| Research news: Kava drinkers liver survey. | |
| yee | FYI. Here's an e-mail (forwarded via Amy Brown) re her research on “The Effect of Traditionally Prepared Kava Beverages on Liver Function Tests.” Thu 8/29/2002 6:42 PM. Notes: 1. As of Dec. 23, 2002, the grant has been provisionally approved. 2. Former title of this topic was "Research news: MD Research Grant Proposal." However, a better title might be as listed. April 22, 2003. August 29, 2002 Ms. Lisa Schiff Attn: Medical Research Funds Hawaii Community Foundation 900 fort Street Mall, Suite 1300 Honolulu, HI 96813 Dear Ms. Schiff Please accept our e-copy version (later to be followed by hard copy) of our grant application entitled, “The Effect of Traditionally Prepared Kava Beverages on Liver Function Tests.” We are submitting it to the following Hawaii Community Foundation’s Medical Research categories:1) Clinical – General, and 2) Basic – General. Our request for one year of funding is $29,725.69. This project is unique in two aspects. First this study is the collaborative effort of five agencies associated with the University of Hawaii: the Department of Human Nutrition, Food & Animal Sciences, John A. Burns School of Medicine, the Department of Complementary and Alternative Medicine, the Department of Anthropology, and the Department of Molecular Biosciences and Bioengineering. Secondly, this proposal would support the work of three graduate students, one of which is a combined medical student and Anthropology graduate student seeking a Research Assistantship to carry out this research on kava. We also have the support of the Association for Hawaiian ‘Awa (See attached letter from Mr. Ed Johnson). If you have any questions or need more information, please don’t hesitate to contact me. Sincerely, Amy C. Brown Principal Investigator -- ************************************************************** Amy C. Brown, PhD, RD Assistant Professor Department of Human Nutrition, Food, & Animal Sciences College of Tropical Agriculture & Human Resources University of Hawaii 1955 East-West Road, Rm 216 Honolulu, HI 96822 808-956-3846 808-956-4024 (fax) amybrown@hawaii.edu http://www.hawaii.edu/fshn "Maluna ae o na lahui a pau ke ola ke kanaka." "Above all nations is humanity." ************************************************************* |
| yee | Seeking participants in kava effects of liver study, via e-mail from Skip Bittenbender, Tue 4/22/2003 5:10 PM. Aloha 'Awa leaders and UH kava colleagues, CTAHR's Amy Brown in conjunction with colleagues in UH's JA Burns School of Medicine is ready to sign up participants for a study on the EFFECT OF CONSUMING TRADITIONALLY PREPARED KAVA BEVERAGES ON LIVER FUNCTION TESTS. This will involve providing a blood sample to be drawn in Honolulu. If you are interested in being participant in this study of drinkers and non-drinkers of kava beverage please contact Dr. Amy Brown, <amybrown@hawaii.edu> or call 808-956-3846 for details and a consent form. Skip -- H.C. 'Skip' Bittenbender , Ph.D. Extension Specialist for Coffee, Kava, and Cacao address: Department of Tropical Plant and Soil Science CTAHR (College of Tropical Agriculture and Human Resources) University of Hawaii at Manoa 3190 Maile Way Honolulu, HI 96822-2279 telephone : 808-956-6043 fax: 808-956-3894 http://www.ctahr.hawaii.edu/ctahr2001 |
| yee | E-mail from Amy Brown, Kava Research Update, Thu 6/5/2003 10:33 AM Kava Research Team, We met with the Clinical Research Center staff to determine how to proceed with utilizing their staff RN to assist us with the study. They will be interacting with the subjects after we recruit and screen them. During the staff-subject meeting, subjects will read and sign consent forms, as well as the questionnaire and have their blood drawn. The blood will be sent to the lab for analysis, and Dr. Onopa will oversee and approve the results as well as ensure any questions regarding medications on the questionnaire are addressed. I was also informed that we need to go through the CRC IRB even though we have UH IRB approval because we are utilizing CRC staff. Although we can still recruit, we can not draw blood without CRC IRB approval. Two IRBs for one study is not easy, but the 7 forms of paperwork will be submitted within the week. In the meantime, we are recruiting and it will just be a matter of organzing the subjects so they meet with the CRC staff. The grant was very generous in providing us with assistance in analyzing the results. Our deadline is December 17, 2003. Best, Amy ************************************************************** Amy C. Brown, PhD, RD Assistant Professor Department of Human Nutrition, Food, & Animal Sciences College of Tropical Agriculture & Human Resources University of Hawaii 1955 East-West Road, Rm 216 Honolulu, HI 96822 808-956-3846 808-956-4024 (fax) amybrown@hawaii.edu Department INFO: http://www.ctahr.hawaii.edu/depart/fshn/ Brief BIO: http://expertise.cos.com/cgi-bin/exp.cgi?id=315479 "Maluna ae o na lahui a pau ke ola ke kanaka." "Above all nations is humanity." ************************************************************* |
