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)
May 20, 2011
MINUTES AND MEETING NOTES
In accordance with the requirements of the United States Code of Federal Regulations, Title 45, Part 46, the sixth 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 12:30 p.m., May 20, 2011, 2011 at 1250 E. Baseline Rd., Suite 205, 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
Heath McAllister, NMD
Kenneth Proefrock, NMD
Phranq Tamburri, NMD
Others who have attended previous meetings or wish to attend future ones are cordially invited to join us for future meetings.
INTRODUCTIONS AND REVIEW OF THE PURPOSE OF OUR ORGANIZATIONS
Everyone introduced themselves.
Dr. Proefrock, ANRI/NORI President, reminded us that:
1. We are a forum of peers as well as public members dedicated to embracing the breadth of naturopathic medicine, including its many and 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.
After the introductions, we pursued the agenda that had been previously e-mailed to the membership.
OUTREACH TO ALLOPATHIC MEDICAL RESEARCH ORGANIZATIONS
The announcement was made of the opportunity for our organizations to meet with the head of a local genomic research organization. The members present unanimously decided that it would not further the interests of ANRI / NORI to pursue such a meeting, or to develop such a relationship, at least not at this time, and we therefore decided to decline the invitation.
SHOULD OUR ORGANIZATIONS PURSUE NON-PROFIT STATUS?
Marilyn Brewer made an argument in favor of becoming non-profit, that donors would be unwilling to donate otherwise, because they could only get a tax write-off if donating to a non-profit.
Dr. Huber agreed, and mentioned that there are many cancer research organizations soliciting money, and they all are non-profit, so that if we don’t become non-profit, it will be harder to compete for the enormous amounts of donation dollars out there.
Jim Mayhew reaffirmed that a non-profit gives a vehicle for donations, and said that it would be best to first establish a business plan, and that we have to determine the following:
– What are we going to use the money for? We need to show a benefit for people donating to us.
– We need to affirm the broad picture of our purpose in order to establish a non-profit.
– We have to make guidelines that would satisfy the IRS.
Jim also warned us that it is notoriously difficult to establish a non-profit, the operation, the paperwork, and that we should get an attorney.
Dr. Proefrock agreed with that and further said that there are considerations of the problems of political influence involved in establishing a 501(c)(3).
He also said that there is an Executive Director, which is a salaried position, and that this is the person who generally writes the grant proposals, and files paperwork each year. There are Board Members. These are non-paid positions. He also said that the non-profit must operate with accountability and transparency.
Jim agreed that the Executive Director would take ultimate responsibility for these criteria, and would be elected by the Board.
It was mentioned that donors would come from the patient base among others outside our clinics who learn of our work.
Dr. Huber said that she would like to see an anti-corruption mechanism in place, so that there would be institutional safeguards against a particularly large potential donor dictating avenues of research or pushing foregone conclusions of that research.
Jim stated that nobody making a donation may make demands of the organization. They can make suggestions as to how they want their money spent, but it will be up to the Board to determine what to do with donated funds.
DESTINATION OF DONATED FUNDS
Dr. Proefrock said that donated funds should be distributed based on the merit of a proposed study, that this should be voted on at board meetings. A clinic who wants funds should apply to ANRI / NORI. If you’re present for the meeting, you’re okay to vote. Not in attendance: no vote.
Dr. Proefrock said that the Executive Director should be the one who writes a grant proposal. However, we should also file a 501(c)(3) first. He said that this would cost $400 to file for a non-profit.
Dr. Huber suggested that we go ahead and nominate someone.
Nobody volunteered, and nobody nominated another person, so that issue was postponed for the present, in this meeting.
Some domain names have been reserved pending approval of this Board. They are:
AZNRI.org, NANORI.org, NaturopathicResearch.org and NatureAgainstCancer.org.
Dr. McAllister asked what the purpose of the website would be.
Dr. Proefrock responded that there are other naturopaths and organizations of naturopaths who have already attempted to establish their methods of treating patients as the only acceptable methods, which would lead the general public to assume that all naturopaths are in agreement on restrictions to our scope of practice.
Dr. Lashutka said that what we are doing and the purpose of our website would be in accordance with the organizations’ purpose, and that is to protect our right to simply practice naturopathic medicine.
Dr. Proefrock pointed out a trend in the naturopathic community to want insurance reimbursement at all costs. Thus there is a tendency to want to narrow what NDs do in order to try to please the insurance companies. Our organizations, by our very existence and cohesion as a group, work against that trend, and we are affirming the breadth of our scope, and our right to practice to the extent of our training.
Dr. Tamburri reminded us that from a historical perspective, when citizens have given up certain rights, it has been very, very hard, and almost always with bloodshed, to take those rights back. Likewise, if naturopaths agree to relinquish our rights to practice to the full extent of our scope of practice, we may very well find ourselves unable to achieve that scope again.
Dr. Tamburri talked about the personal conflict for a Libertarian such as himself to sit on a regulatory board, such as his likely nomination to the NPBOMEX in the near future. However, it is precisely because of people who are mindful of the rights of individuals sitting on regulatory boards that we can help keep such a board from becoming a stifling bureaucratic tyranny. That is, people who tend not to make rules tend not to be on regulatory boards. But the converse is true and far more dangerous. That is: Those who like to wield power and stifle the work of others are too often found gravitating toward positions of power and making their mischief on regulatory boards.
