before/after IRB Review. Workflow process Describe problems/solutions Biobank EMR, consent issues, samples or – Ancillary committees when do they sign? remnants, HIPAA, oversight – How are they determined? Who identifies committees/community advisors, access the need? Coordinated with IRB approval? approval for investigators A dedicated Clinical Trials Office practices RC Interactions programs/ education of – – and policies for MCA/no-MCA, consistency and with RCs. Networks, meetings, support reviews, all trials or just sponsored? How is offices, certification, job descriptions federally funding handled? Listservs communication with – Education activities inside/outside the investigators/ research institution IT keeping up with process and – audits, audits of flex, submission changes, reports, satisfaction QA Activities; satisfactions surveys. Who does them? IRB posted office hours What do results accomplish? Community engagement, education, Incorporating CQI mechanisms in – definitions, Community Members, hierarchy esubmission system/ audits (time in boxes, flags, auto reports) Help share, staff, Community Members, – nation, institution, community, booklets, educating Multitude of databases – meetings research community on proliferation of systems Engagement determinations how to – simplify or work around Ceded review define types and – agreements. Describe problems/solutions, Amendment shortcuts, personnel – benefits provided by SOPs, MOUs changes button, triage (eg. major/ minor), who verifies? Assuring external PIs and institutions comply How to do? – Expanding expedited reviewers of compliance (Attestation/confirmation with the protocol and terms of IRB PI self-determination of whether IRB approval) review is needed for biorepository research (Cedars-Sinai) describe uses other than – language (ex: Emergency Research, any IRB staff smarter use – other uses?)
Workflow process before/after IRB Review. Describe problems/solutions Ancillary committees – when do they sign? How are they determined? Who identifies the need? Coordinated with IRB approval? A dedicated Clinical Trials Office – practices and policies for MCA/no-MCA, consistency reviews, all trials or just sponsored? How is federally funding handled? Education activities inside/outside the institution QA Activities; audits, audits of flex, satisfactions surveys. Who does them? What do results accomplish? Incorporating CQI mechanisms in esubmission system/ audits (time in boxes, flags, auto reports) Multitude of databases – educating research community on proliferation of systems Ceded review – define types and agreements. Describe problems/solutions, benefits provided by SOPs, MOUs Assuring external PIs and institutions comply – How to do? (Attestation/confirmation of compliance with the protocol and terms of IRB approval) – describe uses other than language (ex: Emergency Research, any other uses?) Biobank – EMR, consent issues, samples or remnants, HIPAA, oversight committees/community advisors, access approval for investigators RC Interactions – programs/ education of and with RCs. Networks, meetings, support offices, certification, job descriptions Listservs – communication with investigators/ research IT – keeping up with process and submission changes, reports, satisfaction IRB posted office hours Community – engagement, education, definitions, Community Members, hierarchy Help – share, staff, Community Members, nation, institution, community, booklets, meetings Engagement determinations – how to simplify or work around Amendment – shortcuts, personnel changes button, triage (eg. major/ minor), who verifies? Expanding expedited reviewers PI self-determination of whether IRB review is needed for biorepository research (Cedars-Sinai) IRB staff – smarter use
redefining-flex.docx