| yee | E-mail from Amy Brown, IRB Meeting at Straub, Wed 7/2/2003 3:46 PM... Interesting to note the sort of precise use of language the reviewers prefer. [:D] Kava Research Team, I met with the Straub IRB yesterday at 5:45 pm and they said the kava research proposal (already approved by UH IRB) was straight forward and they just had a few changes: Change the word "donate" (2 tb of blood) to "provide" Add the Straub IRB to the contact list (not just UH IRB) Change the word "lactating" to "nursing" Include the letter to be sent to physicians informing them of positive lab results. We then need to submit the above changes to the UH IRB for their approval too. So now we are going before the IRB(s) several times after which we will be able to have the meeting with the CRC nursing staff that will then be able to draw blood from our subjects. We still have further recruitment to do. Amy -- ************************************************************** Amy C. Brown, PhD, RD Assistant Professor Department of Human Nutrition, Food, & Animal Sciences College of Tropical Agriculture & Human Resources University of Hawaii 1955 East-West Road, Rm 216 Honolulu, HI 96822 808-956-3846 808-956-4024 (fax) amybrown@hawaii.edu Department INFO: http://www.ctahr.hawaii.edu/depart/fshn/ Brief Bio: http://expertise.cos.com/cgi-bin/exp.cgi?id=315479 "Maluna ae o na lahui a pau ke ola ke kanaka." "Above all nations is humanity." ************************************************************* |
| yee | E-mail from Amy Brown, Update on Kava Study, Thu 9/11/2003 3:09 PM Kava Research Team, After our most recent Kava study status meeting with the Clinical Research Center, I have done the following: 1) Emailed HPH-IRB requesting that they send a copy of the application to CRC. 2) Emailed a copy of the protocol to CRC with minor changes. 3) Submitted slightly revised documents (as requested by the CRC): Consent Form Procedure Manual (produced by the CRC to provide step by step instructions for the nurses working with the subjects) Questionnaire (added some cultural kava questions) Thank you letter (to give to the subjects as they leave) Letter to MD (alerting them of the liver function tests) The next step is to submit these five documents to both IRBs. Yes, we have to go before the IRBs again, but it will be an expedited review. We also need to submit a new document to the CRC called a Data Safety and Monitoring Plan. The kava festival is fast approaching on October 4th, so hopefully we'll be ready for that event which should draw a lot of people. I asked if we could draw blood at the festival (with an IRB approval of course), but it looks like it will be easier for potential subjects to have their blood drawn at the CRC/Kapiolani Health Hospital. We're getting there. Just have to wade through the paperwork. Anybody have any scissors? Amy ************************************************************** Amy C. Brown, PhD, RD Assistant Professor Department of Human Nutrition, Food, & Animal Sciences College of Tropical Agriculture & Human Resources University of Hawaii 1955 East-West Road, Rm 216 Honolulu, HI 96822 808-956-3846 808-956-4024 (fax) amybrown@hawaii.edu Department INFO: http://www.ctahr.hawaii.edu/depart/fshn/ Brief Bio: http://expertise.cos.com/cgi-bin/exp.cgi?id=315479 "Maluna ae o na lahui a pau ke ola ke kanaka." "Above all nations is humanity." ************************************************************* Hawaiian Kava Center, LLC http://hawaiiankava.com |
