AAPB Standards for Performing Biofeedback

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AAPB Standards for Performing Biofeedback

AAPB Standards for Performing Biofeedback

Draft 7: 19 July, 2013

Dear members of AAPB’s board of directors: I have incorporated all of the comments I can. Frankly, I decided not to incorporate those changing this from a standards document to a set of guidelines.

AAPB’s and BCIA’s ethical guidelines documents follow our standards document. The committee recommends keeping them in place as part of this document.

Please be ready to vote on this version at the upcoming board meeting.

Thanks.

Rich

1 AAPB Standards for Performing Biofeedback

July 2013

The Association for Applied Psychophysiology and Biofeedback (AAPB) intends the standards detailed in this document to apply to every provider of biofeedback-related services whether or not he or she is a member of AAPB. It is anticipated that State health departments and other professional organizations will use these standards to assist in codifying the requirements for providing biofeedback-related services within their areas of jurisdiction.

This document was prepared by AAPB’s 2013 Standards Committee, which consisted of Richard Sherman (Chair), Paula Amar-Schwartz, Frank Andrasik, Shawn Criswell, Louis Csoka, and Linda Walker.

Table of Contents

I. Definition and Explanation of Biofeedback

II. What Biofeedback is Used for and Efficacy of its Applications

III. Organizations Setting the Standards for Biofeedback

IV. Training Required to Ethically and Knowledgeably Provide Biofeedback-Based Services

A. Professional Training and Credentials Needed to Provide Interventions 1. Technicians 2. Licensed/credentialed providers 3. Academic providers

B. The Requirement to Understand the Physiological and Psychological Relationships Between the Problem and the Underlying Physiological Dysfunction Causing or Contributing to It

C. The Requirement to Know How to Effectively Use Biofeedback Devices to Produce Accurate Readings and to Provide Optimal Learning

D. Maintaining Competency Through Training and Supervision

V. Special Issues Related to Biofeedback Equipment Use

A. Using Biofeedback Devices Initially Designed for Health Care for Optimal Performance Training

2 B. Selling Biofeedback Devices Directly to the Public

VI. Special Issues Related to Biofeedback Practice

A. Selecting and Charging for Interventions, Informed Consent and Duty to Protect/Patient Abandonment

B. Issues in Advertising Biofeedback-Based Services

C. Considerations for Client Privacy and Dignity

1. Touch 2. Chaperones D. Hygiene

E. Providing Distance Interventions

F. Coaching Clients During a Biofeedback Session

G. Medications and Other Co-occurring Therapies

VII. Use of Biofeedback Within the Research Environment

VIII. Appendix

AAPB Ethics Document

BCIA Ethics Document

I. Definition and Explanation of Biofeedback

In 2008, the Association for Applied Psychophysiology (AAPB), the Biofeedback Certification International Alliance (BCIA), and the International Society for Neurofeedback and Research (ISNR) approved the following definition of biofeedback:

“Biofeedback is a process that enables an individual to learn how to change physiological activity for the purposes of improving health and performance. Precise instruments measure physiological activity such as brainwaves, heart function, breathing, muscle activity, and skin temperature. These instruments rapidly and accurately "feed back" information to the user. The presentation of this information — often in conjunction with changes in thinking, emotions, and behavior — supports desired physiological changes. Over time, these changes can endure without continued use of an instrument.”

3 Biofeedback is a physiologically based learning tool to help people recognize how their physiologies are functioning under various circumstances. They can use this information to learn how to control those aspects that are not functioning optimally.

With proper training, biofeedback can be used by professionals in many fields. It should be understood that biofeedback is NOT a treatment alone, nor does it make a diagnosis. Rather it is an adjunctive tool to be combined with other standard interventions carried out by knowledgeable clinicians, educators or coaches.

Biofeedback techniques tend to be known as often by the physiological systems they monitor as by the problems they are used to help. For example, when muscle tension is being monitored, people conducting biofeedback tend to refer to it as “SEMG feedback”. SEMG stands for “surface electromyogram”, which is the way muscle tension is normally recorded. When brain activity is fed back (shown to a client on a monitor, etc.), the process is usually called “neurofeedback”, EEG biofeedback, or brain wave training.

The physiological signals recorded (such as muscle tension and brain waves) have been validated by hundreds of well-controlled studies to be related to the symptoms being treated. The recording technology is standardized and is accepted within professional communities involved with making psychophysiological recordings. The United States Food and Drug Administration (FDA) and equivalent international bodies provide regulatory support for biofeedback equipment.

Some devices used with biofeedback do not actually measure or feed back real-time information about a trainee. Instead, they send signals to entrain or stimulate the body's functioning. These devices do not provide biofeedback, whose hallmarks involve training and self-regulation. An example is audio-visual entrainment devices, which help entrain the brain's functioning by means of an external light and sound stimulus. Other devices may send a micro-current to influence hormone or neurotransmitter production or stimulate muscle activity or blood flow. Some of these devices label themselves as biofeedback devices but do not meet the legally accepted definition and characteristics. II. Biofeedback Uses and Efficacy

A number of biofeedback-based interventions have been well validated while others are at various stages of research. Many biofeedback-based interventions are accepted by medical societies such as the American Colleges of Pediatrics and Neurology as well as by the FDA as being safe and effective for particular conditions. Examples of validated interventions include treatment of migraine and tension headaches and Attention Deficit Hyperactivity Disorder (ADHD). The efficacy of some forms and uses of biofeedback have not yet been established through accepted types of research with sufficient numbers of patients, controls, and long enough follow-up periods. The book “Evidence-Based

4 Practice in Biofeedback and Neurofeedback”, published by AAPB, can be used along with updated information on AAPB’s web site (www.AAPB.org), “White Paper” efficacy reviews published in Applied Psychophysiology and Biofeedback and Journal of Neurotherapy, and other scholarly sources to estimate the level of efficacy for all of the major uses of biofeedback for clinical conditions.

Psychophysiology and biofeedback are used for many purposes in a variety of settings by many different types of professional in many settings including:

1. Assessment and treatment of clinical problems such as headache, ADHD, urinary incontinence, stress / anxiety, respiratory problems, sleep problems, drug addiction, pain, and many others.

2. Education for decreasing test anxiety, increasing focus for learning, and assessing learning processes.

3. Performance enhancement and optimal functioning for sports, business, and military activities.

4. Self-exploration including impact of life events on physiology, stretching the imagination, etc.

Professions incorporating psychophysiology and biofeedback into their work include teachers, physicians, nurses, dentists, physician’s assistants, psychologists, therapists, counselors, physical and occupational therapists / physiotherapists, coaches, corporate trainers, and researchers.

Biofeedback is performed in such places as schools, offices, homes, clinics, hospitals, and sports environments. III. Organizations Setting the Standards for Biofeedback

AAPB is the field’s main professional organization, while BCIA is the field’s main certification body. BCIA sets the minimum training standards anyone providing biofeedback-based interventions must achieve. The AAPB evaluates research on an on- going basis to determine how effective various biofeedback techniques are. It also determines how biofeedback can be provided – in other words, how it is “practiced”.

AAPB and BCIA work together to determine the minimum training standards for individuals providing biofeedback-related interventions. While BCIA certification is voluntary, practitioners must have the equivalent training. AAPB strongly urges practitioners using biofeedback as part of their practice to become certified by BCIA.

5 People providing biofeedback services must work within the scope of practice set by their parent professional organizations and the credentialing bodies in the state in which they work.

States license or certify professionals to provide certain interventions. There are no “national” licenses in the United States. States set the scope of practice for each profession in conjunction with state and national professional organizations. It is unethical for practitioners to provide interventions outside their scope of practice.

BCIA Certification: BCIA presently offers certification in general biofeedback, pelvic floor biofeedback, and EEG biofeedback. BCIA requires relevant background training, at least a Bachelor's level degree in a health care field, and continuing education for certification renewal. BCIA certification is not a license to practice.

Certified biofeedback practitioners must not mislead potential clients by implying that BCIA certification alone is a license to practice. IV. Training Required to Ethically and Knowledgeably Provide Biofeedback-Based Services

Even in cases where a state license includes biofeedback as a practice modality, training required to provide biofeedback services must include:

(a) formal professional training from an accredited university (e.g., education, counseling, health care or athletic training),

(b) an understanding of the physiological and psychological relationships between the problem being addressed and the underlying physiological underpinnings, and

(c) competency in use of the biofeedback device.

A. Professional Training and Credentials Needed to Provide Interventions

It is neither ethical nor appropriate for practitioners to identify themselves as “biofeedback therapists”. A person cannot be a biofeedback therapist because biofeedback is a tool or technique to be applied by a knowledgeable person within the context of an intervention and within the practitioner’s field of expertise.

Levels of Training

BCIA credentials individuals for three levels of expertise: technicians, clinicians, and academic and performance professionals.

