Financial Issues, Grants & Contracts Management

Research and Development Areas of Risk

 ARRA Audits / reporting  Transfer from Pre-award to post-award  Cost transfers  Closing out of expired grants  Coordination of grants  DATA Act  Failure to bill all costs timely  Failure to follow bidding process  Failure to monitor grants  Failure to recognize or misuse of program income  Grant acceptance process  Grant commitment  Improper disposition of equipment  Inadequate grants information system / migrating to new systems (paper to electronic)  Inadequate institutional policies related to grants  Inappropriate charges to grants from service or re-charge centers  Insufficient post-award monitoring  Matching and cost-sharing  Monitoring of off-site grants  NIH salary cap  No cost extensions  Not including required clauses in grants and contracts for privacy and data protection  Ownership and tracking issues of equipment with sub-recipient  Tracking, reporting, and appropriateness of payments to protocol participants

1 | P a g e Animal Research

 Animal protection  Climate control  Commitment to single supplier  Conflict of interest  Containing epidemics in colonies  Contingency procedures  Controlled substances in animal research  Difficulty in recruiting members for the IACUC  Disaster recovery  GLP research  Disposal of biohazard waste  Failure to comply with IACUC regulations  Failure to protect research data  Inadequate veterinary care  Lack of adequate facilities, i.e. cage sizes  Lack of trained staff  Loss of AALAC accreditation  Loss of reputation due to perceived improper testing on animals  PETA  Safety of workers  Sanitation  Security  Unapproved research involving animals being conducted

2 | P a g e Institutional Review Board  Appropriate documentation of minutes, approvals, etc.  Back log of protocol review  Conflict of interest  Continuing reviews not being adequately performed / timely  Managing and dealing with conflicting IRB feedback  Reliance upon other IRBs  Institutional specific requirements (e.g. Catholic ethical and religious directives)  Oversight over recruitment activities  Foreign language requirements (beyond just consent, but throughout the study)  Failure of PI to submit a change to the protocol  Failure to ensure privacy safeguards are in place  Failure to monitor and report adverse events  Failure to properly bill the research protocol  Failure to review safety bulletins  Improper conduct of human subjects research or unethical experimentation  Inadequate informed consent process  Inadequate or no review by the IRB  Inadequate protection for vulnerable populations  Inadequate qualifications  Inadequate staffing  Inappropriate reporting structure  Lack of independence of IRB  Payments to participants  Time constraints for IRB board members  Non-compliance with federal regulations on human subjects research (exemptions, waivers of consent, etc)  Not having external members  Protection of research data  Refund of residual funds when required by contract  Resistance to outside review  Too much control by one person  Training on IRB responsibilities (members)

3 | P a g e Office of Sponsored Projects

 Back log of proposal reviews  Budget justification for expenditures  Bridge funding not properly approved  Communication of outside audits/reviews to OSP  Communication between pre and post-award  Contract reviews  Contracts signed by personnel who are unauthorized  Inadequate communication with principal investigators  Inadequate staffing / time to properly review applications  Insufficient effort to attract research funding  Lack of analysis of contracts (financial, including any cost sharing)  Review of proposals that require new FTEs and a plan for the FTE after the project is completed (esp. in a unionized organization)  Over-commitment of personnel  PI not submitting the pre-award documentation for review before beginning research  Proposals with poorly developed cost budget or not including facilities and administrative (indirect) costs  Research interests that do not match funding availability  Strategic acceptance of grants

4 | P a g e Research Integrity

 Falsification of research data  Inadequate background/health checks of visiting scientists  Inadequate documentation of research  Ensuring scientific value / quality (scientific review)  Balancing administrative review / compliance requirements and encouraging research  Inadequate or inappropriate acceptance of research subjects  Inadequate peer review process  Inadequate protection of research data  Inadequate protection of research subjects  Inadequate supervision of research  Inappropriate action to address/investigate allegations of scientific misconduct  Investigators leaving and coming with data, people, materials, etc.  Loss of research data  Plagiarism  Policies on inquiries and investigations of researcher's conduct not in compliance with federal regulations  Undisclosed financial conflict of interest

5 | P a g e Technology Management

 Define ownership rights  Export controls  Failure to commercialize faculty research  Failure to properly structure agreements  Failure to protect intellectual property  Failure to pursue copyrights or patents  Inadequate management of patent expenses  Ineffective management of start-up companies  Infringement on intellectual property  Insufficient efforts in licensing and technology transfer  Invention disclosure  Lack of timely or accurate royalty distributions  Material transfer agreements  Non-compliance with invention disclosure requirements  Patents and royalties, tracking payments  Researchers leaving with intellectual property

6 | P a g e Training in the Responsibility Conduct of Research

 Failure to track who has taken training  Inadequate/ineffective training  Inappropriate use of real data in training  Lack of consequences for faculty not attending the training  No documentation of training

7 | P a g e Biosafety

 EHS failure to monitor labs  Emergency preparedness to ensure protection of population  Failure to comply with regulatory requirements  Failure to include external member on IBC  Failure to monitor personnel exposures  Failure to report incidences  General lab safety procedures  Inadequate inspection processes  Inadequate labeling  Inadequate management of hazardous materials  Inadequate public relations management  Inadequate staffing and under-funding of EHS office  Inappropriate disposal  Inappropriate transfer  Ineffective management of infectious organisms  Lack of documentation  Management of recombinant DNA  Physical controls over select agents and toxins  Physical security/theft  Proper reporting of incidents  Protection of the environment  Untimely or inappropriate response to accidents or other incidents

8 | P a g e