AMERICAN NATUROPATHIC 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)
August 27, 2010
MINUTES AND MEETING NOTES
In accordance with the requirements of the United States Code of Federal Regulations, Title 45, Part 46, the third 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 11:50 a.m., August 27, 2010 at 1250 E. Baseline Rd., Suite 205, Tempe, AZ 85283.
The following members were present, listed alphabetically by last name:
Turshá Hamilton, NMD
Colleen Huber, NMD
Kenneth Lashutka, NMD
Chad Livdahl, NMD
Glenn Ozalan, NMD
Kenneth Proefrock, NMD
Paul Stallone, NMD
Phranq Tamburri, NMD
Other members, Jesse Adams, Marilyn Brewer, Elizabeth Enright, Rob Milisen, NMD, Tim Peace, NMD, Jonathan Psenka, NMD and Shelly Smekens, NMD, were not able to be present for this meeting, and are cordially invited to future meetings.
Other individuals who may be interested in participating in future meetings, or who are invited by an individual member, are also welcome.
MINUTES OF LAST MEETING
The minutes of the May 7, 2010 meeting were approved as minutes. However, some of the items raised last meeting were discussed as described below.
It was recognized that an Informed Consent form is a necessary initial contract between a naturopathic physician and a patient.
The question was raised if there should be a different Informed Consent for each doctor, or if a common template would best serve the goals of the research organizations. That question was raised but not answered at first.
It was also mentioned that an Informed Consent does not have to be so watertight against possible lawsuit that it should be very long and cumbersome.
This led to the question of shared liability. Specifically, if one of us is sued, would we the IRB members have to share liability? Or would there be a need to have the IRB as a sanctioning entity? It was generally agreed and understood that in the very unlikely event of any individual doctor’s gross negligence or malpractice, the individual doctor in question would have the entire liability. However, if one doctor needs to show that there are other physicians in the naturopathic community that might have or have in the past used similar procedures or treatments, that the rest of us would be there, in person and in spirit, for the one doctor in question, to affirm that we do use similar treatments, if that is the case, should the need or justification for such solidarity ever arise.
Dr. Proefrock said that it is important to make sure that the doctor did not misrepresent anything and did not make guarantees of effectiveness. A doctor should say in advance to the patient that it is impossible for anyone to predict the outcome of a treatment on a given patient. The intent has to be good, but the results are never guaranteed.
Dr. Tamburri spoke of the value of having a unified and thorough Informed Consent in order to strengthen our right to conduct our research.
Dr. Huber mentioned that although we are conducting research, simply because every doctor-patient interaction is different in at least some respects from any previous encounter, even between the same two people, and each such encounter is therefore a learning opportunity, such research exists only within the context of the patient and the doctor coming to a deliberate and thoughtful and mutually respectful agreement about what kind of care is best for the patient.
Dr. Ozalan reiterated that it is not enough simply to defend our right to conduct research, but rather that we should promote naturopathic considerations, and explained the use of that term to mean treating the patient as a unique individual with unique needs, and bringing our intelligence and medical education and experience and creative problem-solving to bear on devising a possible unique and appropriate treatment protocol, in other words, the antithesis of cookbook medicine. Our profession should avoid sclerosis of thought.
Dr. Stallone said that it must be acknowledged in the Informed Consent that adverse events may happen, and Dr. Ozalan agreed that such risk is a fundamental part of the doctor-patient relationship.
Some of the elements to be included in an Informed Consent that were discussed at the last meeting are as follows:
– An agreement to participate in experimental treatments/unconventional treatments/treatments not approved by the FDA;
– An agreement that a specialist in the area of the patient’s main illness is typically employed, but that the patient may choose to only have naturopathic care;
– Disclosure of any known risks. This may include a statement that the treatment is so new that not all potential risks are yet known; and
– There is the option of not agreeing to any treatment or to have that treatment stopped at any time.
Dr. Tamburri emphasized that above all we need to affirm patient rights, and that patient empowerment is the key to our continuing to be able to practice medicine in the manner that we do best: approaching each patient with an open mind, able to listen to them, make the necessary individual considerations, and consult with the patient as an intelligent participant in their own healthcare. We should disclose to the patient what the “Standard of Care” is and how we propose to conform to or differ from that.
Dr. Huber emphatically agreed with Dr. Tamburri on this point, that patient empowerment is the key to our being able to continue practicing in the way we know best, because a patient in consultation with a doctor, or even alone, has the inalienable right to, and can be trusted to, act much more intelligently in their own best interest than a remote overbearing bureaucracy dictating standard of care from cookbook medical dogma. Dr. Huber then reiterated the Patient Bill of Rights that appeared in the last minutes, which are reprinted as follows:
“In 1990 the Association of American Physicians and Surgeons asserted that ‘medical care must be rendered under conditions that are acceptable to both patient and physician’ and adopted a list of Patient Freedoms in 1990, which was then modified in 1995 and adopted as a Patients’ Bill of Rights. It read:
All patients should be guaranteed the following freedoms:
- To seek consultation with the physician(s) of their choice;
- To contract with their physician(s) on mutually agreeable terms;
- To be treated confidentially, with access to their records limited to those involved in their care or designated by the patient;
- To use their own resources to purchase the care of their choice;
- To refuse medical treatment even if it is recommended by their physician(s);
- To be informed about their medical condition, the risks and benefits of treatment and appropriate alternatives;
- To refuse third-party interference in their medical care, and to be confident that their actions in seeking or declining medical care will not result in third-party-imposed penalties for patients or physicians.