6 (1) Biofeedback Technicians are people who do not have formal clinical training but who want to participate in providing biofeedback-based interventions for patients with clinical problems. These individuals can work under the direct supervision of an appropriately trained and licensed clinician. The clinician’s training must include biofeedback.

Knowing how to perform a good psychophysiological recording and produce a useful biofeedback display from the recording is not sufficient for providing the skills needed to train people to control their physiology. Technicians must receive specific direction and guidance from a supervising clinician before facilitating the biofeedback intervention. Any treatment changes must be directed by the supervisor. The supervisor must be present at the location where biofeedback-based training is taking place.

Technicians must meet the minimum training criteria required by BCIA including completion of a course in biofeedback or neurofeedback and in anatomy and physiology.

(2) Clinical Certificants are licensed, degreed practitioners who have added the tool of biofeedback to their practice.

By identity, they should first present themselves as educators, doctors, coaches, therapists and psychologists who happen to have an additional certification.

Clinicians must meet the minimum training criteria required by BCIA including completion of a course in biofeedback or neurofeedback and in anatomy and physiology.

(3) Academic and Performance Certificants are individuals who are using biofeedback devices for research, teaching and performance enhancement. These individuals must have at least a master’s degree from an accredited institution. Refer to www.BCIA.org for further details of required training.

B. The Requirement to Understand the Physiological and Psychological Relationships Between the Problem and the Underlying Physiological Dysfunction Causing or Contributing to It

A provider who lacks a significant understanding of the physiological and psychological relationships between the problems they are working with and the physiological dysfunction causing or contributing to them presents a huge conundrum within the field of biofeedback. [I changed the prior sentence considerably; hope this is better] This can contribute to very poor results upon follow-up outcomes and a less than positive reputation for the field among third party payors insurance companies and regulatory groups. Many people who have never had a course on the biological bases of behavior or

7 pain – blithely assume that they are competent to treat back pain, headaches, and a host of other physiologically based problems. At times, people providing biofeedback do not know that their results are no better than placebo levels because they do not conduct follow-up evaluations or keep abreast of the literature. This situation can occur even when people are true experts in using biofeedback devices and are well qualified professionals in some field but have no or minimal training in how the human body actually works. Many therapists try to train physiological systems to change in ways they cannot because of anatomical and physiological restraints. Anyone conducting any kind of biofeedback must have a thorough and updated understanding of anatomy and physiology. It is also a requirement to be familiar with the effects of medications patients / clients are taking.

C. The Requirement to Know How to Effectively Use the Biofeedback Device to Produce Accurate Recordings and to Provide Optimal Learning

Every person providing services or conducting studies that include use of a biofeedback device must meet BCIA’s standards for training in order to be able to use the device safely and effectively. This training must include practices for safe and hygienic use of biofeedback devices.

D. Maintaining Competency Through Training and Supervision

Biofeedback devices and techniques are changing rapidly. Practitioners providing biofeedback related services cannot remain competent without (a) keeping up with the literature in biofeedback, (b) taking continuing education training and (c) obtaining supervision. Practitioners providing biofeedback-related services must at least meet BCIA’s standards for maintaining competency.

Peer review is one way to assure that the best practices are being applied. Reviewers must be expert in both the condition being treated and in the relevant biofeedback techniques being applied. If a provider’s employer requires peer review, the process should always include built-in safeguards for due process including the right to rebuttal and the rights of both service provider and reviewer to add additional clarification. V. Special Issues Related to Using Biofeedback Devices

Biofeedback devices are used both in the clinical environment to assist in the treatment of diagnosed conditions and in the educational and coaching arenas to help people function better. Because most biofeedback devices were specifically designed for use in treating diagnosed clinical problems, they are under the control of the United States Food and Drug Administration, or the equivalent group in most other nations.

8 Biofeedback devices carry a Class II designation by U.S. Federal law, which means they are low risk, but must conform to special controls such as labeling requirements, post- market surveillance, and performance standards.

When used in the treatment of a diagnosed condition, the FDA requires that use of biofeedback devices be prescribed by an appropriately licensed provider such as a psychologist. In most states, this includes virtually all licensed or certified health care providers; the word “prescribed” does not imply that the provider be a physician or dentist but, rather that the state credentialing and licensing entities permit the use of biofeedback as one of the therapeutic approaches within a professional's scope of practice.

It is both illegal and unethical to treat a diagnosed condition with clinical biofeedback device if the provider does not have the appropriate license or state certification, or is not working under the direct supervision of a professional who does.

A. Using Biofeedback Devices Designed for Health Care for Optimal Performance Training

Biofeedback devices used in conjunction with optimal performance education and training (generally referred to as performance enhancement) are readily available and typically pose no danger when used by qualified practitioners. Most of the guidelines within this document apply equally to performance biofeedback providers. There are some exceptions and they have been noted accordingly throughout this document. Performance biofeedback practitioners in the field of sport or performance psychology must have the prerequisite academic credentials (advanced degrees in the field) and have the appropriate knowledge and experience in the applications of biofeedback. Every person providing services, which include use of a biofeedback device, must meet BCIA’s standards for training. Most sports and performance psychologists are members of the Association for the Advancement of Sport Psychology and many are members of AAPB as well. Both organizations provide guidelines on the proper use of their professionals’ expertise and of biofeedback technology.

B. Selling Biofeedback Devices Directly to the Public

Biofeedback devices expressly designed for clinical purposes and which do not have a clear non-clinical use must not be sold to individuals who are unqualified to prescribe them. Most biofeedback devices, however, can also serve within legitimate self- exploration interventions and be used by any consumer, coach or educator. A gray area concerns the sale of biofeedback devices useable for treating diagnosed clinical problems to the public when there is no intent to use these devices to treat diagnosed problems. Biofeedback devices can be marketed for clinical or non-professional use. It is in the

9 interest of the professionals, public and the manufacturers to clearly designate the intended use. Failure to do so may result in an inappropriate application resulting in an ineffective treatment for the consumer or, in the extreme, harm. Biofeedback devices designed for professional use must be sold only to qualified clinicians, coaches, therapists, members of the medical profession and educators who provide evidence of training as outlined in earlier portions of this document (see section IV, V). Non- professional (i.e. “home” devices) can be used to augment the treatment given in the professional setting. Home devices targeting the general population must have detailed instructions as to the correct use of the unit. Ideally, there would be some resource available (phone/web support) to guide the public. The explosion in the creation of biofeedback “apps” for iphones/droid systems presents unique challenges for the profession. Whenever and wherever possible biofeedback professionals/manufacturers should educate the public on the correct use of such applications. This may include educating the creator of such an app as to how to make the app more effective for the targeted audience. VI. Special Issues Related to Biofeedback Practice

A. Selecting and Charging for Interventions, Informed Consent and Duty to Protect/Patient Abandonment

Providers of biofeedback services must remain abreast of current professional literature related to the problem being addressed. This includes understanding efficacy of the treatments being utilized and the ability to apply current principles of evidence-based medicine to choose the appropriate intervention.

Providers must use their knowledge of the field to develop optimal interventions for each client. The intervention must be based on sound practice principles and include a logical progression through the intervention.

Ethical considerations in charging for non-validated biofeedback based interventions

There is solid evidence, which meets all of the usually accepted criteria for clinical efficacy, that several disorders can be effectively treated with biofeedback-based interventions. Providers having the appropriate training and credentials can ethically provide and charge for these treatments.

AAPB publishes a compilation evaluating the status and quality of research on biofeedback interventions for commonly treated disorders. Additionally, the National Library of Science provides a research database that can be helpful in determining the efficacy of biofeedback in treating specific disorders. Before charging for an intervention,

10 therapists/providers must use their avail themselves of all resources addressing the treatment’s validity of the treatment or intervention (see Section II).

If there is no reasonable support for biofeedback’s efficacy for a particular problem, therapists cannot ethically charge for the treatment.

Failure to adequately evaluate support for an intervention can lead to a therapist losing credibility with patients, third party payors, employers, and colleagues. It may result in loss of license, legal action and/or FDA confiscation of equipment.

The FDA does not approve specific treatments as such but it does provide “labels” indicating that the device has been shown to be safe and effective for a particular disorder.

While many biofeedback devices are now registered with the FDA, very few disorders have received labels. Most are only labeled for stress and incontinence.

Before using any biofeedback device for clinical purposes, the provider must be certain that it is FDA approved. An FDA approved device may not be labeled for the application the therapist intends to use it for. If the device is not labeled for the disorder to be treated, the provider is required by law to inform the patient – in writing - that the provider proposes to use the device “off label” and the patient must agree in writing.

There is nothing unethical about using a device off label as long as there is a strong rationale for doing so and there is strong empirical support from research and scientific organizations.

Therapists must understand that many biofeedback techniques are considered "non- validated" or "off-label" because they have not met any profession’s criteria for demonstrated efficacy. Therefore, the therapist must decide whether to charge for the suggested off-label treatment based on the extent to which it will address the patient's needs. Therapists cannot legally or ethically charge for a treatment for which there is no factual basis to conclude the treatment will succeed.

