an introduction to research compliance ahia northwest regional conference may 7, 2010 nicole jacobs,...
TRANSCRIPT
An Introduction to Research Compliance
AHIA Northwest Regional Conference
May 7, 2010
Nicole Jacobs, CHRCSeattle Children's Research Institute
Objectives
• Provide a broad overview of seven different research compliance categories.
• Describe various topics within each category.
• Review the structure of federal research oversight of research.
• Identify key regulations governing research.
• Highlight research compliance program elements and current compliance issues.
Research Compliance
Environment Health
& Safety
Conflictsof Interest
HumanSubjects
Financial Stewardship
ResearchIntegrity
ResearchAdministration
Animal Subjects
Research Compliance
Conflictsof Interest
Research Misconduct Data Management Authorship & PublicationPeer Review Mentor/Trainee Relationships Collaborative RelationshipsConflicts of Interest
HumanSubjects
Animal Subjects
ResearchIntegrity
Office of Institutional AssurancesHuman Subjects Protection ProgramInstitutional Review BoardConsent & Assent HIPAA ComplianceHIPAA Training & MonitoringPrivacy & Security IssuesInvestigator Initiated StudiesFHCRC studies at SCHIRB Protocol & Grant HarmonizationConduct of the Research
Office of Animal CareInstitutional Animal Care & Use Committee (IACUC)IACUC application review and follow-upVivarium User Training & Education Regulatory Agency ReportingIACUC Protocol & Grant HarmonizationProtocol Deviation
Institutional COIIndividual Financial COIConflicts of CommitmentIRB Conflict of Interest Intellectual COI (mostly peer review)Personal COI (mostly peer review)
Institutional Biosafety Committee (IBC)Radiation SafetyRegulated MaterialsHazardous MaterialsBiological AgentsAll training related to aboveAccurate PI reporting to IBCIncreased Irradiator Controls
• Pre-AwardProposal Narrative & Budget AgreementFinancial Study Document Harmonization • Post-AwardSubcontractor MonitoringCompliance with Special Terms and ConditionsFinancial Post Award Monitoring
(FPAM)
ResearchAdministration
Environment Health
& Safety
Effort ReportingAllowable CostsCost SharingCost TransfersCost Documentation/Expense AuthorizationAccurate Direct & Indirect ChargesService/Recharge Centers (Cores) Facilities & Administrative RateClinical Research Billing
Financial Stewardship
Introduction to Research Compliance
• Research Misconduct• Data Acquisition & Management• Authorship & Publication• Peer Review• Mentor/Trainee Relationships• Collaborative Relationships• Conflicts of Interest
Research Integrity
Research Integrity is the Responsible Conduct of Research
Introduction to Research Compliance
Research Misconduct
Definition: Fabrication, falsification, plagiarism or other practices that seriously deviate from those that are commonly accepted within the scientific community, in proposing, performing or reviewing research or in reporting research results. It does not include honest error or differences of opinion.
Federal Regulations: 42 CFR 93• Define misconduct• Require all institutions receiving PHS funding have adequate policies on research misconduct to ensure proper inquiry and investigation of misconduct allegations.• Require institutions to provide reports to Office Research Integrity (ORI)
Federal Oversight: Office of Research Integrity (ORI) in the Dept. of Health & Human Services (HHS)
Introduction to Research Compliance
• Institutional COI• Individual Financial COI• Conflicts of Commitment• Institutional Review Board (IRB) COI• Intellectual COI (mostly peer review)• Personal COI (mostly peer review)
Conflicts of Interest
The focus on Conflicts of Interest is to ensure objectivity in research.
Introduction to Research Compliance
Conflict of Interest
Generally exist when any interest, financial or otherwise, has the potential to compromise or bias professional judgment or objectivity. More specific definitions of conflicts of interest are contained with federal regulations.
Federal Regulations:• Define conflicts of interest
• Different thresholds set by PHS and FDA• Establish reporting requirements• Provide general guidelines for managing conflicts of interest
Public Health Service (PHS) Food & Drug Administration (FDA) 42 CFR 50 Subpart F (grants) 21 CFR 54 (investigators) 42 CFR Part 94 (contracts) 21 CFR 56.107 (IRB members) 45 CFR 46.107 (IRB members)
Federal Oversight: PHS awarding component (NIH) and/or FDA, depending on funding source and nature of the research.
