Investigator Sponsored Research Agreement

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An investigator sponsored research agreement, commonly referred to as an ISR agreement, is a legal document that outlines the terms of a research collaboration between a sponsor and an investigator. This agreement is often used in the biomedical research industry to establish a partnership between a pharmaceutical company or a medical device manufacturer and a researcher or a research institution.

The purpose of an ISR agreement is to clearly define the roles and responsibilities of both the sponsor and investigator in the research project. It also establishes the terms of payment, intellectual property rights, and the timeline for the completion of the research.

The sponsor, often a pharmaceutical or medical device company, provides funding for the research project. The investigator, usually a researcher or a research institution, is responsible for conducting the research and producing the results. The ISR agreement outlines any restrictions or guidelines that the sponsor has on the research, such as confidentiality or publication rights.

One of the most important aspects of an ISR agreement is the protection of intellectual property rights. The agreement should clearly define who owns the intellectual property of the research results, as well as any inventions or discoveries that arise from the research. Typically, the sponsor retains ownership of any intellectual property that is developed during the research project.

Another important consideration when drafting an ISR agreement is the timeline for completion of the research. The agreement should establish a realistic timeline for completion of the research project, including any milestones or checkpoints that need to be met along the way.

It`s also important to establish the terms of payment for the research project. The agreement should clearly state the amount of funding being provided by the sponsor, as well as any payment milestones or deadlines. The agreement should also outline any expenses that are covered by the sponsor, such as equipment costs or travel expenses.

When drafting an ISR agreement, it`s important to consider any ethical issues that may arise during the research project. This includes obtaining informed consent from any participants in the research, as well as following guidelines for the ethical conduct of research.

In conclusion, an investigator sponsored research agreement is an important legal document that outlines the terms of a research collaboration between a sponsor and an investigator. When drafting an ISR agreement, it`s important to consider the roles and responsibilities of both parties, establish timelines and payment terms, and protect the intellectual property rights of the sponsor. By carefully considering these factors, an ISR agreement can help ensure a successful and ethical research collaboration.