Course IV: Compliance, Regulatory Environments and Legal Issues
RAC 9016
Course Description:
Federal and non-Federal awarding agencies and institutions that provide research grants and awards require rigid adherence to their requirements. Universities, hospitals and other agencies that accept research awards are bound to the term and conditions once a grant is accepted. Students are introduced to the federal requirements and other terms and conditions associated with acceptance of research grants.
Course Objectives:
- Introduce the Federal Circulars that dictate the requirements associated with accepting Federal grants and awards.
- Develop an understanding of the requirements associated with institutional and departmental management of federally sponsored research.
- Gain an understanding of the different types of awards and the various terms and conditions that are negotiated between awarding agencies and research institutions.
- Develop skill with protocols related to clinical research, human subjects, biohazards, stem cell research and IACUC.
Breakdown of Topics
Week 1:
Federal Circulars/ Federal and non-Federal awarding agencies and institutions and their requirements.
Week 2:
Clinical research, human subjects, biohazards, stem cell research and IACUC..
Week 3:
Differences between academic research and hospital research
Week 4:
The requirements associated with institutional and departmental management of federally sponsored research.
Week 5:
Terms and conditions of various types of awards.
Week 6:
Legal issues related to the adherence to requirements, terms and conditions of awarding agencies and institutions.
Week 7:
Negotiations between awarding agencies and research institutions.