| yee | E-mail from Amy Brown, Update on Kava Study, Tue 9/23/2003 11:29 AM Kava Research Team, Good news. We had an article in The Honolulu Advertiser in this past Sunday's paper. Got some calls, but many of them were caucasion non-kava drinkers. This is going to be tough. Any help would be appreciated. We have to foot-target the kava-drinking population which means going into the Tongan and Samoan communities and doing a lot of field recruitment and one-on-one talking. I also the Advertiser to mention the Kava festival this October 4th, and so that got into the article too. Link to article: http://the.honoluluadvertiser.com/article/2003/Sep/21/ln/ln29a.html We also received a second IRB approval from Pacific Health and are waiting on the IRB approval from UH (our third). We should have it before the kava festival and then we are ready to send our current recruits for their survey and blood draw. Amy ************************************************************** Amy C. Brown, PhD, RD Assistant Professor Department of Human Nutrition, Food, & Animal Sciences College of Tropical Agriculture & Human Resources University of Hawaii 1955 East-West Road, Rm 216 Honolulu, HI 96822 808-956-3846 808-956-4024 (fax) amybrown@hawaii.edu Department INFO: http://www.ctahr.hawaii.edu/depart/fshn/ Brief Bio: http://expertise.cos.com/cgi-bin/exp.cgi?id=315479 "Maluna ae o na lahui a pau ke ola ke kanaka." "Above all nations is humanity." ************************************************************* Hawaiian Kava Center, LLC http://hawaiiankava.com |
| yee | E-mail from Amy Brown, Wed 10/8/2003 4:54 PM Kava Research Team, KAVA Festival We (myself and a student) attended the Kava Festival this past Saturday which drew about 2000 people I believe. Skip allowed us to share his CTAHR booth from 9am to 4 pm and we signed up 49 people of which 17 (1/3) were kava drinkers. Bear in mind that some kava drinkers are ceremonial only and their kava drinker is limited to about 2-4 times a year (this is especially true of women). We are looking for the chronic kava drinkers and this will take some extra work. Tongan KAVA Drinkers Good news, however, as one of the people answering the newspaper ad informed me of a Tongan kava circle that meets every Saturday night to drink kava. About 2-3 dozen people attend. She mentioned that an interpreter might be necessary but we'll work through that obstacle. She invited me to the circle, and I'll meet with them this Saturday. CRC Nurse Meeting I met today again with 5 CRC nursing staff and we reviewed once again the protocol for screening patients. They will have a file folder for each person who will be signing a consent form, HIPAA form, questionnaire, and receipt for $20 gift certificate. The subject's blood will be drawn at the lab on the grounds. Abnormal lab reports will be reviewed by Dr. Onopa who will request specific follow-up tests on the already submitted blood sample. She will also be standing by to screen certain medications that potential participants are taking. Bear in mind that hepatitis is more common in the Pacific Island region. We now have OFFICIAL CLEARANCE to send subjects to the CRC! Recruitment Count to Date We have recruited 53 kava drinkers and 41 non-kava drinkers that we have recruited. We are now calling these people and will be sending qualified subjects to the CRC. We are pre-screening them so the CRC does not waste time or coupons. The CRC nursing staff will double-screen for qualification. Just to let you know, about 17 kava drinkers came from the Kava Festival, about 18 from Michelle via the Hale Noa Kava Bar, and the rest via the newspaper. The majority of non-kava drinkers came from the newspaper article. We will let you know how the recruitment to officially qualified subject process goes, Amy ************************************************************** Amy C. Brown, PhD, RD Assistant Professor Department of Human Nutrition, Food, & Animal Sciences College of Tropical Agriculture & Human Resources University of Hawaii 1955 East-West Road, Rm 216 Honolulu, HI 96822 808-956-3846 808-956-4024 (fax) amybrown@hawaii.edu Department INFO: http://www.ctahr.hawaii.edu/depart/fshn/ Brief Bio: http://expertise.cos.com/cgi-bin/exp.cgi?id=315479 "Maluna ae o na lahui a pau ke ola ke kanaka." "Above all nations is humanity." ************************************************************* Hawaiian Kava Center, LLC http://hawaiiankava.com |
| yee | Tue 10/21/2003 3:44 PM Kava Research Team, We have been recruiting from our list of "Kava Subjects" obtained through the newspaper ad, the kava festival, and Hale Noa. Not everyone qualifies and so the list is getting shorter. So far we have about 10 people who indicated that they would go down to the hospital and have their blood drawn. I am very interested in the Tongan kava drinking circles since this is really the group that the results of the study would most likely affect. We want to go to the kava circle which is on King Street and Dillingham, as they most likely would not go to the hospital. The person who promised to show me where it was and introduce me was a no show two weeks in a row. It's no fun sitting at a Shell gas station on a Saturday night for almost an hour. Anyway, I thought I could find it on my own, but had a very hard time finding it, until I convinced a boy on a