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10/11/2016A ResearchAdministrator’sGuide to Non-FinancialResearch ComplianceOverview Role of RAs in compliance Identify key compliancetopics and definitions Who to call and steps totake to facilitate compliance.http://www.udel.edu/research11
10/11/2016Responsible Conduct of ResearchPromote objectivity, protect research subjects, ensure properuse of funds, and minimize opportunities for wrongdoing.Shared ValuesHonestyAccuracyadapted from www.udel.edu/research2Research Compliance – Why Do We care?Proper stewardship of research activities is the responsibility ofthe Institution (PIs, Researchers, RAs, IOs)Research Compliance - Areas of Focus1.2.3.4.5.6.7.8.Research MisconductConflict of InterestHuman Subjects Protection: FWA (HHS)Animal Use in Research: AWA & PHSAgreements (NDAs, CAs, MTAs) / IPExport ControlsFinancial ManagementSafety in Researchhttp://www.udel.edu/research32
tro.pdfhttp://www.udel.edu/research4The Rules of the RoadLaws,Regulations & PoliciesEthical Standards53
10/11/2016General Research AdministrationOverall responsibility for programmatic and financial stewardship of award Approves project PI eligibility Provide guidance and interpretation of federal regulations, agency specific requirements,and University policies and proceduresProvide training as neededRespond to ad hoc audit requests (internal and external)Work with external auditors to complete the A‐133 audit processCreate and maintain management queries used to monitor award activityProposal PreparationAssist principal investigator with proposal preparationInitiate proposal submission Coordinate submission to ensure timelyness, compliance and accuracyRegulatory CompliancePrepares and submits protocols for research involving human subjects, animals, and biosafety hazardsVerifies submission of protocol to appropriate oversight regulatory committeesAct as a liaison between the principal investigator and the Research OfficeSupports regulatory committees to ensure compliance with federal requirements regardingthe responsible conduct of researchWorks with UD Office of EHS regarding research material use, storage, transportation, anddisposition to ensure compliance with federal requirements in biochemical, environmental,and radiation safetyWorks in conjunction with UD OEIPto assure compliance with federal intellectual propertyrequirementsDiscloses existence of research‐staff conflict of interest and/or use of controlled technology or select agents for subject research effortDevelops and submits COI management plan(s), TCP(s), and EC licensing‐application background‐materialsApproval and Maintenance of COIMgt and TCP (when required)Award Management/MonitoringReviews, approves, and submits to federal agencies, as required, COI management plans,http://www.udel.edu/researchTCP(s), and EC licensing pon. Res.Acctg.(Central)Spon. Prog.C&G Admin.(Central)Dept. Res.Admin.College Deanor VPPI(s)Role of RAs in ComplianceDept. Chairhttp://www.udel.edu/research/pdf/Roles and Responsibilities Matrix.pdf 6 1. Research Integrity/MisconductResearch misconductis defined asfabrication,falsification, orplagiarism inproposing, performing,or reviewing research,or in reportingresearch results.U.S. Office of Science and Technology Policy (OSTP)http://www.udel.edu/research74
10/11/2016For there to be a finding of misconduct There must be a significant departure from acceptedscientific practices of the relevant research community;and The misconduct is committed intentionally, or knowingly,or recklessly of accepted practices; and The allegation is proven by a preponderance of evidenceResearch misconduct does NOT include honest error ordifferences of opinion.http://www.ostp.gov/cs/federal policy on research misconducthttp://www.udel.edu/research8Where to ReportAllegations of research misconduct may bereported to the University of Delaware, AssociateProvost for Research and Regulatory AffairsDr. Cordell OverbyUD Policy may be found ntegrity.htmlhttp://www.udel.edu/research95
10/11/20162. Conflict of Interest UD Research Policy 6-11 "apotential conflict of interest occurswhen there is a divergencebetween an individual's privateinterests and his or herprofessional obligations ” All faculty and professional staffmust disclose all significantfinancial and commitmentinterests every year – At UD COIdisclosures are submitted gator SFI Disclosure andInstitutional FCOI Reporting RequirementsInvestigator Disclosesknown SFI(s) to theInstitutionInstitution Reports identified FCOI(s) to theappropriate funding agency.(Designated official(s) review the disclosures tomake determinations of FCOIs).At time of ApplicationPrior to the Expenditure of FundsWithin 30 days of acquiring ordiscovering SFIWithin 60 days of identificationAnnually at the time periodprescribed by the Institutionduring the award periodAnnually: At the same time as when the grantee isrequired to submit the annual progress report,including multi-year progress report, or at time ofextension.http://www.udel.edu/research116
