How should an institution address a clause in a clinical trial agreement that gives the sponsor all rights to new interventions?

Study for the HCCA Certified in Healthcare Compliance (CHC) Exam. Practice with interactive questions and detailed explanations. Get ready to excel in your field!

The appropriate approach to addressing a clause in a clinical trial agreement that grants the sponsor all rights to new interventions is to allow the sponsor to negotiate an exclusive license for fair market value. This option represents a balanced solution that recognizes the sponsor's investment in the clinical trial while also ensuring that the institution retains some level of control over the new interventions that may arise from the research.

Negotiating an exclusive license at fair market value allows both parties to benefit: the sponsor can gain access to innovative developments resulting from the clinical trial, while the institution can secure compensation that reflects the value of its contributions and findings. This arrangement fosters a collaborative relationship where intellectual property rights are addressed transparently and equitably, ultimately promoting further research and development.

In this context, the other choices do not align with the best practices for managing intellectual property rights in clinical trials or promoting collaboration between institutions and sponsors.

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