| • Grants
and Contracts |
• Use
of Animals in Research |
• Regulatory framework:
OMB circulars, FAR
implementing regulations, A133 audit,
etc.
• Pre-award: roles and responsiblities, general overview
with flow chart, proposal preparation, budgeting,
routing for review
• Post-award: financial management including budget
restrictions, time and effort reporting, financial reporting
requirements
• Programmatic management: annual/periodic reporting,
record retention
|
• Mentor/trainee responsibilities
• Publication practices and responsible authorship
• Peer review
• Collaboration between researchers
• Electronic data storage
• Data privacy
• Data selection, retention, sharing and ownership
• Intellectual property and copyrights |
| • Use
of Human Subjects in Research |
• Professional
Relationships and Data Issues |
• Types of human
subject research
• Protection of human subjects
• Clinical trials
• Regulatory framework (FDA, HHS, and HIPAA
regulations - human subject training)
• Roles and responsibilities of investigators and IRBs
• The informed consent process
• Protections
for vulnerable subjects |
• Definition
of animal subject research
• Regulatory framework
• Institutional and individual roles and responsibilities
• Review processes
• Special considerations for animal research |
• Conflicts
of Interest and Scientific
Misconduct |
• Laboratory
Research and Special Research
Issues |
• Regulatory framework
• Identifying conflicts of interest and scientific misconduct
• Managing conflicts of interest
• Handling allegations of misconduct
• Institutional and individual roles and responsibilities
• Reporting requirements |
• Laboratory
Research: safety including use of chemicals
and flammable liquid
storage, relevant OSHA
regulations, EPA regulations
• Biohazardous material: definitions, regulatory
framework, institutional and individual roles and
responsibilities, review
processes, special
considerations
• Radioactive material: types of such material, regulatory
framework, institutional and individual roles and
responsibilities,
review processes, special
considerations
• Recombinant DNA: definitions, regulatory framework,
institutional
and individual roles and responsibilities,
review processes, special consideration |
