who is watching? what are they watching? why should i care? what should i do?

WHO IS WATCHING?WHO IS WATCHING?

WHAT ARE THEY WATCHING?WHAT ARE THEY WATCHING?

WHY SHOULD I CARE?WHY SHOULD I CARE?

WHAT SHOULD I DO?

RASG Meeting January 19, 2005RASG Meeting January 19, 2005

Adrian A. SheltonResearch Compliance [email protected]

WHO IS WATCHING Research?WHO IS WATCHING Research?FEDERAL REGULATORS

DOJ: grant funding, false claims, etc – effort reporting, salary reporting, cost allocation, research billing, HE stem cell research regs

HHS: human subjects research review, informed consent, scientific misconduct

Various: Export controls, data and materials security

WHO IS WATCHING Research?WHO IS WATCHING Research?

STATE REGULATORSAccounting practices

Much more information on this topic will come from Stan Koziol


UNIVERSITY ADMINISTRATORS Campus research review processes

OSR and OCT IRBIACUCCOIEHS OTD


THE PUBLIC Conflict of Interest Informed Consent

WHAT ARE THEY WATCHING?WHAT ARE THEY WATCHING? IRB review and approval for all human

subjects research Informed consent Resource accounting:

• Cost allocations, salary reporting• Time and effort certifications• Clinical research billing

Research information availability (COI, publication restrictions, etc.)

Research information security issues (HIPAA, export controls, classified research)

Research materials controls (HE stem cells, select agents, etc)


The Department is responsible for administering the research contract or grant:

Department judges PI is competent to perform this research

Department gives approval for PI to perform this research as described

Department is responsible for ensuring that resources are accurately budgeted and approved for this research

Department is responsible for ensuring that regulatory requirements are met by PI.


CRIMINAL PENALTIES FINANCIAL PENALTIES LOSS OF RESOURCESBAD PUBLICITY AND LOSS OF

GOODWILL/SUPPORT (internal and external)

OPERATIONAL RESTRICTIONSADDITIONAL COSTS

WHAT SHOULD I DO?WHAT SHOULD I DO?At the beginning of the research At the beginning of the research projectprojectReview the IPF carefully for accuracy and

completeness because it includes significant department obligations for the life of the project. This is the most cost effective time to head off potential problems.

Are all resources (personnel, funds, facilities, equipment, materials) accurately budgeted and approved? Are all the relevant costs included? Are the costs accurately calculated? Is cost matching identified? Approved? Is the percentage effort reasonable relative to existing obligations?

Review the IPF carefully for accuracy Review the IPF carefully for accuracy because it includes department obligationsbecause it includes department obligations

Are security issues adequately understood and addressed?

Classified research, export controls (includes regs re foreign nationals participating in the research, travel, data sharing, etc), proprietary or other confidential information, very sensitive materials (select agents, human embryonic stem cells, etc.)

Review the IPF carefully for accuracy Review the IPF carefully for accuracy because it includes department obligationsbecause it includes department obligations

Have all required institutional reviews occurred?

Institutional Review Board IACUC

Conflict of Interest Institutional Biosafety Committee Radiation safety

Lab Safety

WHAT SHOULD I DO?WHAT SHOULD I DO?At beginning of research projectAt beginning of research project

Support the initial contract and grant review process

What would happen if we just hurried up and signed the agreement without review and negotiation? Isn’t it mostly just petty “wordsmithing?”

What about PI signing agreements that do not include payment obligations?

Provisions that can come back to Provisions that can come back to create significant trouble – words have create significant trouble – words have real meaningreal meaning

Additional performance requirements that create costs not included in the budget (additional reports, deadlines, security obligations, etc.)

Financial restrictions (can’t spend money as PI thought) Publication restrictions (can’t publish as PI plans) Personnel restrictions (can’t include the grad student

planned) Certifications that are fraudulent (e.g. COI not

adequately disclosed and reviewed) Intellectual property transfers (PI’s output owned by

second party) Restrictions on PI’s other research

WHAT SHOULD I DO?WHAT SHOULD I DO?During the research projectDuring the research project Check to ensure required annual reviews are occurring -

IRB, IACUC, COI etc Ensure that effort certification is timely and accurate Document all cost sharing Avoid late cost transfers and make sure to have

appropriate justification for any that occur Maintain supporting documentation for all costs Any budget or personnel changes – comply with

requirements for reporting and approval Program income must be reported On time delivery of required PI reports or other

deliverables

WHAT SHOULD I DO?WHAT SHOULD I DO?At the end of the research projectAt the end of the research projectAt end of research project Timely final reports and deliverables of PI

Timely final accounting of revenues and expenditures including adjustments and cost transfers and any residuals

WHAT SHOULD I DO?WHAT SHOULD I DO?PI is leaving UNC-Chapel HillPI is leaving UNC-Chapel HillExit checklist Prior to PI departure Unexpired contracts or grants for PIs research? Notify

OSR and OCT Human subjects research? Notify IRB Animal research? Notify IACUC Research animals? Notify DLAM What is disposition of PI’s UNC-CH lab facilities,

equipment, materials? Notify EHS Unsponsored research projects? Clarify arrangements for

students or other trainees, co investigators, etc. Intellectual Property (licensing agreements, etc)? Notify

OTD

How can we help each other?How can we help each other?

Call OSR or other research review unit or Research Compliance Officer for help if questions or concerns arise.

Collaborate on checklists and other tools

Other ideas?

who is watching? what are they watching? why should i care? what should i do?

Documents