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)
November 13, 2015
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, as well as Title 45, Part 46, the twenty-fourth 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 12:03 p.m., November 13, 2015 at 1250 E. Baseline Rd., Suite 205, meeting in Suite 203, Tempe, AZ 85283.
MEMBERS AND GUESTS
12 physicians and 5 non-physicians, including one attorney, were in attendance.
AZND BOARD MEETING
Yesterday’s AZND Board meeting was discussed, including 3 topics that were atypical and of interest to the group.
NEW RESEARCH FOR POSSIBLE IRB REVIEW
One of the physicians presented a proposal for review of clinical research of a particular substance, and discussed the mechanism of action, as well as the need for a broad scope of practice and broad pharmacopeia from which to draw, particularly with regard to patient’s facing severe and life-threatening illness, sometimes refractory to previous treatments. The basis of the study is to be able to offer a combination of best effective treatments for the patient’s condition.
The IRB will therefore defer vote for approval until there is some pedigree for the product, that it is indeed what it is purported to be, and of the concentration, quality and sterility that it is supposed to be.
Even a case study of one, even when it seems like a small drop in a large bucket, can make an interesting paper or case to discuss at conferences. Consider the history of your patients, and you certainly have many more to discuss, anonymously of course, than just one.
At a NIH conference last month, a NIH representative told the audience that you can have a well-designed research study where you have a subject serving as their own control, e.g. patient feels better on the days that bitter greens are included in diet. According to the NIH, a clinical trial is “a research study in which one or more persons are subject to one or more interventions.”
RECENT FDA COMMITTEE ACTIONS
A committee in the FDA just decided recently to prohibit some of the most effective known natural treatments for cancer: curcumin and rubidium chloride and germanium sesquioxide, for intravenous use. These are still okay to use at the moment, because next the Secretary of Health and Human Services, HHS, would rubber stamp the recommendation of the FDA committee, and finally it would get published in the Federal Register (Code of Federal Regulations). All that could take from a month to a year to implement.
RECENT NIH / OFFICE OF HUMAN RESEARCH PROTECTIONS TRAINING
The NIH / OHRP recently held a seminar regarding human research protections and ways for researchers and IRBs to stay in compliance, particularly if applying for NIH grants. If anybody wants to attend one of these, the next one is in Miami in April.
For those who still need to do online training and certification in human research protections, especially if you are submitting research to the IRB, please do these modules individually:
The Belmont Report sets out basic principles of human rights as research subjects, and the protections that must be in place. The full text is here: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
The Informed Consent is central to protection of research subjects and was discussed in detail as to required elements.
Informed Consent is discussed in more detail in 21 CFR 50.25 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50&showFR=1
Initial IRB review needs the following criteria for approval of research:
A full protocol
Informed Consent document
How risks to subjects will be minimized; balance of risk/benefit ratio
How privacy and confidentiality will be assured
How subjects will be selected
INTERNATIONAL CONGRESS OF NATUROPATHIC MEDICINE
We decided to again be sponsors of the ICNM, which will convene in Barcelona in July 2016.
BASTYR SAN DIEGO
Bastyr San Diego is interested in having us be their IRB. We decided that we appreciate their interest, and that we will be an audience for their proposed research.
We agreed to meet in the usual place Friday, February 12, noon.
The meeting was adjourned at approximately 2:30 pm.