ARIZONA NATUROPATHIC RESEARCH INSTITUTE

Interim address:

1250 E. Baseline Rd., Suite 205

Tempe, AZ  85283

Tel: 480-839-2800

JOINT MEETING OF THE

ARIZONA NATUROPATHIC RESEARCH INSTITUTE (ANRI)

AND

THE NATUROPATHIC ONCOLOGY RESEARCH INSTITUTE (NORI)

AND

THE INSTITUTIONAL REVIEW BOARD (IRB)

February 5, 2010

MINUTES


 

In accordance with the requirements of the United States Code of Federal Regulations, Title 45, Part 46, the Inaugural Meeting, which was the first regular meeting, of the Arizona Naturopathic Research Institute (ANRI) and the Naturopathic Oncology Research Institute (NORI) and the Institutional Review Board (IRB) was called to order at 11:30 a.m., February 5, 2010 at 4769 N. 20th St., Phoenix, AZ.

MEMBERS

The following founding members were present, listed alphabetically by last name:

Elizabeth Enright

Colleen Huber, NMD

Kenneth Lashutka, NMD

Chad Livdahl, NMD

Robert Milisen, NMD

Timothy Peace, NMD

Kenneth Proefrock, NMD

Jonathan Psenka, NMD

Paul Stallone, NMD

Jeff ———- (Someone please fill in name)

Another founding member, Phranq Tamburri, NMD, was not able to be present for this meeting, and is cordially invited to future meetings.

It was also proposed and agreed that the future meetings include not only all of the above-named persons, but that Glenn Ozalan, NMD, also be cordially invited to participate.

Other individuals who may be interested in participating in future meetings, or who are invited by an individual member, are also welcome.
The members of ANRI comprise the naturopathic physicians listed above.

For the IRB, in addition to all of the naturopathic physicians named above, there was a unanimous welcome for Ms. Elizabeth Enright, who is not a physician or scientist.  In fulfillment of CFR Title 45 requirements that a non-scientist be among the IRB members, and that consideration be given to the health and welfare of human research subjects, Ms. Enright brings decades of experience with human rights issues, having started one of the first shelters for battered women in the U.S. and having worked in many organizations and companies for the rights of children, the poor and other potentially vulnerable populations, in conformity with CFR Title 21, Chapter I, Subchapter A, Part 56, Subpart b, Number 56.107, Paragraphs (a), (b), (c), (d) and (e), as well as CFR 46.107, Paragraph (a).  Her resume is attached to these minutes.

This was also the occasion of the Inaugural Meeting of the Naturopathic Oncology Research Institute (NORI), which is a sub-organization of ANRI, for those members who wish to participate.

No member has yet been nominated or elected to fill any officer positions at this time.

These minutes are recorded by Colleen Huber, NMD, 1250 E. Baseline Rd., Ste. 205, Tempe, AZ, Tel: 480-839-2800, e-mail: ch@naturopathyworks.com, who is functioning as Interim Secretary until such position is filled by nomination and election.

MISSION STATEMENT

The following Mission Statement was proposed:

The Arizona Naturopathic Research Institute (ANRI) and the IRB have been formed in order to explore and to conduct research on treatments for chronic diseases, including but not limited to cancer, diseases of inflammation and disordered immune function, environmentally-caused illness and all other chronic diseases.

The Mission Statement for NORI was proposed as follows:

The Naturopathic Oncology Research Institute (NORI) has been formed in order to explore and to conduct research on treatments related to cancer, its causes and manifestations while striving for the greatest possible wellbeing, strengthening, education and empowerment of cancer patients.

GOALS

Our primary goal in establishing the present formal associations and to continue meeting in the future is to recognize and to strengthen and to expand a community of physicians who are in general agreement on naturopathic principles as applied to patient care, and to affirm those principles, which are listed as follows, as primary considerations in the care of our patients:

First do no harm.

Healing occurs by way of nature.

Treat the whole person.

Treat the cause.

Prevent disease.

Doctor as teacher

Another goal is to be able to freely exchange ideas and information regarding patient care and specific medical treatments.

METHODS

In accordance with the laws governing naturopathic medicine in Arizona, specifically the following:

32-1581. Dispensing of natural substances, drugs and devices; conditions; civil penalty; dispensing minerals; definitions

A. A doctor of naturopathic medicine may dispense a natural substance, drug or device to a patient for a condition being diagnosed or treated by the doctor if:

1. The doctor is certified to dispense by the board and the certificate has not been suspended or revoked by the board.

We agree to conform the administration (as defined below) of the substances we use to the above guidelines for dispensing (as defined below).  Such substances include but are not limited to the following:

  1. Organic and bio-inorganic, sterile, liquid substances delivered by IV, IM, SQ and other routes of delivery as necessary for optimal treatment as determined by the physician in consultation with the patient, and/or
  2. Non-sterile solid, liquid and/or aerosolized substances delivered PO, topically or by nebulizer to the lungs and other routes of delivery as necessary for optimal treatments as determined by the physician in consultation with the patient.