Introduction to Research Compliance
• Human Subjects Protection Program• Institutional Review Board (IRB)• Consent & Assent • HIPAA Compliance• HIPAA Training & Monitoring• Privacy & Security Issues• Investigator Initiated Studies• IRB Protocol & Award (grant or contract) Harmonization• Conduct of the Research
• Protocol Adherence• Regulatory Documentation, etc.
Human Subject Research
Introduction to Research Compliance
Belmont Report – Three Key Principles
1. Respect for PersonsInformed ConsentPrivacy & ConfidentialityAdditional protections for vulnerable populations
2. BeneficenceRisks of research are justified by potential benefits to participant or societyMaximize benefit, minimize risks
3. JusticeEquitable selection of subjectsNo systematic exclusion of subject who may benefit from the research
Human Subject Research
Introduction to Research Compliance
Human Subject Research
Federal Regulations
• HHS - 45 CFR 46
• FDA21 CFR 50 (informed consent)21 CFR 56 (institutional review boards)21 CFR 312 (investigational drugs)21 CFR 812 (investigational devices)
• Health Insurance Portability and Accountability Act (HIPAA)• HITECH Act in ARRA
Also…• Other federal privacy laws
• State Laws• IRB Policies• Other Institutional Policies may apply
Introduction to Research Compliance
Human Subject Research
Compliance Oversight
• HHS Office for Human Research Protections (OHRP)• FDA • Institutional Review Board• Institutional Official• Federal-wide Assurance• Investigator
Institutions are required to comply with all regulations that pertain to a study, so if a study falls under jurisdiction of OHRP and FDA, then all regs. must be followed…and they are not always parallel.
Introduction to Research Compliance
Animal Subject Research
• Office of Animal Care• Institutional Animal Care & Use Committee (IACUC)• IACUC application review and follow-up• Vivarium User Training & Education • Regulatory Agency Reporting• IACUC Protocol & Award (grant or contract) Harmonization• Protocol Adherence
Animal Subjects must be protected to ensure their appropriate care as well as their appropriate use in research.
Research Compliance Areas
Animal Subject Research
Federal Regulatory Agencies1. U.S. Department of Agriculture2. Office of Laboratory Animal Welfare (OLAW) (part of PHS)
Key Regulations1. Animal Welfare Act (AWA)
USDA oversees and enforces AWA through it Animal & Plant Health Inspection Service (APHIS)
2. PHS Policy on Human Care and Use of Laboratory AnimalsOLAW oversees and enforces the PHS Policy
Key GuidanceGuide for the Care and Use of Laboratory Animals
Research Compliance Areas
Animal Subject Research
AWA and PHS PolicySimilar in general, different in details
• Differing applicability, although sometimes both regulations apply• Define Institutional Inspection and Reporting requirements • Require Institutional Animal Care and Use Committees (IACUC) to provide
oversight• Define requirements for IACUC’s
IACUC Oversight• Ongoing review of animal research protocols• Semi-annual Review of facility’s program• Semiannual inspection of the facility• Report findings from reviews and inspections to the Institutional Official (IO)• Annual reports to Federal agencies (USDA and OLAW) through the IO
Introduction to Research Compliance
• Pre-Award• Proposal Narrative and Budget Agreement• Financial Study Document Harmonization
• Post-Award• Subcontractor Monitoring• Compliance with Special Terms and Conditions• Financial Post Award Monitoring (FPAM - Financial Stewardship)
Research Administration
There are rules and regulations regarding the administration of PHS funded research.
Introduction to Research Compliance
Financial Stewardship
• Effort Reporting• Allowable Costs• Cost Sharing• Cost Transfers• Cost Documentation/Expense Authorization• Accurate Direct & Indirect Charges• Financial Reporting• Service/Recharge Centers (Cores) • Facilities & Administrative (F&A) Rate• Clinical Research Billing
All about the proper use of PH research funds, and the appropriate documentation of that use.
Introduction to Research Compliance
Financial Stewardship
Effort Reporting: tool used to enable the proper allocation of salaries to federal awards
Allowable Costs: costs charged to federal awards must meet certain criteria. Research studies consist of direct (allowable) costs and indirect (unallowable) costs.
