STATE OF NEVADA NEVADA INSTITUTIONAL REVIEW BOARD

Transcription

1 Kenny C. Guinn, Governor Dean J. Friesen, Pharm. D., President Roger M. Belcourt, M.D., M.P.H., Vice President Valerie Kilgore, Sec-Treasurer Daniel F. Royal, D.O., H.M.D., J.D., Member Ann O Connell, Member Karen Hayes-King, Member Karla J. Perez, Member 1. CALL TO ORDER STATE OF NEVADA NEVADA INSTITUTIONAL REVIEW BOARD MINUTES Telephone Meeting of the Nevada Institutional Review Board Friday, January 20, 2006 at 2 p.m. Held at: NEW HOPE MEDICAL LLC Eastern Office Park S. Eastern Ave. Suite #200 Henderson, NV Dean Friesen, Pharm.D. asked Daniel Royal, D.O., H.M.D., J.D. to conduct the meeting. Dr. Royal called the meeting to 2:22 p.m. Roll call and determination of a quorum. Members present: Dean J. Friesen, Pharm.D. Daniel F. Royal, D.O., H.M.D., J.D. Ann O Connell Karen Hayes Valerie Kilgore Roger M. Belcourt, M.D., M.P.H. (joined while meeting in progress) Staff present: Jim Smith, Deputy Attorney General Members absent: Karla Perez Approval of the agenda. Motion: Karen Hayes-King moved to approve the agenda. Second: Ann O Connell. 2. APPROVAL OF MINUTES: Valerie Kilgore provided copies of the minutes from meetings held on September 28, 2005 and December 14, 2005, but not from October 7, No action taken. 1

2 Motion: Ann O Connell moved that minutes be provided to board members prior to a meeting. 3. PRESIDENT S REPPORT: Dr. Friesen discussed his presentation made to the Legislative Committee on Health Care on January 10, He informed the committee that the Nevada Institutional Review Board (NIRB) had been created and was operating. Dr. Friesen then called upon David Steenblock, D.O., to make a presentation on stem cell research to the board. Dr. Steenblock, who has been in practice for 35 years, has had experience with stem cells for 5 years and stated that it represents the greatest advance in medicine. Recently, he had a patient who recovered from blindness after receiving stem cells injected into his artery. Dr. Steenblock expressed his wish to work with the NIRB and said that, if done properly, it will shine a spotlight on Nevada. Ann O Connell asked if federal grants were available for stem cells. Dr. Steenblock said that they are, but they cannot be used in the U.S. Rather, they must be used offshore. However, such grants could possibly be used in Nevada under the supervision of the NIRB. In addition, he hopes that such research approval can be accomplished more quickly in Nevada through the NIRB. Dr. Steenblock stated he does not use embryonic stem cells, but autologous stem cells, because embryonic stem cells will become a pharmaceutical product. He is having success in treating cancer patients with a combination of stem cells and gene cell therapy. In his opinion, this treatment will help to change healthcare in Nevada. Mr. Charles Green asked if the stem cells would be considered a drug. Dr. Steenblock replied that anytime something is given to a patient it is considered a drug, but that is something the Pharmacy Board in Nevada will need to define. Dr. Friesen stated this area will have a large impact not only on citizens in Nevada, but on the business parameters of healthcare in Nevada. 4. FINANCIAL REPORT: Financial Statement. Robert Gentry provided a qualified financial statement. A Total of approximately $16,000 is in the NIRB s bank account. Ann O Connell asked why Mr. Gentry gave the financial report, as opposed to the Secretary-Treasurer. Dr. Friesen stated the communication between the Secretary-Treasurer was not able to be coordinated. For this reason, he asked Mr. Gentry, the NIRB s Chief Financial Officer (CFO) to make the report. Valerie Kilgore stated she was not getting receipts. Mr. Gentry offered to provide her any information she needed. Ms. O Connell asked if there was a clear definition between the Secretary-Treasurer and the Chief Financial Officer. Mr. Gentry said he had been volunteering his time and maintaining the books. Dr. Daniel Royal said all information from Mr. Gentry was available to Ms. Kilgore and that, if she needed anything she only had to request it from Mr. Gentry. Dr. Friesen stated the Pharmacy Board has a report presented by its Chief Financial Officer, which is as part of the Secretary-Treasurer s report, because the Secretary-Treasurer does not actually handle the day-to-day operations. As transactions become more frequent, the role of the CFO becomes more important. Policy of check signing for checks >$700 was reviewed. Ms. Kilgore is currently receiving bank statements. Mr. Gentry reminded the board that banks do not recognize two signers on a check, but it can be used for internal control. Ms. Kilgore asked if the Homeopathic Board is receiving reports. Dr. Royal stated that he reports to them in every meeting they hold, he is scheduled to provide a financial report to them tomorrow ( ), he recently provided a financial report to the Osteopathic Board, and that he will provide a financial report to the Board of Medical Examiners in March Ms. O Connell stated that it is important for the board to adhere to the policy of having two signers on checks and the board should know about any other singers added to the account. Ms. Lucas had signed a large check to the Ritz Carlton for an amount greater than $700. Dr. Dean Friesen and Mr. Gentry pointed out that Ms. Lucas did this without authorization. Dr. Royal suggested the board have two signers in Reno and two in Las Vegas. Dr. Friesen reminded the board that it had set-up two accounts: one for the board and one for operations. 2

