This form provides details about the special clinical programs offered by ITM, including potential benefits and risks, the financial aspects, and the responsibilities of the practitioners, staff, and program participants. You are asked to sign this form after you read it carefully, so that we are assured that you understand your involvement with the program. You are not asked to participate in a research project (as would require signing a review board approved consent form), but results of the treatments may be monitored.
The Immune Enhancement Project (IEP) is managed by the Institute for Traditional Medicine (ITM), a non-profit education and research organization. Treatments are provided primarily at our facility on S.E. Hawthorne (IEP Clinic) with some treatments given under certain circumstances at N.W. Lovejoy (An Hao Clinic). Subhuti Dharmananda, Ph.D. is the Director of ITM. For each medical specialty program at IEP, ITM’s Director has collected background information about treatment methods that have been used—mainly traditional Chinese medicine—and has produced one or more articles describing the treatment methods. The practitioners involved in providing treatments read these articles to enhance their knowledge of traditional medicine therapies as well as to be better informed about the potential therapeutic approach to the specific disease categories. All the primary practitioners have been formally trained at a college of traditional medicine and have received a license from the State of Oregon; selected skillful student practitioners, identified as such, may assist during certain shifts. Practitioner training in the basics of traditional medicine instills the techniques needed to offer treatment to any person, regardless of the modern medical diagnosis of any particular disease. The treatment is usually not a specific curative procedure for the disease, but rather a supportive therapy to aid your natural healing abilities and to reduce adverse effects of certain medical therapies prescribed by your medical doctor(s). For each disorder, ITM has developed a number of supplements (herbs and nutritional factors) which are selected and prescribed by the practitioners in accordance with their understanding of your needs, based on their traditional-style diagnosis and, in some cases, based on information provided by your medical doctor.
NATURE OF THE PROGRAM
At IEP, you are participating in a unique program where your case is managed by several members (we have about 20 acupuncturists, massage therapists, and naturopathic physicians), not just one practitioner. This allows you several advantages, including being able to receive treatment frequently and at a day and time convenient for your schedule, and having the input of many experienced practitioners with varying perspectives on your health conditions and their treatment, yet unified in their approach and methods by the ITM orientation. You may, as part of your introduction to the program, be seen by a single practitioner for a few visits but you should not expect to work with a single practitioner throughout your term of treatment. If you have any concerns about consistency of therapy, you should discuss this with the practitioners and/or contact the program’s Director. For those who wish to work with a private practitioner only, you may see any of our practitioner staff at their own private practices, at their regular clinic prices.
COMPONENTS OF THE PROGRAM
Unless another approach is discussed, all individuals will receive Chinese medical treatment based on acupuncture techniques and oral supplements. The methods that are employed are, to our knowledge, comparable to the best treatments available in the United States where the techniques of acupuncture and Chinese herbs are utilized; hundreds of practitioners around the country rely on ITM for information about treatment strategies. In addition, advice about diet, exercise, and other health-promoting behaviors will be provided as deemed appropriate, but we can not offer psychological counseling or assistance in obtaining and utilizing social service programs, nor do we provide services for persons suffering from addiction to alcohol or drugs. Information will be collected about your health status for the duration of your involvement. Massage therapy or other therapeutic methods may be recommended and may be provided. Acupuncture needles were approved as a standard medical device in 1996 and now acupuncture is considered a routine method of therapy, though of uncertain efficacy. The practice of acupuncture is widely recognized in the United States for its potential benefits in treating pain, but it is also considered of help with digestive disorders, stress and sleep disorders, and a variety of other health problems. The World Health Organization (WHO) has listed three dozen medical indications for which it recognizes acupuncture to be a useful treatment. The National Institutes of Health (NIH) has funded several studies of acupuncture and an NIH consensus meeting held in November 1997 presented a conclusion that acupuncture was effective for certain conditions. Acupuncture is licensed as a primary health care method in 36 states. At our clinic, we may apply several therapies other than needling that are considered part of the comprehensive acupuncture therapy, including applying moxibustion (heat via burning artemisia materials), using a heat lamp (radiant heat from a metal plate), applying a poultice (heat from warmed herb extract), cupping (pressure from suction cups), and stimulus of acupuncture needles by pulses of a low voltage (electro-acupuncture).
