AMERICAN NATUROPATHIC RESEARCH INSTITUTE
NATUROPATHIC ONCOLOGY RESEARCH INSTITUTE
1250 E. Baseline Rd., Suite 205
Tempe, AZ 85283
JOINT MEETING OF THE
AMERICAN NATUROPATHIC RESEARCH INSTITUTE (ANRI)
NATUROPATHIC ONCOLOGY RESEARCH INSTITUTE (NORI)
INSTITUTIONAL REVIEW BOARD (IRB)
July 29, 2011
MINUTES AND MEETING NOTES
In accordance with the requirements of the United States Code of Federal Regulations, Title 45, Part 46, the seventh regular quarterly meeting, of the American Naturopathic Research Institute (ANRI) and the Naturopathic Oncology Research Institute (NORI) and the Institutional Review Board(IRB) was called to order at 12:45 p.m., July 29, 2011, 2011 at 1250 E. Baseline Rd., Suite 205, meeting in Suite 203, Tempe, AZ 85283.
The following members were in attendance (alphabetically by last name):
Marilyn Brewer, LAc
Turshá Hamilton, NMD
Colleen Huber, NMD
Thomas Jemison, NMD
Kenneth Lashutka, NMD
Phranq Tamburri, NMD
Kim Wismer, RN
Others who have attended previous meetings or wish to attend future ones are cordially invited to join us for future meetings.
PREPARATION FOR UPCOMING CONVENTION OF THE AMERICAN ASSOCIATION OF NATUROPATHIC PHYSICIANS (AANP)
First we discussed what kind of presence our organization should have at this upcoming convention in Phoenix, AZ, August 17 to 20, 2011. Various possibilities discussed included a booth, or an introductory dinner or an introductory meeting.
Regarding a booth, the advantage would be increased visibility, but the disadvantage would be a lot of commitment and time staffing the booth. Also a lot of planning time and supplies would be needed.
We decided that the best outreach we could have at this time would be an introductory dinner. The advantages would be it would be less costly, and Dr. Hamilton reminded us that it should be scheduled toward the later end of the convention, so we could have time to let people know about the dinner. She also pointed out that with food, there is an additional motivator to attend.
We agreed that the evening of Friday, August 19, 2011 would be the best date.
Jesse mentioned that we would need to contact the hosting hotel, The Biltmore, to find out how to arrange such a dinner.
Dr. Huber mentioned that to begin a dinner seems most feasible at this time. Then after getting more established, with a larger membership, we could start staffing a booth at the semi-annual convention of the Arizona Naturopathic Medical Association (AZNMA).
ANNOUNCING INTRODUCTORY DINNER AT AANP
Dr. Huber will call the AANP this week to ask permission to do the following, which was agreed upon by the members present:
1. Flyer to be placed in the Registration Packet for each attendee:
A single sheet 8.5 x 11” brightly colored flyer with the following text:
“The American Naturopathic Research Institute (ANRI)
and the Naturopathic Oncology Research Institute (NORI)
Invite you to our Introductory Dinner at 6:00 p.m. on Friday, August 19.
If you have ever wanted to expand the scope of practice of naturopathic medicine,
Or to stand up for patients’ freedom of choice in their own health care,
Then you should come and find out what we have been up to!
ANRI / NORI members have done research in natural treatments for cancer,
Rheumatoid arthritis, stem cell therapy and more.”
But primarily we are here to embrace the breadth of our scope of practice and to uphold patients’ freedom of choice in their own health care.”
2. A bookmark sized card to be distributed at the convention, in order to remind attendees about the dinner and to encourage attendance.
WEBSITE CONTENT: NATUROPATHIC STANDARDS.ORG
We then discussed the draft that Dr. Huber had prepared from the material of previous meetings. That draft is reproduced at the end of these minutes.
The home page was adopted as is, with the following changes:
Keep masthead the same. Add a link for a page of legal material.
Dr. Lashutka suggested to have the legal material page as a separate link under the “Scope of Naturopathic Medicine” page.
Marilyn and Dr. Tamburri suggested to move the goal from “Goals and Purpose and Mission Statement” page to the home page of the website. Marilyn said that it should have a border and special typeface to stand out.
The two paragraphs of goals were reworded to say the following:
“The following goal was adopted in our meeting of November 29, 2010 and amended on July 29, 2011:
“The overall tendency in medicine in general, and in naturopathic medicine in particular, is to bend to political and malpractice insurance pressures, and to erode and restrict the scope of practice to an increasingly narrow range of patients and treatment protocols.
