When academic medical centers, hospitals, universities, research institutes, start-up biotechnology companies, and other research stakeholders need advice on a comprehensive range of issues affecting biomedical research, they turn to Kate Gallin Heffernan. Kate counsels clients on issues related to:
Human subjects protection
Research noncompliance and misconduct proceedings
Research affiliations and contracting
Investigator and institutional conflicts of interest
Repositories for data, genomic, and tissue research and the downstream uses of stored materials
FDA requirements for clinical investigations
Treatment with investigational products pursuant to FDA’s expanded access program and “Right to Try” laws
Research involving human embryonic stem cells and induced pluripotent cells
Multi-site global trials
Privacy of research subjects’ information
In addition to her research-focused practice, Kate advises clients on general patient care issues, including clinical informed consent and the protection of sensitive health information, as well as organ donation and transplantation.
Clients benefit from Kate’s prior experience advising from inside the institutional setting, which has given her insight into the hurdles that health care organizations face, not only in analyzing and understanding the complex regulatory scheme in which they pursue their mission but also in developing and implementing solutions that work.
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