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An Introduction to Research Compliance

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An Introduction to Research Compliance AHIA Northwest Regional Conference May 7, 2010 Nicole Jacobs, CHRC Seattle Children's Research Institute – PowerPoint PPT presentation

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Title: An Introduction to Research Compliance


1
An Introduction to Research Compliance
  • AHIA Northwest Regional Conference
  • May 7, 2010

Nicole Jacobs, CHRC Seattle Children's Research
Institute
2
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.

3
Research Integrity
Financial Stewardship
Human Subjects
Research Compliance
Research Administration
Animal Subjects
Conflicts of Interest
Environment Health Safety
4
Research Misconduct Data Management
Authorship Publication Peer Review
Mentor/Trainee Relationships
Collaborative Relationships Conflicts of Interest
Effort Reporting Allowable Costs Cost
Sharing Cost Transfers Cost Documentation/Expense
Authorization Accurate Direct Indirect
Charges Service/Recharge Centers (Cores)
Facilities Administrative Rate Clinical
Research Billing
Office of Institutional Assurances Human Subjects
Protection Program Institutional Review
Board Consent Assent HIPAA Compliance HIPAA
Training Monitoring Privacy Security
Issues Investigator Initiated Studies FHCRC
studies at SCH IRB Protocol Grant
Harmonization Conduct of the Research
Research Integrity
Financial Stewardship
Human Subjects
Research Compliance
  • Pre-Award
  • Proposal Narrative Budget
  • Agreement
  • Financial Study Document
  • Harmonization
  • Post-Award
  • Subcontractor Monitoring
  • Compliance with Special Terms and
  • Conditions
  • Financial Post Award Monitoring
  • (FPAM)

Research Administration
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 Grant Harmonization Protocol
Deviation
Animal Subjects
Environment Health Safety
Conflicts of Interest
Institutional COI Individual Financial
COI Conflicts of Commitment IRB Conflict of
Interest Intellectual COI (mostly peer
review) Personal COI (mostly peer review)
Institutional Biosafety Committee (IBC) Radiation
Safety Regulated Materials Hazardous
Materials Biological Agents All training related
to above Accurate PI reporting to IBC Increased
Irradiator Controls
5
Introduction to Research Compliance
  • Research Integrity

Research Integrity is the Responsible Conduct of
Research
  • Research Misconduct
  • Data Acquisition Management
  • Authorship Publication
  • Peer Review
  • Mentor/Trainee Relationships
  • Collaborative Relationships
  • Conflicts of Interest

6
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)

7
Introduction to Research Compliance
Conflicts of Interest
The focus on Conflicts of Interest is to ensure
objectivity in research.
  • Institutional COI
  • Individual Financial COI
  • Conflicts of Commitment
  • Institutional Review Board (IRB) COI
  • Intellectual COI (mostly peer review)
  • Personal COI (mostly peer review)

8
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.

9
Introduction to Research Compliance
Human Subject Research
  • 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.

10
Introduction to Research Compliance
Human Subject Research
Belmont Report Three Key Principles 1.
Respect for Persons Informed Consent Privacy
Confidentiality Additional protections for
vulnerable populations 2. Beneficence Risks
of research are justified by potential benefits
to participant or society Maximize benefit,
minimize risks 3. Justice Equitable selection
of subjects No systematic exclusion of subject
who may benefit from the research
11
Introduction to Research Compliance
Human Subject Research
  • Federal Regulations
  • HHS - 45 CFR 46
  • FDA
  • 21 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

12
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 followedand they are not
    always parallel.

13
Introduction to Research Compliance
  • Animal Subject Research

Animal Subjects must be protected to ensure their
appropriate care as well as their appropriate use
in 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

14
Research Compliance Areas
  • Animal Subject Research
  • Federal Regulatory Agencies
  • U.S. Department of Agriculture
  • Office of Laboratory Animal Welfare (OLAW) (part
    of PHS)
  • Key Regulations
  • Animal Welfare Act (AWA)
  • USDA oversees and enforces AWA through it
    Animal Plant Health Inspection Service (APHIS)
  • PHS Policy on Human Care and Use of Laboratory
    Animals
  • OLAW oversees and enforces the PHS Policy
  • Key Guidance
  • Guide for the Care and Use of Laboratory Animals

15
Research Compliance Areas
  • Animal Subject Research
  • AWA and PHS Policy
  • Similar 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 IACUCs
  • IACUC Oversight
  • Ongoing review of animal research protocols
  • Semi-annual Review of facilitys 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

16
Introduction to Research Compliance
  • Research Administration

There are rules and regulations regarding the
administration of PHS funded research.
  • 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)

17
Introduction to Research Compliance
  • Financial Stewardship

All about the proper use of PH research funds,
and the appropriate documentation of that use.
  • Effort Reporting
  • Allowable Costs
  • Cost Sharing
  • Cost Transfers
  • Cost Documentation/Expense Authorization
  • Accurate Direct Indirect Charges
  • Financial Reporting
  • Service/Recharge Centers (Cores)
  • Facilities Administrative (FA) Rate
  • Clinical Research Billing

18
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 (FA) Rate FA costs are
considered overhead or indirect costs. The
FA rate is the indirect costs divided by direct
costs. There are specific guidelines as to which
costs can be used in calculating this rate.
19
Introduction to Research Compliance
  • Financial Stewardship

Regulations Federal Cost Principles OMB
Circulars A-21 (2 CFR Part 220)
Universities OMB Circulars A-122 (2 CFR Part 230)
Non-profits 45 CFR Part 74, Appendix E
Hospitals Policies NIH Grants Policy
Statement HHS Grants Policy Statement NSF Grants
Policy Manual Others Federal Acquisitions
Regulation Part 31 (contract cost principles) NIH
Policy Notes
20
Introduction to Research Compliance
  • Research Environment Health Safety

Ensuring a safe research environment, while also
protecting the environment from the research
materials.
  • 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

21
Introduction to Research Compliance
  • Research Environment Health Safety
  • 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.

22
Compliance Area Research Integrity Human Subjects Animal Subjects Conflicts of Interest Research Environment Health Safety Research Admin. Financial Stewardship
Office or Agency ORI NIH OER OHRP FDA OLAW USDA WA Dept of Fish Wildlife NIH FDA OBA, OSHA, EPA, DEA, CDC, APHIS, US DOT, IATA, US Nuclear Regulatory Commission OPERA OPERA
Committees Ad Hoc IRB IACUC COI Review Board IBC
Authority/ Individual Responsible RIO President, Research Institute President, Research Institute RIO President and Safety Officer Vice President, Research Ops Logistics CFO
Policies Regulations 42 CFR 93 45 CFR 689 42 CFR 52h 45 CFR 46 21 CFR 50 21 CFR 56 21 CFR 312 21 CFR 812 HIPAA Privacy Act PHS Policy on Human Care Use of Laboratory Animals Animal Welfare Act 42 CFR 50 Subpart F 42 CFR 94 60 FR 35820 21 CFR 54 45 CFR 46.107 21 CFR 56.107 42 CFR 73 43 FR 60108 10 CFR NUREG 1556 Sections 817(1) (2) of USA Patriot Act IFC 45 CFR 74 NIH HHS Grants Policy Statements 45 CFR 74 OMB A-122 OMB A-21 OMB A-133 OMB A-110 Clinical Trial Policy False Clams Act
23
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

24
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

25
  • Thank you!
  • Questions?
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