bicycle to lead me to them (as kids know everything). He did and I gave him $20 not covered by the study. Our next hurdle - I was informed that if most of the Tongan Communities need to have an interpreter, then we need to get certified copies of the informed consent, the HIPAA form and questionnaire translated in Tongan language and submit the documents to the IRB. Also, need to get a certified interpreter to assist with the visits. We have to make sure the subjects understand everything. Although another major endeavor, I feel that this is worth it since the Tongan kava drinking circle is important to us. There were 25-35 people attending this circle and that would really add to our "real" kava drinker list of subjects. Keeping you in touch, Amy ************************************************************** Amy C. Brown, PhD, RD Assistant Professor Department of Human Nutrition, Food, & Animal Sciences College of Tropical Agriculture & Human Resources University of Hawaii 1955 East-West Road, Rm 216 Honolulu, HI 96822 808-956-3846 808-956-4024 (fax) amybrown@hawaii.edu Department INFO: http://www.ctahr.hawaii.edu/depart/fshn/ Brief Bio: http://expertise.cos.com/cgi-bin/exp.cgi?id=315479 "Maluna ae o na lahui a pau ke ola ke kanaka." "Above all nations is humanity." ************************************************************* Hawaiian Kava Center, LLC http://hawaiiankava.com |
| yee | Fri 10/24/2003 11:14 AM Louise, Thank you for your email below assisting with expanding our blood draws outside of the CRC to the Tongan Community, especially in light of the fact that we may not meet subject number without the Tongan groups. It would be wonderful to obtain half the people we need in one setting. The kava drinking circle near downtown numbered 30-40 drinkers. Dr. Harrigan has kindly volunteered to draw blood if we cannot do so through CRC as is the case due to liability issues or through a subcontract to the CRC which we are now pursuing. This and a Tongan interpreter required to translate the consent form, questionnaire, and HIPPA (and accompany the nurses) will require some increase in budget that must be officially requested. Yes, another IRB submission for the Tongan papers. The fact is that there are not many people outside of the Tongan community that are consistent kava drinkers. It's not unusual for a Tongan to drink kava three times a week and they more often than not do not drink alcohol. It's a perfect combination. Another issue is that non-Tongan kava drinkers are very hard to recruit. Contacts have been made, promises to make appointments follow, and there is an 80% non-follow through. We are making follow-up calls, but this is frustrating. My options are very limited. That's why we need help in this new direction. Actually Tongans are very hard to recruit too because of they value their privacy. I'm working on that. I apologize for the inconvenience, the extra time (that might actually be less in the long run), and the added work of a Tongan interpreter. However, I'm stuck. I also want this study to help the true population for which it was targeted - kava drinkers which is predominantly the Tongan community here in Hawaii. Thanks for all your help, Amy Louise Medina wrote: Dr. Brown, BothEmily Fritz and Maureen Goode are currently out of the office.In their absence, I'll be happy to assist you with your questions. In follow-up to our conversation this morning, you have identified the following additional study needs: Funding to expand your current study contract with ClinLabs (CLH) to enable Phlebotomists to accompany you to the Tongan kava drinking circles on Friday or Saturday evenings. Please note that I have emailed Lori Ikei-Canter at CLH to request a price quote for phlebotomy services. Funding to pay for Tongan interpreter services. This is specifically to accompany you to the Tongan drinking circles, as well as to translate the study consent form, HIPAA form and questionnaire from English to Tongan. You mentioned that you had a Tongan interpreter in mind. Does the interpreter work for a translation service/business or is he/she an independent contractor? Also, do you know what the cost will be for these services? I'll request Lori Chun from our CRC-MIC office to advise on additional RCUH requirements for these services. Upon receipt of price quotes for the above services, I would recommend that you email Joanne Mor (jmor@hawaii.edu) requesting $_____ additional funds (not to exceed $10,000 funding limit) along with a brief budget justification.This request will be submitted for consideration by the CRC Executive Committee. I will be sure to cc: both Joanne Mor