For further information on this situation see: (1) The Belmont report (1988) and (2) Guidelines for providing non-validated practices (Public Law 93-438).

Requirements for informed consent for therapy and/or training:

It is important to distinguish between actual, knowledgeable, informed consent to a treatment or intervention vs. therapist/trainer influenced compliance. This distinction is important because it is difficult to obtain true, informed consent from patient, as they typically do not possess the therapist's concepts, specialized vocabulary and understanding of the problem.

11 Therapists and performance specialists are ethically required to provide a brief, clear description of the intervention they propose and permit the patient to take it home for review. The description must match the reading level of the patient (a reading level at the sixth grade will cover most populations).

The description must set out the limitations and strengths of the treatment openly, honestly, and fairly. The patient must have a verbal explanation, including key aspects of treatment and relevant studies and have an opportunity to ask questions. The patient should be able to summarize key points.

Key aspects of treatment/training to be covered include:

 Any risks of biofeedback and associated techniques (e.g., reactions to sensor tape, abreactions during training, etc.)  Relative risk to benefit ratios of biofeedback techniques  Alternative interventions (e.g., performing progressive muscle relaxation training without biofeedback for tension headaches)  Limits of confidentiality

A provider must work with a client to establish objective, mutually agreed upon goals for the intervention. The client must indicate not only an understanding of the proposed therapeutic approach but acknowledge the possibility that the intervention may not achieve the desired goals. The client needs to be informed and demonstrate an understanding of the importance of informing the practitioner of any changes in medications, symptoms, or behaviors.

Providers are ethically required to take special care in insuring that the following groups understand the proposed intervention to the best of their abilities and can decline if they truly wish to:

(1) Children must be informed within the limits of their ability to understand. Practitioners must obtain their assent as well as the parents' or guardians’ consent.

(2) Prisoners, because they may not be free to decline therapy – especially if it is court ordered.

(3) Individuals who are mentally or intellectually compromised. Practitioners must exert special effort to inform such persons within the limits of their ability to understand and assent. People who may believe that machines control them or have other delusions need special attention.

If data gathered as part of a biofeedback-based intervention are to be used for research or educational purposes, the client must consent to this use in writing. Patient Abandonment and Duty to Protect

12 If the biofeedback treatment does not work or if the patient can no longer pay for a treatment that is progressing (e.g., when insurance is no longer available), therapists cannot abandon the patient. The therapist must make every effort to find a viable alternative for the patient or continue to work with the patient for a reduced fee or at no charge. The duty to protect is a legal concept that exists in most states. If a therapist has any reason to think that a client may be a danger to someone (or an organization) or their property, the therapist must warn that person or organization as well as the police and anyone else who may be concerned. This law takes precedence over any privacy considerations. Many states also have laws that require practitioners to report suspicion of abuse being perpetrated upon children, elders or disabled people. Practitioners are expected to know and follow ethics and regulations related to these issues. B. Issues in Advertising Biofeedback Based Services

Advertising is not restricted to paid advertising, brochures distributed or left in waiting rooms, or posters in public places. Any way potential clients find out about the therapist and the services the therapist offers is a form of advertising. This includes telephone directory listings, letterheads, business cards, items posted on the Internet, public statements about the therapist (relative to clinical practice), media presentations, testimonials, and in-person solicitations. In any advertising or publicity, therapists must clearly distinguish the difference between their state license and biofeedback certification and accurately state the efficacy of the treatment for the disorder or issue being addressed.

Additionally, therapists, researchers, educators, coaches and other practitioners must be accurate about their professional backgrounds and training. Failure to do so is a breach of ethical practice.

Testimonials are generally discouraged as they tend to be biased. Paid testimonials are generally considered to be unethical.

Advertising claims need to either match the biofeedback equipment’s FDA label or the therapist needs to present solid research from peer-reviewed published literature demonstrating a reasonable level of efficacy.

C. Considerations for Client Privacy and Dignity

1. Touch

State practice guidelines for several professions (e.g., psychologists, social workers, marriage and family therapists, counselors) may prohibit their practitioners from touching

13 patients in any way, even though biofeedback is considered within the professional's scope of practice. When practitioners are prohibited from touching their patients, they must explore how sensors can ethically and appropriately be applied to a client or trainee.

In many cases, practitioners can instruct clients in appropriate sensor application without the need to touch their patients. Alternately, they may ask a significant other to place the sensor under supervision, or have an appropriately licensed health care professional assist in placement. Most state organizations have guidelines about touching patients for innocuous purposes, as long as the therapist is appropriately trained and can identify the need to do so for a specific, accepted, therapeutic reason.

Those engaged in sports and performance interventions may need to touch clients to apply sensors, but this touch should never involve areas of the body that would be considered sensitive. Practitioners must ask for and receive permission prior to applying sensors.

Practitioners who have specific concerns regarding touch are advised to discuss their situation with the appropriate state professional organizations.

2. Chaperones

Some therapists mistake their comfort with a client for the client’s comfort with them. Clients can be very uncomfortable in many situations but not be willing to verbalize their feelings. This can potentially disrupt the patient-therapist relationship and can even result in the individual leaving therapy prematurely.

Sensors sometimes need to be attached to the low back, which may mean that parts of the upper buttocks have to be exposed. Other times, sensors need to be placed on the very low abdomen below the normal level of the undergarments. For treatment of fecal incontinence and male urinary incontinence, a rectal probe has to be placed and held in position by an individual trained to do so.

Therapists should not assume that a client of either gender is comfortable having a therapist of either gender see or touch private areas or have them touched during the sensor application process. Before placing sensors in sensitive areas, the therapist must be certain that the patient actually understands why this needs to be done. Patients should place their own sensors when possible.

When sensors must be placed by the client in sensitive areas -- as in a woman inserting a vaginal probe, private dressing areas or facilities must be provided. Further, clinicians facilitating these interventions must be specially certified to address these disorders.

In biofeedback applications involving sensitive anatomical areas, a chaperone must be utilized under all circumstances. Some examples would include the following:

14 1) Sensors attached to the low back at L4, which may mean that parts of the upper buttocks have to be exposed depending on how the patient is configured.

2) Sensors that need to be placed on the very low abdomen below the normal level of the underwear.

3) Rectal or vaginal sensors that must be held in place by the clinician, as in treatment of fecal incontinence and male urinary incontinence.

Therapists must always have a chaperone of the same gender as the patient in the room when applying and removing sensors placed in sensitive areas. This applies even if the therapist and the patient are the same gender. It is unethical not to have a chaperone present under these circumstances.

E. Providing Distance Interventions

If practitioners are providing biofeedback-based services via distance communications such as the Internet, they must follow the requirements of their professional organizations as well as state licensure / certification boards. Being licensed in one state does not necessarily mean the provider can provide services requiring a license / certification in another state. Coaching can be provided throughout a distance based biofeedback session through the use of software providing real time audiovisual communication between the client and provider.

F. Coaching Clients During a Biofeedback Session

Clients do not learn to control their physiologies by merely observing a biofeedback display. Rather, clients must be coached throughout a biofeedback session using the principles of operant conditioning and other training techniques. Clients must not be left alone to attempt changes for significant periods of time unless this is a specific goal for the client.

G. Medications and Other Co-occurring Therapies

Medications can alter the physiological signal, the patient’s ability to regulate the signal, and may even contribute to the problem being addressed with biofeedback. Conversely, biofeedback training can alter the dosage of medication needed. Clinicians must be aware of what medications the client is taking and know which medications dosages are likely to change during the course of biofeedback. Clinicians may need to monitor medication side effects. If clinicians are not the prescribers of medications, they must communicate with the prescriber regarding any concerns pertaining to current medication levels or indications suggesting changes may be needed.

15 Non-prescribers must not recommend that trainees / patients change prescribed medications. Rather, they must discuss the potential need for changes with the provider who prescribed the medication. If the prescriber will not co-ordinate with the biofeedback provider, the provider may have to cease treating the patient rather than risk negative effects. VII. Use of Biofeedback within the Research Environment

Biofeedback devices are used for both human and non-human studies. Five of the most common uses are (a) delineating the limits of psychophysiological self control, (b) exerting voluntary control over some aspect of physiology to determine the effect on a disorder or some performance element, (c) evaluating the effectiveness of various training techniques for establishing psychophysiological self-control, (d) monitoring people’s reactions as they respond to simulated events such as advertisements, and (e) establishing the efficacy of biofeedback techniques for controlling a disorder.

Many researchers have no formal training in teaching, coaching or conducting clinical work. While it is appropriate for scientists and academicians to conduct research utilizing biofeedback devices, they must meet BCIA’s requirements for knowing how to use biofeedback devices of the type they are working with and collaborate with appropriately trained and licensed clinicians, educators, and coaches when disorders are being explored.