We provide a variety of supplements to patients, mainly herbs, “nutriceuticals” (natural substances that have been isolated and concentrated), and dietary components (such as vitamins, minerals, amino acids, etc.). Herbal therapy is within the scope of practice for acupuncturists and naturopathic physicians. Chinese herbal medicine has been an important part of acupuncture practice for centuries, and in the United States for about 40 years. It is considered part of diet therapy, though most herbs are not deemed to have any substantial nutritional value. Chinese herb formulas are used extensively in China, Japan, and throughout most of Southeast Asia. In Japan, prescription of certain herb combinations by medical doctors is covered by the national health insurance program and it is estimated that 40% of Japanese medical doctors prescribe herbs. The principal herbs used in the ITM program (Seven Forests, Pine Mountain, and White Tiger brands) are manufactured under the direction of ITM and are tableted and bottled at a factory in California meeting all quality control standards. Dried decoctions, referred to as granules, are made from spray-dried hot water extracts of herbs and are sometimes used instead of or in addition to the herb tablets; the granules are manufactured in Taiwan. Some supplemental items used in the treatment program may be derived from other sources, for which the origins will be specified upon request. Patients might not receive any supplements if there is a concern about the number and type of drugs or supplements already being taken or if you report chemical sensitivities or frequent reactions to ingested substances.
Massage therapy is performed by practitioners who are certified by the state following an extensive training program. This method of treatment is reported to alleviate body aches, improve digestion and sleep, and produce relaxation. The specific offering is Zen Shiatsu; it involves brief applications of pressure successively to points along defined pathways “meridians” and may also involve movements of the body for stretching purposes. The treatment is performed while you are clothed; you are asked to wear soft, loose clothing when possible to make this treatment easier to perform. Jewelry, watches, belts, and shoes are removed; socks are kept on. The treatment is administered while you lie on a futon on the floor or on a table.
YOU SHOULD BE AWARE OF POSSIBLE RISKS OF THIS PROGRAM
We use sterilized disposable needles that are used only once. This eliminates any possibility of disease transmission via the needles. There are no known cases of disease transmission from accidental needle sticks using the type of fine acupuncture needles we rely upon.
Acupuncture needles are extremely fine but may produce a discomfort upon insertion, and there can be a sensation of light-headedness or numbness while the needles are in place. There may be slight bruising or bleeding evident upon removal of needles. If, while the needles are in place, a painful sensation is noted at the site, please inform the acupuncturist and the needle will be adjusted or removed. When performing moxibustion or application of hot poultice, there is a slight risk of accidental overheating of the skin, causing a burning sensation and, in extremely rare cases, a localized burn. Massage therapy may produce some pain if a sensitive spot is pressed (inform the practitioner if the amount of stimulation is too great).
Chinese herbs provided by IEP are non-toxic but may in a few instances cause gastro-intestinal reactions that include, but are not limited to, nausea, flatulence, loose stool or diarrhea, or abdominal bloating; they may also rarely cause headache, thirst, tiredness, or nervousness, and if taken close to bedtime, may cause insomnia. All such reactions should subside within a few hours of ceasing to consume the herbs. In rare cases, an allergic reaction to herbs may occur; this usually manifests as a skin rash, which should be reported to the practitioners. In extremely rare instances, it is possible that a hypersensitivity reaction (which is unpredictable) of the liver or kidney to an individual herb component may occur, causing liver inflammation or damage or nephritis or kidney damage if ingestion of the herb is continued. Patients undergoing prolonged herb therapy should have routine blood tests to monitor their markers for healthy function of all organs.
Nutritional supplements rarely produce adverse reactions because the components of these supplements are very similar to those found in commonly used foods; the incidence of gastro-intestinal reactions (e.g., diarrhea, bloating) is quite rare. In cases where nutritional supplements include herbs and/or herb extracts, the same potential problems may arise as with simple herb products.
Topical treatments with herbs (plasters, hot poultice, or creams) may cause a rash, in which case the materials should not be used further.
RESPONSIBILITIES OF THE PARTICIPANT You are responsible for:
Setting up appointments and arriving at the clinic on time for those appointments or, if necessary, canceling at the earliest possible time. We recommend arriving about 5 minutes early.
