party payors, because each payor has its own rules and the personalities of the
decision makers influence the decisions made. Some third-party payers pay for neurotherapy
when provided by one provider, but not if provided by another. This may be due to the
degree of competence that the third-party payor judges the provider to have.
The bottom line for a neurotherapy provider is that if you want to reduce your risks,
you will be conservative in terms of what you claim is a non-experimental procedure. As
appropriate data become available and as practitioners and third-party payers become
educated on the utility of neurotherapy, many neurotherapy interventions will move into
the camp of being considered non-experimental procedures. This will take time.
A prudent neurotherapist will practice so that he or she minimizes the possibility that
a client claims he or she was not informed that a procedure was experimental, and that he
or she was injured by this procedure that he or she would not have agreed to receive if
he/she had known. Remember that it can be very expensive and emotionally draining to
defend yourself against charges of negligence, incompetence, failure to inform client,
making exaggerated claims, etc. It is easier to avoid such potential conflicts by being
prudent, being competent and continuing one's education.
Informed Consent
It has become common practice for service providers to obtain informed consent from
clients on all aspects of fees and collections, assessments and treatment procedures. In
fact, Austin, Molene and Williams (1990) state that it is the legal responsibility of a
therapist to obtain informed consent before treatment begins. One way to reduce risk is to
obtain this informed consent in writing. In neurotherapy, this is also the place that one
documents that the client was informed that this procedure is considered by many
practitioners and third-party payors to be experimental; but that many other providers,
including oneself (if you believe differently), have found the procedure to be effective
for the specific treatment being offered. This implies, of course, that evidence on
effectiveness does exist. The fewer data that exist to support a particular neurotherapy
intervention, the more important it is to give the client all of the information that a
reasonable person would want in deciding whether to agree to the treatment and to document
the process and consent in writing.
Being Sensitive
Being sensitive means being aware of areas that have resulted in problems for oneself
or other neurotherapy providers in the past. For example, several providers of
neurotherapy services have been forced by state licensing boards to change the content of
their advertisements and brochures to remove what the Board considered "exaggerated
claims" or failing to inform clients that a specific procedure was
"experimental." Being sensitive to the fact that regulatory groups are
conservative in how they interpret the standards of practice should forewarn
neurotherapists that they should be conservative in terms of what they claim if they want
to reduce their risk.
Being sensitive to the fact that those in private practice will try to protect and/or
increase their own income should forewarn a neurotherapist that he or she should be
prudent, should seek supervision and peer review as needed, and should get to know other
providers so that they can be educated about the benefits of neurotherapy.
FDA
The Federal Food and Drug Administration (FDA) has specific guidelines concerning the
approved use of biofeedback equipment, including that used for neurotherapy. The FDA
requires equipment manufacturers to obtain approval for each piece of equipment, for each
specific use. When buying equipment, find out what uses the FDA has approved for the
specific equipment. Each equipment vendor should be able to tell you if the FDA has
approved the use of a specific piece of equipment, what uses it is approved for, and what
other uses they have filed the necessary paperwork to get approved. The manual should
specify FDA approvals and restrictions, e.g., the Lexicor Manual for the Neuro Search-24
specifies that the equipment "is not intended for use in the evaluation of cerebral
death or diagnosis of tumors, multiple sclerosis, epilepsy or any other disorders of the
brain or nervous system" (no page number given, Lexicor Medical Technology, Inc.,
1994).
Using a piece of equipment for non-FDA approved purposes can be problematic. The FDA
has taken action against at least two manufacturers of EEG equipment for either failure to
get FDA approval on equipment and/or for failing to meet other FDA guidelines. In
addition, the FDA has raided and seized the neurofeedback equipment of at least one
provider that I know of, because the equipment was being used for non-FDA approved
purposes. The FDA believes that unless they have approved a specific use, it is not safe
for consumers. As such, it is in the interest of providers and vendors to abide by FDA
requirements. If appropriate, one might also lobby to change the FDA process, if one feels
strongly about it.