Individuals conducting research using biofeedback devices must work within all relevant federal, state, and institutional standards including approval by the relevant human and animal use committees.

Some organizations and practitioners refer to non-validated techniques as being in the “research” stage of development. This does not imply that actual studies are being conducted to determine the efficacy of the technique. Some practitioners who regularly provide and charge for non-validated techniques refer to these techniques as being “research”. This could lead patients to believe that research is being conducted on the technique. It must be emphasized that providing non-validated interventions outside of a properly delineated and approved study does not constitute research and must not be referred to as such.

16 VIII. Appendix

Ethical principles promulgated by AAPB and BCIA that cover practitioners providing biofeedback:

Every person providing biofeedback services is required to follow the ethical principles stated by AAPB and BCIA. The AAPB and BCIA ethical principles are equally applied to all non-clinical applications of biofeedback by educators, trainings, and coaches. These ethics documents are provided below. Providers must also follow the ethical standards of their professional organizations. AAPB’s Ethical Principles

2003

I. Preamble

The Association for Applied Psychophysiology and Biofeedback (AAPB) and its membership are committed to the protection of human rights. AAPB members strive to maintain the dignity and worth of the individual while rendering service, conducting research, and training others. All members are expected to abide by all relevant laws of the state in which they practice and operate within the principles of ethics governing their own discipline and those outlined herein. Members strive to provide optimum quality services and to differentiate for those served whether procedures provided have been proven effective clinically or if such procedures are, as yet, non-validated. They accept responsibility for their actions and make every effort to protect the welfare of those they serve and the public. They limit their services to those areas in which they have skills and expertise and recognize their needs for competence, objectivity, freedom of inquiry, and honest communication.

This statement of ethical principles is intended for use by all AAPB members and other providers of psychophysiological self-regulation services including practitioners, administrators, researchers, educators, and students. It encompasses all aspects of applied psychophysiology, including, but not limited to, all forms of biofeedback and neurofeedback. Acceptance into AAPB commits the member to adhere to these principles. These ethical principles apply only to AAPB members' professional service, research, administrative, and educational activities.

A copy of these ethical principles will be sent to all members and applicants for membership in AAPB. The principles are intended to be preventive, educational, guiding, and action oriented, and are to be applied with professional maturity. Members are required to cooperate with the Ethics and Standards Committees of AAPB or State

17 Chapters by responding promptly and completely, in writing, to inquiries from ethics and standards review committees. Lack of response by members to inquiries from the Ethics or Standards Committee may be a basis for reprimand and/or expulsion. In addition, members are subject to the principles of ethics of their own professional disciplines. Individuals who are not members of AAPB, but who practice applied psychophysiology and biofeedback, are encouraged to adhere to these ethical standards to help maintain and improve the quality of applied psychophysiology and biofeedback services.

A. Revision

Ethical principles are not static because practice activities are continually changing based on experience. Ethical principles must be updated periodically if they are to continue to provide meaningful guidance to AAPB members. As such, the ethical principles are revised on a regular basis. Comment is invited.

Each ethical situation encountered is different and may require a different solution. AAPB members must learn to enhance their ethical reasoning ability and make a personal, life-long commitment to continue their ethical education and to behave ethically in all of their professional activities. They are encouraged to seek consultation or supervision when they have ethical concerns and to encourage colleagues, supervisees, students, and employees to behave ethically.

This revision supercedes all previous versions as of the date it became effective: 2003.

II. Purpose and Scope

The Ethical Principles of Applied Psychophysiology and Biofeedback consists of a set of guidelines agreed to by the AAPB which outline the moral duty, obligation, or custom on how members should behave professionally. The Ethical Principles that follow are not all-inclusive and should not be viewed as limiting the scope of responsibility of AAPB members. Rather, the principles that follow point out and underscore particular areas in which there is concern.

1. The Ethical Principles of Applied Psychophysiology and Biofeedback are to be followed in the provision of psychophysiological self-regulation services. Members supervising others must ensure that the principles are adhered to by their employees and other supervisees engaged in applied psychophysiology, biofeedback, and all related activities, as well as by individuals receiving training in the use of applied psychophysiology and biofeedback. AAPB members will inform their employers of these Ethical Principles and will make every effort to urge their employers to cooperate with them in adhering to these principles. 2. The Ethical Principles of Applied Psychophysiology and Biofeedback constitutes the ethical guidelines against which the ethical conduct of an AAPB member is measured. 3. A violation of the Ethical Principles of Applied Psychophysiology and Biofeedback may lead to disciplinary action or expulsion from AAPB and/or a letter to BCIA or

18 the appropriate state licensing/certifying agent or the state or national association of the individual's professional discipline concerning the charges or action.

A. Responsibility

In utilizing applied psychophysiology and biofeedback, AAPB members adhere to the highest standards of their profession. They behave responsibly; accept responsibility for their behavior and the consequences of their behavior; ensure that applied psychophysiology and biofeedback services are used appropriately; and strive to educate the public concerning responsible use of applied psychophysiology and biofeedback in treatment, research, and training.

1. Each AAPB member is responsible for adhering to the ethical principles of their profession; the local, state and federal laws relevant to their professional activities; the Ethical Principles of Applied Psychophysiology and Biofeedback and the Practice Guidelines and Standards for Providers of Biofeedback and Applied Psychophysiological Services. 2. As practitioners, AAPB members recognize their obligation to help clients acquire knowledge and skill within the confines of the highest professional standards and in the most cost efficient/effective manner possible. 3. As teachers, AAPB members encourage the free pursuit of learning by their students, consistent with their obligation to help other acquire knowledge and skill, and present information objectively, accurately and fully. They are guided by a conviction of the worth of advancement of knowledge. 4. All AAPB members, either as individuals or through mechanisms available form AAPB or other professional organizations are responsible to be alert to and report to the AAPB Ethics Committee false claims and misrepresentative statements about applied psychophysiology and biofeedback. 5. All practitioners realize that their professional activities with clients may result in changes in the lives of those clients and others. As such, practitioners guard against misuse of their influence and actions and take reasonable steps to minimize and correct the misrepresentation or misuse. They avoid any dual relationship in which there is a high probability of direct or indirect abuse of their power. 6. Applied psychophysiology and biofeedback services are continued only as long as it is reasonably clear that clients are benefiting from the services. If another type of intervention is needed for which the practitioner is not qualified, the practitioner assists the person in obtaining the appropriate therapeutic services. Clients are never to be abandoned. If a conflict occurs between these ethical principles and a law, state or federal regulation, legal authority, or organization with which an AAPB member is affiliated, he or she will make known his/her commitment to these ethical principles, will clarify the conflict, and take reasonable steps to resolve the conflict in accordance with law and these ethical principles.

B. Competence

AAPB members recognize the boundaries of their competence and operate within their level of competence using only those biofeedback, other psychophysiological self- regulation techniques, and other client assessment and intervention techniques in which

19 they are competent based on education, training and experience (supervised and unsupervised), study, consultation or other professional experience. They also recognize the proper limitations of psychophysiological self-regulation and inform all concerned parties about the clinical utility of particular procedures, possible negative effects, and whether the procedures are nonvalidated or clinically verified. AAPB members remain current on knowledge concerned with scientific and professional applications in those areas in which they practice.

1. AAPB service providers should have at least “entry level” competence; i.e., licensing or certification from the appropriate state or national association relevant to their professional activities. 2. Applied psychophysiology and biofeedback assistants and technicians who are not professionally licensed or certified shall engage in applied psychophysiology and biofeedback practice activities only under the supervision of a qualified professional. 3. Misrepresentation of one's qualifications, training, experience, degrees, and/or specialty is a violation of ethics and may be a violation of the law in some states. 4. Practitioners take it upon themselves to seek and obtain appropriate training and supervision when providing services in areas in which they are not yet competent. In addition, they seek continuing education, training, and supervision or consultation, as needed to maintain and expand their areas of competence.

In new service applications for which competence has not yet been defined, or where treatment standards do not yet exist, practitioners take extra precautions to protect those they serve and to keep those served informed (informed consent).

C. Standards

AAPB members are sensitive to prevailing community moral and ethical standards and to the possible negative impact that deviating from those standards may have upon the quality of their performance in providing applied psychophysiology and biofeedback services, in fulfilling their professional responsibilities and in maintaining public trust in applied psychophysiology and biofeedback. Sexual contact with patients/clients, trainees, and research subjects is never ethical.

1. No member may resign from AAPB while an ethical investigation of their behavior in relation to his or her professional applied psychophysiology and biofeedback services is in progress. 2. It is an obligation of AAPB members to report alleged ethical violations concerning applied psychophysiology and biofeedback and their application to the Ethics Committee of the alleged violator's professional discipline and/or to the Ethics Committee of AAPB. 3. Members will charge only for services actually provided by them or those provided by others under their direct supervision. In billing third-party payers, practitioners abide by the rules and regulations of the third-party pay or which generally means to clearly specify which service they provided directly, which they supervised, as well as providing information on degree, licensure, and/or certification information about the provider.