3 Motion: Dr. Friesen moved to reimburse New Hope Medical for expenses advanced to the board as funds become available. Second: Roger Belcourt. Reimbursement request for coins commemorating 2005 legislative session. Dr. Daniel Royal discussed his purchase of commemorative coins for the 2005 legislative session. This was done to provide potential donors with an incentive to contribute, as well as some value in exchange for donations. Karen Hayes-King suggested that, in the future, the board have a breakdown of what was spent. Dr. Royal said the coins had been purchased prior to the establishment of the board. Dr. Dean added that the coins had been purchased at a time when the board had no money. Motion: Karen Hayes-King moved to reimburse Dr. Dan Royal for commemorative coins purchased for board to provide donors in exchange for donations as funds become available. Second: Roger Belcourt. Yea: Dean. Friesen, Karen Hayes-King, Daniel Royal, Roger Belcourt. Nay: Ann O Connell, Valerie Kilgore. 5. LEGAL TOPICS: LCB Regulations. R reviewed. Ann O Connell asked whether the homeopathic Board had reviewed the regulations. Dr. Daniel Royal pointed out that a workshop and hearing were held in September 2005 and that the Homeopathic Board approved them on September 30, Some language clarifications considered for Sections 10.2, 14, 15, and 16. Dr. Royal offered to further review the regulations, compare them with the original language submitted to the LCB, follow-up with the LCB, and report back to the board. Motion: Dr. Friesen moved to authorize Dr. Daniel Royal to act as a liaison with the LCB on the language changes and report back the final changes to the board. Investigational Research Applications. Dr. Daniel Royal requested the board consider fees to charge for research applications. Dr. Dean Friesen informed the board that it would not be charging a fee but that it would be able to receive a donation. This discrepancy will be corrected in the next legislative session. Motion: Ann O Connell moved to authorize Dr. Daniel Royal work on research application and submit it to the board. Policy for calling a meeting. Ann O Connell said boards on which she had served had always planned its next meeting at the end of each meeting. Dr. Daniel Royal said the board could consider alternate ways to call a meeting. Jim Smith suggested the Board and Commission Manual might be helpful. Ms. O Connell asked Jim Smith to supply the board with some options for how to plan future meetings. Dr. Friesen suggested we have regular scheduled board meetings throughout the year and then schedule other meetings as needed. Dr. Royal suggested the board meet at least quarterly, if not every other month. Review of past conflict of interest for Ned Reed, Deputy Attorney General. Dr. Daniel Royal read a letter from Mr. Reed regarding the issue of conflict of issue. Supreme Court Rule 159, Conflict of Interest: Former Client, quoted from Mr. Reed s letter. Waiving the conflict of interest would allow Mr. Reed to 3