“In response to this tendency, our organizations are needed to uphold the necessary breadth in our professional practice, in accordance with the original intent and role of naturopathic medicine as a comprehensive system of medicine, designed to offer the maximum range of effective and safe treatments, and to uphold patient choice among those treatments.”
MISSION STATEMENTS AND PURPOSE REVISITED
We moved on to the Mission Statements. Dr. Huber read the ANRI Mission Statement out loud. Marilyn pointed out redundancy here. So this was revised today to read as follows:
“The American Naturopathic Research Institute (ANRI) and the IRB have been formed in order to explore and to conduct research on causes and treatments for chronic diseases, including but not limited to cancer, diseases of inflammation and disordered immune function and environmentally-caused illness. We have also come together in order to preserve naturopathic medicine, as practiced in all the diversity, synergy and comprehensiveness as it presently exists in the states with the broadest scope of practice, as well as to create the possibility of growth in ideas, research and treatment opportunities, in order to further expand the knowledge and capabilities of our profession.”
Dr. Huber then read the NORI Mission Statement. Dr. Tamburri pointed out that we had neglected to mention choice in treatment protocol. So it was amended to read as follows:
“The Naturopathic Oncology Research Institute (NORI) and the IRB 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 treatment choice, wellbeing, strengthening, education and empowerment of patients with cancer.”
We then moved on to discuss Purpose. The first two paragraphs were accepted as is.
Dr. Tamburri suggested that we edit the 3rd paragraph to read as follows:
“3. We also recognize that two or more individual practitioners in the naturopathic community practicing in a particular way with regard to patient care, or as taught in a naturopathic school of medicine, are generally considered as adequate by NPBOMEX to establish such treatments as valid for ongoing study and practice.”
Dr. Jemison suggested eliminating the fourth paragraph regarding an IRB, because it aimed to unnecessarily establish restrictions. This was seconded by both Marilyn and Dr. Lashutka, and unanimously agreed on by the membership in attendance.
It was also agreed to put legal information on a separate page, under the Scope of Naturopathic Medicine page.
SCOPE OF NATUROPATHIC MEDICINE REVISITED
This page was essentially unchanged in its content, except that Dr. Hamilton and Marilyn suggested to indent and italicize actual quotes from the laws and rules affecting naturopathic practice, in order to distinguish them from our comments on the law. Dr. Jemison said to move these to the Legal page.
Dr. Jemison pointed out that we also need to clarify which of the Definitions are ours, and which are quoted from the law.
Dr. Lashutka pointed out that the new definition of intravenous therapy, which became law after we prepared the Definitions page, should be included in the Definitions.
Both by-laws of the organizations were read allowed and unanimously approved today, July 29, 2011.
The Informed Consent had been scrutinized and debated sentence-by-sentence so vigorously throughout 2010, and finally approved on February 18, 2011, that we mercifully left it alone today.
The membership agreed to include on the website all of the minutes from all of the quarterly board meetings, having nothing to hide from public examination.
We agreed to only list the officers of the organization, Dr. Kenneth Proefrock, Dr. Colleen Huber, and Dr. Kenneth Lashutka, with a common e-mail address, for correspondence from the public. We agreed to list the address of the meetings, and the phone number for the clinic of Drs. Huber, Lashutka and Jemison. Jesse would field phone calls and e-mails.
Dr. Hamilton mentioned that Google Voice can be a voice mail with a transcript of a message to go to e-mail. Jesse said that she would prefer this arrangement.
Dr. Lashutka said to have separate e-mail accounts for each officer, that for now would forward to the office, to Jesse’s attention.
No changes were suggested to the Donations page.
The meeting was adjourned at 2:35 p.m.
NEXT BOARD MEETING: Friday, November 4, 2011 at noon, at the usual place, the clinic of Drs. Huber, Lashutka and Jemison, in Tempe. Chipotle’s will be served, unless objections surface before then.
Dr. Huber continues to offer for her clinic to provide lunch for the meetings at no cost to the membership, in order to save up the usual $10 dues per quarter per person to pay the $400 fee for the eventual incorporation of the non-profit.
POSSIBLE AGENDA ITEMS FOR NOVEMBER 4, 2011 BOARD MEETING
What happens when the AZ vaccine exemption form isn’t enough to get out of a vaccine?
