Research has become a critical component of the strategic vision and goals of the health care industry. Robinson+Cole’s lawyers work collaboratively with sponsors, clinical research organizations, sites, and investigators to assist our clients in navigating regulatory and ethical concerns while achieving the goals of research. We can help with navigating ethical and regulatory complexities associated with research activities as well as with the heightened concerns raised by involving certain subject groups, such as children.

Our lawyers advise on all aspects of the clinical trial setting — from nondisclosure agreements to material transfer agreements to clinical trial agreements and related informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization forms. We can assist with issues related to study structure and regulatory and contractual matters before an institutional review board (IRB). We have experience implementing multiparty collaborative research agreements as well as the intellectual property management arrangements and policies that go hand in hand with a strong research program.

We advise on establishing and operating IRBs, complying with government regulations, and funding clinical research, as well as on laws and guidance relating to sponsor interactions with providers.

Many of our clients also turn to us for assistance with the exploitation of results stemming from their research efforts. We implement commercialization arrangements, including licenses and invention administration agreements. We also assist with implementing consulting arrangements in which a consultant is engaged to assist with aspects of the research or the exploitation of developments.