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NAR FOUNDATION Study Identification No: NAR Foundation Autism Study 102

Letter For Parent's (Guardian's) Informationletter

Date: To:

The Legal Guardians of Prospective Research Participants:

The Nambudripad's Allergy Research Foundation is contemplating a pilot Research Study using the Nambudripad's Allergy Elimination Techniques to eliminate or reduce Autism in young children. In response to your request we are sending a package explaining the procedures of this program. If you are interested to take part in this study please complete the forms and send back to us immediately. Please return the following. 1. 2. 3. 4. 5. 6. 6. 7. Patient Information form. Consent to Treat Experimental Subject's Bill of Rights. AETC Form NAET Autism Rating Scale NAET Allergy Symptom Rating Questionnaire Autistic Traits Recording form Your physician's diagnostic Report on your child.

On receipt of the above, we will have the papers evaluated by appropriate experts and will contact you to let you know if your child will be eligible for this study. In case your child is selected for the study, the laboratory evaluations, psychiatric evaluations, other diagnostic evaluations will be done on your child before beginning the NAET treatments. Each child will be given 50 office visits in a year and we hope to desensitize 50 commonly used foods, chemical, environmental allergens and immunizations during this period. All the above testing and 50 NAET treatments are completely free for your child provided you complete the program in 12 months time (52 weeks). Please try to bring your child for the scheduled visits. The schedule will be given to you once accepted. 50 treatments may not be sufficient in certain cases to return to normality. But the completion of 50 treatments will produce significant changes in your child's autistic condition to demonstrate that NAET can be used in helping with allergy-related autistic conditions. Mohan Moosad, DBA., M.Ac., N.D. Managing Director/program Coordinator NAR Foundation

6714-32 Beach Blvd, Buena Park, CA 90621. e.mail. [email protected] 1

NAR FOUNDATION Study Identification No: NAR Foundation Autism Study 102

Experimental Subject's Bill of Rights About the Study

We are planning a study to determine the effectiveness of NAET in helping children with autism spectrum disorders. You have been asked to participate as a subject in this experimental procedure. Before you decide whether you want to participate in the experimental procedure, you have a right to: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. Be informed of the nature and purpose of the experiment. Be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized. Be given a description of any discomforts and risks reasonably to be expected from your participation in the experiment. Be given an explanation of any benefits reasonably to be expected from your participation in the experiment. Be given a disclosure of any appropriate alternative procedures, drugs or devices that might be advantageous to you, and their relative risks and benefits. Be informed of the avenues of medical treatment, if any, available to you after the experimental procedure if complications arise. Be given an opportunity to ask any questions concerning the medical experiment or the procedures involved. Be instructed that your child will be given free testing and treatments on 50 allergens within a span of 1 year. Be instructed that consent to participate in the experimental procedure may be withdrawn at any time and you may discontinue participation in the medical experiment even though we encourage you to complete the program for your child's benefit. Be given a copy of this form and the signed and dated written consent form and Be given the opportunity to decide to consent or not to consent to the medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion or undue influence on your decision.

I have carefully read the information contained above in the "Experimental Subject's Bill of Rights" and I understand fully my rights as a potential subject in a medical experiment involving people as subject.

Name of the Participant. _____________________________ Age _____________Sex ________________ Name of the Mother (or Legal guardian) ____________________________________________________ Address. _____________________________________________________________________________ Signature:------------------------------------phone. Day/night_____________________ (Legal Guardian for the Child) Indicate the relationship to Participant:------------------Date ------------Time AM/PM_______ Witness:________________________________________________Date ________________

6714-32 Beach Blvd, Buena Park, CA 90621. e.mail. [email protected] 2

NAR FOUNDATION Study Identification No: NAR Foundation Autism Study 102

INFORMED CONSENT I. Sponsors: 1. NAR Foundation (Nambudripad Allergy Research Foundation),