Being a Supervisor
A supervisor shares legal and ethical responsibility for what does and does not happen
to the clients of those whom one supervises. A practitioner should not agree to supervise
someone who is doing neurotherapy, unless the supervisor is him/ herself competent to
provide the specific type of neurotherapy service to the type of client being served. This
means, e.g., that if one has not used the alpha/theta protocol to treat alcoholism, one
does not agree to supervise someone using that protocol, even if one does other types of
neurotherapy.
Some state laws specify who can legally supervise others for specific purposes, e.g.,
the Texas Administrative Code for Licensed Professional Counselors (Texas State Board of
Examiners of Professional Counselors, 1994) specifies that a licensed Professional
Counselor (LPC) cannot supervise other LPC's for purposes of licensing, until after they
have been licensed for at least two years. A law may even restrict a professional to
supervising only those in one's own discipline, e.g., psychologists in Texas cannot
legally supervise unlicensed individuals engaged in what the law defines as the practice
of psychology (Texas Register, 1997). It is important for neurotherapists to be familiar
with the licensing laws used by their own discipline.
If one is not an experienced supervisor, one should receive training on being a
supervisor, before agreeing to supervise others. Ethical practitioners do not engage in
activities in which they themselves are not competent, which includes being a supervisor.
Besides training, a would be supervisor, should receive supervision on being a supervisor,
until competent. Supervising others when not present for any or all of the treatment
sessions provided by the supervisee requires unique skills, in terms of what type of
information to collect, to assure that what is agreed to in supervision is actually what
happens (baring extenuating circumstances). Supervisors should document their client
related activities in the client's file (Woody, 1988).
Advertising and Public Statements
Because written advertisements and public statements can be heard or passed on to
others, neurotherapists should be sure that they consider the development and distribution
of information carefully. Asking whether a prudent practitioner of neurotherapy would
agree with the statements made in an advertisement or public statement is not enough. One
must also ask, what would the response of the state licensing board or ethics committee of
associations to which I belong or should belong, be, if they saw this ad or heard this
statement? As Neal Miller has said often, "Be cautious in the claims you make."
Do not make statements that could be interpreted as promising cures. If you make such
claims and then fail to "cure" a client's problem, you can probably be sued for
breach of contract. Do not make claims that suggest that what you offer is better than
anything else available, unless you have the data to back up the statement. In essence, be
sure that your advertisements and public statements are honest, accurate and can be backed
up with data if you get called before an ethics committee, a court or another regulatory
agency. As pointed out by Woody (1988), even the general public is put off by claims that
sound too good to be true and thus will not seek services from a provider who makes such
claims. In addition, other health care providers will not make referrals to a provider
whose advertisements "turn them off."
State Laws
It is important to know whether the laws of the state in which one practices restrict
the practice of neurotherapy to providers with specific licenses or credentials. Some
state laws restrict the practice of biofeedback to licensed health care providers or even
to providers from specific disciplines. Neurotherapy could easily be defined by the courts
to be a form of biofeedback, since it is. It is also defined as such by AAPB and by the
Academy of Certified Neurotherapists. Practice neurotherapy within the guidelines of all
relevant laws of the state, e.g., Colorado law requires mental health providers to obtain
written informed consent before providing mental health services (Handelsman, et al.,
1995). Do you know if neurotherapy or EEG biofeedback is mentioned in any of the licensing
laws of the state in which you practice? You should know or should find out.
Medical and other Consultation
Certain diagnosis can legally be made only by licensed practitioners of specific
disciplines, as specified in state laws. For example, neurotherapists who are not also
medical doctors should avoid making medical diagnosis of conditions like epilepsy or
closed head injury, unless specifically allowed by the laws for their own discipline. When
a diagnosis is needed, a client/patient should obtain that diagnosis from an appropriately
licensed and competent practitioner. For some neurotherapists, this means referring the
client to an appropriate source. In making a referral, it is best to give the client
several sources from which to choose. Doing so protects the neurotherapist from being
accused of malpractice, if the source chosen provides negligent services.
