Document NeDDqmq9O4kp16VGZNEDj4JMV

29 July 2004 BHRC Benzene Health Research Consortium Draft Conference Call Minutes Scientific & Ethics Review Panels (SRP/ERP) Conference Call Participants E: ERP; S: SRP 1Consortium Technical Committee Co-Chair; 2 SRP Vice-Chair; 3SRP Chair, 4API Staff S Richard Albertini Stuart Cagen1 S John Cherrie E Ellen Clayton E Paul Lombardo S Helmut Greim2 S Richard Larson S Jerry Rice3 S Howard Rockette S Robert Herrick E Zong-Liang Xu & translator Bruce Jarnot4 Absent: S Harvey Checkoway E Juhana E. Idanpaan-Heikkila S Guilan U S Mark Minden Administrative Items Ellen Clayton & Paul Lombardo were welcomed to the ERP The Consortium's "charge" to external review panels is available for review on Shanghai Health Study (SHS) website Feedback on Progress since first annual research meeting (Asilomar 2003) Dick Albertini: Has JCML's analytic capability been validated? Concern with analyses of Bz & Bz-metabolites in blood, bone marrow Did protocol changes include adoption of cytogenetic markers? Helmut Greim: Progress of Bz & Bz-metabolite analysis in blood, bone marrow? o Detectable levels? Useful information? Practical? o Urinary metabolites (eg, SPMA) more useful Why was ELISA technique selected? Adducts may be better parameter in blood & bone marrow Bob Herrick: 2003 DP/ME report suggested problems with QA/QC Is Dr. Liang best suited to provide data quality oversight? Jerry Rice - expanding on QA/QC topic: Data quality expectations should be explicit; assumptions may be poorly founded Pis need to exercise continued diligence in quality control Data quality expectations might not otherwise be met 1 SH ELL-MCCLU RG-056426 29 July 2004 BHRC Benzene Health Research Consortium Draft Conference Call Minutes Scientific & Ethics Review Panels (SRP/ERP) Helmut & Howard - HEI QA approach: Site visits, data quality audits? ACTION: Helmut/Howard to elaborate at Asilomar Jerry- DP/ME study Consent Form language: Compliance with good ethical research practices needs to be appropriate Discrepancies have been noted in consent form language Xong-Liang Xu (through interpreter): Consent forms are appropriate and are consistent with contemporary Chinese practice ACTION: Panels to review issue & Forms at Asilomar Jerry - Compensation: Assurance of proper payment to individual, or applied to defray Paul noted issue of control selection raised in mid-year CC report Compensation sufficient to attract inappropriate control selection I participation Ellen: difficult to parse amount of compensation (neither too low nor too high) from "ease of selection" by coordinator Compliance with good ethical research practices needs to be appropriate ACTION: Panels to discuss compensation, Consent Forms and control selection with Otto at Asilomar Jerry - Neoplasia classification: WHO (ICDO, 3rd ed) provides the most current diagnostic criteria Leukemic vs. solid mass presentation recognized as variants of same disease, not different dieases, for many B-ceillymphoid neoplasms Need to assure no inappropriate exclusion (e.g., of "leukemias" from cases of "NHL" of same cell type), no artificial 'skewing' of disease population Potential for unconscious bias by using convenient terms (eg, NHL) Helmut - Distribution of classification criteria reference: Summary on classification & diagnosis suitable for distribution ICD-(O)-3 too voluminous Need a shorter, illustrated publication (IARCIWHO "blue book" on lymphoid & hematopoietic neoplasms?) ACTION: Jerry to locate a suitable summary-type document ACTION: Bruce to distribute electronically, or post to website 2 SH ELL-MCCLU RG-056427