6714-6732 Beach Blvd., Buena Park, CA 90621 Tel. (714) 523- 2817; Fax: (714) 523-3068. e. mail: [email protected]

II. Location: PNIB Research Center, 6714-6732 Beach Blvd., Buena Park, CA 90621.

Tel. (714) 523-3500; Fax: (714) 523-3068. email: [email protected] 111. Program Coordinators: 1. Mohan Moosad, DBA, M.Ac, N.D. NAR Foundation, 6714-32 Beach Blvd., Buena Park, Ca 90621 Tel. (714) 523- 2817; Fax: (714) 523-3068. email: [email protected] 2. Adam Vigil, D.C.

4455 Riverside Drive Chino, CA 91710 USA Phone: (909) 628-0090. Email: [email protected]

3. Kris K. Nambudripad, BSEE, M.Ac., L.Ac.(Acupuncture, Allergies, NAET) PNIB Research Center, 6714-36 Beach blvd., Buena Park, CA 90621 email: [email protected]

Iv. Investigators:

1. Principal investigators: 1. Devi S. Nambudripad, M.D., D.C., L.Ac., Ph.D. (Specialty: Chiropractic, Acupuncture, Allergies, NAET) Director for Research, PNIB Research Center, 6714-36 Beach Blvd., Buena Park, CA Phone: (714) 523-3500; Fax: (714) 523-3068. email: [email protected] 2. Jacob Teitelbaum, M.D., (Internal Medicine, CFS/FMS, NAET) Director of the Annapolis Research Center for Effective CFS/ Fibromyalgia Therapies, 466 Forelands Road Annapolis, MD 21401 USA Phone: 410 266 6958. E. mail: [email protected] 3. Jing Li, M.D., L.Ac., O.M.D. 4050 Barranca Pkwy, Ste # 110 Irvine, CA 92604 USA. 949 552 8133 Fax: 949 552 1882. E. mail: [email protected]

6714-32 Beach Blvd, Buena Park, CA 90621. e.mail. [email protected] 3

NAR FOUNDATION Study Identification No: NAR Foundation Autism Study 102

2. Co-investigators: 1. Mala Moosad, R.N., L.Ac., N.D. (Acupuncture, Allergies, NAET) Clinical Director, PNIB Resarch Center, 6714-36 Beach Blvd., Buena Park, CA 90621 Phone: (714) 523- 2817; Fax: (714) 523-3068. email: [email protected] 2. Yvonne Tyson, M.D., Family Medicine, Board Certified in Acupuncture, Board Certified in Holistic Medicine, NAET Assistant Director for Research, PNIB Research Center, 6714-36 Beach Blvd., Buena Park, CA 90621 Phone: (714) 523-3500; Fax: (714) 523-3068. email: [email protected] Alternate address: 911 E. San Antonio Dr. Ste. 1, long Beach, Ca 90807. phone. (562) 498-0606. fax: (562) 423-0396. 3. Robert Prince, M.D. (Psychiatry, NAET) and Iris Prince, R.N. NAET of North Carolina 1955 Woodberry Road, Charlotte, NC 28218. Phone: (704) 537-0221. E. mail: [email protected] 4. Ross Stark, BSEE, D. Ac., L.Ac 1925 Sleepy Hollow Lane Annapolis, MD 21401 USA Phone: 410 266 3350. [email protected] 5. James Benjamin, M.D., and Joyce Menjamin, R.N. 7507 Old Chapel Dr. Bowie, MD 20715 USA Phone: 301 805 8399 Fax: 301 805 9417. E. mail: [email protected] 6. Anthony De Siena, D.C. (Chiropractic, NAET, Allergies). Washington Street Chiropractic Center, LLC 771 Washington Street, Eugene, OR 97401 USA Phone: (541) 686-2225 Fax: 541 687 6975. E. mail: [email protected] 7. Nancy B. Rosen, R.N., M.Ac., L.Ac. 114 Lowell Ave Newtonville, MA 02460-1503 USA Phone: 617 558 7619 E.mail: [email protected] 8. Gary Erkfritz, D.C. (Chiropractic, Allergies, NAET) 187 East Wilbur, Suite 1 Thousand oaks, CA 91360 USA