Consultation with other professionals has become a common part of any health care
practice. Many, if not most, referrals are received from other health care providers. As
such, good relationships with other providers are critical to staying in practice. In
addition, a provider should know his or her areas of competence so that he/she: a) accepts
only those types of clients he/she is competent to treat, and b) refers clients elsewhere
when it becomes clear that a client needs a service one is not competent to provide or
when the client is not making progress in spite of consultation with knowledgeable
colleagues.
Responsibility
Neurotherapists, like other health care providers, are responsible for what they do or
fail to do in working with clients. In addition to being responsible for their own
behavior, they are also ethically responsible for trying to correct misleading or
unethical behavior by the agency in which they are employed and for addressing the
unethical behavior of other professionals. When one becomes aware of unethical behavior it
is useful to seek consultation in working through the process of what and how to deal with
the problem. If one is employed in an agency where one has a supervisor and the complaint
is not about the supervisor, then one can start by talking with that person. If legal
advise or specialized information is needed one will need to identity an appropriate
source for obtaining the needed information. Almost all of the ethical codes of
professional associations specify that one must either report the unethical behavior of
other professionals, one must try to resolve the issue through discussion with that
individual, or both. Approaching a colleague or referral source can be difficult, as can
reporting the person to an ethics committee. Failing to deal with ethical violations can
result in harm to clients and in this case, to the reputation of neurotherapy. For
professionals in some disciplines, e.g., psychology, failure to deal with the unethical
behavior of a colleague is by itself an ethical violation. If neurotherapists do not try
to educate or restrict the activities of providers who engage in unethical behavior, the
courts or state legislators will. In addition, liability insurance rates for all
neurotherapists will likely increase.
Vendors
Vendors are in a unique position to help increase the growth and reputation
of neurotherapy by continuing to act responsibly. Practitioners and vendors have similar
responsibilities. Ethical neurotherapy practitioners must put the needs and welfare of
clients before their own. This is so, even when the lure of extra income is strong, e.g.,
terminating services to a client when the goals of treatment have been achieved although
more income could be generated by keeping the client in service. In like manner, ethical
vendors are responsible for putting the reputation of biofeedback ahead of making extra
dollars that could be generated by selling neurotherapy equipment to those not qualified
to use it correctly or those excluded by the rules and\or regulations of the FDA or State.
Damage to the reputation of neurotherapy could also reduce the overall sale of
neurotherapy equipment. By not buying equipment from unethical vendors pressure can be
placed on them to change their behavior in ways that enhance the reputation of
neurotherapy.
Acceptance of Neurotherapy
Selling any, but especially, complex equipment (like that used for
Neurotherapy) to the general public can have a very negative impact on the reputation of
neurotherapy and on its acceptance by the general public, professionals and third-party
payors. Professionals still encounter other professionals and members of the general
public who bought alpha trainers in the early 1970s and were unsuccessful in producing the
desired mental state changes. These individuals probably did not have the skills needed to
use the equipment correctly, even if the equipment was of a quality nature. Even after
twenty years, some of these individuals still believe, that biofeedback is a hoax.
Neurotherapy does not need a repeat of this phenomenon because someone sells EEG equipment
to the general public or others not qualified to use it correctly. There will be enough
concern with individuals who are licensed, have taken a weekend workshop, bought a piece
of equipment and now think they can provide competent services.
Legal Implications
It is important that vendors sell EEG equipment only as specified by law.
This generally means selling only to licensed health care professionals and perhaps to
individuals who are appropriately certified, e.g., by the Academy of Certified
Neurotherapists. Doing so will help protect the general public, the reputation of
neurotherapy, the reputation and financial interests of equipment vendors and the
practices of professionals who make their living providing neurotherapy services. Selling
EEG equipment to the general public can readily become problematic. It may also be against
the rules of the FDA and thus illegal, could result in a vendor being sued if someone is
harmed and could delay the acceptance of neurotherapy by the general public and
professionals alike. Let me explain.