Dr. Tamburri also informed us that FABNO policies have been put in the AANP “standards of care,” after FABNO has spent years forming close connections with the AANP.
Dr. Tamburri drew the contrast this way of what we at ANRI / NORI represent:
“We are saving the rights and options of our patients. We are the source of defending this for our own patients.” He also described how ANRI / NORI is the highest standard for informed consent, in that we defend these patient rights.
(For reference, the Informed Consent that we spent more than a year discussing and working on is reprinted at the end of this document.)
Dr. Proefrock often attends AANP meetings as part of his role with NABNE. From his perspective, we need to create a position paper, in order to establish a standard, to present to the AANP. A major theme of that paper is affirming and embracing a broader scope that supersedes efforts to curtail our scope. And that we should have a position statement on that level, affirming patients’ rights. And that we should put this on the website.
Dr. Tamburri asked again: Who is the audience for the website? In addition to the website for the general audience, there should be a structure for a closed system website, especially considering that a good number of people are here each time, more and different people, yet some would like to come and can never make it to the meetings. So we should find a way to involve them.
Dr. Tamburri said that at the AANP Conference in August, we should have an ANRI / NORI dinner meeting.
Dr. Jemison agreed that it would be good to get something in place for the AANP in August.
Dr. Proefrock said that we should have a website manager.
Marilyn agreed that a website would be a good first step as a lead-up to a non-profit.
Dr. Huber reminded everyone that we have a lot in place that can already go into a website. These include:
– Quarterly board meetings, having a quorum each time and always exceeding the minimum number and composition of participants, and their backgrounds, specified in the US Code of Federal Regulations for an IRB involving human research subjects. For each meeting there have been exhaustive minutes, all of which can be posted on the website, ad infinitum.
– A mission statement, which has been proposed, debated extensively and adopted in previous meetings.
– An informed patient consent, which took nearly a year of sentence-by-sentence scrutiny and revision in these meetings to put together, and was finally adopted by the Board in February, 2011.
Dr. Tamburri agreed that we need all the basics.
Dr. Proefrock said that we should go ahead and establish the website, and that we should go ahead and set up paperwork.
Dr. Tamburri asked how do we explain what we’re doing without bashing those who would restrict the naturopathic scope of practice?
Dr. Proefrock replied that we are preserving the integrity of naturopathic medicine, which is the cutting edge of medicine.
Dr. Tamburri added that, in contrast to the perspective of the uninitiated among naturopathic students and patients, it’s not about our modalities. It’s that we bring choices to patients when they otherwise don’t have any. He said that this is the reason we have ANRI / NORI, in order to defend patient choice and to embrace the breadth of naturopathic medicine.
Dr. Huber read the current website choices again. NaturopathicResearch.org was approved by the membership.
Dr. Proefrock said to have each of ANRI and NORI under that.
Dr. Tamburri said that we should have the website NaturopathicStandards.org, in order to establish our position as vanguards and standard bearers for the naturopathic profession. He said that it should reflect our position as upholding the highest standards in patient choice and alternative medical research.
He also advised to reserve the .com and .org forms of each of the domain names NaturopathicResearch and NaturopathicStandards.
Dr. Lashutka simultaneously checked on the availability of NaturopathicStandards. He informed us that both dot com and dot org domain names were available.
Dr. Huber volunteered to draft sample pages for a home page and various sub-linked pages in Word for our website content. Because these will be discussed and revised until found to be favorable by the majority of us, these drafts will be in Word. Then the final adopted form can be converted to HTML by a professional webmaster.
(CH note, 8:49 p.m. on 5/20/11: I have just reserved for us all of the domain names on the above wish list, except for NaturopathicResearch.com, which had already been taken by someone else by the time I looked for it, over a month ago. To clarify, of the names we want, we have NaturopathicResearch.org, NaturopathicStandards.com and NaturopathicStandards.org. Per Dr. Proefrock’s instruction, NaturopathicResearch.org will be set to automatically forward to NaturopathicStandards.org.
I will try to get some initial draft pages to the membership by e-mail in early June.
Dr. Tamburri said that because of recent developments and controversy regarding medical marijuana, we should take a position on that issue.
Dr. McAllister informed us that soon AZNMA will set up trainings in how to counsel patients on medical marijuana.
Dr. Proefrock told us that the matter of medical marijuana has become a complete fiasco, for the allopathic community especially, and that we should perhaps choose our battles and let this particular one go, at least for the present.
Dr. Huber again asked if Friday is the best day for everyone for these meetings. The majority affirmed yes.
Also, it was agreed to meet next time in late July, earlier than otherwise, in order to be prepared for the August AANP Convention.
NEXT BOARD MEETING: Friday July 29, 2011 at noon. Chipotle’s will be served, unless objections surface before then.
Dr. Huber offered 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 JULY 29 BOARD MEETING
Preparation for AANP meeting in August. Do we want a booth? If so, shall we discuss ahead of time coordinating hours for staffing that booth? Dr. Tamburri suggested an ANRI / NORI dinner. Would this be announced to the AANP membership and one of the Biltmore conference rooms reserved for this? – Let’s discuss by e-mail before July.
Discussion and revision of draft of website material. The Word documents for the drafted pages for NaturopathicStandards.org will be e-mailed to members before the 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
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 ______________________________