Phone: 805 371 8082. E. mail: [email protected]

9. Sue Anderson, D.C.(Chiropractic, NAET).

2160 Huron Pkwy, Suite 1 Ann Arbor, MI 48104 USA Phone: (734) 973-9692. E. mail: [email protected]

6714-32 Beach Blvd, Buena Park, CA 90621. e.mail. [email protected] 4

NAR FOUNDATION Study Identification No: NAR Foundation Autism Study 102

10. Ray Alexander, D.C. (Chiropractic and Acupuncture)

Alexander Chiropractic Clinic, 911 Duluth Hwy. N.W. Ste. B6 Lawrenceville, GA 30043 USA Phone: 770 339 1311 Fax: 770 339 3608.E. mail: [email protected]

Research associates: 1. Roya Nikzad, L.Ac., Ph.D. (Acupuncture, NAET).

8950 Villa La Jolla Dr., Suite C-117 La Jolla (San Diego), CA 92037 USA Phone: (858) 202-0322.E. mail: [email protected]

2. Farangis Tavily, L.Ac.(Acupuncture, Allergies, NAET)

20 Sunnyside Ave. A397 Mill Valley, CA 94941 USA Phone: (415) 302-7907. E. mail: [email protected] 3. Michael Liang, L.Ac. 39 Redhawk Irvine, CA 92604 USA Phone: (949) 433-4628. E. mail: [email protected]

4. Tom Anderson, D.C. (Chiropractic, NAET)

4568 So. Highland Dr #320 Salt Lake City (Holladay), UT 84117 USA Phone: (801) 272-9989 Fax: 801 272 1482. E. mail: [email protected]

5. Laurie Teitelbaum, M.S., NP (Nutrition, NAET)

466 Forelands Road Annapolis, MD 21401 USA Phone: (410) 266-6958. E. mail: [email protected]

6. . Gloria Phillips, D.C. (Chiropractic)

Healings Arts West 2001 Barrington Ave., Suite 316 West Los Angeles, CA 90025 USA Phone: (310) 473 2020 Fax: 310 473 2588.

IV. Topic for Study: Investigation into the Effectiveness of NAET on Autism Spectrum disorders in a multiclinical setting. V. Requirement for consideration in the study: Established diagnosis of autism spectrum disorders from a qualified medical practitioner. VI. Inclusion Criteria: Established diagnosis of autism spectrum disorders

6714-32 Beach Blvd, Buena Park, CA 90621. e.mail. [email protected] 5

NAR FOUNDATION Study Identification No: NAR Foundation Autism Study 102

Autism Spectrum Disorder (ASD) with food allergies Asperger's disorder with food allergies Food Allergies Age limit below 10, both sexes VII. Exclusion Criteria: The subjects with any of the following conditions will be disqualified. 1. Previous surgeries, congenital deformities of heart, lung, liver, brain, kidney, etc. 2. Any type of cancer 3. Aids 4. Any physically debilitating disorders and diagnosed mental retardation, Down's syndrome, etc. 5. Children with the history of severe allergies or anaphylactic reactions will be rejected. 6. Children over 10 years of age VII. Selection of the Subjects: 80 Subjects with the above specification from a group of previously diagnosed autism spectrum disorders, below the age of 10 years, both sexes, will be screened to include in the study. 40 subjects will be enrolled as "Treatment Group" and other 40 subjects will be used as "control group." The following standard evaluation measures will be used to determine the eligibility for inclusion in the study. An invitation to take part in the study will be posted on the internet sites, in the newsletters and at the local coomunity places like churches and schools. VIII. Selection of The Practitioners: Out of 45 practitioners responded to the invitation to take part in the study, 10 NAET practitioners were selected randomly to participate in the study. They are distributed all over the country. Each one of them has had adequate NAET training and experience over five years treating autism using NAET in their respective clinics. The ten selected participating practitioners' name and offices are listed as Co-investigators on page 4 and 5 in this document. VIII. Description of testing modalities: (The following list of evaluations will be done on the subjects before beginning the study, after completion of and after 50 treatments). Some of them will be done monthly as marked after each test. 1. History