Some time ago one of our patients registered at ASU and was told that the medical exemption form that I had signed was not enough, and they badgered him into getting a flu shot and a tetanus shot. This was a perfectly healthy, fit, strong, young landscaper. Predictably, after the shots he got the flu, first time in his life, and his health has not been as good since. How about if ANRI sponsors a Vaccine Research Program, and makes a letter on our ANRI letterhead, which doesn’t exist yet, that says, “the abovementioned person is strictly NOT to receive any immunizations outside of our research program, and the program ensures that all the participant’s immunization needs have been met.” Or something like that.
Search for an Executive Director.
Colleen Huber, NMD
Secretary, ANRI / NORI
[home page draft prior to 7/29/11 meeting]
The website of the
American Naturopathic Research Institute (ANRI)
Naturopathic Oncology Research Institute (NORI)
Institutional Review Board (IRB)
Upholding the Standards of Medical Freedom and Breadth of Scope in Naturopathic Medical Practice
|Goals and Purpose andMission Statement||Scope of Naturopathic Practice||By-Laws||Informed Consent||Minutes of our Quarterly Meetings||Who we are: Officers and Members||Support the Work of ANRI or NORI|
“The Constitution of this Republic should make special provision for medical freedom. . . Unless we put medical freedom into the Constitution the time will come when medicine will organize into an undercover dictatorship and force people who want doctors and treatment of their own choice to submit to only what the dictating outfit offers.”
Benjamin Rush, MD (1745 – 1813)
Colonial Physician and Signer of the Declaration of Independence
“We are a forum of peers as well as public members dedicated to embracing the breadth of naturopathic medicine, including its many diverse practice modalities in a non-judgmental way.”
Kenneth Proefrock, NMD
President, ANRI / NORI
[Goals and Purpose and Mission Statement page draft prior to 7/29/11 meeting – 2 pages total]
We agreed on the following goal in our first meeting on February 5, 2010:
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.
Doctor as teacher
The following goal was adopted in our meeting of November 29, 2010:
As the governing bodies of a minority profession, the State of Arizona through the Naturopathic Board are strongly subject to the tendency to erode and restrict the scope of naturopathic practice to an increasingly narrow range of patients and treatment protocols.
In response to this tendency, our organizations are needed to uphold the necessary breadth in our professional practice, in accordance with the original intent and role of naturopathic medicine as a comprehensive system of medicine, designed to offer the maximum range of effective and safe treatments.
The ANRI Mission Statement was adopted by the membership in our May 7, 2010 board meeting:
The American Naturopathic Research Institute (ANRI) and the IRB have been formed in order to explore and to conduct research on causes and 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. We have also come together in order to preserve naturopathic medicine, as practiced in all the diversity, comprehensiveness, synergy and breadth of scope as it presently exists, in the states with the broadest scope of practice, as well as to create the possibility of growth in ideas, research and treatment opportunities in order to further expand the knowledge and capabilities of our profession.
The Mission Statement for NORI was adopted by the membership in our May 7, 2010 board meeting:
The Naturopathic Oncology Research Institute (NORI) and the IRB 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 patients with cancer.
In the May 20, 2011 quarterly meeting, Kenneth Proefrock, NMD, President of ANRI / NORI, reminded us of the following purpose of our organizations:
1. We are a forum of peers as well as public members dedicated to embracing the breadth of naturopathic medicine, including its many diverse practice modalities in a non-judgmental way.
2. The reason we have come together over a year ago to form these organizations is to re-affirm the standard of care in naturopathic medicine being based on the greater good of our patients’ need for the optimal treatment strategy for their health circumstances, and that this best treatment protocol for any given patient is most likely be found among a very broad scope of practice rather than one that is unnecessarily restricted.
3. We also recognize that two or more individual practitioners in the naturopathic community practicing in a particular way with regard to patient care are generally considered as adequate by NPBOMEX to establish such treatments as valid for ongoing study and practice.
4. Any practice that is considered by other naturopaths to be unusual or on the margins of the naturopathic scope of practice must by law have an Institutional Review Board (IRB), such as we have formed here over a year ago and that we continue to maintain in accordance with the aforementioned pertinent codes of the United States Code of Federal Regulations.
[Scope of Naturopathic Practice Page Draft prior to 7/29/11 meeting – 3 pages total]
The following text was adopted in the first meeting of our joint organizations on February 5, 2010:
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:
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
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.
“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.
[By-Laws page draft prior to 7/29/11 meeting]
It was decided that approved by-laws would be for both ANRI and NORI.
