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Research Compliance in the area of clinical and basic research has become a formidable and demanding undertaking.  Research organizations have come under scrutiny from Federal and State lawmakers and are challenged to assure compliance with constantly changing rules and regulations.  Large organizations with excellent reputations have been subject to program suspensions and charges of fraud, and have been assessed multi-million dollar fines.  
 

Research Compliance & Research Integrity

 

Research Compliance & Research Integrity - A single individual or a breakdown in simple procedures can cause a large problem for an entire organization, throwing expensive and vital research programs into disarray.  Research organizations must protect themselves by educating their staff on complex and sometimes confusing government regulations, and by familiarizing them with institutional policies and procedures.

This multimedia suite of courses is for all staff directly involved in basic or clinical research such as principle investigators, lab personnel, administrators, coordinators, and data handlers. It is also for staff who serve on institutional review boards (IRB), boards of directors, institutional executives, etc. Ultimately, the information contained in the courses is of vital importance to all medical research professionals and support personnel whose work is funded by government, foundation or other sponsor monies or falls under the auspices of government oversight agencies.

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Research Compliance Courseware Titles

Select the course link below:

Grants & Contracts
Human Subjects
Conflicts of Interest and Scientific Misconduct
Professional Relationships and Data Issues

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Courseware Descriptions

 

Grants & Contracts

Now Available

This course will familiarize students with the regulatory framework and contractual considerations that must be addressed when applying for a research grant as well as the financial and management responsibilities that must be observed once the grant has been awarded.

The course will cover:

• Regulatory framework
• Pre-award
• Post-award
• Programmatic management

Human Subjects

Now Available

 

This course addresses the myriad rules, regulations, and ethical considerations pertaining to the use of human subjects in medical research. The course will cover:

• Types of human subjects research
• Protection of human subjects
• Regulatory framework
• Roles and responsibilities
• Review processes
• Implementation and management of a human subject research project
• Budgeting and billing issues

Conflicts of Interest and Scientific Misconduct

Now Available

This course will provide students with the information they need to recognize conflicts of interest and scientific misconduct. The course will cover:

• Identifying
• Regulatory framework
• Roles and responsibilities
• Managing conflicts of interest
• Investigating and reporting

Professional Relationships and Data Issues

Now Available

This course addresses professional standards and ethics in regard to relationships between researchers. The course will cover:

• Mentor/trainee responsibilities
• Publication practices and responsible authorship
• Peer review
• Collaboration between researchers
• Data types
• Data privacy
• Data selection, retention, sharing and ownership
• Intellectual property and copyright

 
 
 
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