Cost Sharing: when a portion of the research projects costs are born by the institution and not the federal government. Any cost sharing must be tracked & documented..
Cost Transfers: moving costs from one award to another after the expense has been incurred. There are restrictions regarding cost transfers.
Cost Documentation/Expense Authorization: costs charged to federal awards must be authorized by appropriate individual and documented as allowable
Facilities & Administrative (F&A) Rate: F&A costs are considered “overhead” or “indirect” costs. The F&A rate is the indirect costs divided by direct costs. There are specific guidelines as to which costs can be used in calculating this rate.
Introduction to Research Compliance
Financial Stewardship
Regulations
Federal Cost PrinciplesOMB Circulars A-21 (2 CFR Part 220) – UniversitiesOMB Circulars A-122 (2 CFR Part 230) – Non-profits45 CFR Part 74, Appendix E – Hospitals
PoliciesNIH Grants Policy StatementHHS Grants Policy StatementNSF Grants Policy Manual
OthersFederal Acquisitions Regulation Part 31 (contract cost principles)NIH Policy Notes
Introduction to Research Compliance
• Institutional Biosafety Committee (IBC)• Radiation Safety• Regulated Materials• Hazardous Materials• Biological Agents• All training related to above• Accurate Investigator reporting to IBC• Increased Irradiator Controls
Research Environment Health & Safety
Ensuring a safe research environment, while also protecting the environment from the research materials.
Introduction to Research Compliance
Regulations are federal, state and local
Some of the Regulatory Agencies include:• NRC: Nuclear Regulatory Commission • DHS: Department of Homeland Security• DEA: Drug Enforcement Administration• EPA: Environmental Protection Agency• OHSA: Occupational Health & Safety Organization• State Department of Health• State Department of Transportation• County Department of Health
… and there are many, many more.
Research Environment Health & Safety
Compliance Area
Research Integrity
Human Subjects
Animal Subjects
Conflicts of Interest
Research Environment
Health & SafetyResearch
Admin.Financial
Stewardship
Office or Agency
ORINIH OER
OHRPFDA
OLAWUSDAWA Dept of Fish & Wildlife
NIHFDA
OBA, OSHA, EPA, DEA, CDC, APHIS, US DOT, IATA, US Nuclear Regulatory Commission
OPERA OPERA
Committees Ad Hoc IRB IACUCCOI Review Board
IBC
Authority/ Individual Responsible
RIOPresident, Research Institute
President, Research Institute
RIOPresident and Safety Officer
Vice President, Research Ops & Logistics
CFO
Policies & Regulations
42 CFR 93 45 CFR 68942 CFR 52h
45 CFR 46 21 CFR 50 21 CFR 56 21 CFR 312 21 CFR 812HIPAAPrivacy Act
PHS Policy on Human Care & Use of Laboratory AnimalsAnimal Welfare Act
42 CFR 50 Subpart F42 CFR 9460 FR 3582021 CFR 5445 CFR 46.10721 CFR 56.107
42 CFR 7343 FR 6010810 CFR NUREG 1556Sections 817(1) & (2) of USA Patriot ActIFC
45 CFR 74NIH & HHS Grants Policy Statements
45 CFR 74OMB A-122OMB A-21OMB A-133OMB A-110Clinical Trial PolicyFalse Clams Act
Introduction to Research Compliance
Elements of a Research Compliance Program
1. Ensure compliance with federal, state, and local regulations regarding research and Institution policies
2. Develop and implement policies and procedures as needed for compliance with regulations
3. Conduct effective training and education programs on the responsible conduct of research and current compliance issues
4. Perform compliance risk assessment and internal compliance auditing and monitoring
5. Respond promptly to detected problems and undertake corrective action
6. Enforce compliance standards through well publicized disciplinary guidelines
7. Provide effective lines of communication regarding compliance
Introduction to Research Compliance
Recent Research Compliance Issues & Risks
• Effort Reporting
• Cost Allocation (Proper charging of Direct and Indirect Costs)
• Cost Sharing
• Cost Transfers
• Clinical Research Billing
• Conflicts of Interest – Individual and Institutional
• Sub-recipient Monitoring
• Recharge centers
Thank you!Questions?