“Current or past practices, whether done independently, via preceptorship, externship, internship or other, have adequately demonstrated that there is no further educational or workshop requirements needed for our naturopathic physician members, other than the standard CE credits required for our profession, in order to practice in fields ranging from but not limited to: Allergy and Immunology, Anesthesiology, Cardiology, Dermatology, Emergency Medicine, Endocrinology, Family Medicine, Gastroenterology, Internal Medicine, Neurology, Obstetrics and Gynecology, Oncology, Ophthalmology, Orthopedics, Otorhinolaryngology, Pediatrics, Psychiatry, Pulmonology, Radiology, Surgery and Urology. The purpose of these organizations is not to restrict the practices of the members but rather to affirm and uphold all therapies that offer more potential benefits 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. Any restriction made by the organizations to members’ practices should be rare, only if necessary and only if adopted by unanimous consent of all members.”
This By-Law was unanimously approved and became effective as a By-Law of both organizations as of 5/7/2010.
Dr. Kenneth Lashutka presented his proposed By-Law, which was read, then was modified as follows:
“ANRI and NORI shall establish a comprehensive primary care naturopathic medical residency program for post-doctorate Naturopathic Medical Doctors. Each residency shall be comprised of rotations among the clinics and offices of various supervising naturopathic physicians who are members of ANRI and NORI and who are willing to participate in the program. Ideal candidates should demonstrate the desire to practice primary care Naturopathic Medicine based on the stated principles of ANRI and NORI. These principles include but are not limited to: 1) First do no harm; 2) Healing occurs by way of nature; 3) Treat the whole person; 4) Treat the cause; 5) Prevent disease; 6) The doctor is a teacher. Funding for the residency program(s) will be determined, but may include pro-rated wages paid by the clinics at which a resident consults with patients.”
Dr. Lashutka’s proposed By-Law was unanimously approved and became effective as a By-Law of both organizations as of 5/7/2010.
[Informed Consent page – approved by membership on February 18, 2011]
INFORMED CONSENT FOR NATUROPATHIC MEDICAL TREATMENT
I hereby authorize and direct Dr. __________________, who is a naturopathic physician licensed in the State of Arizona, to do the following:
1) to consult with me about my health concerns, and
2) to run laboratory tests and perform physical exams that we discuss and agree on, and
3) to treat me with naturopathic medicine and/or conventional medicine, as my health condition requires, and as we discuss and agree on over time on a case-by-case basis.
I understand that there may be risks and consequences to my medical treatment, some of which may have never yet been discovered, and that the practice of medicine involves many variables, some of which would be impossible to account for in every situation. There is no medical procedure in which no complication has ever been reported. I understand that it is impossible to guarantee the outcome of any medical procedure, and that I have been given no guarantee as to the results that may be obtained. I understand that the FDA does not necessarily approve of any of these treatments. I further understand that the conventional treatments for cancer are chemotherapy, radiation and surgery. Although my doctor(s) and I will together choose the best treatments for my health condition and goals, I understand that the results and data therefrom will be used anonymously in reporting naturopathic research, as in a case review.
I further understand that Dr. ____________ honors the following Patient Bill of Rights. The following list of my rights includes but is not limited to the rights below:
1) I have the right to seek consultation with any physician(s) of my choice, or refuse the same.
2) I have the right to medical treatments from my physician(s) on mutually agreeable terms.
3) I have the right to be treated confidentially, with access to my records limited to those involved in my care or designated by me.
4) I have the right to use my own resources to purchase the care of my choice.
5) I have the right to refuse medical treatment, even if it is recommended by my physician or any other physician, hospital or clinic.
6) I have the right to be informed about my medical condition, and the risks and benefits of treatment and appropriate alternatives.
7) I have the right to refuse third-party interference in my medical care.
Signature of Patient________________________________ Date: ____________
Patient’s printed name ______________________________
[Minutes – too lengthy to reproduce in this Word document – you should all have received over the last year and a half all meeting minutes, 6 documents total. If they got misplaced, don’t worry; once they’re on the website, they’ll be indexed and easy to find. – CH]
[Who we are: Officers and Members draft page prior to 7/29/11 meeting]
President: Kenneth Proefrock, NMD contact info in this column?
Executive Director: To be elected
Secretary: Colleen Huber, NMD
Treasurer: Kenneth Lashutka, NMD
Members: [I would like to list everybody here, with contact info and websites.
Any objections? – CH
Address, phone for ANRI / NORI, etc.
[Donations page draft]
Support the work of ANRI / NORI
Click here to donate
[Note: we can get a SSI Certificate to have secure credit card transactions online, or we can put an address, and have donors write a check. Of course, we should get the non-profit up and running first.]