Changes in Brain States. The human brain is involved in the control
of all human functions. Neurotherapy can produce change in brain states; otherwise, it
would not be used. Neurotherapy produced change, is also associated with concomitant
changes in other human functions, like blood flow and glucose metabolism. If the service
provider uses the wrong protocol with an individual, it can result in negative side
effects like agitation and the inability to sleep. Such side effects are easily alleviated
if the person providing the training is competent to do neurotherapy or is supervised by
someone who is competent. What is the potential implication if the person doing the
training on themselves or others is not trained, licensed or certified and is not
competent, i.e., "Joe Public," and continues to train an inappropriate state
because of a lack of skill and knowledge, e.g., theta training with someone with a history
of seizures? Could harm occur to the individual? Could that harm result in professionals
considering the vendor and/or all neurotherapists to be irresponsible? Could such a
situation have a negative influence on the reputation of neurotherapy? Could the vendor be
sued? The answer to these questions is probably "Yes." The probability of
occurrence is higher if the incompetent person is already mentally unstable, has no
background in human physiology, is not trained or licensed in a health care field or
certified in neurotherapy or neurofeedback.
FDA Classification. The FDA probably classifies all EEG equipment as
a medical device. As I understand the FDA rules, the statement of purpose for a piece of
equipment cannot be changed to sell it to different groups, e.g., professionals versus the
public. Unless biofeedback equipment is used only for relaxation or "non
therapy" purposes, it is classified by the FDA as a "class two prescriptive
device." Prescriptive devices are not to be used for any other stated purposes (e.g.,
therapy), unless approved by the FDA which usually means being "prescribed" by
someone competent to do so. Generally, this means a physician, a psychologist or others if
so specified in FDA Regulations. One could readily conclude that such devices should not
be sold to the public. Therefore, EEG equipment should be sold only as allowed by law.
Defense. If harm comes to a member of the public who was sold a piece
of EEG equipment outside the rules of the FDA, the vendor may have compromised their
defense in a negligence lawsuit. It will probably be very difficult to defend oneself, if
one has already violated the law.
Harm and Negative Effects. If professionals who do not practice
neurotherapy learn of harm to even one person who did neurotherapy on themselves or others
when not qualified to do so, it can result in even stronger attempts to squelch
neurotherapy. Especially if those professionals have already seen a negative effect on
their own income because of neurotherapists who are practicing in the local area. At
minimum, negative publicity could have a negative influence on the reputation of
neurotherapy and neurotherapists. Any negative impact could further delay acceptance by
third party payors. It could also result in additional attempts to regulate the use of
neurotherapy by specific groups. It would not be unexpected for some professional
discipline, e.g., neurology to use such information to keep all other disciplines from
using neurotherapy. The American Association of Neurologists adopted some standards
several years ago in an attempt to prevent psychiatrists from doing EEGs.
Responsible and Ethical Vendors
Professionally responsible and ethical vendors should do their part by a)
agreeing to sell EEG equipment only to those legally qualified to purchase the equipment,
b) striving to protect the public and the reputation on neurotherapy by working with other
vendors and neurotherapists to control the sale of equipment and to maintain high
standards of honest advertising, c) helping to assure that those who are trained in the
use of neurotherapy do not believe they are competent to practice just because they
attended one training workshop and d) reporting those who do not abide by the law and/or
appropriate ethical principles.
When neurotherapy equipment is marketed or sold to the public, professionals and
ethical vendors should work together to prevent harm to the public and thus to the
reputation of neurotherapy. Does a vendor really want to be visited by the FDA for
violating the rules? Can a vendor afford it, emotionally or financially? Should ethical
neurotherapists buy equipment from such a vendor?
