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)
INTERNATIONAL NATUROPATHIC CLINICAL RESEARCH INSTITUTE
INSTITUTIONAL REVIEW BOARD (IRB)
May 12, 2017
MINUTES AND MEETING NOTES
In accordance with the requirements of the United States Code of Federal Regulations, Title 21, Chapter 1, Subchapter A, Part 56, the twenty-first regular quarterly meeting of the American Naturopathic Research Institute (ANRI) and the Naturopathic Oncology Research Institute (NORI) and the International Naturopathic Clinical Research Institute (INCRI) and the Institutional Review Board (IRB) was called to order at 12:00 p.m., May 12, 2017 at 1250 E. Baseline Rd., Suite 205, meeting in Suite 203, Tempe, AZ 85283.
MEMBERS AND GUESTS
Physician and non-physician members and guests were in attendance.
FEDERAL REGULATIONS GOVERNING IRBS
We opened the meeting with a conversation about requirements made by the FDA for the operation of Investigational Review Boards (IRBs), and we went through a checklist of requirements specified in the Code of Federal Regulations for the composition, operation, responsibilities, attendance and conduct of IRBs.
We verified that a non-physician had been present, at least one, usually more, at all of our IRB meetings in our 7.5 year history, that we had quarterly meetings with a quorum for all of our history, and that minutes were kept for each. We verified that our organization is registered with the FDA and Office of Human Research Protections, as is each one of our research projects.
We verified that the Informed Consent that we established over an entire year of meetings had been previously voted on and approved by us. It is attached herewith as the last page of these minutes. Our Informed Consent is relatively unique in that it honors and articulates patient rights, without necessarily being a complete list of patient rights. It was noted that the list of rights enumerated were mostly borrowed from the American Association of Physicians and Surgeons, with credit to them.
One participant mentioned that the Informed Consent is not supposed to exceed an eighth-grade education. Another participant commented that eighth-grade vocabulary is not uniform from one school to the next. Informed Consent forms have had to be re-written in order to achieve a common parlance for best understanding.
We noted that our type of Informed Consent is very often ignored by conventional medicine. For example, in conventional medicine, cancer patients are routinely bullied and coerced into chemotherapy and radiation treatments that often prove to be fatal. Such horrifying practices as “prophylactic whole brain radiation” were mentioned. Very often cancer patients in particular are herded into such treatments with the message that “Nothing else is going to work.”
If we learned anything from World War II and the Nuremberg Trials, it is that you do not force medical treatments on people against their will. If the International Declaration of Human Rights counts for anything, then individuals MUST be free of coercion, pressure, bullying, threats and intimidation when choosing among options for medical treatment. And all applicable options must be at least mentioned to them.
NEW PROPOSALS FOR RESEARCH ON THE HORIZON
The group was informed of new research projects that we are being asked and considered for review from various parts of the world.
RECENT CONFERENCES ATTENDED
One member mentioned attending Best Answer For Cancer, and an interesting discussion about melatonin. For one of the presenting doctors, dosing is consistently over 100 mg/day. Another doctor at that conference takes and doses 180 mg. In case of active cancer, 40 mg QID is given. Light is avoided throughout the night, except for red lights, which do not seem to inactivate melatonin. Bacterial lysates in the GI tract produce serotonin, precursor to melatonin. We also discussed supplemental melatonin having variable results against insomnia. One attendee had discussed this with another naturopathic physician who preferred not to dose over 300 mcg melatonin for insomnia.
Other attendees had recently had the pleasure of hearing a talk on endobiogeny. We discussed the proposition that migraines and asthma are spasms of the brain and lungs respectively, and the role of the autonomic nervous system and its fluctuations between parasympathetic and sympathetic dominance. The heart rate variability test was also discussed in this regard.
It was agreed that migraine was extremely complex, vasodilatory for some, vasoconstrictive for others, hormonally related for others, light and sound related for others. It was acknowledged that migraine is a symptom resulting from complex causes. Quinolinic acid was also mentioned. This is an endogenous metabolite that, when unopposed, can generate reactive oxygen species. Vitamin B-6 helps keep it in check, and better-balanced in its position on the tryptophan/5-HTP pathway.
One participant had had a particularly debilitating migraine, which disappeared almost immediately with IV nutrients, including high-dose vitamin C.
Another mentioned that prevention with adequate nutrient intake may be the best cure.
We discussed both federal and state news related to compounded medication.
NEXT MEETING: FRIDAY, AUGUST 11, NOON, THE USUAL PLACE
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:
- to consult with me about my health concerns, and
- to run laboratory tests and perform physical exams that we discuss and agree on, and
- 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, as adapted from the American Association of Physicians and Surgeons. The following list of my rights includes but is not limited to the rights below:
- I have the right to seek consultation with any physician(s) of my choice, or refuse the same.
- I have the right to medical treatments from my physician(s) on mutually agreeable terms.
- I have the right to be treated confidentially, with access to my records limited to those involved in my care or designated by me.
- I have the right to use my own resources to purchase the care of my choice.
- I have the right to refuse medical treatment, even if it is recommended by my physician or any other physician, hospital or clinic.
- I have the right to be informed about my medical condition, and the risks and benefits of treatment and appropriate alternatives.
- I have the right to refuse third-party interference in my medical care.
Signature of Patient________________________________ Date: ____________
Patient’s printed name ______________________________