Document VKGeo187VQ1O74RGDgo7K385w

From: Sent: To: Cc: Subject: Attach: Matt Todd <ToddM@api.org> Wednesday, December 18, 2002 3:33 PM (GMT) BHRC Technical Committee (E-mail) <benzconsort-tc@api.org> Jim Vail (E-mail)<brec@rockbridge.net> Benzene Health Research Consortium: Ethics Review Panel ethics IT finall.doc Members of the Benzene Health Research Consortium Technical Committee: API is in the process of formalizing the Ethics Review Panel, with Dr. Brody (Baylor College of Medicine) as Chair. Other members will be Dr. Zongliang Xu (Center for Applied Ethics, Shanghai) and Dr. IdanpaanHeikkilato (World Health Organization). A copy of the final Roles and Responsibilities document for this group is attached for your use. The Panel plans to have a conference call in late January to review the final protocols and consent forms for the China studies. In preparation for this activity, I queried both Dr. Wong and Dr. Irons for a copy of the latest versions of these documents. Dr. Irons sent me the following email in response describing the lengthy, iterative process he has experienced in obtaining approval for the informed consent forms. Dr. Wong indicated he will supply me the requested documents later this week. Regards, - Jim - James M. Vail, PhD blue ridge environmental consulting, I.l.c. attachment -----Original Message----From: Richard.lrons@UCHSC.edu [mailto:Richard.lrons@UCHSC.edu] Sent: Saturday, December 14, 2002 11:52 AM To: brec@rockbridge.net Subject: RE: China benzene study Dear Jim: ProvisionallRB approval of the translated informed consent forms (with modifications) was obtained in May, 2002. This was contingent upon certified re-translation into Chinese and triggered another round of approval by the Fudan University Medical Ethics Panel in August, 2002. This was obtained (again with modifications) in August, 2002 and translated back into English .Final IRB approval of the Informed consent forms was only obtained in November, 2002. This has just been submitted to the the Shanghai Public Health Bureau in December, 2002. After review (together with any modification) these will subsequently be submitted to the Beijing Central Goverment for review under Chinese Interim Measures for the Administration of Genetic Resources. Subsequent to this final approval, they can be again- re-translated back into English. At each stage in the regulatory review process changes have been made in the wording of the informed consents that were required for approval and harmonization of US and Chinese law. It is not clear, what, if any additional changes will be required for final approval by Beijing. This approval process has is still underway. It is still possible that the US IRB will require another review subsequent to any additional changes mandated by the Chinese Government, although I suspect they will take "pitty" on us and approve Chinese changes as final. The issues raised at each stage "post Ethics panel review" have been limited to the specific wording of the informed consents, which has taken the better part of the year to resolve. In none of these instances: International Ethics Panel review, US IRB review, or Shanghai IRB review, have the same issues been raised. If memory serves me correctly the past 6 months of iterative exchange have focused on primarily on two sentences. My suggestion would be to wait until we have "final resolution" and licensing of the informed consents in both countries so SHELL-MCCLURG-052061 that we can begin study operations before proceeding with still another round of Ethics Panel review. Moreover, any further changes suggested by the Ethics Panel at this time will trigger the process all over again, and would almost certainly delay start-up, because both US and Chinese authorities jealously maintain that each have the "final word" in approval of these documents. As it is, final Chinese licensing approval may be the limiting factor in the start of the project. If this year has been any judge, a complete cycle of informed consent review requires about 9 months. In short, we do not yet have final regulatory harmonization of language. We are technically approved in the US but not China. Barring this, I can provide official copies of the November 2002 IRB approved informed consents, together with officially sanctioned Chinese translations, together with the understanding that the actual documents we will ultimately use will probably be slightly different. I believe Professor Xu has already seen these as part of the Fudan Ethics review in August, 2002. Any translation accepted by US and Chinese bodies must be certified by both, which is also an iterative process. I don't believe either would accept a translation comissioned by the sponsors. If Dr. Twerdock has software that is compatable with both English and Chinese, we can submit documents electronically. Otherwise, it will have to be hard copy. In regard to Professor Xu. His English is indeed very limited, and a discussion of the details you raise related to his participation in Ethics Panel deliberations would be best done in person. The first opportunity that I can schedule to meet with him to discuss these issues is after the Chinese "New Year" in mid-February. At that time, we should have some indication as to the resolution of Chinese licensing issues as well. Please let me know how you wish to proceed. RDI -----Original Message----From: James M. Vail [mailto:brec@rockbridge.net] Sent: Friday, December 13, 2002 3:36 PM To: Robert Irons Cc: Lorraine Twerdok Subject: China benzene study Dr. Irons: Hopefully you have previously received information from API that, on a temporary basis, I am filling in for George Woodall until API is able to find a suitable replacement for George's position. One of the activities in which I'm involved is helping to formally constitute the Ethics Review Panel, with Dr. Baruch Brody as Chair. In a recent conversation with Dr. Brody, he requested we send him copies of yours and Dr. Wong's latest IRB-approved protocols, including any associated questionnaires and consent forms. I believe that API has copies of this material that we can distribute to Dr. Brody and other members of the Panel. There is, however, a problem that I am asking your help to resolve. One of the ethicists that Dr. Brody is contacting to invite to become a panel member is Dr. Xu Zong-Liang of the Fudan University Medical Center. Dr. Xu has done some work for us previously, as you are aware. Apparently Dr. Xu speaks very little English and Dr. Brody has therefore requested Chinese-language versions of the protocols/consent forms for Dr. Xu's use. My questions are these: Have you had your protocols translated into Chinese and if so, are they available in electronic format? If the answers to both of these questions are yes, I would appreciate you sending these documents electronically to Lorraine Twerdok, as soon as practicable. If they are not in electronic format, would it be possible for you to send a hard copy to Lorraine? If it turns out the documents have not been translated, we will have this done in Washington for Dr. Xu's use. On a related, but separate note, I wonder if you could provide some guidance in helping us to determine a reasonable reimbursement rate for Dr. Xu? In addition to his review work, Dr. Xu will also need a translator to help him in conference calls and to assist him on his trips to the US for annual meetings, and this additional cost should be factored in. I realize the above is an imposition, given your heavy workload, but your assistance in this matter would be greatly appreciated. Thank you. SH ELL-MCCLU RG-052062 With regards, - Jim Vail James M. Vail, PhD blue ridge environmental consulting, I.l.c. SH ELL-MCCLU RG-052063 Final 12111102 Shanghai Health Study Review Panel Roles and Responsibilities Ethics Review Panel: Membership: The initial membership of the Ethical Review Panel (ERP) will be determined by the Business Oversight Committee. Members will have expertise in bioethics. Following initial formation, the ERP will be responsible for adding appropriate members up to its authorized limit.. The Panel may seek advice from others, including a Consortium Oversight Committee, on filling its authorized limit and may request an increase in that limit. The ERP should have at least three members; one each from the U.S., Europe, and China. Responsibilities: The responsibility of the ERP is to make the recommendations necessary to ensure that the research conducted under this program meets internationally accepted ethics standards and reflects relevant cultural or other patterns in Shanghai. To meet this responsibility, the panel: (1) reviews and approves the protocols and consent forms before the research commences to ensure that recommendations of the earlier ethics review process have been incorporated; (2) reviews any changes in the protocols or the consent forms before they are implemented; (3) reviews, at periodic in-person meeting, the conduct and progress of the research to see that the ethics standards are being followed; (4) responds, on an as-needed basis, to issues raised by the Principal Investigators, the Scientific Review Panel, or the Consortium. Its recommendations will be given to the Oversight Committee who will distribute them to the appropriate individuals and who will oversee any response to them. Meetings: The Ethics Review Panel will have an annual meeting as described above to review conduct of the research as it relates to ethics issues. Members will also be invited to attend the Consortium Annual Meeting. All other business will be conducted by conference calls and/ or email exchanges. Interactions: In order to facilitate interaction with other bodies: (1) the chair of the ERP and SRP (or his designee) will be an ex officio member of the SRP and ERP, respectively, and will attend its meetings and participate in its conference calls; (2) the Principal Investigators will be responsible for submitting proposed changes and annual reports to the ERP through the Technical Committee; (3) the ERP will be available to respond to concerns raised by the SRP, Oversight Committee, Technical Committee, Communications Committee and Principal Investigators. Support: The Oversight Committee will provide to the Ethics Review Panel reasonable support to accomplish its mission including: (1) costs of travel to the annual meetings (one or more of which may be in Shanghai) and costs of running 10f2 SH ELL-MCCLU RG-052064 Final 12111102 that meeting; (2) costs of the conference calls; (3) consulting fees for the members and the chair at an agreed rate; and (4) support staff to facilitate the activities and communication needs for the ERP. 20f2 SH ELL-MCCLU RG-052065