4 represent the Homeopathic Board on future NIRB matters that might come before the Homeopathic Board. Currently, Deputy Attorney General, Robert Auer, has been assigned to the Homeopathic Board to handle conflicts between the two boards. Dr. Royal said waiving the conflict would be done as a favor to the Homeopathic Board. Dr. Friesen asked Jim Smith if he had an opinion or statement on the matter. Mr. Smith had no comment. Motion: Dean Friesen moved to waive the past conflict of interest Ned Reed where he had served as Deputy Attorney General for the Nevada Institutional Review Board. Second: Valerie Kilgore. Nancy Lucas. Terri Stuckey provided the board with a copy of her power of attorney from Ms. Lucas. Ms. Stuckey read a statement from Ms. Lucas to the board in which Ms. Lucas claimed to be providing testimony to Nevada government entities and that she was still an employee of New Hope Medical LLC. Karen Hayes-King asked if Ms. Lucas was still employed by the board. Dr. Daniel Royal stated Ms. Lucas had been terminated from both the Nevada Institutional Review Board and New Hope Medical LLC on November 16, Ms. Stuckey stated Ms. Lucas did not appear because of a restraining order. Dr. Royal reminded Ms. Stuckey that there would have been no violation by her appearance, since Dr. Dean Friesen was not physically present at the meeting. Further, Dr. Royal noted that Ms. Lucas cannot be an employee and file a restraining order against her employer. Ann O Connell asked if there was any indication as to why Ms. Lucas had not returned property back to the board. Dr. Royal said that although Ms. Lucas had been demanded to return property by mail, she had not responded to those demands. On December 9, 2005, family court had ordered Ms. Lucas to return property, but she failed to do so. Ms. Lucas has been ordered by the court again to exchange property on Sunday, January 21, 2006, with threat of fine and jail time if she refuses to do so. She has also given property to Fuller Royal, M.D. The board s property has now been missing for two months. Ms. Hayes-King said it was board s responsibility to determine whether Ms. Lucas had property because the board was held personally liable for its whereabouts. Dr. Royal said the purpose of this meeting was to get answers from Ms. Lucas so that the board could fulfill its fiduciary responsibility. Ann O Connell asked Jim Smith what the board s options would be. Mr. Smith said he didn t know. Dr. Royal reminded Mr. Smith that Ms. Lucas was a former employee of the board and that she did take property from the board. Mr. Smith said he didn t know if this was a criminal or civil matter. If it was a criminal matter, he advised the board to go to the police. Ms. Hayes-King expressed concern as to whether the board had received all of its receipts, checks, and monies and, if not, we need to know where it is located. Ms. O Connell asked whether the loss of property centered around the events of November 12, 2005 and whether Ms. Lucas was the individual responsible for taking receipts on November 12 th. Valerie Kilgore said she was the one who was receiving monies on November 12 th. Mr. Gentry stated he believed most of the funds came thought the mail and that Ms. Kilgore only collected monies given at the door; because Ms. Lucas had her name on the board s mailbox account, she retrieved the mail most of time; the majority of receipts came in the mail either through checks of credit card authorizations; and we don t know is what might have been diverted without his or Ms. Kilgore s knowledge. Ms. O Connell asked whether any authorities are doing any investigation. Dr. Royal said Wayne Fazzino, Investigator for the AG s Office, had a box that contained papers, love letters, and so forth. Ms. O Connell asked whether the board was in a holding pattern until we get a report from the AG s Office. Dr. Royal affirmed. Ms. Hayes-King again emphasized that the board needs to possess what belongs to it. F. Fuller Royal, M.D., H.M.D.. Dr. Fuller Royal provided a faxed letter to the board that made an assertion that he was an elected official and that the notice of a closed meeting did not apply to him. Dr. Daniel Royal asked Jim Smith if he had an opinion. Mr. Smith said he did not, but that a better statute would be NRS , which deals with any person. Mr. Smith stated that proof must be given before character of an individual can be discussed. Dr. Daniel Royal stated the board had proof of a certified letter sent to Dr. Fuller Royal on December 16, Mr. Smith said he was uncomfortable discussing a person who was 4