20 4. Members clarify any potential or actual conflict of interest that exists when serving clients, conducting training or research, or when engaged in any other professional activity. 5. Informed consent shall be obtained from clients for all assessment, treatment procedures, billing, fee collection, and procedures to protect confidentiality (limits of confidentiality, and any such other procedures and activities where informed consent is deemed appropriate. 6. Written informed consent shall be obtained from clients for all nonvalidated treatment procedures. Determining which procedures are nonvalidated can be difficult, yet it is a necessary activity. To determine which procedures are nonvalidated requires being familiar with documents such as AAPB's current version of the Clinical Efficacy and Cost Effectiveness of Biofeedback Therapy: Guidelines for Third-Party Reimbursement, the Clinical Applications of Biofeedback and Applied Psychophysiology: A Series of White Papers Prepared in the Public Interest by AAPB , and the published scientific literature related to biofeedback and psychophysiological self-regulation.

Practitioners are responsible for informing clients about the intervention that has the best documented outcome data so that clients can make informed decisions.

Each practitioner has the right and responsibility to use the intervention for which the best empirical outcome documentation exists, provided that he/she is competent in the use of that intervention and provided that the client has given informed consent. If not competent in the use of the desired intervention the practitioner seeks additional training, supervision and/or consultation, or refers the client elsewhere as deemed most appropriate to the situation and the client's needs.

AAPB members make reasonable efforts to ensure that their assessments, diagnoses, recommendations, and reports are accurate, appropriate to a client's needs, and based on techniques and information that substantiates their findings.

D. Public Statements

AAPB members recognize that all public statements, announcements of services and products, advertising, and promotional activities concerned with applied psychophysiology and biofeedback should be conducted in such a manner as to help the public make informed choices. Statements about applied psychophysiology and biofeedback will be based on scientifically verifiable information, including recognition of the limits and uncertainties of such data. AAPB members accurately represent their qualifications, affiliations, and functions and do not mislead the public.

1. Providers of applied psychophysiology and biofeedback services shall accurately represent the efficacy of applied psychophysiology and biofeedback procedures for all disorders or conditions being treated. 2. In providing service, publishing, marketing a product, and in all other professional activities, AAPB members use truthful and do not use misleading information in either direct or indirect statements about applied psychophysiology and

21 biofeedback. AAPB members consider the context and source requesting information when making a public statement and guard against misrepresentation. 3. AAPB members recognize that they have financial or career interest in the promotion of applied psychophysiology and biofeedback activities and agree that this interest must be superseded by professional objectivity, humanistic concern, and their ethical principles. When a question arises as to their objectivity, they seek professional consultation and guidance from appropriate professional sources such as AAPB, the professional association of the discipline in which they are licensed, or from other qualified sources. 4. Membership in AAPB will not be used directly or indirectly as evidence of competence in applied psychophysiology and biofeedback or as justification for offering to provide applied psychophysiology and biofeedback services or any other service. AAPB does not evaluate the competence of individuals who apply for membership; therefore, membership by itself is not to be interpreted as an endorsement of competence. The Biofeedback Certification International Alliance and other appropriate professionally recognized certification may be used directly as an indication of at least entry-level competence in biofeedback. 5. Announcement and listings of services and training offered by AAPB members, such as telephone directory listing, letterheads, business cards, and descriptive brochures should be made in a professional manner and must adhere to the guidelines of the profession to which the member belongs. Only factual and accurate claims are to be made. 6. AAPB members shall disclose any conflict of interest to all relevant parties; e.g., if a member is conducting a workshop and recommends a specific product in which the trainer has a financial interest, such interests shall be disclosed to all attendees.

E. Confidentiality

AAPB members maintain confidentiality of information obtained from persons in the course of their professional activities. Release of information requires the written consent of the client, the client's legal representative or the existence of a situation in which not to do so could result in danger to the client or others. AAPB members specify in advance the legal limits of confidentiality to clients/patients, particularly as it pertains to collection of fees and laws that require reporting, such as child abuse and neglect reporting laws. Confidentiality applies to clients in treatment, students in training and to research participants.

AAPB members keep appropriate records of all professional activities engaged in with or on behalf of a client as specified in AAPB's Practice Guidelines and Standards. Client records are stored or disposed of in ways that maintain confidentiality. Records will be kept for a minimum of 7 years and will be retained longer if required by state law or by the AAPB member's own professional discipline. All AAPB members will be familiar with and comply with any relevant state or federal laws and regulations concerning confidentiality, e.g., the new federal law known as HIPAA (Health Insurance Portability and Accountability Act).

F. Protection of Client Rights and Welfare

22 AAPB members protect the welfare of clients, students, research participants, and other groups with whom they work. They inform all consumers of their rights, provide them with a written statement of these rights, and fully inform consumers as to the purpose and nature of procedures to be implemented and assure that clients' rights are not abridged.

1. In attaching biofeedback sensors (electrodes), AAPB members assure that the privacy and rights of the clients are protected. They respect the feelings and sensitivities of the client and make every effort to act within the client's desire for modesty. 2. Special care will be taken to protect the rights and consent of children receiving service, training, or when involved as research subjects. 3. Caution and common sense are required whenever an AAPB member has physical contact with a client: e.g., in attaching electrodes. Sexual intimacies with clients are prohibited. In addition, touching and massage require client permission and are restricted to those body areas considered appropriate for touch or massage within the realm of “common practice” for one's professional discipline. Touching of sensitive body parts, such as breasts or genitals, is not acceptable in applied psychophysiology and biofeedback practice with the exception of an appropriate medical exam or medical treatment provided by a licensed medical practitioner. Clients can be instructed in electrode placement using visual aids such as diagrams of the body. 4. AAPB members do not discriminate against or refuse services to anyone on the basis of gender, ethnicity, race, sexual orientation, age, disability, socioeconomic status, language spoken, religion or national origin. Members should, however, refuse to provide services in areas in which they are not competent unless appropriate supervision or consultation by someone competent in that area of service is available, so that the services provided do not fall below the “expected minimal standard or care.”

G. Professional Relationships

AAPB members recognize the interdisciplinary nature of applied psychophysiology and biofeedback and respect the competencies of colleagues in all professions. They strive to act in accordance with the obligations of the organizations with which they and their colleagues are associated.

1. AAPB members are responsible for assuring that all patients/clients referred for treatment of a medical disorder or in whom a medical disorder is later identified are treated only in conjunction with medical consultation, as necessary, to best serve the welfare of the client. 2. Members should strive to be objective in their professional judgment of colleagues and should strive to maintain good professional relationships even when opinions differ. Members cooperate with other professionals in an effort to ensure that the professional service needs of clients are met. 3. AAPB members avoid dual relationships with their patients/clients that could impair their professional judgment or increase the risk of exploitation. At any time, a patient/client may re-enter treatment either for the same symptom or another problem. The dictum “once a patient, always a patient,” should be adhered to regarding not having any sexual contact with patients/clients. Members do not

23 exploit clients, students, supervisees, employees, research participants or third party payers. 4. Members do not engage in any form of sexual harassment or any other form of harassment that is demeaning to a person with whom they work based on, but not limited to, factors such as gender, ethnicity, race, sexual orientation, age, disability, socioeconomic status, language spoken, religion or national origin.

H. Research with Humans and Animals

AAPB members conduct research to advance understanding of basic behavioral principles, to improve human health and welfare, and/or to advance science. As such, members ensure that in the conduct of research the welfare of research participants (human and animal) is prohibited. All research will adhere to federal and state regulations and the professional standards of the member's profession with regard to the conduct of research. Research involving humans is subject to governance by local institutional review boards and to the Code of Federal Regulation as appropriate and/or required by the Department of Health and Human Service' Regulations for the Protection of Human Research Subjects (45 CFR 46 and 56 FR 28003) . All animal research is subject to local institutional animal care and use committees, as appropriate, and must be in compliance with the Federal Policies on Humane Care and Use of Animal (A 3434-01)

1. The results of research will be released in a manner which accurately reflects research results, and only when the findings have satisfied widely accepted scientific criteria. Any limitations regarding factors such as long-term effects and population samples will be explicitly stated. All descriptive materials regarding clinical practice will be factual and straightforward. 2. Responsibility for the establishment and maintenance of acceptable ethical practice in research always remains with the individual investigator. The investigator is also responsible for the ethical treatment of research participants by collaborators, assistants, students and employees all of whom, however, incur similar obligations. 3. Information obtained about research participants during the course of an investigation is confidential. When the possibility exists that others may obtain access to such information, ethical research practice requires that this possibility, together with the plans to protect confidentiality, be explained to the participants as part of the procedure for obtaining written informed consent. 4. Ethical practice and federal regulations require the investigator to inform the participant of all features of the research that reasonably might be expected to influence willingness to participate and to explain to other aspects of the research about which the participant inquires. The ethical investigator protects participants from physical and mental discomfort, harm, and danger. If the risk of such consequences exists, the investigator is required to inform the participant of that risk, secure informed consent before proceeding, and take all possible measures to minimize distress. A research procedure may not be used without consideration of the risk/benefit ratio particularly if there is more than minimal risk to participants. As risk for participants increases so does the responsibility of the researcher to protect the research participants. 5. Ethical research practice requires the investigator to respect the individual's freedom to decline to participate in research or to discontinue participation at any time. Participants must be informed of their right to decline to participate or to