Dr. Hamilton has spoken to an attorney about Informed Consent in general, and said that according to the attorney, an Informed Consent should acknowledge and inform patients about other treatment options, and should disclose potential dangers. An Informed Consent should also be written by a lawyer.
The consensus was that the matter of Informed Consent is large enough to not be finished in this meeting. It was also proposed that since we are looking for common Informed Consent Language, and will be working in drafts, it would be more useful to do this in writing. Dr. Proefrock reported that Dr. Milisen has already set up the internet forum/group, and that it is just waiting to be activated.
Dr. Huber promised to get information about how to use that out to the group, as soon as available.
A nomination had been made at the May meeting for Dr. Kenneth Proefrock to be President. That motion was followed by a second, and third. Then Dr. Ozalan said that an organization of naturopathic physicians does not need officers, but rather can exist with an egalitarian structure.
Dr. Huber disagreed, noting that just moments after the May meeting ended, there appeared suddenly ten dollars, as payment of dues to the organizations, and the question of what to do with that money, necessitating the office of Treasurer. At that moment, a Treasurer was promptly appointed, namely Dr. Lashutka.
Dr. Huber then called for any alternate nominations for President. There were none. Dr. Huber gave her reasons for the nomination of Dr. Proefrock, namely that an articulate person such as he would be a very good spokesperson for these organizations. Dr. Huber also expressed that she did not feel herself best qualified or talented to carry out this function, to be the organization’s best face to the public. Furthermore, these organizations were the brainchild of Dr. Proefrock, and it was only on his suggestion that Dr. Huber realized the need and started organizing the first meeting earlier this year.
It was suggested by a number of people, this time as well as last, that the position of President/Spokesperson be a rotating one, and that in the future that position of President rotate to another member. It seems that there was general agreement on that point.
A number of members agreed emphatically that an egalitarian structure, not a tyranny, was best and most suited to our talents and mutual respect.
Dr. Huber then called for any alternate nominations for President, including the option of “No President at all.” There were none. Dr. Huber called for a vote. Dr. Proefrock was then overwhelmingly elected President of our organizations.
PURPOSE AND MISSION
Dr. Stallone asked that we then focus on the purpose of our organization going forward.
Dr. Huber asked if we have dispensed with enough of the founding and administrative matters to be able to go on to discussing actual research or treatments in a Grand Rounds format.
The other members answered yes, except for the Informed Consent, which will be further resolved in e-mail outside of the meetings for now.
Dr. Proefrock said that we should decide what we’re going to be sanctioning or supporting.
Dr. Livdahl clarified that we want to know what other doctors are doing to assess and see if we want to incorporate this new information into our own practices.
Dr. Proefrock encouraged us to come up with different ideas, to look at the margins of naturopathic medicine.
Therefore it was agreed that the next meeting would begin to focus on case presentations and other matters pertaining to medicine as each of us practices it.
Members are encouraged to bring in one or more enlightening cases to share with the group.
The next meeting has not yet been scheduled, and we unfortunately forgot to do that during the meeting. Dr. Huber proposes that we meet next on Friday, November 19, at 11:00 a.m. at the same location, the clinic of Drs. Huber and Lashutka at 1250 E. Baseline Rd., Suite 205, Tempe, AZ 85283. Each member will be asked if November 19 works, and if so, will be reminded of the meeting date in early November.
Please let Dr. Huber’s assistant Jesse, Tel: 480-839-2800, know ASAP if Friday, November 19 is good or not good for you.
This meeting was adjourned at approximately 1:45 p.m., Friday, August 27, 2010
Colleen Huber, NMD, Secretary and Meeting Coordinator
Possible topics for November, 2010 meeting:
Decide if and how to amend the 8/27/2010 minutes, vote to approve or amend.
In the May meeting a question was raised if there should be Vice Presidents, a question which got forgotten about in the August meeting. Dr. Huber suggests that anyone and everyone who has attended most of the meetings held so far, and who does not already hold another office, could reasonably be a Vice President. This could be discussed, or not. Perhaps the only value in this is by for the members to take some responsibility, “ownership” and feel a personal stake in the success of these organizations. Maybe this is possible without formal titles.
Also, no term limits for offices were discussed. Perhaps one year? However, that time goes quickly. Three of the four meetings of 2010 have already been held. Perhaps when someone wants to step up to a particular office, an election could be held within a certain amount of time.
Another possible item for discussion is how much, how broadly and how soon would it be advisable to let the public, the board and other naturopaths know that our organization exists? Dr. Huber has reserved a couple of possible web domain names, which are just waiting for content, and wonders why not go public soon?
Are any really important matters being ignored or forgotten about? Please suggest topics that are important to you, or topics that are vital for our profession or our organizations to address.
Case presentation: Please bring one or more enlightening cases to report.
Presentation of any specific research proposal to IRB for approval.