and Lori Chun on this email so that they can provide additional guidance on this process. Mahalo, ~ Louise ~ Louise A. Medina, R.N., M.H.A. Program Administrator ClinicalResearchCenter University of Hawai'i / Kapi'olani Health 1319 Punahou St., Bingham Bldg. Honolulu, Hawai'i 96826 Phone (808) 983-6235 Fax (808) 983-6240 Pager (808) 363-9639 email: louisem@kapiolani.org CONFIDENTIALITY NOTICE: This e-mail message, including any attachments, is for the sole use of the intended recipient(s) and may contain confidential and privileged information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message. -- ************************************************************** Amy C. Brown, PhD, RD Assistant Professor Department of Human Nutrition, Food, & Animal Sciences College of Tropical Agriculture & Human Resources University of Hawaii 1955 East-West Road, Rm 216 Honolulu, HI 96822 808-956-3846 808-956-4024 (fax) amybrown@hawaii.edu Department INFO: http://www.ctahr.hawaii.edu/depart/fshn/ Brief Bio: http://expertise.cos.com/cgi-bin/exp.cgi?id=315479 "Maluna ae o na lahui a pau ke ola ke kanaka." "Above all nations is humanity." ************************************************************* Hawaiian Kava Center, LLC http://hawaiiankava.com |
| yee | Mon 10/27/2003 1:56 PM Kava Research Team, Here are the numbers regarding recruitment on just the 50 kava drinkers that we need: 46 people who drink kava signed up 15 said YES to making an appointment with the CRC to have their blood drawn 4 have actually gone so far We just started heavy calling since the kava festival when we were given the IRB green light We are then matching this people who actually have their blood drawn 15 were not qualified (usually not enough kava consumption) 12 have not yet been reached (no response to phone messages or email despite repeated attempts) We'll keep trying until they are all reached 4 as possible Yesses We have no more kava drinkers other than these 46 people as a result of our fairly extensive recruitment - statewide newspaper story, kava bars (Michelle Harmen has been very helpful), and the kava festival. The only other real source of subjects are the kava drinking circles. This is why we are eager to pursue this avenue. Without the Tongan kava drinking circles, this study will not finish. We are currently having Paki translate the consent form, questionnaire and HIPPA forms. These documents then go before the IRB, and upon approval we are ready to approach the people in the kava drinking circles. We also need a CRC subcontract for blood drawing. So far, so good, Amy ps. December 31st is around the corner. We may need an extension... ************************************************************** Amy C. Brown, PhD, RD Assistant Professor Department of Human Nutrition, Food, & Animal Sciences College of Tropical Agriculture & Human Resources University of Hawaii 1955 East-West Road, Rm 216 Honolulu, HI 96822 808-956-3846 808-956-4024 (fax) amybrown@hawaii.edu Department INFO: http://www.ctahr.hawaii.edu/depart/fshn/ Brief Bio: http://expertise.cos.com/cgi-bin/exp.cgi?id=315479 "Maluna ae o na lahui a pau ke ola ke kanaka." "Above all nations is humanity." ************************************************************* Hawaiian Kava Center, LLC http://hawaiiankava.com |
| yee | per Amy, 12/5/03 Kava Research Team, We received approval from both IRB's for the Tongan documents. Another big thank you for Paki. We are in the midst of seeking a budget modification from the CRC to switch labs since only the later lab will allow us to draw blood off the CRC site. We plan to go to the Tongan kava drinking circles. Yesterday, I also submitted 14 copies of the UH Commitee on Human Studies status report form (and consent form) to the UH IRB for extending our IRB deadline past December 17th, 2003. They will let us know Dec 17th. Happy Holidays Everybody, Amy -- ************************************************************** Amy C. Brown, PhD, RD Assistant Professor Department of Human Nutrition, Food, & Animal Sciences College of Tropical Agriculture & Human Resources University of Hawaii 1955 East-West Road, Rm 216 Honolulu, HI 96822 808-956-3846 808-956-4024 (fax) amybrown@hawaii.edu Department INFO: http://www.ctahr.hawaii.edu/depart/fshn/ Brief Bio: http://expertise.cos.com/cgi-bin/exp.cgi?id=315479 "Maluna ae o na lahui a pau ke ola ke kanaka." "Above all nations is humanity." ************************************************************* Hawaiian Kava Center, LLC http://hawaiiankava.com |
