AMERICAN NATUROPATHIC RESEARCH INSTITUTE
1250 E. Baseline Rd., Suite 205
Tempe, AZ 85283
JOINT MEETING OF THE
AMERICAN NATUROPATHIC RESEARCH INSTITUTE (ANRI)
(formerly the Arizona Naturopathic Research Institute (ANRI))
NATUROPATHIC ONCOLOGY RESEARCH INSTITUTE (NORI)
INSTITUTIONAL REVIEW BOARD (IRB)
May 7, 2010
MINUTES AND MEETING NOTES
In accordance with the requirements of the United States Code of Federal Regulations, Title 45, Part 46, the second 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 11:35 a.m., May 7, 2010 at 1250 E. Baseline Rd., Suite 205, Tempe, AZ 85283.
The following members were present, listed alphabetically by last name:
Marilyn Brewer, L.Ac.
Colleen Huber, NMD
Kenneth Lashutka, NMD
Chad Livdahl, NMD
Robert Milisen, NMD
Glenn Ozalan, NMD
Kenneth Proefrock, NMD
Shelley Smekens, 4th year medical student
Paul Stallone, NMD
Other members, Elizabeth Enright, Tim Peace, NMD, Jonathan Psenka, NMD and Phranq Tamburri, 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.
For the IRB, in addition to all of the naturopathic physicians, the acupuncturist and the medical student named above, we also welcomed Ms. Jesse Adams. 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. Adams has a history of concern and work regarding the health and welfare of individuals and 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). Elizabeth Enright is a member who also fulfills this role, but could not be present for this meeting.
All members present expressed the desire to be a member of both ANRI and NORI.
MINUTES OF LAST MEETING
The minutes of the February 5, 2010 meeting were discussed and approved as minutes. However, some of the items in the last meeting’s minutes were further discussed and amended as noted below.
The ANRI Mission Statement was discussed and modified 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, 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 discussed and modified 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 wellbeing, strengthening, education and empowerment of patients with cancer.
It was recognized that an Informed Consent form is a necessary initial contract between a naturopathic physician and a patient.
Some of the elements to be included in an Informed Consent were mentioned 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.
It was agreed that the matter of Informed Consent forms is complex enough to warrant an entire meeting devoted to that topic. It was then agreed that the next meeting on August 27, 2010 would be devoted to this topic.
Members who have written drafts of Informed Consent Forms are encouraged to bring these to the August 27 meeting. It would be especially useful to see language in the Informed Consent drafts that is broadly applicable to all naturopaths rather than focused on the specific nature of any one clinic or any one treatment modality.
A question was raised as to whether we all needed to have the same Informed Consent. That question has not yet been definitively answered. However, one response was that one could reassure the patient orally that the Informed Consent exists only for formal or legal purposes, especially if the form seems to be very long or intimidating, and is not the most important aspect of the relationship between doctor and patient.
It was mentioned that one of the main purposes of the Informed Consent was to validate the existence of ANRI/NORI and the IRB.
INTERNET FORUM/GROUP SET-UP
We then discussed a way to communicate with each other between meetings. An internet forum was suggested. With such a forum, each member can have a separate e-mail in-box that may be a subset inbox, allowing quick reference – without wading through many other incoming messages. Also, messages that should be communicated quickly will not have to wait for the next meeting. Dr. Milisen thought that a friend of his would be interested in setting that up for us, and will talk to his friend about that.
A nomination was made for Dr. Kenneth Proefrock to be President. That motion was followed by a second, third and fourth. Before Dr. Proefrock could accept or reject the nomination, however, it was suggested that an organization of naturopathic physicians does not need officers, but rather someone to take responsibility to co-ordinate and chair meetings and write up minutes and meeting notes. The recommendation was then made that a Secretary/Meeting Coordinator be elected for that role. Dr. Colleen Huber, who has been functioning as Interim Secretary was nominated for this position, received a second and a third motion, was elected informally by default of not having any opposition or competing candidates, and accepted the position. The length of term of the office was not determined, but it was agreed that the position of Secretary/Meeting Coordinator would eventually rotate to another person who will commit to diligently carrying out such functions in the future.
The nomination of Dr. Proefrock for President, having received four enthusiastic endorsements, was interrupted, rather than rejected, which leaves the matter to be addressed at the next meeting.
A distinction was suggested between the internal function of a Secretary/Meeting Coordinator and the external function of a Spokesperson/Public Relations person to act as the organization’s voice to the outside. This role is open for the time being.
It was also suggested that as roles, or the need for various roles, evolve, then various new positions would be created and filled from among the members.
It was decided that approved by-laws would be for both ANRI and NORI.
Dr. Chad Livdahl presented his proposed By-Law, which was read, then was modified as follows:
“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.”
Dr. Livdahl’s proposed 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.
Dr. Colleen Huber then read her proposed By-Law, the text of which was as follows:
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.
The last half of that text was adopted and attached to Dr. Livdahl’s proposed By-Law, and appears included in that By-Law above.
The first half of that text was rejected as a By-Law. The main difficulty was with the definition of chemotherapy and radiation, which may be interpreted so broadly as to include many of the treatments, such as vitamins and minerals and physiotherapy, which are in the naturopathic physicians’ legal scope of practice, at least in Arizona, where all current members live and practice.