24 discontinue participating at any time. The obligation to protect this freedom requires special vigilance when the investigator is in a position of power over the participant. The decision to limit this freedom increases the investigator's responsibility to protect the participant's dignity and welfare. 6. After the data are collected, ethical practice requires the investigator to provide the participant with the opportunity to obtain full clarification of the nature of the study. When scientific or human values justify delaying or withholding information, the investigator acquires a special responsibility to assure that there are no damaging consequences for the participant. 7. In doing clinical research, researchers consider all possible research designs. They take care to not to use a waiting-list control when another validated treatment exists without due consideration of the consequences of doing so. Generally, a waiting–list control is not appropriate if a validated treatment exists and the risk of harm to the subjects is more than minimal. Potential research subjects must be informed of the validated treatment and must consent to participate thereafter. Members will be in compliance with AAPB's current research guidelines concerning research validation and methodology.

III. Complaints and Concerns

When the above standards are unclear and whenever appropriate, the ethical standards of the American Psychological Association, American Psychiatric Association, the American Nurses Association, the American Physical Therapy Association, the American Medical Association, the American Dental Association, the American College of Sports Medicine, the American Academy of Physical Medicine and Rehabilitation, or other professional associations pertinent to the individual in question shall be used as a guide in determining whether the member has violated his/her professional standards.

When a complaint is made, the AAPB Ethics Committee shall use these ethical principles in evaluating the AAPB member's conduct. The Ethics Committee shall recommend appropriate additions, deletions or revisions to these Ethical Principles, as necessary, to the AAPB Board for approval. Thereafter the membership of the AAPB shall be required to adhere to the revised Ethical Principles.

The AAPB will advocate for psychophysiological self-regulation, biofeedback, applied psychophysiology and biofeedback research, training and service. As such, AAPB will be responsive to individuals or agencies when questions arise concerning what is “common practice” in applied psychophysiology and biofeedback.

IV. Ethics Committee Procedures

The major concerns of the Ethics Committee of AAPB are to protect the public against unethical practices by AAPB members and to educate the membership concerning acceptable ethical practice. The committee attempts to have complaints resolved by the ethics committee of a member's profession whenever possible.

25 When that avenue fails, is inappropriate, or when the AAPB member is not professionally licensed or certified, the committee attempts to resolve complaints privately and informally and to recommend disciplinary action when unethical conduct is found to exist.

The goal of the ethics committee is to be constructive and educative, rather than punitive. The committee will attempt to have the complaint resolved by the local or state biofeedback society if one exists. When a complaint is received, the formal procedures of the AAPB will be followed.

Individuals desiring more information about the ethical principles or wishing to register a complaint may contact the Executive Director of AAPB or any member of the Ethics Committee.

V. History of the Document

Appreciation is expressed to the American Psychological Association whose format for ethical principles was used as a guide for these principles. Copyright 1981 by the American Psychological Association. Adapted by permission of the publishers.

Originally prepared by Sebastian Striefel, Ph.D. and the AAPB Ethics Committee for the March 1983, Board meeting. The ethical principles were adopted by the Board in January 1984.

The First Revision was prepared by Sebastian Striefel, Ph.D., in August, 1986 and was adopted by AAPB Board in March 1987.

The Second Revision was prepared by Sebastian Striefel, Ph.D., in August, 1989 and adopted by AAPB in October 1989.

The Third Revision was prepared by Sebastian Striefel, Ph.D., in January 1995 and adopted by AAPB in April, 1995.

The Fourth Revision was prepared by Sebastian Striefel, Ph.D., in October 2002 and adopted by AAPB in 2003.

Enforcement of these ethical principles commenced with the first publication in January of 1984.

26 BCIA’S ETHICS DOCUMENT – just provided for information. It will not be part of AAPB’s document. Biofeedback Certification Institute of America

Ethical Principles of Biofeedback – 2005

Preamble Because the Biofeedback Certification Institute of America (BC IA) and its certificants are committed to the protection of human rights, its certificants strive to maintain the dignity and worth of the individual while rendering service, conducting research, and training others. All certificants are expected to belong to and operate within the principles of ethics governing their own discipline and those outlined herein. The certificants strive to provide optimum quality services, and to differentiate for those served whether procedures provided have been proven effective clinically, or if such procedures are experimental. Certificants accept responsibility for their actions and make every effort to protect the welfare of those they serve. They limit their services to those areas in which they have skills arid expertise and recognize their needs for competence, objectivity, freedom of inquiry, and honest communication.

This statement of Ethical Principles of Biofeedback is intended for use by all BCIA certificants. Licensure and certification laws and regulations should reflect and support these Principles, and acceptance as a BCIA certificant commits the certificant to adhere to these Principles. A copy of these Principles will be sent to all applicants for BCIA certification. The Principles are intended to be preventive, educational, guiding, and action oriented, and are to be applied with professional maturity. Certificants are required to cooperate with the Ethics Committee of BCIA by responding promptly and completely, in writing, to inquiries from the Ethics Committee. Lack of response may be a basis for reprimand and decertification. Individuals who are not BCIA certificants, but who practice biofeedback, are encouraged to adhere to these ethical standards to help maintain and improve the image of biofeedback providers. In addition, certificants are subject to the principles of ethics of their own professional disciplines.

Purpose and Scope The Ethical Principles of Biofeedback (EPOB or Principles) consist of a set of guidelines agreed to by the BCIA which outline the moral duty, obligation, or custom on how certificants should behave professionally. The Principles that follow are not all-inclusive and should not be viewed as limiting the scope of ethical responsibility of BCIA certificants. Rather, the EPOB point out and underscore particular areas in which there is

27 concern.

1. The EPOB are to be followed by ECIA certificants in the provision of biofeedback and related services. Certificants must assure that the Principles are also adhered to by their employees engaged in biofeedback and biofeedback related activities, and by individuals receiving training in the use of biofeedback under their supervision. BCIA certificants will inform their employers of the EPOB and will make every effort to urge their employers to cooperate with them in adhering to these Principles.

2. The EPOB constitute the guidelines against which the ethical conduct of a BCIA certificant is measured.

3. A violation of the EPOB may lead to disciplinary action, decertification, and/or a letter to the appropriate state licensing/certifying agent or the state or national association of the individual's professional discipline concerning the charges or actions.

A. Responsibility In utilizing biofeedback, BCIA certificants adhere to the highest standards of their profession. They behave responsibly; accept responsibility for their behavior and the consequences of their behavior; ensure that biofeedback is used appropriately; and strive to educate the public concerning responsible use of biofeedback in treatment, research, and training.

1. Each BCIA certificant is responsible for adhering to the ethical principles of their profession; the local, state and federal laws relevant to their professional activities; and the EPOB. Additional related documents include those of the Association for Applied Psychophysiology and Biofeedback.1'2

2. As practitioners, BCIA certificants recognize their obligation to help clients acquire knowledge and skill within the confines of the highest professional standards and in the most cost efficient, effective manner possible.

3. As teachers, BCIA certificants encourage the free pursuit of learning by their students, consistent with the best interest of their obligation to help others acquire knowledge and skill, and present information objectively, accurately and fully. They are guided by a conviction of the worth of advancement of knowledge.

4. All BCIA certificants are responsible to be alert to and report to the BCIA Ethics Committee false claims and misrepresentative statements about biofeedback.

28 5. All practitioners realize that their professional activities with clients may result in changes in the lives of those clients and others. As such, practitioners guard against misuse of their influence and actions.

6. Biofeedback services are continued only as long as it is reasonably clear that clients are benefiting from the relationship. If another type of intervention is needed for which the practitioner is not qualified, the practitioner assists the person in obtaining the appropriate therapeutic services. Clients are never to be abandoned.

B. Competence BCIA certificants recognize the boundaries of their competence and operate within their level of competence, using only those biofeedback techniques in which they are trained and experienced. They also recognize the proper limitations of biofeedback and inform all concerned parties about the clinical utility of particular procedures, possible negative effects, and whether the procedures are experimental or clinically verified. BCIA certificants remain current on knowledge concerned with scientific and professional applications of biofeedback in those areas in which they practice.

I. BCIA certificants should operate within applicable local, state, and federal laws as well as in accordance with the ethical principles of their profession/occupation. BCIA Certification is not a license to practice.

2. The treatment of medical or psychological conditions requires the demonstration of professional competence as defined by applicable local, state, and federal licensing / credentialing laws.