10/11/2016REQUIRED FCOI REPORTS TO BE PROVIDED TO THE FUNDING ENTITYReportContentRequired when?Initial FCOIReportGrant Number, PI, Name of Entity with FCOI,Nature of FCOI, Value of financial interest (inincrements), Description of how FI relates toresearch, Key Elements of Management Plan.(1) Prior to expenditure of funds(2) Within 60 days of anysubsequently identified FCOIAnnual FCOIReportStatus of FCOI and Changes to Management PlanAnnual report due at same timeas when submitting annualprogress report or at time ofextension.Revised FCOIReportIf applicable, update a previously submitted FCOIreport to describe actions that will be taken tomanage FCOI going forward.After completion ofretrospective review, if needed.MitigationReportProject Number, Project Title, Contact PI/PD,Name of Investigator with FCOI, Name of Entitywith FCOI, Reason for review, DetailMethodology, Findings and Conclusion.When bias is found as a result ofa retrospective review.http://www.udel.edu/research123. Human Subjects in ResearchResearch: A systematic investigation .designed to develop or contribute togeneralizable knowledge.Human Subject: A living individual about whom an investigator (whether professional orstudent) conducting research obtains (1) data through intervention orinteraction with the individual or (2) identifiable private informationThe Belmont Report (April 18, 1979)Ethical Principles and Guidelines for ResearchInvolving Human Subjects1. Respect for Persons Informed Consent2. Beneficence Risks vs. Benefits3. Justice Participants Selectionhttp://www.udel.edu/research137
10/11/2016Regulations Common Rule (19 agencies) 45 CFR 46 A,B,C, and D FDA (Investigational Products) 21 CFR 50 and 56Federalwide Assurance UD FWA00004379: In compliance with U.S. Department ofHealth and Human Services (DHHS) At UD the FWA applies to ALL human subjects researchhttp://www.udel.edu/research14Human Subjects in Research Training for the protection of human subjects in research is requiredfor all researchers (faculty, students, staff) who will be directlyinteracting with research participants or who will have access toidentifiable private informationUD Protocol and Approval Procedure All research involving human subjects must be reviewed andapproved by the UD Institutional Review Board (IRB) before anyresearch activities start:– IRB meets monthly– Submit protocol through http://www.irbnet.org– See Research Calendar for submission deadlines and meetingdates htmlhttp://www.udel.edu/research158
10/11/2016Levels of Review Exempt (Minimal Risk; 6 Categories) Granted by the Chair or IRB designee Approval for 3 years Expedited (Minimal Risk; 9 Categories) Reviewed on a rolling basis by one or more IRB members Requires annual continuing review Full Board Review Reviewed by convened IRB at monthly meeting (see researchcalendar) Requires at least annual continuing reviewThe timing for when IRB approval is required depends on funding agency.http://www.udel.edu/research16University of Delaware Policy andProcedures UD research policy 6-4http://www.udel.edu/ExecVP/polprod/6-04.html UD human subject protocol submission rotocolreview.html IRB Standard Operating rb-sop.htmlhttp://www.udel.edu/research179
10/11/20164. Use of Animals in Research Laboratory animals are an integral part of the researchprocess Virtually every major medical advance in the last centuryis due, in part, to research with animals Good animal care and good science go hand-in-handwww.npx.autismspot.comScientists using animals: The 3 “R”s Refine ‐ consider alternatives to procedures causing more than momentary pain or distress Reduce ‐ the number of animals used should be the minimum that is consistent with theaims of the experiment Replace ‐ use non‐animal models when possible (e.g., in vitro methods)Russell, W.M.S. and Burch, R.L. "The Removal of Inhumanity: The Three R's“, 1959http://www.udel.edu/research18Regulations and Policies Ensure . Animals are used in research only when absolutely necessary When animals are used in research, they are used humanelyResponsible for oversight of theanimal care and use program and itscomponents. Its oversight functionsinclude ongoing assessment ofanimal care and are.htmlhttp://www.udel.edu/research1910
10/11/2016UD Office of Laboratory Animal Medicine(OLAM) Dedicated to the care and well-being of research animals Provides and properly maintains the animals used inapproved research Provides specialized resources, services, andconsultation Provides information and trainingWho to Contact?Gwen Talham, DVMFrank Warrenx2980 gtalham@udel.edux2400 fwarren@udel.eduhttp://www.udel.edu/research205. Agreements and Contracts/Intellectual Property Non-Disclosure AgreementsMaterial Transfer AgreementsCopyright LawPatent LawData Use Agreements .http://www.udel.edu/research2111
10/11/2016Non-Disclosure Agreements Allows for the exchange ofconfidential and proprietaryinformation. Confidential Information maybe oral or in writing. Includes information which isof a non-public, proprietaryor confidential nature.http://www.udel.edu/research22Material Transfer Agreements Establishes rights and obligations ofparties when research material isexchanged. Webform established to process, monitor,and track MTAs.http://www.udel.edu/research2312