SUMMARY
In summary, risk management requires ongoing attention and training. Applied
psychophysiology, biofeedback (including Neurotherapy) and behavior medicine providers
should remain knowledgeable (competent) in all areas in which they practice; should be
sensitive to individual client and situation differences; should think and act
preventively; should seek consultation/ supervision when in doubt or practicing in new
areas; and should document their activities carefully. Well developed, written risk
management policies and procedures can help providers minimize risk while simultaneously
implementing services that follow the motto, "First and foremost is the welfare of
the client".
Whereas the management procedures for neurotherapy are similar to those for biofeedback
in general, risk may be slightly higher. Neurotherapy is a newer procedure, considered
experimental by many, and as yet, has no specifically established standards of practice,
thus increasing potential risks for providers. Neurotherapists should follow all of the
ethical principles and standards of practice for their discipline, AAPB and any other
relevant group. Written informed consent procedures are suggested. Providers should be
sensitive to prevailing standards, should practice only in areas in which they are
competent and should arrange for supervision and/or consultation, as needed. Educating
colleagues, clients/patients, regulatory boards, and third-party payers is essential for
neurotherapy to become better accepted. In addition, more research is needed to verify the
specific utility of neurotherapy. In the meantime, neurotherapists are advised to use
caution and prudence, in terms of claims made on the effectiveness of neurotherapy.
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Table 1. Most common areas for malpractice and ethical complaints *
A r e a s Percent
A.Poor office operation and poor records 38.7
1. Sexual Misconduct 22.5
2. Violations of confidentiality/privacy 8.5
3. Fee collection disputes 7.2
B. Lack of clinical sophistication and ongoing consultation 37.5
1. Improperly conducted treatment 18.5
2. Client lost due to evaluation 11.8
3. Incorrect diagnosis or failure to diagnose 7.2
C. Causing physical damage 14.8
1. Death of a client 10.5
2. Bodily injury 3.0
3. Assault and battery 1.3
D. Other 9.5
1. Slander, libel, or defamation of character 5.3
2. Involuntary treatment 3.6
3. Failure to warn 0.6
Total...100.0
_______________________________________________________________________
* Table created from information taken from Zuckerman and Guyett (1991).
Table 2. Items from the Percival and Striefel Survey which respondents found
controversial in terms of ethicalness
Controversial Items
1.Giving gifts to those who refer clients to you.
2.Having clients take tests (e.g., MMPI) at home.
3.Refusing to let clients read their chart notes.
4.Raising the fee during the course of therapy.
5.Using the same biofeedback instructions for all clients.
6.Performing forensic work for a contingency fee.
7.Accepting only male or female clients.
8.Crying in the presence of a client.
9.Telling clients of your disappointment in them.
10.Terminating therapy if the client cannot pay.
11.Obtaining only verbal permission to treat client.
12.Not allowing clients access to raw test data.
13.Avoiding certain clients for fear of being sued.
14.Giving personal advice on radio, TV, etc.
15.Telling clients what they should do.
16.Helping a client file a complaint about a colleague.
17.Allowing clients to run up a large unpaid bill.
18.Using a law suit to collect fees from clients.
19.Charging a client no fee for therapy.
20. Engaging in sexual fantasy about a client.
21.Accepting services from a client in lieu of fee.
22.Going into business with a former client.
23.Accepting goods (rather than money) as payment.
24.Being sexually attracted to a client.
25.Inviting clients to an office open house.
26.Becoming social friends with a former client.
27.Telling a client you are angry at him or her.
28.Going to a client's special event (e.g., wedding).
29.Sending holiday greeting cards to your clients.
Table 3.
Ten Samples of Controversial Ethical Items From The Percival and Striefel
Survey of AAPB Members and Possible Ethical Position
1. Giving gifts to those who refer clients to you.
2. Refusing to let clients read their charts/notes.
3. Raising the fee during the course of therapy.
4. Using the same biofeedback instructions for all clients.
5. Accepting only male or female clients.
6. Obtaining only verbal permission to treat client.
7. Telling clients what they should do.
8. Helping a client file a complaint about a colleague.
9. Allowing clients to run up a large unpaid bill.
10. Charging a client no fee for therapy.
Professionals do not engage in activities which the public might interpret to be a
conflict of interest. Fees are based on actual services received or given and not on the
referral itself.
