Financial Issues, Grants & Contracts Management
Research and Development
Areas of Risk
Financial Issues, Grants & Contracts Management
- 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
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
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)
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
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
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
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
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
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