| yee | Thu 1/15/2004 2:47 PM Bill, Thank you for the IRB extension provided to our kava study. We acknowledge and understand the requirement of having a bilingual Tongan interpreter present to explain the study to the participants in case they do not understand English. I had another organizational meeting with the CRC Staff this past Monday. The first item on the agenda was obtaining your letter. Other items discussed to update the Kava research team are as follows: We are now cleared to work with Clinical Laboratories of Hawaii that allows their employees to leave the site which we needed to go to the kava drinking circles. Budget change submitted.. The budget change was submitted to include a Tongan translator and phlebotomists from a different lab. Completed folders with consent forms, gift certificates, etc will be ready to take to the circle. Police escort to be arranged. Scale, desk, chair, and screen needed for taking consent and drawing blood. Recruitment Paki Kaufusi and I plan to pre-visit the site this Friday (8 pm) to ask for formal permission to visit the following Friday 1/23/04 from 7:30 to 9:30 pm. I already visited and asked for informal permission. Hopefully, they will not change their minds. We have also requested police escort as desired by the Tongan kava drinkers and Clinical Laboratories of Hawaii. They also requested that the phlebotomists be in white coats with ID badges. Also present in addition to the police officer and the phlebotomists will be myself, Paki Kaufusi (interpreter), and another research volunteer. Our next update will report the number of volunteers we were able to recruit next Friday. Amy ************************************************************** Amy C. Brown, PhD, RD Assistant Professor Department of Human Nutrition, Food, & Animal Sciences College of Tropical Agriculture & Human Resources University of Hawaii 1955 East-West Road, Rm 216 Honolulu, HI 96822 808-956-3846 808-956-4024 (fax) amybrown@hawaii.edu Department INFO: http://www.ctahr.hawaii.edu/depart/fshn/ Brief Bio: http://expertise.cos.com/cgi-bin/exp.cgi?id=315479 "Maluna ae o na lahui a pau ke ola ke kanaka." "Above all nations is humanity." ************************************************************* Hawaiian Kava Center, LLC http://hawaiiankava.com |
| yee | Kava Research Team and CRC Staff, Permission was granted on Friday night by not one, but two kava drinking circles on King Street. About 20-40 people attend these kava drinking circles every day of the week except Sunday and Friday/Saturday are the more attended days. A wooden bowl of kava is in the center of the floor and people drink about 3-5-10 "bowls" (1/2 a coconut or plastic bowl) an hour. A female in traditional clothing serves the Tongan kava drinkers (all male). A bowl of kava is consumed all at once (like a shot). The residue is discarded. People come and go, but it usually the circle runs from about 9-3 am. I might add, that the night is spent in a good mood and part of that was noticing the "smoking" and "no smoking" signs. They had divided the one room in half with a sign on each side. I had a bowl of kava and it is much lighter in both color and taste compared to other kava drinks that I have tasted. They ship it directly from Tonga. We also might have trouble finding matched controls for our Tongan kava drinkers as I'm told very few do not avoid kava. We plan to actively recruit kava drinkers this coming Friday at one circle, and the next Friday at the other circle. Amy ************************************************************** Amy C. Brown, PhD, RD Assistant Professor Department of Human Nutrition, Food, & Animal Sciences College of Tropical Agriculture & Human Resources University of Hawaii 1955 East-West Road, Rm 216 Honolulu, HI 96822 808-956-3846 808-956-4024 (fax) amybrown@hawaii.edu Department INFO: http://www.ctahr.hawaii.edu/depart/fshn/ Brief Bio: http://expertise.cos.com/cgi-bin/exp.cgi?id=315479 "Maluna ae o na lahui a pau ke ola ke kanaka." "Above all nations is humanity." ************************************************************* Hawaiian Kava Center, LLC http://hawaiiankava.com |
