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

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


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


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)


• 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.


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.


• 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


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




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



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.


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


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


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


• 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.



• 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.



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.



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


• 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.


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


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


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?

Documents

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