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RESIN (Research Support Information Network)Presented by: Office of the Vice Chancellor for Research Date: August 7, 2012
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Research Updates & Timely Information:Office of the VCR COIRSC ORSPIRB ORCIACUC DLAMCOM Finance & Admin OGSPUAMS Library TRI/Core FacilitiesBioVentures UAMS Library Occupational Health & Safety
Agenda
RESIN 8/7/2012
Basics of BiosafetyCarol Price, Director, OH&S
History
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No formal program available in the pastNIH guidelines - “ensure appropriate training”OSHA Bloodborne Pathogens Standard
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Basics of BiosafetyCarol Price, Director, OH&S
Proposed- for all laboratory staffOn-line = access through OH&S websiteTest to follow training moduleAnnual reminderUAMS OH&S - Biological Safety Division
RESIN 8/15/2012
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Basics of BiosafetyCarol Price, Director, OH&S
BenefitsAll employees have basic knowledgeUnderstanding of biosafety levels and risksEnsure employees are offered appropriate care-
HBV vaccine - if working with human blood/body fluidsRegulatory compliance
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Basics of BiosafetyCarol Price, Director, OH&S
Contact Information!Carol Price, Director
[email protected] Building, G-154
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Revised Federal Conflict of Interest RegulationsJennifer Smith, JD, RN, Conflict of Interest Director
Revised Conflict of Interest Regulations
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Investigator ResponsibilitiesCompliance Deadline: August 24, 2012
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Revised Federal Conflict of Interest RegulationsJennifer Smith, JD, RN, Conflict of Interest Director
Academic Staff (Faculty & Key Research Personnel) must complete a COI disclosure at least annually and within 30 days of a change.
Disclosures must be current at the time a grant application is submitted.
Investigators whose disclosure has expired (>365 days since last disclosure) may not participate in research until the deficiency is cured.
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Revised Federal Conflict of Interest RegulationsJennifer Smith, JD, RN, Conflict of Interest Director
All Investigators involved in federally -funded research must receive COI trainingprior to engaging in the research and at least every 4 years thereafter.
RESIN 8/15/2012
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Revised Federal Conflict of Interest RegulationsJennifer Smith, JD, RN, Conflict of Interest Director
For current projects, COI Training must be completed by August 24, 2012.Training Schedule:
August 10, 2012, 10am, ACHRI, Brandon
AuditoriumAugust 23, 2012, 2pm, COPH 8240
Intranet:http://intranet.uams.edu/staffeducation/E_Learning/PublishedFiles/FCOI/FCOI_fs.htm
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Revised Federal Conflict of Interest RegulationsJennifer Smith, JD, RN, Conflict of Interest Director
Conflicts of interest related to federally-funded research must be identified and managed prior to fund expenditure or within 60 days (for any COIs that arise after the research project begins).
RESIN 8/15/2012
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Revised Federal Conflict of Interest RegulationsJennifer Smith, JD, RN, Conflict of Interest Director
Non-ComplianceRetrospective Reviews must be conducted in cases where a COI is not identified and managed in a timely manner, either because an investigator failed to disclose the conflict within the required time frame or UAMS failed to identify and manage the conflict within the required time frame.
Non-compliance with the COI policy may result in removal from research projects or other sanctions.
RESIN 8/15/2012
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Revised Federal Conflict of Interest RegulationsJennifer Smith, JD, RN, Conflict of Interest Director
QUESTIONS?
Jennifer Smith, JD, RN
Director of Conflict of Interest Office686-6447
RESIN 8/15/2012
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Post Approval Monitoring Bill Gurley, Ph.D., IACUC Chair, and Nancy Rhea, MS, Research Compliance Analyst
What is Post Approval Monitoring (PAM) for Animal Research at UAMS?