| yee | Kava Research Team & Staff, We (myself, Paki, 2 RNs, 2 police officers) were eager to recruit kava drinkers tonight, however, an email yesterday from the CRC has asked us to meet next Wednesday to discuss the budget changes and to delay our recruitment. We are hopefully only delaying our kava recruitment for one week. The change in protocol from the CRC location to the kava drinking circles has made several budget changes necessary (no extra monies required, just different allocations), and we just need final approval of the Executive Committee, even though last week I attended another meeting where we received budget approval. The police officers were not free via "community service" and the question arose as to how they would be paid (consulting agreement vs PO to the City). Will keep in touch, Amy ************************************************************** Amy C. Brown, PhD, RD Assistant Professor Department of Human Nutrition, Food, & Animal Sciences College of Tropical Agriculture & Human Resources University of Hawaii 1955 East-West Road, Rm 216 Honolulu, HI 96822 808-956-3846 808-956-4024 (fax) amybrown@hawaii.edu Department INFO: http://www.ctahr.hawaii.edu/depart/fshn/ Brief Bio: http://expertise.cos.com/cgi-bin/exp.cgi?id=315479 "Maluna ae o na lahui a pau ke ola ke kanaka." "Above all nations is humanity." ************************************************************* Hawaiian Kava Center, LLC http://hawaiiankava.com |
| yee | Kava Research Team and CRC Staff, Just to let everyone know where we are.... I had to submit to the IRBs again due to the fact that there was some concern about us drawing blood now at a different location and at night. That location/time was just approved by both IRBs. We also were required to submit a consultant contract and several series of employment papers for the Tongan translator and that approval is pending. We await the official hiring of the translator as it is imperative that he accompany us to the kava drinking circles (it's stated in the IRB approval that he be present). We anticipate going to the kava drinking circles in about two weeks. Amy ************************************************************** Amy C. Brown, PhD, RD Assistant Professor Department of Human Nutrition, Food, & Animal Sciences College of Tropical Agriculture & Human Resources University of Hawaii 1955 East-West Road, Rm 216 Honolulu, HI 96822 808-956-3846 808-956-4024 (fax) amybrown@hawaii.edu Department INFO: http://www.ctahr.hawaii.edu/depart/fshn/ Brief Bio: http://expertise.cos.com/cgi-bin/exp.cgi?id=315479 "Maluna ae o na lahui a pau ke ola ke kanaka." "Above all nations is humanity." ************************************************************* Hawaiian Kava Center, LLC http://hawaiiankava.com |
| yee | KAVA Research Team, Yes, we were able last week to receive official written notice that the Tongan translator was cleared through the paperwork to work. And work we did. Last Friday, he, I and a RN went to King street from 7 pm to midnight and recruited 12 kava drinkers. Everything went fine. Filling out the paperwork took some time. We had to work with each subject to fill out consent forms, HIPPA form, gift certificate form, and a 7-page questionnaire. They also gave blood. We go again this Friday to another kava drinking circle on King Street. We now have a total of 20 kava drinkers. I hope to recruit 30 on Friday. We'll let you know about the blood results when we have the total number of 50 kava drinkers. That will then have to be balanced against 50 non-kava drinkers. Amy -- ************************************************************** Amy C. Brown, PhD, RD Assistant Professor Department of Human Nutrition, Food, & Animal Sciences College of Tropical Agriculture & Human Resources University of Hawaii 1955 East-West Road, Rm 216 Honolulu, HI 96822 808-956-3846 808-956-4024 (fax) amybrown@hawaii.edu Department INFO: http://www.ctahr.hawaii.edu/depart/fshn/ Brief Bio: http://expertise.cos.com/cgi-bin/exp.cgi?id=315479 "Maluna ae o na lahui a pau ke ola ke kanaka." "Above all nations is humanity." ************************************************************* Hawaiian Kava Center, LLC http://hawaiiankava.com |
| yee | Kava Team, We had to go through another budget/protocol revision since their was a need to adjust the budget. That meant going through the Scientific Advisory Committee and two IRBs again. We got approval at all three levels. Now we are free to recruit again. We are waiting for one of our recruitment members to get back into town before starting again on May 9th. We are also up against the problem of trying to find non-kava drinking male Tongans. We are closer to the end than the beginning. I hope to have results for you by mid-summer or preferably sooner. Amy -- ************************************************************** Amy C. Brown, PhD, RD Assistant Professor Department of Human Nutrition, Food, & Animal Sciences College of Tropical Agriculture & Human Resources University of Hawaii 1955 East-West Road, Rm 216 Honolulu, HI 96822 808-956-3846 808-956-4024 (fax) amybrown@hawaii.edu Department INFO: http://www.ctahr.hawaii.edu/depart/fshn/ Brief Bio: http://expertise.cos.com/cgi-bin/exp.cgi?id=315479 "Maluna ae o na lahui a pau ke ola ke kanaka." "Above all nations is humanity." ************************************************************* Hawaiian Kava Center, LLC http://hawaiiankava.com |