Each of our patients with whom we use any therapy, experimental or FDA-approved, will be given a Statement of Informed Consent to sign, the form and purpose of which is described below.  The Informed Consent will conform to the Naturopathic Rule as follows:

R4-18-802. Informed Consent and Duty to Follow Protocols

A. A physician, medical student engaged in an approved clinical training program, preceptee, or intern who conducts research involving an experimental procedure, medication, or device, shall ensure that all research subjects give informed consent to participate.

B. A physician, medical student engaged in an approved clinical training program, preceptee, or intern, that conducts research on humans involving an experimental procedure, medication, or device shall have a protocol for that research approved by an Institutional Review Board.

Patients will be informed that the therapies used may be experimental and investigational according to the FDA; however, we use them with the knowledge that most of our therapies have been in use for decades or much longer, and that there is a body of medical literature that discusses their use. Utmost consideration will be given by each of the members to each patient with regard to their understanding of the nature of the treatments to be used and the complete absence of coercion, preserving the patient’s free will to engage in any of our treatments or not.  The members agreed to only offer therapies to patients that are likely to improve their condition or remove the cause of their condition without causing further harm.

DEFINITIONS

“Administer” means the direct application of a prescription-only drug, homeopathic medication, natural substance, or non-prescription drug, whether by injection, inhalation, ingestion or any other means, to the body of a patient or research subject by a naturopathic physician, a naturopathic physician’s nurse or assistant, or by the patient or research subject at a naturopathic physician’s direction.

“Natural substance” means herbal phytotherapeutic or oxygen, carbon, or nitrogen-based therapeutic agent, vitamin, mineral, and food factor concentrate isolated from animal, vegetable or mineral sources for nutritional augmentation.

From R4-18-101 of the Rules of the Naturopathic Medical Board of Arizona, the following definitions will be used in our discussions and deliberations:

“Informed consent” means a document, signed by a patient or the patient’s legal guardian, that verifies that the patient or legal guardian understands the type of treatment the patient is to receive, and whether the clinician is a physician, preceptee, or an intern who is treating the

patient. If an experimental or investigational protocol is to be followed, the informed consent form shall clearly state that the patient understands the procedures to be carried out, the risks and benefits of the procedure, medication or device to be used, that the patient can withdraw at any

time, that the patient is voluntarily complying, and that the protocol meets the requirements of the institutional review board that approves the protocol.

“Institutional review board” means a group of persons that reviews investigational or experimental protocols and approves its use on animals or humans within an institution for the purposes of protecting the subjects of the investigational or experimental protocol from undue harm and assures that the research and its review is carried out according to guidelines of the United States Department of Health and Human Services, Office of Human Research Protection

The Arizona Law defines the following terms:

32-1581. Dispensing of natural substances, drugs and devices; conditions; civil penalty; dispensing minerals; definitions

1. “Device” means an appliance, apparatus or instrument administered or dispensed to a patient by a doctor of naturopathic medicine.

2. “Dispense” means the delivery by a doctor of naturopathic medicine of a natural substance, drug or device to a patient and only for a condition being diagnosed or treated by that doctor, except for free samples packaged for individual use by licensed manufacturers or repackagers, and includes the prescribing, administering, packaging, labeling and security necessary to prepare and safeguard the natural substance, drug or device for delivery to the treating doctor’s own patient.

MEETINGS

It was proposed and agreed that future meetings should be held once every 3 months.  The next meeting is tentatively scheduled for Friday, May 7, 2010, at 11:30 a.m. at the same location.  Each member is asked to confirm that Friday May 7 is feasible.  If it is not feasible for anyone, that person should communicate as such as soon as possible to the others, so an alternate date and time may be selected.  After the members communicate ability to attend, the next meeting date and time will be confirmed.

E-mail addresses were then recorded, although are still missing for some members.   Members are asked to share their e-mail address with other members. This initial draft of the minutes of the Feb 5, 2010 meeting is being forwarded to all members for their editing and approval.

This meeting was adjourned at 3:00 p.m., Friday, February 5, 2010.

Colleen Huber, NMD, Interim Secretary

[Topics for May 2010 meeting:]

Decide if and how to amend the 2/5/2010 minutes, vote to approve.

Write a standardized informed consent?  Or minimal basic boilerplate to be modified by each physician?

Presentation of any specific research proposal by ANRI and/or NORI to IRB for approval

Election of officers

Proposal for a Bylaw:

Submitted by C. Huber:

Recognizing that both chemotherapy and radiation are outside the scope of practice and prescription rights of a naturopathic physician practicing in Arizona, members of this organization are [discouraged?/strongly discouraged?/prohibited?] from threatening to withhold treatment from any patient who chooses not to have chemotherapy or radiation, because such threat would be equivalent to an illegal prescription of the same, and because such threat would significantly weaken the decision-making authority of the patient regarding critical life-altering choices that only the patient should make and should be able to make freely without coercion.   However, the purpose of this organization is not to restrict the practices of the members but rather to affirm and uphold all therapies that offer more potential benefit to patients than risk, as well as encouraging and educating patients in their options, so that they are able to make the best decisions they can.  Therefore this restriction to members’ practice, as well as any future restrictions should be rare, only if necessary, and only if adopted by unanimous consent of all members.

Call for papers

If time, trade ideas and information on various treatment strategies?