10/11/2016Intellectual Property The Copyright Act prevents theunauthorized copying of a work ofauthorship. Patent law gives to the patent holder theright to exclude others from making,using, offering to sell, or selling theinvention.http://www.udel.edu/research246. Export ControlsWHAT IS AN EXPORT?Any item that is sent from the United States to a foreigndestination is an export. “Items” include commodities,software, and technology.How the item is transported outside of the U.S. does notmatter in determining export license requirementsWHAT IS A DEEMED EXPORT?A “deemed” export is the release within the U.S. of a technology or source codeto a foreign national.Exports are controlled for National security by: U.S. Department of State: ITAR (International Traffics in Arms Regulations) U.S. Department of Commerce: EAR (Export Administration Regulations) U.S. Department of the Treasury: OFAC (Office of Foreign Assets Control)http://www.udel.edu/research2513
10/11/2016Fundamental Research Information resulting from basic and applied research in scienceand engineering conducted at an accredited institution of highereducation in the U.S. that is ordinarily published and broadly sharedwithin the scientific community.UD Export Control PolicyIs your UD project in compliance with Export Controls?6-17 Export Controls and Trade SanctionsExport Compliance l.edu/research2714
10/11/20167. Fiscal Compliance Definition:– Oversight/stewardship of financial aspect ofaward Responsible party:– Everyone is responsible to ensure properspending of sponsored project funds– Principal Investigator has overall responsibility– Purchaser has secondary responsibilityhttp://www.udel.edu/research288. Safety in Research– EHS Mission is to maintain a safe andhealthful campus environment whileensuring compliance with applicablefederal, state and local regulations. Chemical Biological Radiological (Lasers, X-Rays) Environmental Fire and Life Safety General Safety Industrial Hygiene (occupational)http://www.udel.edu/research2915
10/11/2016Examples of Institution Requirements -- PriorApproval Needed Environmental Health and Safety must be notified when certainoperations or projects occur. The notification is required in orderfor EHS to help researchers and students safely perform the taskor process. when in doubt call EHS 302‐831‐8475 !!–––––––––Renovations to laboratory and research spacesUse of Class IIIB or IV lasersExplosive laboratory reactions or use of high explosivesUse of highly toxic chemicals, radioactive materials, carcinogenic materials, reproductive toxins ormaterials of unknown toxicityPurchasing of refrigerators for chemical storagePurchasing, moving or installing a chemical fume hood, laboratory exhaust ventilation or laminar flowequipmentMinors (under 18 years of age) working with hazardous materials or performing hazardous operationsExperiment or process that impacts building or laboratory design, i.e. a large piece of equipment orapparatus that blocks sprinkler headsPurchase or use of a w.udel.edu/research3116
10/11/2016Potential Consequences ofNoncompliance PI Suspension and/or Debarment from federally funded researchLoss of employmentPublic notice of misconductInvestigator degree revokedRetraction of publicationsAudit findings and fines for the researchers and/or the UniversityLoss of institutional credibilityRestriction, suspension, or termination of the University’s ability toperform researchhttp://www.udel.edu/research32Summary Be aware of compliance issues Read your award document & know your awardterms & conditions– Does your award allow human subjects, animal research?– Does human subjects research require prior approval?– Does your award include Dissemination of Information or ExportControl terms? Know your investigators– Do your PIs frequently study humans, animals, rDNA?– Does your PI have financial stake/ownership in companies? Review proposal abstracts and look for key words that mayindicate a compliance issuehttp://www.udel.edu/research3317
10/11/2016Points of Contact - Compliance- Animal CareGwen Talham, DVMx2980 gtalham@udel.eduFrank Warrenx2400 fwarren@udel.edu- Conflict of InterestMaria Palazuelos, PhDx8619 mariapj@udel.edu- Contractual Agreements / IPSean Hayes, JD, PhDx7445 hayes@udel.edu- Environmental Health and Safetyx8475 dehsafety@udel.edu- Export ControlsCordell Overby, ScDx2383 overbyc@udel.edu- Human ProtectionsMaria Palazuelos , PhDx8619 mariapj@udel.eduClara Simpers, BA, CIPx2137 csimpers@udel.edu- Research Integrity/MisconductCordell Overby, ScDx2383 overbyc@udel.edu- General QuestionsIf you’re not sure who to call, contact your Contract & Grant Specialist!http://www.udel.edu/research3418
4. Use of Animals in Research www.npx.autismspot.com Laboratory animals are an integral part of the research process Virtually every major medical advance in the last century is due, in part, to research with animals Good animal care and good science go hand-in-hand Scientists using animals: The 3 "R"s