A program designed to assist the research community with animal based compliance, regulatory standards and UAMS policiesPAM audits all aspects of the animal care program by
Providing a deeper look into animal activities Suggesting training opportunities to the IACUC
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Post Approval MonitoringBill Gurley, Ph.D., IACUC Chair, andNancy Rhea, MS, Research Compliance Analyst
What PAM is notPAM is not intended to be the “animal cops”PAM is not a replacement for the IACUC semi-annual site visitsPAM is not required by regulation (but is a “should” in the new Guide)
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Post Approval Monitoring Bill Gurley, Ph.D., IACUC Chair, andNancy Rhea, MS, Research Compliance Analyst
Goals and Benefits of PAMEnsure animal well-beingSupport scienceProtect the institutionFacilitate communication between research staff and IACUC/Compliance staffEnsure regulatory complianceProvide a paper trail documenting compliance
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Post Approval Monitoring Bill Gurley, Ph.D., IACUC Chair, andNancy Rhea, MS, Research Compliance Analyst
What Happens During a PAM Visit?An analyst from the Office of Research Compliance along with a veterinarian from DLAM will visit the animal research lab and:
Compare protocols to lab activitiesCommunicate changes in regulations or policiesProvide education and support to animal research staffIdentify problems and determine action planCommunicate any ongoing compliance concerns to the IACUCTake feedback to the IACUC and DLAM
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Post Approval Monitoring Bill Gurley, Ph.D., IACUC Chair, andNancy Rhea, MS, Research Compliance Analyst
Who Will Be Selected for a PAM visit?All active IACUC protocols will be eligibleSelection will usually be randomIACUC may request a Directed visitInvestigators may request a visit
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Post Approval Monitoring Bill Gurley, Ph.D., IACUC Chair, andNancy Rhea, MS, Research Compliance Analyst
Common Areas of NoncomplianceChanges in procedures without a protocol amendmentProblems with recordkeepingLack of proper trainingUnexpected mortality or morbidity rates
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Post Approval Monitoring Bill Gurley, Ph.D., IACUC Chair, andNancy Rhea, MS, Research Compliance Analyst
Office of Research Compliance
Nancy Rhea, [email protected]
501-686-6340
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IRB UpdatesJennifer Sharp. J.D., IRB Director
New FacesIRB ChairIRB Office
New SystemCLARA
Newly Re-accreditedIRB by the Numbers
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Predatory Open Access Publishers Mary L. Ryan, UAMS Library Director
Legitimate Open Access PublishingArticles freely available Author usually pays publication feeAuthor retains copyrightPLoS, Biomed Central, etc.
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Predatory Open Access Publishers Mary L. Ryan, Library Director
Predatory OA PublishersMain goal is profit, not promoting scholarshipIndicators
Not indexed in PubMedMass email solicitations for articles and editorsNo editor-in-chief and/or very large editorial boardVery short turnaround on peer reviewNo publication fee indicated on web site
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Predatory Open Access Publishing Mary L. Ryan, Library Director
Beall‘s List of Predatory OA Publishershttp://carbon.ucdenver.edu/~jbeall/Beall's%20List%20of%20Predatory,%20Open-Access%20Publishers%202012.pdf [PDF Version]
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NIH Update - What to Expect in FY13 Larry Cornett, Vice Chancellor for Research
RESIN 8/15/2012
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NIH Update - What to Expect in FY13 Larry Cornett, Vice Chancellor for Research
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NIH Update - What to Expect in FY13 Larry Cornett, Vice Chancellor for Research
RESIN 8/15/2012
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NIH Update - What to Expect in FY13 Larry Cornett, Vice Chancellor for Research
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NIH Update - What to Expect in FY13 Larry Cornett, Vice Chancellor for Research
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NIH Update - What to Expect in FY13 Larry Cornett, Vice Chancellor for Research
RESIN 8/15/2012
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Next RESIN
Next RESINSeptember 4, 2012 @ 12:00p.m.Location - Walton Auditorium, Winthrop P. Rockefeller Cancer Institute, 10th floor All RESIN presentations archived on the UAMS Research website
http://www.uams.edu/research/RESIN_Achive.asp
RESIN 8/7/2012