3. It is the responsibility of certificants who are not licensed or credentialed to practice independently to seek appropriate supervision according to applicable state laws and professional codes/regulations.

4. It is the responsibility of BCIA certificants to take it upon themselves to seek and obtain appropriate training and supervision when providing services in areas in which they are not competent.

5. Misrepresentation of one's qualifications, training, experience, degrees, and/or specialty is a violation of BCIA ethics.

C. Standards

29 BCIA certificants are sensitive to prevailing community moral and ethical standards and to the possible negative impact that deviating from those standards may have upon the quality of their performance in applying biofeedback, in fulfilling their professional responsibilities, and in maintaining public trust in biofeedback.

I. No certificant may resign his or her BCIA certificate while an ethical investigation of behavior relating to biofeedback is in progress.

2. BCIA certificants are obligated to report alleged ethical violations concerning biofeedback and its application to the ethics committee of the alleged violator's professional discipline and/or to the Ethics Committee of BCIA.

3. Certificants will charge only for services actually provided by them or those provided by others under their direct supervision. In billing third party payers, practitioners abide by the ~les and regulations of the third-parry payer, including clearly specifying which services the practitioner provided directly and which were supervised, as well as providing information regarding qualifications (degree, license, certification, etc.).

4. Certificants clarify any potential or actual conflict of interest that exists when serving clients, conducting training or research, or when engaged in any other professional activity (such as a workshop in which a certificant as trainer recommends a specific product).

5. Informed consent shall be obtained from clients for all assessment procedures, treatment procedures, billings and fee collections, and procedures to protect confidentiality, as well as conditions that limit confidentiality.

6. Written informed consent shall be obtained from clients for all experimental treatment procedures. To distinguish experimental and clinically reliable procedures is difficult and requires familiarity with related documents.3

D. Public Statements BCIA certificants recognize that all public statements, announcements of services and products, advertising, and promotional activities concerned with biofeedback should be conducted in such a manner as to help the public make informed choices. Statements about biofeedback will be based on scientifically verifiable information, including recognition of the limits and uncertainties of such data. BCIA certificants accurately represent their qualifications, affiliations, and functions and do not mislead the public.

30 1. Biofeedback providers shall accurately represent the efficacy of biofeedback procedures for all disorders or conditions being treated.

2. In providing services, publishing and marketing a product, and in all other professional activities, BCIA certificants use truthful and not misleading information in both direct and indirect statements about biofeedback. BCIA certificants consider the context and source requesting information when making a public statement and guard against misrepresentation.

3. BCIA certificants recognize that they have financial or career interests in the promotion of biofeedback activities and agree that these interests must be superseded by professional objectivity, humanistic concern, and the EPOB and the other professional societies of which they are members. When a question arises as to their objectivity, certificants seek professional guidance from appropriate professional sources such as BCIA, the Association for Applied Psychophysiology and Biofeedback, the professional association of the discipline in which they are credentialed, or other qualified sources.

4. Announcements and listing of services and training offered by BCIA certificants, such as telephone directory listings, letterheads, business cards, and descriptive brochures should be made in a professional manner and must adhere to the guidelines of the profession to which the certificant belongs. Only factual and accurate claims are to be made.

E. Confidentiality BCIA certificants maintain confidentiality of information obtained from persons in the course of their biofeedback activities. Release of information requires the written consent of the client, the client's legal representative, or the existence of a situation in which not to do so could result in danger to the client or others. 1. BCIA certificants specify in advance the legal limits of confidentiality to clients/patients, particularly as it pertains to collection of fees and laws requiring reporting (such as abuse or neglect). Confidentiality applies to clients in treatment, students in training and to research participants.

2. Client records are stored or disposed of in ways that maintain confidentiality. Records will be kept for a minimum of 7 years and will be retained longer if required by state law.

F. Protection of Client Rights and Welfare BCIA certificants protect the welfare of clients, students, research participants, and other groups with whom they work. They inform all consumers of their rights, provide them with a written statement of these rights, fully inform them as to the purpose and nature of

31 procedures to be implemented, and assure that client's rights are not abridged.

1. Sexual intimacies, with patients/clients during therapy and for two years following therapy, and with trainees, supervisees, and research subjects are prohibited.

2. In attaching biofeedback electrodes or other sensors, BCIA certificants assure that the privacy and rights of the client are protected. Certificants respect the feelings and sensitivities of the client.

3 Special care will be taken to protect the rights and consent of children receiving service, training, or when involved as research subjects.

4. Caution and common sense are required whenever a BCIA certificant has physical contact with clients, for example, in attaching electrodes. In addition, touching and massage require client permission and are restricted to those body areas considered appropriate for touch or massage within the realm of "common practice" for one's professional discipline. Touching of sensitive body parts, such as breasts or genitals is not acceptable in biofeedback practice, with the exception of a medical exam or medical treatment provided by a licensed medical practitioner. Clients can be instructed in electrode placement using visual and auditory aids (such as diagrams of the body).

5. BCIA certificants do not discriminate against or refuse services to anyone on the basis of sex, race, religion, disability, or national origin.

G. Professional Relationships BCIA certificants recognize the interdisciplinary nature of biofeedback and respect the competencies of colleagues in all professions. They strive to act in accordance with the obligations of the organizations with which they and their colleagues are associated.

1. BCIA certificants are responsible for assuring that all patients/clients referred for treatment of a medical disorder or in whom a medical disorder is later identified are treated only in conjunction with medical consultation, as necessary, to best serve the welfare of the client.

2. Certificants should strive to be objective in their professional judgment of colleagues and should strive to maintain good professional relationships even when opimons differ.

32 3. BCIA certificants avoid dual relationships with their patients/clients that could impair their professional judgment or increase the risk of exploitation. Because a patient/client may reenter treatment either for the same symptom or another problem, the dictum, "Once a patient, always a patient," should be adhered to. lf in the professional judgment of the biofeedback practitioner, ethical, moral, or other considerations render reentry into treatment unwise, these issues must be discussed fully with the patient, and a satisfactory resolution found. Certificants do not exploit clients, students, supervisees, employees, research participants or third parry payers.

H. Research with Humans and Animals BCIA certificants conduct research to advance understanding of basic behavioral principles, to improve human health and welfare, and to advance science. As such, certificants carefully consider alternative research directions and assure that in the conduct of research the welfare of research participants (human and animal) is protected. All research will adhere to federal and state regulations and the professional standards of the certificant's profession with regard to the conduct of research. Research involving humans is subject to governance by local institutional review boards and to the Federal regulations as appropriate or required by the Department of Health and Human Services.5 All animal research is subject to local institutional animal care and use committees and must be in compliance with Federal policies on use of aininals.6

1. The results of research will be released in a manner which accurately reflects research results and only when the findings have satisfied widely accepted scientific criteria. Any limitations regarding factors such as longterm effects and population samples will be explicitly stated. All descriptive materials distributed regarding clinical practice will be factual and straightforward.

2. Responsibility for the establishment and maintenance of acceptable ethical practice in research always remains with the individual investigator. The investigator is also responsible for the ethical treatment of research participants by collaborators, assistants, students, and employees, all of whom also incur similar obligations.

3. Information obtained about research participants during the course of an investigation is confidential. When the possibility exists that others may obtain access to such information, ethical research practice requires that this possibility, together with the plans to protect confidentiality, be explained to the participants as part of the procedure for obtaining informed consent.

4. Ethical practice requires the investigator to inform the participant of all features of the research that reasonably might be expected to influence willingness to participate and to explain all other aspects of the research about which the participant inquires. The ethical investigator protects participants from physical and mental discomfort, harm, and danger. If the risk of such consequences exists, the investigator is required

33 to inform the participant of that fact, secure informed consent before proceeding, and take all possible measures to minimize distress. A research procedure may not be used if it is likely to cause serious and lasting harm to participants. As risk for participants increases so does the responsibility of the researcher to protect the research participants. Written informed consent or a verbal plus written summary of the research is customary for most kinds of non-survey research (including signature by the research participant in both cases). Written consent form signatures to participate in research will be obtained from children 7 years of age and older in addition to signatures of a parent or guardian.

5. Ethical research practice requires the investigator to respect the individual's freedom to decline to participate in research or to discontinue participation at any time. The obligation to protect this freedom requires special vigilance when the investigator is in a position of power over the participant. The decision to limit this freedom increases the investigator's responsibility to protect the participant's dignity and welfare. 6. After the data are collected, ethical practice requires the investigator to provide the participant with full clarification of the nature of the study. When scientific or human values justify delaying or withholding information, the investigator acquires a special responsibility to assure that there are no damaging consequences for the participant.

Additional Standards When the above standards are unclear and whenever appropriate, the ethical standards of the American Psychological Association, American Psychiatric Association, the American Nurses Association, the American Physical Therapy Association, the American Medical Association, the American Dental Association, the American College of Sports and Rehabilitation, the American Academy of Physical Medicine & Rehabilitation, or other professional associations pertinent to the individual in question shall be used as a guide in determining whether the certificant has violated his/her professional standards.