5 not present. Dr. Daniel Royal said the point of giving notice was to allow an individual to attend or not attend. However, Dr. Daniel Royal also stated that the point of asking Dr. Fuller Royal to attend was to get answers to questions and, like Nancy Lucas, he refused to attend. 6. OLD BUSINESS: Nevada Institutional Review Board and NIRB Medical Foundation. Jim Smith, Deputy Attorney General, did not offer an opinion, but said they sounded the same to him. Dr. Daniel Royal said they were not the same because the Nevada Institutional Review Board does not use the accronymn NIRB as part of its name. In addition, NIRB is also used to describe a genome. Ann O Connell expressed her concern that because the foundation can raise money on its own to fund projects for the board and the board does not have any oversight. Mr. Smith said it should be a decision the board should make because the board set it up. Dr. Royal said this board did not set it up. Rather, the Homeopathic Board approved it. Dr. Friesen said if there was conflict the Secretary of State would not have allowed the name. Karen Hayes-King said a state organization is not registered with the state. Dr. Royal stated he did not see a conflict in the names because one organization uses the name and the other uses the acronym; in addition, in order for the foundation to be a supporting organization there must be interlocking directors. Ms. O Connell expressed her concern the board had no oversight on how the funds would be spent. Dr. Royal said that, if there was a mistake made, it would be in the legislation because the legislature permitted the creation of a 501(c)(3) organization for the support of the Nevada Institutional Review Board; nevertheless, since the board is accountable to the Homeopathic Board for all of its activities, there is no reason why the board couldn t be fully informed of everything that s going on. Mr. Robert Gentry informed the board that an application had already been filed with the IRS, interlocking directors were needed for a supporting organization, and the only use for the funds were to be fore the benefit of the Nevada Institutional Review Board. Ms. Hayes- King said the foundation was similar to the UNLV Foundation, a private organization that raises money to support the University of Nevada at Las Vegas. Dr. Royal asked that someone who had the concern about the name should follow-up on this matter Motion: Karen Hayes-King moved the Attorney General s Office provide the board information on the structure between the UNLV Foundation and its accountability to the UNLV Board of Regents, that such research not be exclusive to this relationship but include any other similar organizations and their interlocking relationships, and have Mr. Smith report back to the board at its next meeting. Second: Valerie Kilgore. 7. ADMINISTRATIVE BUSINESS: Tausha Larsen. Ms. Larsen has been recommended to serve as a financial consultant to the board. She has offered to volunteer her services to the board at no charge. No resume received. No action taken. Robert K. Gentry. Mr. Gentry has been functioning as Chief Financial Officer to the board as a volunteer and without compensation. He is recommended to serve temporarily as acting Executive Director. Mr. Gentry expressed his willingness to serve in this capacity without compensation until such time as circumstances change. Ann O Connell asked whether the board had a job description for the Executive Director and, if not, that it be provided to the board at its next meeting. Motion: Roger Belcourt moved to approve Robert Gentry as temporary acting Executive Director for the board without compensation and that he provide the board with a job description. 5

6 Board Office. Currently, the board does not have a permanent office. If there is no urgency for such an office, the board can continue to function with a virtual office. Karen Hayes-King asked whether the board could use the Grant-Sawyer building. Dr. Dean Friesen said there are three rooms there that are available to the board and that we can reserve them in advance. Dr. Daniel Royal explained that the LCB charges $25/hour for its room, but that the room with police security does not charge a fee. No action taken. Fax Number. Dr. Daniel Royal suggested the board change its fax number to the home of Mr. Robert Gentry, Executive Director for the board. Motion: Karen Hayes-King moved to approve change of the board s fax number to the home of Robert Gentry ((702) ). Second: Ann O Connell. Website: Dr. Daniel Royal informed the board that, in order for Tim Kline to continue hosting the board s website for 2006, there will be a cost of $180/year. Mr. Charles Green offered a place on his server to host its website at no charge, but that there would be a charge for any redesign or development of the site. Mr. Kline charges $50/hour for website design and requires an advance payment for one year be given in order for the board to continue hosting its website at the present location. Discussion tabled until next board meeting. Dr. Royal offered to work with Mr. Green to discuss possible transfer of the website. 8. ELECTION OF OFFICERS: Dr. Daniel Royal reviewed Duties of Officers and Board Members pursuant to R154-05; Duties of the Board Members pursuant to R159-05; Terms of Officers pursuant to R No action taken. 9. PUBLIC COMMENT: Tiffany Van der Stoker said she receives inquiries on the website for the Nevada Homeopathic Integrative Medical Association about the Nevada Institutional Review Board (NIRB), Dr. Dean Friesen, Members of the NIRB. Dr. Daniel Royal said Ms. Van der Stoker could forward any such contacts directly to Dr. Royal, Dr. Friesen, or Robert Gentry. Debbie Bolca asked whether Mr. Gentry is a licensed CPA in the State of Nevada. Dr. Daniel Royal said Mr. Gentry was not under investigation, was not required to answer any questions, but that she could speak with him after the meeting. 10. ANNOUNCEMENTS; NEXT MEETING DATE; ADJORNMENT: Dr. Friesen suggested the board look into the possibility of having future meetings at the Grant Sawyer Building. Motion: Dr. Dean Friesen moved to adjourn the meeting. Next Meeting: Friday, February 24, 2005 at 2 p.m. Meeting adjourned at 4:33 p.m. 6