It was suggested that some of that text be saved for the Informed Consent.
It was also mentioned that some protection is needed for patients who have been threatened by one or more naturopathic physicians to forgo treatment unless that patient agrees to also undergo conventional medical treatments, such as conventionally defined chemotherapy, in addition.
Dr. Huber’s response is to alter the proposed text as follows, with an effort to make the language inclusive and proactive, rather than restrictive and reactive, in accordance with Dr. Ozalan’s urging, while at the same time honoring the patient’s need and inalienable and self-evident right to be the primary decision-maker regarding his or her own health care, and the responsibility of naturopathic physicians to uphold that sovereignty of the patient over his or her own body and health. The proposed change is as either a new proposed By-Law or part of the Informed Consent. Dr. Huber requests that the following be discussed and considered as a By-Law:
“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 at 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.
ANRI and NORI support and uphold these rights for all patients regardless of health status or diagnosis.”
INTERACTION WITH CONVENTIONAL PHYSICIANS AND SPECIALISTS
A question was then raised regarding how to respond to Medical Doctors who express curiosity about naturopathic treatments. It was generally agreed that there is no harm in sharing not only detailed information about specific treatments used with a mutual patient, but to also forward any research papers discussing the use of those treatments, regardless of which treatments are used, as long as they fall within the naturopathic scope of practice.
It was observed that there will come a time soon, perhaps toward the end of this year, after agreeing on basic by-laws, informed consent, etc., that our organization will have a sufficient structure and history, that it would be advantageous to present our organization and its minutes and other documents to the general public and to the Naturopathic Physicians Board of Medical Examiners. It was agreed that now is not the optimal time to do that, but that we would be willing to do so at any time if the need arose.
It was agreed that each member will pay $10 at each meeting to cover the cost of bringing in lunch. No dues are due until the next meeting on August 27, 2010. Members may use cash, check or credit card payable to the hosting clinic. RSVPs will be requested so that lunch may be planned and ordered. Dr. Ozalan has a $20 credit.
Because Dr. Ozalan’s payment occurred as the meeting ended, something had to be done with the money, and it was too late to bring the members back to debate the need for a treasurer or to elect a treasurer. Therefore, the Secretary appointed Dr. Kenneth Lashutka as Interim Treasurer, until such designation is confirmed or rejected at a subsequent meeting.
THE NEXT MEETING
The next meeting is scheduled for Friday, August 27, 2010, 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 reminded of the meeting date in early August.
E-mail addresses were then recorded, although are still missing for some members who were absent. Members are asked to share their e-mail address with other members. This draft of the minutes and meeting notes for the May 7, 2010 meeting is being forwarded to all members for their editing and approval.
This meeting was adjourned at 2:10 p.m., Friday, May 7, 2010. It was agreed that the meeting time and length were appropriate.
Colleen Huber, NMD, Secretary and Meeting Coordinator
Topics for August 27, 2010 meeting:
Decide if and how to amend the 5/7/2010 minutes, vote to approve.
Informed Consent Form: drafts presented, discussed and common language to be adopted. Note: please get copies of your informed consent draft to the Secretary ahead of the meeting, so that we can get hard copies or e-mails to everybody ahead of time, so that there may be unhurried reading and reflection prior to discussion.
Unfinished business: The nomination of Dr. Proefrock for President of our organizations received a second, third and fourth motion. One member’s question about the need for officers then interrupted that process and diverted the discussion. It was not at all generally agreed upon that there was no need for officers, but rather that a secretary/meeting coordinator would be essential. Therefore the nomination of Dr. Proefrock as President has been interrupted and questioned rather than cancelled. It may be that the only fair way to resolve this question would be to proceed with calling for any further nominations and holding an election. Given the discussion of the need or lack of need for officers, the choice of “No President at all” may be fair to include as a choice among all nominated candidates. Because of the need for our organizations to present a face to the public and the Board in the future, perhaps the role of President, should we choose to have one, could be amended to President/Spokesperson. The question of whether to proceed with an election needs to be addressed, as well as whether to vote aloud or to have a secret ballot.
Discussion topic: Dr. Ozalan presented a persuasive case for our organizations to be proactive rather than reactive, which he explained as focusing on what naturopaths would like to accomplish in the future as physicians and researchers, rather than focusing on strategic defense against hypothetical attacks on our ability to practice naturopathic medicine as we presently do. This implies that our time in meetings and our interactions with each other will eventually move away from procedural, organizational and legal questions, as each of these becomes resolved, toward discussion of medical and treatment issues.
Is there then a risk that those doctors who have been practicing longer will be unfairly and disproportionately “brain-picked” by those of us who have been in practice for a short time? Is there a way to guard against such unfairness, or to at least ensure that it will be worthwhile for the mentors of our profession to continue to participate? Should there be a commitment from the newer doctors to come up with the majority of the research proposals and to do a majority of the work involved in the research, or to be prepared to actively participate in a Grand Rounds sort of meeting? In other words, is there a way to ensure that every member is deriving value from the organizations and is not facing demands to give more than his fair share?
Presentation of any specific research proposal to IRB for approval.