Accurately filling out any forms or answering verbal inquiries regarding health status and health history, and, if requested, providing information collected by your medical doctor (either bringing the information with you or signing a release form so that we may obtain it); in most cases, we do not need an extensive medical history record.
Following the recommendations for acupuncture frequency, herb supplement dosage, and activities that directly impact the health condition under treatment. Inform us if there is a barrier to compliance.
Reporting to the practitioners any adverse reactions that you believe you have experienced. In the event that you believe a negative reaction is occurring which might be harmful in nature, the ingestion of herbs or other supplements should be discontinued and the experience should be reported to a practitioner. You are under no obligation to continue the program if adverse reactions are deemed to be unavoidable and unacceptable.
Meeting financial responsibilities, either by paying the standard fees in a timely manner or by accurately filling out the appropriate financial aid forms so as to gain permission to pay a lower fee or no fee.
Having good conduct during clinic visits, which includes maintaining a quiet and peaceful atmosphere.
Informing us when you are discontinuing participation and providing an explanation (for our records).
Please note that due to our limited offering (adjunctive clinical services onsite), you must have sufficient mobility to come to the clinic routinely and participate in the therapies that are provided, and you must have adequate mental competence to answer questions about symptoms and medical conditions as well as understand instructions related to the treatments. Also because of our limitations, our policy is that persons with problems associated with unregulated addiction to alcohol or drugs may not participate in our programs; those who have had such problems in the recent past must be drug free for a minimum of six months prior to enrolling. ITM will provide a reference to another community program that offers acupuncture if you are not eligible for participation at ITM. If our staff members believe that you are not meeting your responsibilities to the program, you will be alerted to the concerns, and with persisting problems, you could be required to discontinue participation. In such cases, we can suggest alternative treatment sites.
RESPONSIBILITIES OF THE PROGRAM
To assist you as necessary in arranging appointments within the scheduled clinic hours and to provide the designated services at the appointment time.
To provide excellent services. If you do not feel that the services you are receiving meet this criterion, please let us know as soon as possible. We will either make the needed changes or provide an explanation for any limitations.
To respond, as best possible, to any problems you report having with program components, such as difficulties with using herbs, making dietary changes, or getting appointments at convenient times.
To keep you informed of any new developments in our knowledge of therapeutics related to the condition under treatment.
No changes in physician-prescribed medications will be recommended as part of the treatment program; however, you may be advised to discuss with your prescribing physician the continued use of a medication. Participants may continue to use any natural supplements they already have, but are advised that most of them are likely unnecessary due to overlap with the herb/nutrition program. In case you are not satisfied with the conduct of ITM’s staff or other aspects of the program, please bring this to our attention; if necessary, contact the Director by calling the ITM office (503-233-4907) or, preferably, by e-mail (firstname.lastname@example.org).
ITM special programs are offered at prices that are considerably less than the community standard. This is done via the support of the ITM general fund and any grants, gifts, or other contributions that may be received. Unless arranged otherwise by mutual agreement, participants are expected to pay an established monthly fee for all prescribed services and supplements. For the monthly fees, the same fee is collected regardless of the level of participation (office visits, obtaining supplements); it is expected that low participation months will be made up by higher participation months. In some cases, ITM may limit the number of individuals who may join certain programs at reduced fees. Supplements provided by ITM that are not prescribed, and those provided as simple alternatives to store-bought materials, must be paid for by the participant unless arranged otherwise.
New patients are asked to visit the clinic before beginning a treatment program to observe the open nature of the setting (limited privacy). The IEP Clinic observes many standard procedures regarding confidentiality of medical information, but because of the particular clinical setting, you may be discussing medical matters where others can hear. And, because you are a patient of the clinic as a whole rather than of an individual practitioner, your file may be accessed by the practitioners of IEP, as well as by the staff and the Clinic Director. If you have privacy concerns, please let us know so that we can make appropriate arrangements to the extent possible for this setting. YOUR SIGNATURE By signing this consent form, you are indicating that you have read this form, understand its contents, and that you are participating voluntarily, agreeing to abide by the responsibilities outlined here.
____________________________________________ ________________________ Name (please print) Date ____________________________________________ _________________________ Signature Program (to be filled out by ITM staff)