Ethics Committee Procedures When a complaint is made, the BCIA Ethics Committee shall use the EPOB in evaluating BCIA certificants conduct. The BCIA Ethics Committee Operational Guidelines and Procedures will be followed. The major concerns of the Ethics Committee of BCIA are to protect the public against unethical practices by BCIA certificants and to educate the certificants concerning acceptable ethical practice. The Committee attempts to have complaints resolved by the ethics committee of a member's profession whenever possible or the local or state biofeedback society, if one exists. When that avenue fails or is inappropriate, or when the BCIA certificant is not professionally licensed or certified, the committee attempts to resolve complaints privately and informally and to recommend disciplinary action when unethical conduct is found to exist. The goal of the Ethics Committee is to be constructive and educative, rather than punitive.

34 The Committee shall recommend appropriate additions, deletions, or revisions of these Principles as necessary for adoption by the BCIA Board. Thereafter BCIA certificants shall be required to adhere to the revised EPOB. Comment is invited.

Individuals desiring more information about these Principles or wishing to register a complaint may contact the BCIA Executive Director.

Related Documents and Acknowledgments

'Ethical Principles of Applied Psychophysiology and Biofeedback. (1995). Wheat Ridge, Colorado: Association for Applied Psychophysiology and Biofeedback.

2Striefel, 5. (1999). Practice Guidelines and Standards in Psychophysiological Self Regulation. Wheat Ridge, Colorado: Association for Applied Psychophysiology and Biofeedback.

3Clinical Efficacy and Cost Effectiveness of Biofeedback Therapy; Guidelines for Third Partv Reimbursement (1994, second edition). Wheat Ridge, Colorado: Association for Applied Psychophysiology and Biofeedback.

4Clinical Applications of Biofeedback and Applied Psychophysiology: A Series of White Papers Prepared in the Public Interest by AAPB. (1995). Wheat Ridge, Colorado: Association for Applied Psychophysiology and Biofeedback.

5Regulations for the Protection of Human Research Subjects (45 CFR46 and 56 FR 28003) (Federal Regulations).

6 Humane Care and Use of Animals (A 343401) (Federal Regulations).

We thank the Association for Applied Psychophysiology and Biofeedback, whose Ethical Principles were modified and adapted for these Principles.

Original version adopted by BCIA Board of Directors, August 26, 1990.

35 First revision prepared by John G. Carlson, Adopted by the BCIA Board of Directors, October 14, 1999.

Second revision prepared and adopted by the BCIA Board of Directors, March 24, 2002.

36 THESE ARE ISNR’S NEW PRACTICE GUIDELINES. THEY ARE PROVIDED HERE ONLY FOR REVIEWERS’ INFORMATION. THEY WILL NOT BE INCLUDED IN THE FINAL DOCUMENT.

Practice Guidelines for Neurofeedback

Purpose These guidelines are intended to provide a reference to both practitioners and the public with regard to basic methods for delivery of neurofeedback, also known as EEG Biofeedback. These guidelines are an extension of the Code of Ethical Principles and Professional Conduct of the International Society for Neurofeedback and Research (ISNR) which can be found on the ISNR.org website. ISNR is the recognized international professional organization for neurofeedback providers, educators, and researchers.

The Practice of Neurofeedback Neurofeedback developed as a multidisciplinary treatment modality, and is now practiced by a wide variety of providers who may or may not be licensed healthcare professionals who treat mental or other illnesses. Its range of practice includes assessment and treatment for conditions diagnosed by licensed healthcare providers, training for optimal performance (e.g., among athletes, executives, students, performing artists, and other healthy individuals), and both clinical and applied scientific research.

In general, neurofeedback involves placing sensors on the scalp of the individual, and connecting the sensors to an amplifier and computer. Through these connections, the electrical activity of the brain is recorded, and then presented back to the individual on the computer screen in the form of a video game or soundtrack that changes depending on what state the brain is in. This is the “feedback” aspect of neurofeedback that enables the individual to change their brain function and keep the game or sound on more. The means by which this signal is displayed and controlled is the responsibility of the neurofeedback practitioner and should be done in accord with the guidelines below.

37 training and Credentials for Neurofeedback Practitioners Membership in ISNR and certification by the Biofeedback Certification International Alliance (BCIA) are voluntary and help demonstrate to the public that a neurofeedback provider is able to provide ethical and competent training. When training objectives include the treatment of a diagnosed mental or other health condition and the delivery of a regulated assessment or intervention, it helps demonstrate to the public that the provider is able to deliver ethical and competent neurofeedback training when the provider is licensed by a government-recognized health profession board, and the provider’s scope of practice with their professional board includes assessment and intervention for that diagnosed condition. Regulations regarding licensure and scope of practice are determined and enforced by various governmental agencies, depending on state, country, or province. Consumers should ascertain that the practitioner has appropriate credentials, training, experience, and licensure to treat their problem, or is supervised by someone who does.

Guidelines The following guidelines are applicable to neurofeedback practitioners regardless of client background or training objective.

ISNR members: 1. Follow the ethical principles of the International Society for Neurofeedback and Research and any other professional organization to which s/he might belong. 2. Accurately represent their training and any professional qualifications and/or licenses they have achieved, and disclose relevant limitations. 3. Provide neurofeedback training only for those problems or goals for which they are competent, as demonstrated by their training, experience, licensure, or supervision. 4. Provide neurofeedback training for the treatment of diagnosed mental or other health conditions only if they are regulated healthcare practitioners whose scope of practice includes the diagnosis and treatment of the specific client population, and who are further trained or supervised in the application of neurofeedback for those clients. 5. When an unlicensed neurofeedback provider is assessing a client and the severity or complexity of the problem suggests that a diagnosable mental health problem or medical illness may be related to the goal being addressed by neurofeedback, then it is prudent for the provider to discuss this possibility with the client, review the limits of their practice, encourage the client to

38 consult with their family physician or licensed healthcare providers, and document the discussion. 6. Maintain their competency through continuing education. 7. Regularly seek consultation and supervision for cases in order to assure themselves and the client that training is in keeping with current knowledge and practice. 8. Document their client’s consent to the specifics of training, including where and how the client will be touched, acknowledgment of training benefits, risks, and costs. 9. Accurately represent the degree of scientific support reported in peer-reviewed publications for assessment and training methods for the various problems to which neurofeedback training may be applied. 10. If technicians are used, document the client understanding of the technician’s qualifications, role, and degree of supervision. 11. Document the client’s consent for their data to be used for research and/or educational purposes, if applicable. 12. Document their client’s acknowledgement of the limits of confidentiality. 13. Document their client’s acknowledgment that training will not necessarily achieve agreed upon goals, either completely or at all. Further document the client’s acknowledgment that unexpected changes in the client’s experience or behavior may occur during the course of training which may or may not be related to the training itself, and that in those cases it is important for the client to inform the neurofeedback provider so that the training methods can be either adjusted or discontinued, if necessary, and the unexpected changes can be appropriately addressed. 14. Provide training regardless of race, creed, color, nationality, gender, sexual orientation, religion, or social affiliation. 15. Collaborate with their clients to develop measurable training goals, a clear plan for training, and methods for measuring progress toward those goals. This collaboration includes regular review of progress with the client with the objective of asking for their decision regarding whether the benefit of continuing training merits the cost. 16. Carry out effective practices for maintaining good hygiene, applying electrodes and establishing an adequate electrical connection, and maintaining software and hardware in good and up-to-date condition. 17. Use hardware and software that is safe, accurate, and effective for the purpose to which it is applied. Equipment which meets the IEEE (Institute of Electrical

39 and Electronics Engineers) standards or has been FDA registered is recommended for clinical use. 18. Carefully assess and document the benefits, risks, and the abilities of the person who may conduct remote or home training, before such training is begun. In general, home training should be discouraged for conditions with a clinical diagnosis. Where it is chosen, careful attention must be given to the training and supervision of the person who will be responsible for performing the neurofeedback sessions at the home. Additional full disclosure and informed consent of potential problems, how and when to report them, and methods to resolve them should be discussed, and the client’s understanding of these documented with their signature. Steps to prevent or limit the use of neurofeedback software and hardware beyond their intended purpose should be documented. The issue of performing services outside of one’s geographic region of license or certification must be taken into consideration. 19. Plan and carry out neurofeedback training that is based on scientifically validated principles and methods. 20. Plan and carry out an organized course of neurofeedback that is based on an initial assessment that is adequate for the presenting problem and goal, including a pre-training EEG assessment. 21. Provide therapeutic support, coaching, and direct supervision during client neurofeedback training that is sufficient to achieve the agreed-upon goals of the client’s training. Document the client’s understanding of the degree to which the individual who is responsible for training will be present during training.

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