Many states now have laws allowing clients access to their file. Good practice would
indicate that client files be maintained on the assumption that clients might access them.
Public distrust of the providers and of the field of biofeedback is likely to occur if
access in not provided within the guidelines of professional practice.
Fee disputes are one of the leading causes of malpractice lawsuits and complaints
against health care providers. It is prudent not to raise fees during treatment without
obtaining informed consent from the client first.
Each client's physiology and cognitive style is different; thus, the instructions given
to clients receiving biofeedback services should be individualized as needed by each
client. Giving the same instructions to all clients could preclude efficient progress.
Ethical service providers do not discriminate against anyone purely on the basis of
gender. If one is not competent to provide services to both males and females, more
training is recommended for the provider.
It is not unethical to obtain only verbal informed consent before providing treatment
to a client. Should a problem arise, however, failure to have documentation can result in
difficulties verifying that consent was obtained.
The goal of biofeedback is self-regulation; thus, paternalism can be problematic in all
but rare circumstances. In addition, ethical complaints and malpractice lawsuits have been
filed against health care practitioners on the basis of exerting "undue
influence". Care should be taken not to use coercion or even give the impression of
using coercion.
Clients have a right to know how to file ethical complaints against unethical
providers. Only by helping to "police" other providers can public trust be
maintained. Unethical behavior raises the cost of professional liability insurance for
everyone.
It is not unethical to allow clients to run up large unpaid bills. However, since
attempts to collect large unpaid bills leads to many complaints being filed against
providers, it is good practice to establish a payment schedule at the onset of treatment
and to maintain it within the guidelines of common practice.
It is not unethical to provide free (pro bono) services to some clients. Providing some
free or reduced fee services is one way to help make services available to clients who
might not otherwise have access.
Figure 1. INFORMED CONSENT FORM
Client Name: Date: Proposed Procedure:
a. Purpose:
b. Rationale: The proposed procedure is . . . is not experimental (circle the
appropriate answer)
Risks Benefits
Alternative Options:
1.
2.
3.
Option # Risks Benefits
Questions asked by provider to assure client understood options, risks and benefits.
1. 2. 3.
The proposed procedure, its purpose, the rationale for it, its risks and benefits,
alternatives, and their risks and benefits have been explained to me. I have received all
of the information that I need to make an informed decision. I understand my choices, am
competent to give consent, and voluntarily consent to the proposed procedure.
Signature of ClientDate Witness Signature Date
I do not consent to the proposed procedure:
Signature of Client Date Witness Signature Date
I n d e x
- Advertising
- Applied psychophysiology
- Assault and battery
- Behavior medicine
- Biofeedback
- Bodily injury
- Client
- loss
- records
- Competence
- Competent
- Confidentiality
- limits of
- violations
- exceptions
- Consultation
- Consultation and supervision
- Death
- Diagnosis
- Documentation
- Dual relationship
- Duty to warn
- EEG biofeedback
- Ethical
- complaints
- guidelines
- principles
- Ethics
- Evaluation
- Experimental
- evidence
- procedure
- FDA
- Fee collection disputes
- Grandfathered
- Improperly conducted treatment
- Incompetent
- Informed consent
- Injury
- Involuntary treatment
- Laws
- duty to warn and protect
- privileged communication
- Lawsuit
- Lawyer
- Legal
- Malpractice
- Managed care
- Medical clearance
- Misdiagnosis
- Negligence
- Neurofeedback
- Neurotherapist
- Neurotherapy
- Office procedures
- Ongoing education
- Physical damage
- Policies and procedures
- Privileged communications
- exceptions
- Professional conduct
- Release of records
- Respect
- Responsibility
- Risk
- Risk Management
- Policies and procedures
- Sexual misconduct
- Slander
- Standard of care
- Standards and guidelines of practice
- State laws
- Supervision
- Supervision/consultation
- Supervisor
- Touching
- Vendors
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