6714-32 Beach Blvd, Buena Park, CA 90621. e.mail. [email protected] 6

NAR FOUNDATION Study Identification No: NAR Foundation Autism Study 102 2. The Autism Behavior Checklist (ABC). Report is needed from the child's behavior therapist prior to beginning the treatment. Child will be sent for evaluation after 25 treatments, after 50 treatments at the completion of the program as a final evaluation from the same therapist. 3. Evaluation by an independent psychologist (child psychologist, school psychologist who is not involved with this study) before beginning the study, and at the end of 50 treatments. 4. Blood CBC and chemistry panel, IgE specific antigen (immunoglobulin E specific by RAST) (list is given below) before the study and after 50 treatments. 5. Allergy Symptom-Rating questionnaire (ASR) (once a month) 6. NAET Autism Rating Scale (ARS) (Once a month) 7. Childhood Autism Rating Scale (CAR) to be completed by a psychologist or a trained staff at the facility prior to the study and after 50 treatments (not by the subject's family) 8. NST (Neuromuscular sensitivity testing) for 50 allergens per NAET Autism treatment protocol. 9. Videotaping of the child will be done for 5 minutes before beginning the treatment, after 25 treatments and after 50 treatments. 10. AETC check list: all subjects will be given a baseline evaluation exam using the Autism Treatment Evaluation checklist (ATEC from Autism Research Institute) prior to beginning the NAET protocol., then once a month. IX. Testing and Treatment Procedures: NAET Testing and treatment procedure will be shown via video (Video by Dr. Prince) and demonstrated to the participant and the parent (guardian) by one of our co-investigators. This is done for the purpose of helping to eliminate fear, anxiety and concern about the procedure from the participant and the parent or guardian. Questions are answered. This will assist the parent (guardian) to provide the consent of willingness to have the child join the study at the parent's (guardian's) free will.

6714-32 Beach Blvd, Buena Park, CA 90621. e.mail. [email protected] 7

NAR FOUNDATION Study Identification No: NAR Foundation Autism Study 102

Please apply a check mark indicating the understanding of the procedures that will be provided to your child. I understand that on the first visit, I will be asked to do the following on my child (Ward): [ ] 1. I will be asked to fill out the history form. [ ] 2. I will be asked to fill out an Allergy Symptom Rating questionnaire form. [ ] 3. I will be asked to complete NAET Autism Rating Scale form. [ ] 4. I will be asked to complete AETC evaluation form Autism Research Institute (ARI). [ ] 5. General physical examination and acupuncture meridian integrity check will be done on my child. [ ] 6. Laboratory testing will be done for standard evaluation or I should bring a copy of the recent lab results from my child's pediatrician on CBC and blood chemistry. [ ] 7. My child will be tested by NST for basic allergens through a surrogate. [ ] 8. Blood may be taken for other laboratory evaluation such as immunoglobulins. [ ] 9. My child will be evaluated by an independent psychiatrist or psychologist who is not involved in the study. [ ] 10. A 5 minutes Video of my child will be taken before beginning the treatment and after completion of 25 and 50 treatments respectively. When the tests are completed, My child will begin NAET for food, chemicals, and environmental allergies according to the list given below. My child will be treated once a week in the NAET Clinic. I will be asked to bring my child on every Saturday for treatment. If Saturday is not suitable for me then I can arrange another convenient day with the practitioner. I need to bring my child for 50 times to be treated for 50 selected allergens. Sometimes my child may take more NAET treatments in order to desensitize each allergen depending on his sensitivity to the item treated. In such instances, I will be asked to bring my child more often than once a week to help complete the treatment along with peers. My child will be evaluated after 25 treatments using all of the above listed evaluation measures. At the end of 50 NAET desensitization treatments, my child will be evaluated using all of the above measures again. I will not be charged for the above described testing or for 50 treatments. My child will be permitted to continue with all his/her medications and supplements as before, during the study. Special instructions will be given to me about the necessary avoidance after each desensitization treatment. X. Purpose:

I agree to (have my ward or child) participate as a subject in this project to determine the effectiveness of NAET in helping children with Autism Spectrum Disorders using natural therapies. XI. Procedure and treatment: 6714-32 Beach Blvd, Buena Park, CA 90621. e.mail. [email protected] 8

NAR FOUNDATION Study Identification No: NAR Foundation Autism Study 102 I understand that the project consists of the usage of noninvasive testing procedures and desensitization procedures done by Dr. Devi Nambudripad and her associates who have been properly trained by Dr. Nambudripad in this method. These procedures have been described and demonstrated to me. XII. Risks: I understand that the study consists of noninvasive procedures. I understand that there are limited risks involved in the NAET treatment using the energy vials of the food and environmental allergens. I have been taught the acupressure points for energy balancing which I am instructed to use on my child (Ward) twice a day (Morning and evening) and to calm my child using acupressure techniques whenever my child gets violent or show out of control behaviors. I have been instructed to continue all his/her usual supplements and medications, and call my child's pediatrician as and when needed help with any of his/her medical conditions. I understand that medical treatment will be available for more severe reactions, but the likelihood of serious reactions is low.

XIII.

Benefits:

I understand that if the research can prove that the NAET can successfully eliminate or reduce Autistic behaviors in children using natural treatments, this treatment procedure will be of great benefit to the children who suffer from this disorder and to their frustrated parents, all over the world.

XIV.

CONFIDENTIALITY:

I understand that all information about me (my ward or child) will be strictly confidential. However, for research purposes I am willing to have my results from this study published or shared with other interested parties if I (my ward or my child) am not personally identified. XV. FINANCIAL RESPONSIBILITY:

I understand that I am not responsible for payments of the diagnostic tests and for 50 NAET treatments. I understand that there is no other compensation available in case of injury or illness as a consequence of my ward or child's involvement in this research, but this does not take away my legal rights in case of negligence of any person associated with this research project.

XVI.

NEW FINDINGS:

6714-32 Beach Blvd, Buena Park, CA 90621. e.mail. [email protected] 9

NAR FOUNDATION Study Identification No: NAR Foundation Autism Study 102 I understand that any important information discovered about my child's health during the term of this project will be given to me (my ward or child) if it will make a difference in my ward's or child's health care for willingness to continue in this study. XVII. VOLUNTARY CONSENT AND CERTIFICATION: I (my ward or child) take part in this study of my own free will and I understand that I (my ward or child) can stop at any time for any reason before I received the first, actual NAET. But I understand that I (my ward or child) should not stop the treatment in the middle of the sessions before the successful completion of the allergy elimination treatment once it is started for that particular item. I also understand that if I have any questions about my ward's or (child) test or treatment or other matters relating to this project, I may contact the principal investigators listed in the beginning of this form and I can discuss any questions which I might have.

XVIII

SIGNATURES: I verify that I have read the above and that my permission is given with my free Will.

________________________ Patient's Name

________________ Signature

___________________ Date _____________________ Date

__________________________ ____________________ Parent's (guardian) Name & Relationship Signature

______________________________________________________________________________ Address of the parent (Guardian) Day time phone. ________________________________________________________________ Witness' Name _________________ Signature _____________________________________

6714-32 Beach Blvd, Buena Park, CA 90621. e.mail. [email protected] 10

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