| yee | Kava Research Team, We would like to be drawing more blood from kava drinking subjects, but had to fill out some more paperwork as our protocol had to change again, and go before the IRBs. Approval is slated for June 1st after which we will be cleared to go into the field again. Thank you for your patience. Amy -- ************************************************************** Amy C. Brown, PhD, RD Assistant Professor Department of Human Nutrition, Food, & Animal Sciences College of Tropical Agriculture & Human Resources University of Hawaii 1955 East-West Road, Rm 216 Honolulu, HI 96822 808-956-3846 808-956-4024 (fax) amybrown@hawaii.edu Department INFO: http://www.ctahr.hawaii.edu/depart/fshn/ Brief Bio: http://expertise.cos.com/cgi-bin/exp.cgi?id=315479 "Maluna ae o na lahui a pau ke ola ke kanaka." "Above all nations is humanity." ************************************************************* Hawaiian Kava Center, LLC http://hawaiiankava.com |
| yee | Kava Research Team, This study is going on and on like the Ever Ready Easter bunny. We just got approval of all the IRB forms which had to be done since we hit the one year mark and all the forms needed reapproval. We have another recruitment set for this coming WED where we will try to find non-kava drinking Tongans. I was told that finding male non-kava drinkers would be very difficult if not impossible. The good news is that Mormon male Tongans usually don't drink kava, but that means going up to Laie at BYU. We are having difficulty reaching this group, as it is their end of finals. We'll let you know how WED goes. Some good news to add is that we are submitting a supplemental NIH/NCCAM grant with Dr. Gary Henderson (Medical Pharmacology/UC Davis) to expand slightly on the current study. Thank you Gary for making this possible and for the people who brought us together at a previous kava meeting. We should hear back from NIH around December. Amy Hawaiian Kava Center, LLC http://hawaiiankava.com |
| yee | Kava Research Team, We attempted to recruit non-kava drinkers last week, but the group attendance was very low. Basically, we have been told that finding male Tongans that don't drink kava is not realistic. We even tried the Mormon church as recommend because they are not supposed to drink kava, but were told that despite the recommendation not to drink kava, we could not be sure. Since the data must be clean, we will recruit from the same Tongan drinking circle, but recruit women who do not drink kava. This is a holiday weekend (Happy July 4th), so we will recruit the following two dates next week at the Methodist Church: July 8th - Thursday evening July 11th - Sunday service at 7pm Amy Hawaiian Kava Center, LLC http://hawaiiankava.com |
| yee | Kava Research Team We recruited 11 new non-kava drinkers at the Methodist Church last night from 5-8:45 pm. That's about 3 people an hour. It's slow with all the paperwork and not everyone wants their blood drawn. We only have 16 people left to recruit, and we will do so when I return from a 2-week trip to the mainland where I will present the poi research results at a conference. If all goes well we are scheduled to recruit again on the first Sunday that I will be back which will be August 1st. I'm eager to see the results of this study, Amy Hawaiian Kava Center, LLC http://hawaiiankava.com |
| yee | Kava Research Team, We are not moving as quickly as we would like with the next recruitment. The church staff for the Tongan Methodist Church in Waimanalo has been on the mainland. We waited for their return as this church has a large number of members. We must receive permission from this Methodist Church minister in Waimanalo before we can recruit. He said it was most likely that we will be given permission, but he needs to check on another level by this Wednesday. Our goal is to recruit this coming Sunday at 5:30 pm. We only have 16 people to go (and 13 must be Tongans that do not drink kava which means they are female). Amy Hawaiian Kava Center, LLC http://hawaiiankava.com |
| KAVAnSurf | so what was the outcome of your traditional kava drinker study? [img]http://www.deanclearysurfboards.com/images/kneeboard_gallery/davesmall.gif [/img] |
| Jim | Id be interested to know too. |
| hcbitt | I spoke with Dr. Amy Brown at the 2005 KavaFest. She indicated that her manuscript was sent to a journal for review and publishing. We'll get a copy once its published. I'll ask her if she can provide a summary. Skip H.C "Skip" Bittenbender |